83 FR 27895 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Fluid Jet System for Prostate Tissue Removal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 116 (June 15, 2018)

Page Range		27895-27898
FR Document		2018-12829

The Food and Drug Administration (FDA or we) is classifying the fluid jet system for prostate tissue removal 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 fluid jet system for prostate tissue removal'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 83 Issue 116 (Friday, June 15, 2018)

[Federal Register Volume 83, Number 116 (Friday, June 15, 2018)]
[Rules and Regulations]
[Pages 27895-27898]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12829]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2018-N-1894]


Medical Devices; Gastroenterology-Urology Devices; Classification 
of the Fluid Jet System for Prostate Tissue Removal

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the fluid jet system for prostate tissue removal 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 fluid jet

[[Page 27896]]

system for prostate tissue removal'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 June 15, 2018. The classification was 
applicable on December 21, 2017.

FOR FURTHER INFORMATION CONTACT: Jessica Cades, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G246, Silver Spring, MD, 20993-0002, 240-402-3900, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the fluid jet system for prostate 
tissue removal 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 
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 (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 (21 U.S.C. 360(k) and part 807 (21 CFR part 807).
    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 (21 U.S.C. 360c(f)(2)). 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 PMA 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 April 17, 2017, PROCEPT BioRobotics Inc. submitted a request for 
De Novo classification of the AQUABEAM System. 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 the 
general controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on December 21, 2017, FDA issued an order to the 
requester classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 876.4350. We have named 
the generic type of device fluid jet system for prostate tissue 
removal, and it is identified as a prescription device intended for the 
resection and removal of prostatic tissue for the treatment of benign 
prostatic hyperplasia. The device cuts tissue by using a pressurized 
jet of fluid delivered to the prostatic urethra. The device is able to 
image the treatment area, or pairs with an imaging modality, to monitor 
treatment progress.
    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--Fluid Jet System for Prostate Tissue Removal Risks and
                           Mitigation Measures
------------------------------------------------------------------------
             Identified risks                    Mitigation measures
------------------------------------------------------------------------
Injury from device operation causing one    Clinical performance
 or more of the following:                   testing, Animal testing,
                                             Labeling, and Training.
     Bleeding
     Bruising
     Penile or pelvic pain

[[Page 27897]]

 
     Dysuria
     Incontinence
     Bladder or prostate capsule
     perforation
     Sexual dysfunction, including
     ejaculatory and erectile dysfunction
     Transurethral resection
     syndrome
     Urethral damage causing false
     passage or stricture
     Rectal incontinence/
     perforation
     Embolism
Adverse tissue reaction...................  Biocompatibility evaluation.
Infection.................................  Sterilization validation,
                                             Reprocessing validation,
                                             Shelf life testing, and
                                             Labeling.
Failure to remove target tissue or removal  Clinical performance
 of non-target tissue.                       testing, Animal testing,
                                             Software verification,
                                             validation, and hazard
                                             analysis, Non-clinical
                                             performance testing,
                                             Labeling, and Training.
Electrical shock or electromagnetic         Electrical safety testing,
 interference.                               Electromagnetic
                                             compatibility testing, and
                                             Labeling.
------------------------------------------------------------------------

    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. We encourage sponsors to consult 
with us if they wish to use a non-animal testing method they believe is 
suitable, adequate, validated, and feasible. We will consider if such 
an alternative method could be assessed for equivalency to an animal 
test method. This device is subject to premarket notification 
requirements under section 510(k) of the FD&C Act.
    At the time of classification, fluid jet systems for prostate 
tissue removal 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 and 21 CFR 801.5, as 
long as the conditions of 21 CFR 801.109 are met (referring to 21 
U.S.C. 352(f)(1)).

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 order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations and guidance. 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 the guidance document ``De Novo Classification 
Process (Evaluation of Automatic Class III Designation)'' have been 
approved under OMB control number 0910-0844; the collections of 
information in 21 CFR part 814, subparts A through E, regarding 
premarket approval, have been approved under OMB control number 0910-
0231; 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.  876.4350 to subpart E to read as follows:


Sec.  876.4350  Fluid jet system for prostate tissue removal.

