Rule2022-11699
Medical Devices; Cardiovascular Devices; Classification of the Coronary Artery Disease Risk Indicator Using Acoustic Heart Signals
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Published
June 1, 2022
Effective
June 1, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is classifying the coronary artery disease risk indicator using acoustic heart signals 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 coronary artery disease risk indicator using acoustic heart signals' 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 87 Issue 105 (Wednesday, June 1, 2022)</title>
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[Federal Register Volume 87, Number 105 (Wednesday, June 1, 2022)]
[Rules and Regulations]
[Pages 32988-32990]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-11699]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 870
[Docket No. FDA-2022-N-0713]
Medical Devices; Cardiovascular Devices; Classification of the
Coronary Artery Disease Risk Indicator Using Acoustic Heart Signals
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the coronary artery disease risk indicator using acoustic heart signals
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 coronary artery disease risk indicator using
acoustic heart signals' 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 June 1, 2022. The classification was
applicable on November 24, 2020.
FOR FURTHER INFORMATION CONTACT: Kimberly Crowley, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2531, Silver Spring, MD, 20993-0002, 301-
796-6017, <a href="/cdn-cgi/l/email-protection#feb597939c9b8c9287d0bd8c9189929b87be989a9fd096968dd0999188"><span class="__cf_email__" data-cfemail="e9a280848b8c9b8590c7aa9b869e858c90a98f8d88c781819ac78e869f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the coronary artery disease risk
indicator using acoustic heart signals 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.
Under either procedure for De Novo classification, FDA is required
to classify the device by written order
[[Page 32989]]
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 4, 2019, FDA received Acarix A/S's request for De Novo
classification of the CADScor 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 November 24, 2020, 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
870.1420.\1\ We have named the generic type of device coronary artery
disease risk indicator using acoustic heart signals, and it is
identified as a device that records heart sounds including murmurs and
vibrations to calculate a patient-specific risk of presence of coronary
artery disease, as an aid in cardiac analysis and diagnosis.
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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--Coronary Artery Disease Risk Indicator Using Acoustic Heart
Signals Risks and Mitigation Measures
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Identified risks Mitigation measures
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Adverse tissue reaction........... Biocompatibility evaluation,
Labeling, and Usability testing.
Skin burn/irritation.............. Electrical safety testing, and
Electromagnetic compatibility
testing.
False positive leading to Software verification, validation,
unnecessary medical procedures. and hazard analysis; Usability
testing; Acoustic performance
testing; Clinical performance
testing; and Labeling.
False negative leading to failure Software verification, validation,
to detect coronary artery disease. and hazard analysis; Usability
testing; Acoustic performance
testing; Clinical performance
testing; and Labeling.
Delay in calculation due to device Software verification, validation,
failure resulting in a delay of and hazard analysis; Clinical
treatment. performance testing; Usability
testing; Acoustic performance
testing; and Labeling.
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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 part 801, regarding labeling, have been approved
under OMB control number 0910-0485.
List of Subjects in 21 CFR Part 870
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
870 is amended as follows:
PART 870--CARDIOVASCULAR DEVICES
0
1. The authority citation for part 870 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
[[Page 32990]]
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2. Add Sec. 870.1420 to subpart B to read as follows:
Sec. 870.1420 Coronary artery disease risk indicator using acoustic
heart signals.
(a) Identification. A coronary artery disease risk indicator using
acoustic heart signals is a device that records heart sounds including
murmurs and vibrations to calculate a patient-specific risk of presence
of coronary artery disease, as an aid in cardiac analysis and
diagnosis.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Clinical performance testing must fulfill the following:
(i) Testing must include a discussion of the patient population and
any statistical techniques used for analyzing the data; and
(ii) Testing must be representative of the intended use population
for the device. Any selection criteria or sample limitations must be
fully described and justified.
(2) Acoustic performance testing must evaluate microphone
sensitivity, sound acquisition bandwidth, and amplitude accuracy. The
acoustic sensor specifications and mechanism used to capture heart
sounds must be described.
(3) A scientific justification for the validity of the algorithm(s)
must be provided. This justification must fulfill the following:
(i) All inputs and outputs of the algorithm must be fully
described;
(ii) The procedure for segmenting, characterizing, and classifying
the acoustic signal must be fully described; and
(iii) This justification must include verification of the algorithm
calculations and validation using an independent data set.
(4) The patient-contacting components of the device must be
demonstrated to be biocompatible.
(5) Software verification, validation, and hazard analysis must be
performed.
(6) Human factors/usability testing must demonstrate that the user
can correctly use the device, including device placement, based solely
on reading the directions for use.
(7) Performance data must demonstrate the electromagnetic
compatibility and electrical safety of the device.
(8) Labeling must include the following:
(i) A description of what the device measures and outputs to the
user;
(ii) Instructions for proper placement of the device;
(iii) Instructions on care and cleaning of the device;
(iv) Warnings identifying sensor acquisition factors that may
impact measurement results and instructions for mitigating these
factors; and
(v) The expected performance of the device for all intended use
populations and environments.
Dated: May 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-11699 Filed 5-31-22; 8:45 am]
BILLING CODE 4164-01-P
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