---
kind: "section"
citation: "21 C.F.R. § 870.1420"
title: "21"
number: "870.1420"
heading: "Coronary artery disease risk indicator using acoustic heart signals."
url: "https://uscodex.org/cfr/21/870.1420"
---

# §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.**

## Notes

### Amendments

[87 FR 32990, June 1, 2022]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.

### Amendments

[87 FR 32990, June 1, 2022]