    (a) Identification. A fluid jet system for prostate tissue removal 
is a prescription device intended for the resection and removal of 
prostatic tissue for the treatment of benign prostatic hyperplasia. The 
device cuts tissue by using a pressurized jet of fluid delivered to the 
prostatic urethra. The device is able to image the treatment area, or 
pairs with an imaging modality, to monitor treatment progress.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must evaluate the following:
    (i) All adverse events associated with the device, and
    (ii) Improvement in lower urinary tract symptoms (LUTS).
    (2) Physician training must be provided that includes:
    (i) Information on key aspects and use of the device, and
    (ii) Information on how to override or stop resection.
    (3) Animal testing must demonstrate that the device resects 
targeted tissue in a controlled manner without injury to adjacent non-
target tissues.
    (4) 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) Measurement of targeting accuracy and reproducibility of high 
velocity fluid jet, and
    (ii) High pressure fluid jet verification testing at target and 
non-target tissues.
    (5) Software verification, validation, and hazard analysis must be 
performed.
    (6) The patient-contacting elements of the device must be 
demonstrated to be biocompatible.
    (7) Performance data must demonstrate the electrical safety and 
electromagnetic compatibility of the device.
    (8) Performance data must demonstrate the sterility of the patient-
contacting components of the device.

[[Page 27898]]

    (9) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the identified shelf life.
    (10) Performance data must validate the instructions for 
reprocessing and reliability of reusable components.
    (11) Labeling must include the following:
    (i) A section that summarizes the clinical testing results, 
including the adverse event profile and improvement in LUTS;
    (ii) A shelf life for single use components;
    (iii) A use life for reusable components; and
    (iv) Reprocessing instructions for reusable components.

    Dated: June 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12829 Filed 6-14-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Rules and Regulations 27895

