FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)

FaceHeart Vitals SDK-RR is a software-only respiratory rate measurement tool integrated into mobile devices, laptops, or computers. It performs non-contact, spot-check respiratory rate measurement by analyzing chest wall movement from video input when a subject is still and properly positioned in front of a camera in adequate lighting. It is intended for use under healthcare professional supervision in clinical or home environments for adults aged 18+ who do not require critical care, and is not intended for continuous monitoring, apnea detection, or as the sole assessment method.

Both the subject device and predicate (Philips VitalSigns) are software-only respiratory rate monitors using chest motion analysis from video input. The subject device operates on Windows 10, Android 14, and iOS 17 with tested compatibility on Logitech C930 webcams and iPhone/Samsung front-facing cameras, whereas the predicate specifications were less detailed. Both measure respiratory rate with 60-second windows in still subjects under healthcare professional supervision. The subject device has a validated range of 5–36 bpm with ±2 bpm accuracy, compared to the predicate's 7–30 bpm range with ±3 bpm accuracy.

IEC 62304 (Medical Device Software Life Cycle Processes), IEC 62366-1 (Usability Engineering for Medical Devices), ISO 14971 (Risk Management for Medical Devices). FDA guidance documents cited include Content of Premarket Submissions for Device Software Functions, Applying Human Factors and Usability Engineering to Medical Devices, Cybersecurity in Medical Devices, and Off-The-Shelf Software Use in Medical Devices.

Both devices share identical intended use: contactless spot-check respiratory rate measurement under healthcare professional supervision for non-critical adult patients, neither designed for apnea detection or continuous monitoring. Both use the same operating principle (chest motion analysis from video) and measurement window (60 seconds). The subject device's broader patient age range (18+ vs. ASA I patients 22+) and wider respiratory rate measurement capability (5–36 bpm vs. 7–30 bpm) do not raise new safety or effectiveness questions because clinical data from 420 subjects demonstrated ±2 bpm accuracy across all respiratory rate levels and demographic groups with no significant performance differences. The expanded hardware compatibility and slightly improved accuracy do not represent a fundamental technological departure from the predicate.