82_FR_45914 82 FR 45725 - Medical Devices; Gastroenterology-Urology Devices; Classification of the High Intensity Ultrasound System for Prostate Tissue Ablation

82 FR 45725 - Medical Devices; Gastroenterology-Urology Devices; Classification of the High Intensity Ultrasound System for Prostate Tissue Ablation

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 189 (October 2, 2017)

Page Range45725-45727
FR Document2017-21074

The Food and Drug Administration (FDA or we) is classifying the high intensity ultrasound system for prostate tissue ablation into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the high intensity ultrasound system for prostate tissue ablation's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Federal Register, Volume 82 Issue 189 (Monday, October 2, 2017)
[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Rules and Regulations]
[Pages 45725-45727]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-21074]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2017-N-5153]


Medical Devices; Gastroenterology-Urology Devices; Classification 
of the High Intensity Ultrasound System for Prostate Tissue Ablation

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the high intensity ultrasound system for prostate tissue ablation into 
class II (special controls). The special controls that apply to the 
device type are identified in this order and will be part of the 
codified language for the high intensity ultrasound system for prostate 
tissue ablation's classification. We are taking this action because we 
have determined that classifying the device into class II (special 
controls) will provide a reasonable assurance of safety and 
effectiveness of the device. We believe this action will also enhance 
patients' access to beneficial innovative devices, in part by reducing 
regulatory burdens.

DATES: This order is effective October 2, 2017. The classification was 
applicable on October 9, 2015.

FOR FURTHER INFORMATION CONTACT: John Baxley, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G210, Silver Spring, MD 20993-0002, 301-796-6549, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the high intensity ultrasound 
system for prostate tissue ablation as class II (special controls), 
which we have determined will provide a reasonable assurance of safety 
and effectiveness. In addition, we believe this action will enhance 
patients' access to beneficial innovation, in part by reducing 
regulatory burdens by placing the device into a lower device class than 
the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law 
and without any action by FDA, regardless of the level of risk posed by 
the new device. Any device that was not in commercial distribution 
before May 28, 1976, is automatically classified as, and remains

[[Page 45726]]

within, class III and requires premarket approval unless and until FDA 
takes an action to classify or reclassify the device (see 21 U.S.C. 
360c(f)(1)). We refer to these devices as ``postamendments devices'' 
because they were not in commercial distribution prior to the date of 
enactment of the Medical Device Amendments of 1976, which amended the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to 
classify or reclassify a device into class I or II. We may issue an 
order finding a new device to be substantially equivalent under section 
513(i) of the FD&C Act to a predicate device that does not require 
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new 
device is substantially equivalent to a predicate by means of the 
procedures for premarket notification under section 510(k) of the FD&C 
Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    FDA may also classify a device through ``De Novo'' classification, 
a common name for the process authorized under section 513(f)(2) of the 
FD&C Act. Section 207 of the Food and Drug Administration Modernization 
Act of 1997 established the first procedure for De Novo classification 
(Pub. L. 105-115). Section 607 of the Food and Drug Administration 
Safety and Innovation Act modified the De Novo application process by 
adding a second procedure (Pub. L. 112-144). A device sponsor may 
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device 
that has not previously been classified. After receiving an order from 
FDA classifying the device into class III under section 513(f)(1) of 
the FD&C Act, the person then requests a classification under section 
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k) 
and then a request for classification, if the person determines that 
there is no legally marketed device upon which to base a determination 
of substantial equivalence, that person requests a classification under 
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA shall 
classify the device by written order within 120 days. The 
classification will be according to the criteria under section 
513(a)(1) of the FD&C Act. Although the device was automatically within 
class III, the De Novo classification is considered to be the initial 
classification of the device.
    We believe this De Novo classification will enhance patients' 
access to beneficial innovation, in part by reducing regulatory 
burdens. When FDA classifies a device into class I or II via the De 
Novo process, the device can serve as a predicate for future devices of 
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a 
result, other device sponsors do not have to submit a De Novo request 
or premarket approval application in order to market a substantially 
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial 
equivalence''). Instead, sponsors can use the less burdensome 510(k) 
process, when necessary, to market their device.