CFR 10.115)). We are implementing this Petition (21 CFR 10.30)’’ and an and keep records to verify the amount
guidance without prior public comment accompanying document titled of non-digestible carbohydrates added
because we have determined that prior ‘‘Evaluation of the Beneficial to food that do not meet the definition
public participation is not feasible or Physiological Effects of Isolated or of dietary fiber. Under our policy, when
appropriate (§ 10.115(g)(2)). We made Synthetic Non-Digestible a mixture of dietary fiber and one or
this determination because this Carbohydrates,’’ the availability of more of these eight added non-digestible
guidance sets out compliance policy which we announced in the Federal carbohydrates (that are not currently
that reduces burden and is consistent Register of November 23, 2016 (81 FR listed as a ‘‘dietary fiber’’ in the
with the public health. Although this 84516 and 81 FR 84595), in addition to definition in § 101.9(c)(6)(i)) are present
guidance document is immediately in our independent evaluation of the in a food, we do not expect
effect, it remains subject to comment in available scientific data, we intend to manufacturers to make and keep records
accordance with FDA’s GGP regulation. add certain isolated or synthetic non- in accordance with § 101.9(g)(10) and
Before 2016, FDA regulations did not digestible carbohydrates to the dietary (11) to verify the declared amount of
define the term ‘‘dietary fiber’’ for fiber definition in § 101.9(c)(6)(i) one or more of these eight added non-
purposes of the Nutrition Facts and through our regular rulemaking process. digestible carbohydrates in the label and
Supplement Facts labels. In the Federal The eight non-digestible carbohydrates labeling of food.
Register of May 27, 2016 (81 FR 33742), that we intend to add are: Mixed plant This guidance is being issued
we published a final rule amending our cell wall fibers; arabinoxylan; alginate, consistent with FDA’s good guidance
Nutrition Facts and Supplement Facts inulin and inulin-type fructans; high practices regulation (21 CFR 10.115).
Labels regulations (hereafter referred to amylose starch (resistant starch 2); The guidance represents the current
as ‘‘the final rule’’). The final rule, galactooligosaccharide; polydextrose; thinking of FDA on this topic. It does
among other things, defines dietary fiber and resistant maltodextrin/dextrin. One not establish any rights for any person
as non-digestible soluble and insoluble category of non-digestible carbohydrate and is not binding on FDA or the public.
carbohydrates (with 3 or more that we intend to add to § 101.9(c)(6)(i) You can use an alternative approach if
monomeric units), and lignin that are through our regular rulemaking it satisfies the requirements of the
intrinsic and intact in plants; isolated or process—mixed plant cell wall fibers— applicable statutes and regulations. This
synthetic non-digestible carbohydrates encompasses a number of fiber guidance is not subject to Executive
(with 3 or more monomeric units) ingredients, such as rice bran fibers, soy Order 12866.
determined by FDA to have fibers, and sugar cane fibers. We have
physiological effects that are beneficial II. Electronic Access
tentatively determined that each of
to human health (§ 101.9(c)(6)(i) (21 Persons with access to the internet
these isolated or synthetic non-
CFR 101.9(c)(6)(i))). The final rule also may obtain the document at either
digestible carbohydrates has a
identifies seven isolated or synthetic https://www.fda.gov/FoodGuidances or
physiological effect that is beneficial to
non-digestible carbohydrates, each of https://www.regulations.gov. Use the
human health. Several petitions are still
which has a physiological effect that is FDA website listed in the previous
pending with FDA and reviewing this
beneficial to human health and that sentence to find the most current
information is a very high priority for
must be declared as dietary fiber on version of the guidance.
FDA. Firms also can submit new citizen
Nutrition and Supplement Facts labels petitions, and we will review the Dated: June 8, 2018.
when present in a food. petitions on a rolling basis. Firms whose Leslie Kux,
Interested parties can ask us to list
non-digestible carbohydrates do not Associate Commissioner for Policy.
additional isolated or synthetic non-
meet our regulatory definition of [FR Doc. 2018–12867 Filed 6–14–18; 8:45 am]
digestible carbohydrates in the
definition of dietary fiber in ‘‘dietary fiber’’ and are not one of the BILLING CODE 4164–01–P

§ 101.9(c)(6)(i). For example, a eight non-digestible carbohydrates
manufacturer can request FDA to identified in the guidance can still use
those non-digestible carbohydrates in DEPARTMENT OF HEALTH AND
include another added isolated or
synthetic non-digestible carbohydrate in foods. Although those non-digestible HUMAN SERVICES
the listing of dietary fibers by carbohydrates cannot be listed as
dietary fiber in the Nutrition Facts label, Food and Drug Administration
submitting a citizen petition under 21
CFR 10.30. FDA would review the they would still be declared as part of
the amount of total carbohydrate and 21 CFR Part 876
scientific evidence to determine
whether the evidence supports the non- listed by name in the ingredients on the [Docket No. FDA–2018–N–1894]
digestible carbohydrate as having a food package. In addition, based on our
physiological effect that is beneficial to review of the scientific evidence, Medical Devices; Gastroenterology-
human health. If so, FDA would including evidence we received in a Urology Devices; Classification of the
propose a rule to include the non- citizen petition, we intend to establish Fluid Jet System for Prostate Tissue
digestible carbohydrate in the listing of a caloric value for polydextrose at 1 Removal
dietary fibers. kcal/g in § 101.9(c)(1)(i)(C).
AGENCY: Food and Drug Administration,
Based on our review of citizen Pending completion of the rulemaking HHS.
petitions that FDA has received process, we are announcing a policy for ACTION: Final order.
requesting that we identify additional the eight identified isolated or synthetic
isolated or synthetic non-digestible non-digestible carbohydrates when one SUMMARY: The Food and Drug
sradovich on DSK3GMQ082PROD with RULES

