[Federal Register Volume 88, Number 1 (Tuesday, January 3, 2023)]
[Rules and Regulations]
[Pages 8-10]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-28494]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2022-N-3207]


Medical Devices; Gastroenterology-Urology Devices; Classification 
of the Gastrointestinal Lesion Software Detection System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
classifying the gastrointestinal lesion software detection system 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 gastrointestinal lesion software detection 
system'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.

DATES: This order is effective January 3, 2023. The classification was 
applicable on April 9, 2021.

FOR FURTHER INFORMATION CONTACT: Pramodh Kariyawasam, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 2536, Silver Spring, MD 20993-0002, 
301-348-1911, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the gastrointestinal lesion 
software detection system 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 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 (see 21 U.S.C. 360c(i)) to a predicate device 
that does not require premarket approval. We determine whether a new 
device is substantially equivalent to a predicate device 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. Section 207 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) established the first procedure for De 
Novo classification. Section 607 of the Food and Drug Administration 
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo 
application process by adding a second procedure. 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.

[[Page 9]]

    Under either procedure for De Novo classification, FDA is required 
to 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 placed 
within class III, the De Novo classification is considered to be the 
initial classification of the device.
    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 section 513(f)(2)(B)(i) of the FD&C 
Act). As a result, other device sponsors do not have to submit a De 
Novo request or premarket approval application to market a 
substantially equivalent device (see section 513(i) of the FD&C Act, 
defining ``substantial equivalence''). Instead, sponsors can use the 
less-burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On November 30, 2020, FDA received Cosmo Artificial Intelligence--
AI, LTD's request for De Novo classification of the GI Genius. 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 April 9, 2021, FDA issued an order to the requester 
classifying the device into class II. In this final order, FDA is 
codifying the classification of the device by adding 21 CFR 
876.1520.\1\ We have named the generic type of device gastrointestinal 
lesion software detection system, and it is identified as a computer-
assisted detection device used in conjunction with endoscopy for the 
detection of abnormal lesions in the gastrointestinal tract. This 
device with advanced software algorithms brings attention to images to 
aid in the detection of lesions. The device may contain hardware to 
support interfacing with an endoscope.
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    \1\ FDA notes that the Action caption for this final order is 
styled as ``Final amendment; final order,'' rather than ``Final 
order.'' Beginning in December 2019, this editorial change was made 
to indicate that the document ``amends'' the Code of Federal 
Regulations. The change was made in accordance with the Office of 
Federal Register's (OFR) interpretations of the Federal Register Act 
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and 
parts 21 and 22), and the Document Drafting Handbook.
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    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--Gastrointestinal Lesion Software Detection System Risks and
                           Mitigation Measures
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            Identified risks                   Mitigation measures
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Algorithm failure leading to:            Clinical performance testing;
 False positives resulting in     Non-clinical performance
 unnecessary patient treatment; or.       testing; Software
 False negatives resulting in     verification, validation, and
 delayed patient treatment..              hazard analysis; and Labeling.
Failure to identify lesions, resulting   Software verification,
 in delayed patient treatment, due to     validation, and hazard
 software/hardware failure including:     analysis; Non-clinical
 Incompatibility with hardware    performance testing; Labeling;
 and/or data source..                     Electromagnetic compatibility
                                          (EMC); and Electrical safety,
                                          thermal safety, mechanical
                                          safety testing.
     Inadequate mapping of
     software architecture.
     Degradation of image
     quality.
     Prolonged delay of real-
     time endoscopic video.
False positive or false negative due to  Labeling, and Usability
 user overreliance on the device.         assessment.
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    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. 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) of the FD&C Act.

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. 3501-3521). The collections 
of information in 21 CFR part 860, subpart D, regarding De Novo 
classification 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; the collections of information in 
21 CFR part 820, regarding quality system regulation, have been 
approved under OMB control number 0910-0073; and the collections of 
information in 21 CFR parts 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:

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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.  876.1520 to subpart B to read as follows:


Sec.  876.1520   Gastrointestinal lesion software detection system.

    (a) Identification. A gastrointestinal lesion software detection 
system is a computer-assisted detection device used in conjunction with 
endoscopy for the detection of abnormal lesions in the gastrointestinal 
tract. This device with advanced software algorithms brings attention 
to images to aid in the detection of lesions. The device may contain 
hardware to support interfacing with an endoscope.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must demonstrate that the device 
performs as intended under anticipated conditions of use, including 
detection of gastrointestinal lesions and evaluation of all adverse 
events.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. 
Testing must include:
    (i) Standalone algorithm performance testing;
    (ii) Pixel-level comparison of degradation of image quality due to 
the device;
    (iii) Assessment of video delay due to marker annotation; and
    (iv) Assessment of real-time endoscopic video delay due to the 
device.
    (3) Usability assessment must demonstrate that the intended user(s) 
can safely and correctly use the device.
    (4) Performance data must demonstrate electromagnetic compatibility 
and electrical safety, mechanical safety, and thermal safety testing 
for any hardware components of the device.
    (5) Software verification, validation, and hazard analysis must be 
provided. Software description must include a detailed, technical 
description including the impact of any software and hardware on the 
device's functions, the associated capabilities and limitations of each 
part, the associated inputs and outputs, mapping of the software 
architecture, and a description of the video signal pipeline.
    (6) Labeling must include:
    (i) Instructions for use, including a detailed description of the 
device and compatibility information;
    (ii) Warnings to avoid overreliance on the device, that the device 
is not intended to be used for diagnosis or characterization of 
lesions, and that the device does not replace clinical decision making;
    (iii) A summary of the clinical performance testing conducted with 
the device, including detailed definitions of the study endpoints and 
statistical confidence intervals; and
    (iv) A summary of the standalone performance testing and associated 
statistical analysis.

    Dated: December 27, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-28494 Filed 12-30-22; 8:45 am]
BILLING CODE 4164-01-P