II. De Novo Classification

    On March 23, 2015, SonaCare Medical, LLC submitted a request for De 
Novo classification of the Sonablate[supreg] 450. FDA reviewed the 
request in order to classify the device under the criteria for 
classification set forth in section 513(a)(1) of the FD&C Act. We 
classify devices into class II if general controls by themselves are 
insufficient to provide reasonable assurance of safety and 
effectiveness, but there is sufficient information to establish special 
controls that, in combination with the general controls, provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the 
information submitted in the request, we determined that the device can 
be classified into class II with the establishment of special controls. 
FDA has determined that these special controls, in addition to general 
controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on October 9, 2015, FDA issued an order to the requestor 
classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 876.4340. We have named 
the generic type of device high intensity ultrasound system for 
prostate tissue ablation, and it is identified as a prescription device 
that transmits high intensity therapeutic ultrasound energy into the 
prostate to thermally ablate a defined, targeted volume of tissue, 
performed under imaging guidance. This classification does not include 
devices that are intended for the treatment of any specific prostate 
disease and does not include devices that are intended to ablate non-
prostatic tissues/organs.
    FDA has identified the following risks to health associated 
specifically with this type of device and the measures required to 
mitigate these risks in table 1.

 Table 1--High Intensity Ultrasound System for Prostate Tissue Ablation
                      Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Thermal injury from high intensity       Non-clinical performance
 ultrasound exposure to non-target        testing; Software
 tissue:                                  verification, validation, and
  Erectile dysfunction            hazard analysis; In vivo
  Urinary incontinence            testing; Clinical testing;
  Rectal fistula                  Labeling; and Physician
  Osteomyelitis pubis             training.
Thermal injury from high intensity       Clinical testing, Labeling, and
 ultrasound exposure to target tissue:    Physician training.
  Urethral stricture
  Bladder neck contracture
  Urinary retention
  Tissue debris/obstruction
  Voiding dysfunction
  Dysuria
  Hematuria
  Ejaculation disorder
Mechanical injury from unintentional     Software verification,
 movement of ultrasound components:       validation, and hazard
  Patient rectal injury           analysis; Clinical testing;
  Operator hand injury            Labeling; and Physician
                                          training.

[[Page 45727]]

 
Infection..............................  Sterilization validation,
                                          Reprocessing validation, Shelf
                                          life validation, and Labeling.
Electrical shock/electromagnetic         Electrical safety testing,
 interference.                            Electromagnetic compatibility
                                          testing, and Labeling.
Adverse tissue reaction................  Biocompatibility testing.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of safety and effectiveness. In order for a device to fall 
within this classification, and thus avoid automatic classification in 
class III, it would have to comply with the special controls named in 
this final order. The necessary special controls appear in the 
regulation codified by this order. This device is subject to premarket 
notification requirements under section 510(k).
    At the time of classification, high intensity ultrasound systems 
for prostate tissue ablation are for prescription use only. 
Prescription devices are exempt from the requirement for adequate 
directions for use for the layperson under section 502(f)(1) of the 
FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the 
conditions of 21 CFR 801.109 are met.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final administrative order establishes special controls that 
refer to previously approved collections of information found in other 
FDA regulations. These collections of information are subject to review 
by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of 
information in part 807, subpart E, regarding premarket notification 
submissions have been approved under OMB control number 0910-0120, and 
the collections of information in part 801, regarding labeling, have 
been approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 876

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
876 is amended as follows:

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
1. The authority citation for part 876 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
2. Add Sec.  876.4340 to subpart E to read as follows:


Sec.  876.4340  High intensity ultrasound system for prostate tissue 
ablation.