carbohydrates in the listing of dietary or more are present in food and declared Administration (FDA or we) is
fibers, and comments that we have in the amount of ‘‘dietary fiber’’ on classifying the fluid jet system for
received on a draft guidance entitled Nutrition Facts and Supplement Facts prostate tissue removal into class II
‘‘Scientific Evaluation of the Evidence labels and when the caloric value of 1 (special controls). The special controls
on the Beneficial Physiological Effects kcal/g is used to determine the calorie that apply to the device type are
of Isolated or Synthetic Non-Digestible contribution of polydextrose. Section identified in this order and will be part
Carbohydrates Submitted as a Citizen 101.9(g) requires manufacturers to make of the codified language for the fluid jet

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27896 Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Rules and Regulations

system for prostate tissue removal’s premarket approval (see 21 U.S.C. market a substantially equivalent device
classification. We are taking this action 360c(i)). We determine whether a new (see 21 U.S.C. 360c(i), defining
because we have determined that device is substantially equivalent to a ‘‘substantial equivalence’’). Instead,
classifying the device into class II predicate by means of the procedures sponsors can use the less-burdensome
(special controls) will provide a for premarket notification under section 510(k) process, when necessary, to
reasonable assurance of safety and 510(k) of the FD&C Act (21 U.S.C. 360(k) market their device.
effectiveness of the device. We believe and part 807 (21 CFR part 807).
FDA may also classify a device II. De Novo Classification
this action will also enhance patients’
access to beneficial innovative devices, through ‘‘De Novo’’ classification, a On April 17, 2017, PROCEPT
in part by reducing regulatory burdens. common name for the process BioRobotics Inc. submitted a request for
DATES: This order is effective June 15, authorized under section 513(f)(2) of the De Novo classification of the
2018. The classification was applicable FD&C Act (21 U.S.C. 360c(f)(2)). Section AQUABEAM System. FDA reviewed the
on December 21, 2017. 207 of the Food and Drug request in order to classify the device
Administration Modernization Act of under the criteria for classification set
FOR FURTHER INFORMATION CONTACT:
1997 established the first procedure for forth in section 513(a)(1) of the FD&C
Jessica Cades, Center for Devices and
De Novo classification (Pub. L. 105– Act.
Radiological Health, Food and Drug
115). Section 607 of the Food and Drug
Administration, 10903 New Hampshire We classify devices into class II if
Administration Safety and Innovation
Ave., Bldg. 66, Rm. G246, Silver Spring, general controls by themselves are
Act modified the De Novo application
MD, 20993–0002, 240–402–3900, insufficient to provide reasonable
process by adding a second procedure
Jessica.Cades@fda.hhs.gov. assurance of safety and effectiveness,
(Pub. L. 112–144). A device sponsor
SUPPLEMENTARY INFORMATION: may utilize either procedure for De but there is sufficient information to
I. Background Novo classification. establish special controls that, in
Under the first procedure, the person combination with the general controls,
Upon request, FDA has classified the submits a 510(k) for a device that has provide reasonable assurance of the
fluid jet system for prostate tissue not previously been classified. After safety and effectiveness of the device for
removal as class II (special controls), receiving an order from FDA classifying its intended use (see 21 U.S.C.
which we have determined will provide the device into class III under section 360c(a)(1)(B)). After review of the
a reasonable assurance of safety and 513(f)(1) of the FD&C Act, the person information submitted in the request,
effectiveness. In addition, we believe then requests a classification under we determined that the device can be
this action will enhance patients’ access section 513(f)(2). classified into class II with the
to beneficial innovation, in part by Under the second procedure, rather establishment of special controls. FDA
reducing regulatory burdens by placing than first submitting a 510(k) and then has determined that these special
the device into a lower device class than a request for classification, if the person controls, in addition to the general
the automatic class III assignment. determines that there is no legally controls, will provide reasonable
The automatic assignment of class III marketed device upon which to base a assurance of the safety and effectiveness
occurs by operation of law and without determination of substantial of the device.
any action by FDA, regardless of the equivalence, that person requests a
level of risk posed by the new device. Therefore, on December 21, 2017,
classification under section 513(f)(2) of FDA issued an order to the requester
Any device that was not in commercial the FD&C Act.
distribution before May 28, 1976, is classifying the device into class II. FDA
Under either procedure for De Novo
automatically classified as, and remains is codifying the classification of the
classification, FDA shall classify the
within, class III and requires premarket device by adding 21 CFR 876.4350. We
device by written order within 120 days.
approval unless and until FDA takes an have named the generic type of device
The classification will be according to
action to classify or reclassify the device fluid jet system for prostate tissue
the criteria under section 513(a)(1) of
(see 21 U.S.C. 360c(f)(1)). We refer to the FD&C Act. Although the device was removal, and it is identified as a
these devices as ‘‘postamendments automatically within class III, the De prescription device intended for the
devices’’ because they were not in Novo classification is considered to be resection and removal of prostatic tissue
commercial distribution prior to the the initial classification of the device. for the treatment of benign prostatic
date of enactment of the Medical Device We believe this De Novo classification hyperplasia. The device cuts tissue by
Amendments of 1976, which amended will enhance patients’ access to using a pressurized jet of fluid delivered
the Federal Food, Drug, and Cosmetic beneficial innovation, in part by to the prostatic urethra. The device is
Act (FD&C Act). reducing regulatory burdens. When FDA able to image the treatment area, or pairs
FDA may take a variety of actions in classifies a device into class I or II via with an imaging modality, to monitor
appropriate circumstances to classify or the De Novo process, the device can treatment progress.
reclassify a device into class I or II. We serve as a predicate for future devices of FDA has identified the following risks
may issue an order finding a new device that type, including for 510(k)s (see 21 to health associated specifically with
to be substantially equivalent under U.S.C. 360c(f)(2)(B)(i)). As a result, other this type of device and the measures
section 513(i) of the FD&C Act to a device sponsors do not have to submit required to mitigate these risks in table
predicate device that does not require a De Novo request or PMA in order to 1.

