[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 [www.gpo.gov]
[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, [email protected].

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]]



0
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