    (a) Identification. A high intensity ultrasound system for prostate 
tissue ablation is a prescription device that transmits high intensity 
therapeutic ultrasound energy into the prostate to thermally ablate a 
defined, targeted volume of tissue, performed under imaging guidance. 
This classification does not include devices that are intended for the 
treatment of any specific prostate disease and does not include devices 
that are intended to ablate non-prostatic tissues/organs.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance data must demonstrate that the device 
performs as intended under anticipated conditions of use. The following 
performance characteristics must be tested:
    (i) Characterization of acoustic pressure and power output at 
clinically relevant levels;
    (ii) Measurement of targeting accuracy and reproducibility of high 
intensity ultrasound output;
    (iii) Ultrasound-induced heating verification testing at target and 
non-target tissues;
    (iv) Electrical safety testing; and
    (v) Electromagnetic compatibility testing.
    (2) Software verification, validation, and hazard analysis must be 
performed.
    (3) The elements of the device that may contact the patient's 
mucosal tissue must be demonstrated to be biocompatible.
    (4) Performance data must demonstrate the sterility of the device 
components that contact the patient's mucosal tissue.
    (5) Performance data must support shelf life by demonstrating 
continued sterility of the device or the sterile components, package 
integrity, and device functionality over the identified shelf life.
    (6) Performance data must support the instructions for reprocessing 
all reusable components.
    (7) In vivo testing must demonstrate that the device thermally 
ablates targeted tissue in a controlled manner without thermal injury 
to adjacent, non-target tissues.
    (8) Clinical testing must document the adverse event profile, 
provide evidence of prostatic ablation, and demonstrate that the device 
performs as intended under anticipated conditions of use.
    (9) Training must be provided so that upon completion of the 
training program, the physician can:
    (i) Use all safety features of the device;
    (ii) Accurately target the high intensity ultrasound energy within 
the desired region of the prostate; and
    (iii) Perform the ablation procedure in a manner that minimizes 
damage to non-target tissues.
    (10) Labeling must include:
    (i) A section that summarizes the clinical testing results, 
including the adverse event profile and evidence of prostate ablation 
achieved; and
    (ii) An expiration date or shelf life for single use components.

    Dated: September 25, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-21074 Filed 9-29-17; 8:45 am]
 BILLING CODE 4164-01-P



                                                                  Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Rules and Regulations                                         45725

