Rule2022-28494
Medical Devices; Gastroenterology-Urology Devices; Classification of the Gastrointestinal Lesion Software Detection System
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Published
January 3, 2023
Effective
January 3, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 1 (Tuesday, January 3, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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, <a href="/cdn-cgi/l/email-protection#eaba988b87858e82c4a18b9883938b9d8b998b87aa8c8e8bc4828299c48d859c"><span class="__cf_email__" data-cfemail="14446675797b707c3a5f75667d6d756375677579547270753a7c7c673a737b62">[email protected]</span></a>.
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.
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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;
<bullet> False positives resulting in Non-clinical performance
unnecessary patient treatment; or. testing; Software
<bullet> 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
<bullet> Incompatibility with hardware performance testing; Labeling;
and/or data source.. Electromagnetic compatibility
(EMC); and Electrical safety,
thermal safety, mechanical
safety testing.
<bullet> Inadequate mapping of
software architecture.
<bullet> Degradation of image
quality.
<bullet> 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
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