21 CFR 870.2790 — Photoplethysmograph Analysis Software For Over-The-Counter Use
Cardiovascular (CV) · Part 870 Subpart C—Cardiovascular Monitoring Devices · § 870.2790
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:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QDB | Photoplethysmograph Analysis Software For Over-The-Counter Use | 2 | 5 | SaMD |
| SDY | Loss Of Pulse Notification Software | 2 | 1 | SaMD |
Special Controls
QDB — Photoplethysmograph Analysis Software For Over-The-Counter Use
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.
De Novo Order DEN180042
QDB — Photoplethysmograph Analysis Software For Over-The-Counter Use
*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.
eCFR
QDB — Photoplethysmograph Analysis Software For Over-The-Counter Use
(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.
Ecfr Llm
SDY — Loss Of Pulse Notification Software
*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.
eCFR