                                                17 CFR Part 230                                         PART 230—GENERAL RULES AND                            DEPARTMENT OF HEALTH AND
                                                                                                        REGULATIONS, SECURITIES ACT OF                        HUMAN SERVICES
                                                  Reporting and recordkeeping                           1933
                                                requirements, Securities.                                                                                     Food and Drug Administration
                                                  In accordance with the foregoing, title               ■ 3. The authority citation for part 230
                                                                                                        continues to read in part as follows:                 21 CFR Part 876
                                                17, chapter II of the Code of Federal
                                                Regulations is amended as follows:                        Authority: 15 U.S.C. 77b, 77b note, 77c,            [Docket No. FDA–2017–N–5153]
                                                                                                        77d, 77f, 77g, 77h, 77j, 77r, 77s, 77z–3, 77sss,
                                                PART 227—REGULATION                                     78c, 78d, 78j, 78l, 78m, 78n, 78o, 78o–7 note,        Medical Devices; Gastroenterology-
                                                                                                        78t, 78w, 78ll(d), 78mm, 80a–8, 80a–24, 80a–          Urology Devices; Classification of the
                                                CROWDFUNDING, GENERAL RULES
                                                                                                        28, 80a–29, 80a–30, and 80a–37, and Pub. L.
                                                AND REGULATIONS                                                                                               High Intensity Ultrasound System for
                                                                                                        112–106, sec. 201(a), sec. 401, 126 Stat. 313
                                                                                                        (2012), unless otherwise noted.                       Prostate Tissue Ablation
                                                ■  1. The authority citation for part 227               *     *    *      *    *                              AGENCY:   Food and Drug Administration,
                                                is revised to read as follows:                                                                                HHS.
                                                                                                        ■ 4. Amend § 230.257 by adding
                                                   Authority: 15 U.S.C. 77d, 77d–1, 77s, 77z–           paragraph (f) to read as follows:                     ACTION:   Final order.
                                                3, 78c, 78o, 78q, 78w, 78mm, and Pub. L.
                                                112–106, secs. 301–305, 126 Stat. 306 (2012).           § 230.257 Periodic and current reporting;             SUMMARY:    The Food and Drug
                                                                                                        exit report.                                          Administration (FDA or we) is
                                                ■ 2. Amend § 227.202 by adding                          *       *    *     *     *                            classifying the high intensity ultrasound
                                                paragraph (c) to read as follows:                          (f) Temporary relief from ongoing                  system for prostate tissue ablation into
                                                                                                        reporting requirements. (1) An issuer                 class II (special controls). The special
                                                § 227.202   Ongoing reporting requirements.             that is not able to meet a filing deadline            controls that apply to the device type
                                                *       *    *     *     *                              for any report or form required to be                 are identified in this order and will be
                                                   (c) Temporary relief from certain                    filed by Rule 252(f)(2)(i)                            part of the codified language for the
                                                reporting requirements. (1) An issuer                   (§ 230.252(f)(2)(i)) or this section (Rule            high intensity ultrasound system for
                                                that is not able to meet a filing deadline              257), as applicable:                                  prostate tissue ablation’s classification.
                                                for any report or form required to be                      (i) During the period from and                     We are taking this action because we
                                                filed by this section (Rule 202), Rule                  including August 25, 2017 to and                      have determined that classifying the
                                                203(a)(3) (§ 227.203(a)(3)), or Rule                    including October 26, 2017 due to                     device into class II (special controls)
                                                                                                        Hurricane Harvey and its aftermath                    will provide a reasonable assurance of
                                                203(b) (§ 227.203(b)), as applicable:
                                                                                                        shall be deemed to have satisfied the                 safety and effectiveness of the device.
                                                   (i) During the period from and                       filing deadline for such report or form               We believe this action will also enhance
