
[Federal Register Volume 80, Number 225 (Monday, November 23, 2015)]
[Rules and Regulations]
[Pages 72899-72901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29632]



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  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