TABLE 1—FLUID JET SYSTEM FOR PROSTATE TISSUE REMOVAL RISKS AND MITIGATION MEASURES
sradovich on DSK3GMQ082PROD with RULES

Identified risks Mitigation measures

Injury from device operation causing one or more of the following: Clinical performance testing, Animal testing, Labeling, and
Training.
• Bleeding
• Bruising
• Penile or pelvic pain

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Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Rules and Regulations 27897

TABLE 1—FLUID JET SYSTEM FOR PROSTATE TISSUE REMOVAL RISKS AND MITIGATION MEASURES—Continued
Identified risks Mitigation measures

• Dysuria
• Incontinence
• Bladder or prostate capsule perforation
• Sexual dysfunction, including ejaculatory and erectile dysfunction
• Transurethral resection syndrome
• Urethral damage causing false passage or stricture
• Rectal incontinence/perforation
• Embolism
Adverse tissue reaction ............................................................................................. Biocompatibility evaluation.
Infection ..................................................................................................................... Sterilization validation, Reprocessing validation, Shelf life
testing, and Labeling.
Failure to remove target tissue or removal of non-target tissue .............................. Clinical performance testing, Animal testing, Software
verification, validation, and hazard analysis, Non-clinical
performance testing, Labeling, and Training.
Electrical shock or electromagnetic interference ...................................................... Electrical safety testing, Electromagnetic compatibility test-
ing, and Labeling.