                                                including August 25, 2017 to and                        if the issuer files such report or form               patients’ access to beneficial innovative
                                                including October 26, 2017 due to                       with the Commission on or before                      devices, in part by reducing regulatory
                                                Hurricane Harvey and its aftermath                      October 27, 2017;                                     burdens.
                                                shall be deemed to have satisfied the                      (ii) During the period from and                    DATES: This order is effective October 2,
                                                filing deadline for such report or form                 including September 6, 2017 to and                    2017. The classification was applicable
                                                if the issuer files such report or form                 including November 7, 2017 due to                     on October 9, 2015.
                                                with the Commission on or before                        Hurricane Irma and its aftermath shall
                                                                                                                                                              FOR FURTHER INFORMATION CONTACT: John
                                                October 27, 2017;                                       be deemed to have satisfied the filing
                                                                                                        deadline for such report or form if the               Baxley, Center for Devices and
                                                   (ii) During the period from and                                                                            Radiological Health, Food and Drug
                                                including September 6, 2017 to and                      issuer files such report or form with the
                                                                                                        Commission on or before November 8,                   Administration, 10903 New Hampshire
                                                including November 7, 2017 due to                                                                             Ave., Bldg. 66, Rm. G210, Silver Spring,
                                                                                                        2017; or
                                                Hurricane Irma and its aftermath shall                                                                        MD 20993–0002, 301–796–6549,
                                                                                                           (ii) During the period from and
                                                be deemed to have satisfied the filing                                                                        john.baxley@fda.hhs.gov.
                                                                                                        including September 20, 2017 to and
                                                deadline for such report or form if the                 including November 21, 2017 due to                    SUPPLEMENTARY INFORMATION:
                                                issuer files such report or form with the               Hurricane Maria and its aftermath shall
                                                Commission on or before November 8,                                                                           I. Background
                                                                                                        be deemed to have satisfied the filing
                                                2017; or                                                deadline for such report or form if the                 Upon request, FDA has classified the
                                                   (ii) During the period from and                      issuer files such report or form with the             high intensity ultrasound system for
                                                including September 20, 2017 to and                     Commission on or before November 22,                  prostate tissue ablation as class II
                                                including November 21, 2017 due to                      2017.                                                 (special controls), which we have
                                                Hurricane Maria and its aftermath shall                    (2) In any report or form filed                    determined will provide a reasonable
                                                be deemed to have satisfied the filing                  pursuant to paragraph (f)(1) of this                  assurance of safety and effectiveness. In
                                                deadline for such report or form if the                 section, the issuer must disclose that it             addition, we believe this action will
                                                issuer files such report or form with the               is relying on this paragraph (f) (Rule                enhance patients’ access to beneficial
                                                Commission on or before November 22,                    257(f) of Regulation A) and state the                 innovation, in part by reducing
                                                                                                        reasons why, in good faith, it could not              regulatory burdens by placing the
                                                2017.
                                                                                                        file such report or form on a timely                  device into a lower device class than the
                                                   (2) In any report or form filed                      basis.                                                automatic class III assignment.
jstallworth on DSKBBY8HB2PROD with RULES




