Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2790](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2790) → QDB — Photoplethysmograph Analysis Software For Over-The-Counter Use

# QDB · Photoplethysmograph Analysis Software For Over-The-Counter Use

_Cardiovascular · 21 CFR 870.2790 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/QDB

## Overview

- **Product Code:** QDB
- **Device Name:** Photoplethysmograph Analysis Software For Over-The-Counter Use
- **Regulation:** [21 CFR 870.2790](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2790)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis.

## Classification Rationale

Class II (special controls). The special controls for this device are:

## Special Controls

In combination with the general controls of the FD&C Act, the photoplethysmograph analysis software for over-the-counter use is subject to the following special controls:

- 1. Clinical performance testing must demonstrate the performance characteristics of the detection algorithm under anticipated conditions of use.
- 2. Software verification, validation, and hazard analysis must be performed. Documentation must include a characterization of the technical specifications of the software, including the detection algorithm and its inputs and outputs.
- 3. Non-clinical performance testing must demonstrate the ability of the device to detect adequate PPG signal quality.
- 4. Human factors and usability testing must demonstrate the following:
	- The user can correctly use the device based solely on reading the device labeling; a. and
	- b. The user can correctly interpret the device output and understand when to seek medical care.
- 5. Labeling must include:
	- a. Hardware platform and operating system requirements;
	- b. Situations in which the device may not operate at an expected performance level;
	- A summary of the clinical performance testing conducted with the device: C.
	- d. A description of what the device measures and outputs to the user; and
	- Guidance on interpretation of any results. e.

In combination with the general controls of the FD&C Act, the hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate and/or respiratory rate is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate the performance characteristics of the detection algorithm under anticipated conditions of use.
(2) Software verification, validation, and hazard analysis must be performed. Documentation must include a characterization of the technical specifications of the software, including the detection algorithm and its inputs and outputs.
(3) Non-clinical performance testing must demonstrate the ability of the device to detect adequate photoplethysmograph signal quality.
(4) Human factors and usability testing must demonstrate the following:
(i) The user can correctly use the device based solely on reading the device labeling; and
(ii) The user can correctly interpret the device output and understand when to seek medical care.
(5) Labeling must include:
(i) Hardware platform and operating system requirements;
(ii) Situations in which the device may not operate at an expected performance level;
(iii) A summary of the clinical performance testing conducted with the device;
(iv) A description of what the device measures and outputs to the user; and
(v) Guidance on interpretation of any results.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K231173](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/QDB/K231173.md) | Irregular Rhythm Notification Feature (IRNF) | Apple, Inc. | Jul 21, 2023 | SESE |
| [K213971](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/QDB/K213971.md) | Atrial Fibrillation History Feature | Apple, Inc. | Jun 3, 2022 | SESE |
| [K212372](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/QDB/K212372.md) | Fitbit Irregular Rhythm Notifications | Fitbit, Inc. | Apr 8, 2022 | SESE |
| [K212516](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/QDB/K212516.md) | IRNF App | Apple, Inc. | Oct 22, 2021 | SESE |
| [DEN180042](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/QDB/DEN180042.md) | Irregular Rhythm Notification Feature | Apple, Inc. | Sep 11, 2018 | DENG |

## Top Applicants

- Apple, Inc. — 4 clearances
- Fitbit, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/QDB](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/QDB)

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