SDY · Loss Of Pulse Notification Software
Cardiovascular · 21 CFR 870.2790 · Class 2
Overview
| Product Code | SDY |
|---|---|
| Device Name | Loss Of Pulse Notification Software |
| Regulation | 21 CFR 870.2790 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242967 | Loss of Pulse Detection | Fitbit | Feb 25, 2025 | SESE |
Top Applicants
- Fitbit — 1 clearance