                                                pursuant to paragraph (c)(1) of this                                                                            The automatic assignment of class III
                                                section, the issuer must disclose that it                 By the Commission.
                                                                                                                                                              occurs by operation of law and without
                                                is relying on this paragraph (c) (Rule                    Dated: September 27, 2017.                          any action by FDA, regardless of the
                                                202(c) of Regulation Crowdfunding) and                  Brent J. Fields,                                      level of risk posed by the new device.
                                                state the reasons why, in good faith, it                Secretary.                                            Any device that was not in commercial
                                                could not file such report or form on a                 [FR Doc. 2017–21094 Filed 9–28–17; 4:15 pm]           distribution before May 28, 1976, is
                                                timely basis.                                           BILLING CODE 8011–01–P                                automatically classified as, and remains


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                                                45726             Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Rules and Regulations

                                                within, class III and requires premarket                the device into class III under section                under the criteria for classification set
                                                approval unless and until FDA takes an                  513(f)(1) of the FD&C Act, the person                  forth in section 513(a)(1) of the FD&C
                                                action to classify or reclassify the device             then requests a classification under                   Act. We classify devices into class II if
                                                (see 21 U.S.C. 360c(f)(1)). We refer to                 section 513(f)(2).                                     general controls by themselves are
                                                these devices as ‘‘postamendments                          Under the second procedure, rather                  insufficient to provide reasonable
                                                devices’’ because they were not in                      than first submitting a 510(k) and then                assurance of safety and effectiveness,
                                                commercial distribution prior to the                    a request for classification, if the person            but there is sufficient information to
                                                date of enactment of the Medical Device                 determines that there is no legally                    establish special controls that, in
                                                Amendments of 1976, which amended                       marketed device upon which to base a                   combination with the general controls,
                                                the Federal Food, Drug, and Cosmetic                    determination of substantial                           provide reasonable assurance of the
                                                Act (the FD&C Act).                                     equivalence, that person requests a                    safety and effectiveness of the device for
                                                  FDA may take a variety of actions in                  classification under section 513(f)(2) of              its intended use (see 21 U.S.C.
                                                appropriate circumstances to classify or                the FD&C Act.                                          360c(a)(1)(B)). After review of the
                                                reclassify a device into class I or II. We                 Under either procedure for De Novo                  information submitted in the request,
                                                may issue an order finding a new device                 classification, FDA shall classify the                 we determined that the device can be
                                                to be substantially equivalent under                    device by written order within 120 days.               classified into class II with the
                                                section 513(i) of the FD&C Act to a                     The classification will be according to                establishment of special controls. FDA
                                                predicate device that does not require                  the criteria under section 513(a)(1) of                has determined that these special
                                                premarket approval (see 21 U.S.C.                       the FD&C Act. Although the device was                  controls, in addition to general controls,
                                                360c(i)). We determine whether a new                    automatically within class III, the De                 will provide reasonable assurance of the
                                                                                                        Novo classification is considered to be                safety and effectiveness of the device.
                                                device is substantially equivalent to a
                                                                                                        the initial classification of the device.
                                                predicate by means of the procedures                                                                              Therefore, on October 9, 2015, FDA
                                                                                                           We believe this De Novo classification
                                                for premarket notification under section                will enhance patients’ access to                       issued an order to the requestor
                                                510(k) of the FD&C Act and part 807 (21                 beneficial innovation, in part by                      classifying the device into class II. FDA
                                                U.S.C. 360(k) and 21 CFR part 807,                      reducing regulatory burdens. When FDA                  is codifying the classification of the
                                                respectively).                                          classifies a device into class I or II via             device by adding 21 CFR 876.4340. We
                                                  FDA may also classify a device                        the De Novo process, the device can                    have named the generic type of device
                                                through ‘‘De Novo’’ classification, a                   serve as a predicate for future devices of             high intensity ultrasound system for
                                                common name for the process                             that type, including for 510(k)s (see 21               prostate tissue ablation, and it is
                                                authorized under section 513(f)(2) of the               U.S.C. 360c(f)(2)(B)(i)). As a result, other           identified as a prescription device that
                                                FD&C Act. Section 207 of the Food and                   device sponsors do not have to submit                  transmits high intensity therapeutic
                                                Drug Administration Modernization Act                   a De Novo request or premarket                         ultrasound energy into the prostate to
                                                of 1997 established the first procedure                 approval application in order to market                thermally ablate a defined, targeted
                                                for De Novo classification                              a substantially equivalent device (see 21              volume of tissue, performed under
                                                (Pub. L. 105–115). Section 607 of the                   U.S.C. 360c(i), defining ‘‘substantial                 imaging guidance. This classification
                                                Food and Drug Administration Safety                     equivalence’’). Instead, sponsors can use              does not include devices that are
                                                and Innovation Act modified the De                      the less burdensome 510(k) process,                    intended for the treatment of any
                                                Novo application process by adding a                    when necessary, to market their device.                specific prostate disease and does not
                                                second procedure (Pub. L. 112–144). A                                                                          include devices that are intended to
                                                device sponsor may utilize either                       II. De Novo Classification                             ablate non-prostatic tissues/organs.
                                                procedure for De Novo classification.                      On March 23, 2015, SonaCare                            FDA has identified the following risks
                                                  Under the first procedure, the person                 Medical, LLC submitted a request for De                to health associated specifically with
                                                submits a 510(k) for a device that has                  Novo classification of the                             this type of device and the measures
                                                not previously been classified. After                   Sonablate® 450. FDA reviewed the                       required to mitigate these risks in
                                                receiving an order from FDA classifying                 request in order to classify the device                table 1.

                                                  TABLE 1—HIGH INTENSITY ULTRASOUND SYSTEM FOR PROSTATE TISSUE ABLATION RISKS AND MITIGATION MEASURES
                                                                                Identified risks                                                                Mitigation measures

                                                Thermal injury from high intensity ultrasound exposure to non-target tis-            Non-clinical performance testing; Software verification, validation, and
                                                  sue:                                                                                 hazard analysis; In vivo testing; Clinical testing; Labeling; and Physi-
                                                       • Erectile dysfunction                                                          cian training.
                                                       • Urinary incontinence
                                                       • Rectal fistula
                                                       • Osteomyelitis pubis
                                                Thermal injury from high intensity ultrasound exposure to target tissue:             Clinical testing, Labeling, and Physician training.
                                                       • Urethral stricture
                                                       • Bladder neck contracture
                                                       • Urinary retention
                                                       • Tissue debris/obstruction
                                                       • Voiding dysfunction
                                                       • Dysuria
jstallworth on DSKBBY8HB2PROD with RULES