FDA has determined that special information are subject to review by the for the treatment of benign prostatic
controls, in combination with the Office of Management and Budget hyperplasia. The device cuts tissue by
general controls, address these risks to (OMB) under the Paperwork Reduction using a pressurized jet of fluid delivered
health and provide reasonable assurance Act of 1995 (44 U.S.C. 3501–3520). The to the prostatic urethra. The device is
of safety and effectiveness. In order for collections of information in the able to image the treatment area, or pairs
a device to fall within this classification, guidance document ‘‘De Novo with an imaging modality, to monitor
and thus avoid automatic classification Classification Process (Evaluation of treatment progress.
in class III, it would have to comply Automatic Class III Designation)’’ have (b) Classification. Class II (special
with the special controls named in this been approved under OMB control controls). The special controls for this
final order. The necessary special number 0910–0844; the collections of device are:
controls appear in the regulation information in 21 CFR part 814, (1) Clinical performance testing must
codified by this order. We encourage subparts A through E, regarding evaluate the following:
sponsors to consult with us if they wish premarket approval, have been (i) All adverse events associated with
to use a non-animal testing method they approved under OMB control number the device, and
believe is suitable, adequate, validated, 0910–0231; the collections of (ii) Improvement in lower urinary
and feasible. We will consider if such an information in part 807, subpart E, tract symptoms (LUTS).
(2) Physician training must be
alternative method could be assessed for regarding premarket notification
provided that includes:
equivalency to an animal test method. submissions, have been approved under (i) Information on key aspects and use
This device is subject to premarket OMB control number 0910–0120; and of the device, and
notification requirements under section the collections of information in part (ii) Information on how to override or
510(k) of the FD&C Act. 801, regarding labeling, have been stop resection.
At the time of classification, fluid jet approved under OMB control number (3) Animal testing must demonstrate
systems for prostate tissue removal are 0910–0485. that the device resects targeted tissue in
for prescription use only. Prescription a controlled manner without injury to
List of Subjects in 21 CFR Part 876
devices are exempt from the adjacent non-target tissues.
requirement for adequate directions for Medical devices. (4) Non-clinical performance data
use for the layperson under section Therefore, under the Federal Food, must demonstrate that the device
502(f)(1) of the FD&C Act and 21 CFR Drug, and Cosmetic Act and under performs as intended under anticipated
801.5, as long as the conditions of 21 authority delegated to the Commissioner conditions of use. The following
CFR 801.109 are met (referring to 21 of Food and Drugs, 21 CFR part 876 is performance characteristics must be
U.S.C. 352(f)(1)). amended as follows: tested:
III. Analysis of Environmental Impact (i) Measurement of targeting accuracy
PART 876—GASTROENTEROLOGY- and reproducibility of high velocity
The Agency has determined under 21 UROLOGY DEVICES fluid jet, and
CFR 25.34(b) that this action is of a type (ii) High pressure fluid jet verification
that does not individually or ■ 1. The authority citation for part 876
testing at target and non-target tissues.
cumulatively have a significant effect on continues to read as follows: (5) Software verification, validation,
the human environment. Therefore, Authority: 21 U.S.C. 351, 360, 360c, 360e, and hazard analysis must be performed.
neither an environmental assessment 360j, 360l, 371. (6) The patient-contacting elements of
nor an environmental impact statement ■ 2. Add § 876.4350 to subpart E to read the device must be demonstrated to be
is required. as follows: biocompatible.
sradovich on DSK3GMQ082PROD with RULES

(7) Performance data must
IV. Paperwork Reduction Act of 1995 § 876.4350 Fluid jet system for prostate demonstrate the electrical safety and
This final order establishes special tissue removal. electromagnetic compatibility of the
controls that refer to previously (a) Identification. A fluid jet system device.
approved collections of information for prostate tissue removal is a (8) Performance data must
found in other FDA regulations and prescription device intended for the demonstrate the sterility of the patient-
guidance. These collections of resection and removal of prostatic tissue contacting components of the device.

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Document Created: 2018-11-02 12:00:30
Document Modified: 2018-11-02 12:00:30

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final order.
Dates		This order is effective June 15, 2018. The classification was applicable on December 21, 2017.
Contact		Jessica Cades, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G246, Silver Spring, MD, 20993-0002, 240-402-3900, [email protected]
FR Citation		83 FR 27895

83 FR 27895 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Fluid Jet System for Prostate Tissue Removal

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 116 (June 15, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration