80 FR 72899 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Prostate Lesion Documentation System
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 225 (November 23, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 225 (November 23, 2015)
| Page Range | 72899-72901 | |
| FR Document | 2015-29632 |
[Federal Register Volume 80, Number 225 (Monday, November 23, 2015)] [Rules and Regulations] [Pages 72899-72901] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-29632] ======================================================================== Rules and Regulations Federal Register ________________________________________________________________________ This section of the FEDERAL REGISTER contains regulatory documents having general applicability and legal effect, most of which are keyed to and codified in the Code of Federal Regulations, which is published under 50 titles pursuant to 44 U.S.C. 1510. The Code of Federal Regulations is sold by the Superintendent of Documents. Prices of new books are listed in the first FEDERAL REGISTER issue of each week. ======================================================================== Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Rules and Regulations [[Page 72899]] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 876 [Docket No. FDA-2015-N-3720] Medical Devices; Gastroenterology-Urology Devices; Classification of the Prostate Lesion Documentation System AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is classifying the prostate lesion documentation system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the prostate lesion documentation system classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. DATES: This order is effective November 23, 2015. The classification was applicable on April 27, 2012. FOR FURTHER INFORMATION CONTACT: Robert J. De Luca, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G214, Silver Spring, MD, 20993-0002, 301- 796-6551, robert.deluca@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations. Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112- 144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of ``low-moderate risk'' or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed. In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA will classify the device by written order within 120 days. This classification will be the initial classification of the device. In accordance with section 513(f)(1) of the FD&C Act, FDA issued an order on April 22, 2010, classifying the prostate mechanical imager into class III, because it was neither substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, nor a device which was subsequently reclassified into class I or class II. On May 21, 2010, Artann Laboratories, Inc., submitted a request for classification of the prostate mechanical imager under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II (Ref. 1). In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request for de novo classification in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies 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 to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on April 27, 2012, 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 876.2050. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a prostate lesion documentation system will need to comply with the special controls named in this final order. The device is assigned the generic name prostate lesion documentation system, and it is identified as a prescription device intended for use in producing an image of the prostate as an aid in documenting prostate abnormalities previously identified during a digital rectal [[Page 72900]] examination. The device uses pressure sensors and image reconstruction software to produce a prostate image that highlights regional differences in intraprostatic tissue elasticity or stiffness. The device is limited to use as a documentation tool and is not intended for diagnostic purposes or for influencing any clinical decisions. 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--Prostate Lesion Documentation System Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risks Mitigation measures ------------------------------------------------------------------------ Failure to consistently produce an Performance Testing (non- accurate image. clinical and clinical) Software Verification, Validation, and Hazard Analysis Labeling Misinterpretation of displayed images.. Labeling User error............................. Labeling Microbial contamination from reusable Labeling components. Validation of Reprocessing Methods and Instructions Adverse tissue reaction................ Biocompatibility Testing Electromagnetic incompatibility........ Electromagnetic Compatibility Testing Electrical injury...................... Electrical Safety Testing Thermal injury......................... Thermal Safety Testing Mechanical injury...................... Mechanical Safety Testing ------------------------------------------------------------------------ FDA believes that the measures set forth in the following special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness:Non-clinical and clinical performance testing must demonstrate the accuracy and reproducibility of the constructed image. Appropriate analysis/testing must validate electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety. Appropriate software verification, validation, and hazard analysis must be performed. All elements of the device that may contact the patient must be demonstrated to be biocompatible. Methods and instructions for reprocessing of any reusable components must be properly validated. The labeling must include specific information needed to ensure proper use of the device. Prostate lesion documentation systems are prescription devices restricted to patient use only upon the authorization of a practitioner licensed by law to administer or use the device; see 21 CFR 801.109 (Prescription devices). Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the prostate lesion documentation system they intend to market. II. Environmental Impact We have 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. III. 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 21 CFR part 801, regarding labeling have been approved under OMB control number 0910-0485. IV. Reference The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at http://www.regulations.gov. 1. DEN100016: De novo request per section 513(f)(2) of the FD&C Act from Artann Laboratories, Inc., dated May 21, 2010. 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 21 CFR part 876 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 876.2050 to subpart C to read as follows: Sec. 876.2050 Prostate lesion documentation system. (a) Identification. A prostate lesion documentation system is a prescription device intended for use in producing an image of the prostate as an aid in documenting prostate abnormalities previously identified during a digital rectal examination. The device uses pressure sensors and image reconstruction software to produce a prostate image that highlights regional differences in intraprostatic tissue elasticity or stiffness. The device is limited to use as a documentation tool and is not intended for diagnostic purposes or for influencing any clinical decisions. [[Page 72901]] (b) Classification. Class II (special controls). The special controls for this device are: (1) Non-clinical and clinical performance testing must demonstrate the accuracy and reproducibility of the constructed image. (2) Appropriate analysis/testing must validate electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety. (3) Appropriate software verification, validation, and hazard analysis must be performed. (4) All elements of the device that may contact the patient must be demonstrated to be biocompatible. (5) Methods and instructions for reprocessing of any reusable components must be properly validated. (6) The labeling must include specific information needed to ensure proper use of the device. Dated: November 16, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-29632 Filed 11-20-15; 8:45 am] BILLING CODE 4164-01-P
![72899
Rules and Regulations Federal Register
Vol. 80, No. 225
Monday, November 23, 2015
This section of the FEDERAL REGISTER generally referred to as postamendments FDA will classify the device by written
contains regulatory documents having general devices, are classified automatically by order within 120 days. This
applicability and legal effect, most of which statute into class III without any FDA classification will be the initial
are keyed to and codified in the Code of rulemaking process. These devices classification of the device.
Federal Regulations, which is published under remain in class III and require In accordance with section 513(f)(1) of
50 titles pursuant to 44 U.S.C. 1510.
premarket approval, unless and until the FD&C Act, FDA issued an order on
The Code of Federal Regulations is sold by the device is classified or reclassified April 22, 2010, classifying the prostate
the Superintendent of Documents. Prices of into class I or II, or FDA issues an order mechanical imager into class III,
new books are listed in the first FEDERAL finding the device to be substantially because it was neither substantially
REGISTER issue of each week. equivalent, in accordance with section equivalent to a device that was
513(i) of the FD&C Act, to a predicate introduced or delivered for introduction
device that does not require premarket into interstate commerce for commercial
DEPARTMENT OF HEALTH AND approval. The Agency determines distribution before May 28, 1976, nor a
HUMAN SERVICES whether new devices are substantially device which was subsequently
equivalent to predicate devices by reclassified into class I or class II. On
Food and Drug Administration means of premarket notification May 21, 2010, Artann Laboratories, Inc.,
procedures in section 510(k) of the submitted a request for classification of
21 CFR Part 876 FD&C Act (21 U.S.C. 360(k)) and part the prostate mechanical imager under
[Docket No. FDA–2015–N–3720] 807 (21 CFR part 807) of the regulations. section 513(f)(2) of the FD&C Act. The
Section 513(f)(2) of the FD&C Act, as manufacturer recommended that the
Medical Devices; Gastroenterology- amended by section 607 of the Food and device be classified into class II (Ref. 1).
Urology Devices; Classification of the Drug Administration Safety and In accordance with section 513(f)(2) of
Prostate Lesion Documentation Innovation Act (Pub. L. 112–144), the FD&C Act, FDA reviewed the
System provides two procedures by which a request for de novo classification in
person may request FDA to classify a order to classify the device under the
AGENCY: Food and Drug Administration, device under the criteria set forth in criteria for classification set forth in
HHS. section 513(a)(1). Under the first section 513(a)(1). FDA classifies devices
ACTION: Final order. procedure, the person submits a into class II if general controls by
premarket notification under section themselves are insufficient to provide
SUMMARY: The Food and Drug
510(k) of the FD&C Act for a device that reasonable assurance of safety and
Administration (FDA) is classifying the
has not previously been classified and, effectiveness, but there is sufficient
prostate lesion documentation system
within 30 days of receiving an order information to establish special controls
into class II (special controls). The
classifying the device into class III to provide reasonable assurance of the
special controls that will apply to the
under section 513(f)(1) of the FD&C Act, safety and effectiveness of the device for
device are identified in this order and
the person requests a classification its intended use. After review of the
will be part of the codified language for
under section 513(f)(2). Under the information submitted in the request,
the prostate lesion documentation
second procedure, rather than first FDA determined that the device can be
system classification. The Agency is
submitting a premarket notification classified into class II with the
classifying the device into class II
under section 510(k) of the FD&C Act establishment of special controls. FDA
(special controls) in order to provide a
and then a request for classification believes these special controls, in
reasonable assurance of safety and
under the first procedure, the person addition to general controls, will
effectiveness of the device.
determines that there is no legally provide reasonable assurance of the
DATES: This order is effective November marketed device upon which to base a safety and effectiveness of the device.
23, 2015. The classification was determination of substantial Therefore, on April 27, 2012, FDA
applicable on April 27, 2012. equivalence and requests a classification issued an order to the requestor
FOR FURTHER INFORMATION CONTACT: under section 513(f)(2) of the FD&C Act. classifying the device into class II. FDA
Robert J. De Luca, Center for Devices If the person submits a request to is codifying the classification of the
and Radiological Health, Food and Drug classify the device under this second device by adding 21 CFR 876.2050.
Administration, 10903 New Hampshire procedure, FDA may decline to Following the effective date of this
Ave., Bldg. 66, Rm. G214, Silver Spring, undertake the classification request if final classification order, any firm
MD, 20993–0002, 301–796–6551, FDA identifies a legally marketed device submitting a premarket notification
robert.deluca@fda.hhs.gov. that could provide a reasonable basis for (510(k)) for a prostate lesion
SUPPLEMENTARY INFORMATION: review of substantial equivalence with documentation system will need to
the device or if FDA determines that the comply with the special controls named
I. Background device submitted is not of ‘‘low- in this final order. The device is
In accordance with section 513(f)(1) of moderate risk’’ or that general controls assigned the generic name prostate
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the Federal Food, Drug, and Cosmetic would be inadequate to control the risks lesion documentation system, and it is
Act (the FD&C Act) (21 U.S.C. and special controls to mitigate the risks identified as a prescription device
360c(f)(1)), devices that were not in cannot be developed. intended for use in producing an image
commercial distribution before May 28, In response to a request to classify a of the prostate as an aid in documenting
1976 (the date of enactment of the device under either procedure provided prostate abnormalities previously
Medical Device Amendments of 1976), by section 513(f)(2) of the FD&C Act, identified during a digital rectal
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![Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Rules and Regulations 72901
(b) Classification. Class II (special DATES: Effective date: January 17, 2016. 2 Conditions for Mailing
controls). The special controls for this FOR FURTHER INFORMATION CONTACT: 210 Global Express Guaranteed
device are: Paula Rabkin at 202–268–2537.
(1) Non-clinical and clinical * * * * *
performance testing must demonstrate SUPPLEMENTARY INFORMATION: The 213 Prices and Postage Payment
the accuracy and reproducibility of the United States Postal Service® gives Methods
constructed image. notice that on October 22, 2015, the
(2) Appropriate analysis/testing must Postal Service filed with the Postal * * * * *
validate electromagnetic compatibility, Regulatory Commission a notice of a 213.5 Destinating Countries and Price
electrical safety, thermal safety, and minor classification change to add Groups
mechanical safety. Bonaire, Sint Eustatius, and Saba to the
(3) Appropriate software verification, Mail Classification Schedule (MCS). The * * * * *
validation, and hazard analysis must be Commission concurred with the notice Exhibit 213.5
performed. in its Order No. 2808, issued on
(4) All elements of the device that November 9, 2015. Documents are Destinating Countries and Price Groups
may contact the patient must be available at www.prc.gov, Docket No. * * * * *
demonstrated to be biocompatible. MC2016–10. Consequently, the Postal [Add a listing for Bonaire, Sint
(5) Methods and instructions for Service will revise IMM sections 213.5, Eustatius, and Saba to read as follows:]
reprocessing of any reusable 292.45, 293.45, the Index of Countries
components must be properly validated. and Localities, the Country Price Groups Country GXG Price
(6) The labeling must include specific and Weight Limits, and the Individual group
information needed to ensure proper Country Listings, to add a new listing
use of the device. for Bonaire, Sint Eustatius, and Saba * * * * *
Dated: November 16, 2015. and to modify Curaçao’s listing. Bonaire, Sint Eustatius, and
Leslie Kux, List of Subjects in 39 CFR Part 20 Saba .................................. 7
Associate Commissioner for Policy.
Foreign relations, International postal * * * * *
[FR Doc. 2015–29632 Filed 11–20–15; 8:45 am]
services.
BILLING CODE 4164–01–P * * * * *
Accordingly, 39 CFR part 20 is
amended as follows: 290 Commercial Services
POSTAL SERVICE * * * * *
PART 20—[AMENDED]
39 CFR Part 20 292 International Priority Airmail
■ 1. The authority citation for 39 CFR (IPA) Service
International Service Changes— part 20 continues to read as follows: * * * * *
Bonaire, Sint Eustatius, and Saba, Authority: 5 U.S.C. 552(a); 13 U.S.C. 301–
Curaçao, Netherlands Antilles 307; 18 U.S.C. 1692–1737; 39 U.S.C. 101,
292.4 Mail Preparation
401, 403, 404, 407, 414, 416, 3001–3011, * * * * *
AGENCY: Postal ServiceTM.
3201–3219, 3403–3406, 3621, 3622, 3626,
ACTION: Final rule. 3632, 3633, and 5001. 292.45 IPA Foreign Office of Exchange
Codes and Price Groups
SUMMARY: At the request of the ■ 2. Revise the following sections of
designated operator for Bonaire, Sint Mailing Standards of the United States * * * * *
Eustatius, and Saba, the Postal Service Postal Service, International Mail Exhibit 292.45a
is adding this country to Mailing Manual (IMM), as follows:
Standards of the United States Postal IPA Foreign Office of Exchange Codes
* * * * *
Service, International Mail Manual and Price Groups
(IMM®), to reflect these islands’ status Mailing Standards of the United States [Add a separate listing for Bonaire,
as special municipalities of the Postal Service, International Mail Sint Eustatius, and Saba and remove
Netherlands with their own designated Manual (IMM) Bonaire, Saba, and Sint Eustatius from
operator. * * * * * Curaçao’s listing as follows:].
Price
Country labeling name Foreign office of exchange code group
* * * * * * *
Bonaire, Sint Eustatius, and Saba ......................................................................... BON 17
* * * * * * *
Curaçao .................................................................................................................. CUR 17
* * * * * * *
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293 International Surface Air Lift 293.4 Mail Preparation 293.45 ISAL Foreign Office of
(ISAL) Service * * * * * Exchange Codes and Price Groups
* * * * * * * * * *
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Document Created: 2018-03-01 11:18:32
Document Modified: 2018-03-01 11:18:32
| 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 November 23, 2015. The classification was applicable on April 27, 2012. | |
| Contact | Robert J. De Luca, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G214, Silver Spring, MD, 20993-0002, 301- 796-6551, [email protected] | |
| FR Citation | 80 FR 72899 |
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