                                                       • Hematuria
                                                       • Ejaculation disorder
                                                Mechanical injury from unintentional movement of ultrasound compo-                   Software verification, validation, and hazard analysis; Clinical testing;
                                                  nents:                                                                               Labeling; and Physician training.
                                                       • Patient rectal injury
                                                       • Operator hand injury




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                                                                         Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Rules and Regulations                                                                    45727

                                                 TABLE 1—HIGH INTENSITY ULTRASOUND SYSTEM FOR PROSTATE TISSUE ABLATION RISKS AND MITIGATION MEASURES—
                                                                                              Continued
                                                                                           Identified risks                                                                                Mitigation measures

                                                Infection ....................................................................................................   Sterilization validation, Reprocessing validation, Shelf life validation,
                                                                                                                                                                   and Labeling.
                                                Electrical shock/electromagnetic interference ..........................................                         Electrical safety testing, Electromagnetic compatibility testing, and La-
                                                                                                                                                                   beling.
                                                Adverse tissue reaction ............................................................................             Biocompatibility testing.



                                                   FDA has determined that special                                           Therefore, under the Federal Food,                             (4) Performance data must
                                                controls, in combination with the                                          Drug, and Cosmetic Act and under                               demonstrate the sterility of the device
                                                general controls, address these risks to                                   authority delegated to the Commissioner                        components that contact the patient’s
                                                health and provide reasonable assurance                                    of Food and Drugs, 21 CFR part 876 is                          mucosal tissue.
                                                of safety and effectiveness. In order for                                  amended as follows:
                                                                                                                                                                                            (5) Performance data must support
                                                a device to fall within this classification,
                                                                                                                           PART 876—GASTROENTEROLOGY–                                     shelf life by demonstrating continued
                                                and thus avoid automatic classification
                                                                                                                           UROLOGY DEVICES                                                sterility of the device or the sterile
                                                in class III, it would have to comply
                                                with the special controls named in this                                                                                                   components, package integrity, and
                                                                                                                           ■ 1. The authority citation for part 876                       device functionality over the identified
                                                final order. The necessary special                                         continues to read as follows:
                                                controls appear in the regulation                                                                                                         shelf life.
                                                codified by this order. This device is                                       Authority: 21 U.S.C. 351, 360, 360c, 360e,                     (6) Performance data must support the
                                                subject to premarket notification                                          360j, 360l, 371.
                                                                                                                                                                                          instructions for reprocessing all reusable
                                                requirements under section 510(k).                                         ■ 2. Add § 876.4340 to subpart E to read                       components.
                                                   At the time of classification, high                                     as follows:
                                                                                                                                                                                            (7) In vivo testing must demonstrate
                                                intensity ultrasound systems for
                                                                                                                           § 876.4340 High intensity ultrasound                           that the device thermally ablates
                                                prostate tissue ablation are for                                           system for prostate tissue ablation.                           targeted tissue in a controlled manner
                                                prescription use only. Prescription
                                                                                                                              (a) Identification. A high intensity                        without thermal injury to adjacent, non-
                                                devices are exempt from the
                                                requirement for adequate directions for                                    ultrasound system for prostate tissue                          target tissues.
                                                                                                                           ablation is a prescription device that                            (8) Clinical testing must document the
                                                use for the layperson under section
                                                                                                                           transmits high intensity therapeutic                           adverse event profile, provide evidence
                                                502(f)(1) of the FD&C Act (21 U.S.C.
                                                                                                                           ultrasound energy into the prostate to
                                                352(f)(1)) and 21 CFR 801.5, as long as                                                                                                   of prostatic ablation, and demonstrate
                                                                                                                           thermally ablate a defined, targeted
                                                the conditions of 21 CFR 801.109 are                                                                                                      that the device performs as intended
                                                                                                                           volume of tissue, performed under
                                                met.                                                                                                                                      under anticipated conditions of use.
                                                                                                                           imaging guidance. This classification
                                                III. Analysis of Environmental Impact                                      does not include devices that are                                 (9) Training must be provided so that
                                                   The Agency has determined under 21                                      intended for the treatment of any                              upon completion of the training
                                                CFR 25.34(b) that this action is of a type                                 specific prostate disease and does not                         program, the physician can:
                                                that does not individually or                                              include devices that are intended to                              (i) Use all safety features of the
                                                cumulatively have a significant effect on                                  ablate non-prostatic tissues/organs.                           device;
                                                                                                                              (b) Classification. Class II (special
                                                the human environment. Therefore,                                                                                                            (ii) Accurately target the high
                                                                                                                           controls). The special controls for this
                                                neither an environmental assessment                                                                                                       intensity ultrasound energy within the
                                                                                                                           device are:
                                                nor an environmental impact statement                                         (1) Non-clinical performance data                           desired region of the prostate; and
                                                is required.                                                               must demonstrate that the device                                  (iii) Perform the ablation procedure in
                                                IV. Paperwork Reduction Act of 1995                                        performs as intended under anticipated                         a manner that minimizes damage to
                                                                                                                           conditions of use. The following                               non-target tissues.
                                                  This final administrative order
                                                                                                                           performance characteristics must be
                                                establishes special controls that refer to                                                                                                   (10) Labeling must include:
                                                                                                                           tested:
                                                previously approved collections of                                            (i) Characterization of acoustic
                                                information found in other FDA                                                                                                               (i) A section that summarizes the
                                                                                                                           pressure and power output at clinically                        clinical testing results, including the
                                                regulations. These collections of                                          relevant levels;
                                                information are subject to review by the                                                                                                  adverse event profile and evidence of
                                                                                                                              (ii) Measurement of targeting accuracy                      prostate ablation achieved; and
                                                Office of Management and Budget                                            and reproducibility of high intensity
                                                (OMB) under the Paperwork Reduction                                        ultrasound output;                                                (ii) An expiration date or shelf life for
                                                Act of 1995 (44 U.S.C. 3501–3520). The                                        (iii) Ultrasound-induced heating                            single use components.
                                                collections of information in part 807,                                    verification testing at target and non-                          Dated: September 25, 2017.
                                                subpart E, regarding premarket                                             target tissues;
                                                notification submissions have been                                                                                                        Leslie Kux,
                                                                                                                              (iv) Electrical safety testing; and
                                                approved under OMB control number                                             (v) Electromagnetic compatibility                           Associate Commissioner for Policy.
jstallworth on DSKBBY8HB2PROD with RULES




                                                0910–0120, and the collections of                                          testing.                                                       [FR Doc. 2017–21074 Filed 9–29–17; 8:45 am]
                                                information in part 801, regarding                                            (2) Software verification, validation,                      BILLING CODE 4164–01–P
                                                labeling, have been approved under                                         and hazard analysis must be performed.
                                                OMB control number 0910–0485.                                                 (3) The elements of the device that
                                                                                                                           may contact the patient’s mucosal tissue
                                                List of Subjects in 21 CFR Part 876                                        must be demonstrated to be
                                                  Medical devices.                                                         biocompatible.


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Document Created: 2017-09-30 04:41:21
Document Modified: 2017-09-30 04:41:21
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal order.
DatesThis order is effective October 2, 2017. The classification was applicable on October 9, 2015.
ContactJohn Baxley, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G210, Silver Spring, MD 20993-0002, 301-796-6549, [email protected]
FR Citation82 FR 45725 

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