PreemptiveAI Clinical SDK

The PreemptiveAI Clinical SDK is a smartphone-based software tool that measures pulse rate noninvasively by recording a 30-second video of a user's fingertip using the phone's camera. It is designed for spot-check pulse rate measurement in adults 18 years and older who are not in critical care or requiring continuous monitoring, and is explicitly not intended for patients with known or suspected heart arrhythmias.

The SDK uses reflectance photoplethysmography (PPG) to detect blood volume changes from optical signals captured by the smartphone camera. It partitions the 30-second signal into overlapping 10-second windows, applies an autocorrelation-based signal quality check, and uses a proprietary locked deep learning algorithm to calculate pulse rate. The device operates on Android and iOS platforms and outputs a single pulse-rate value without arrhythmia detection capability.

Not stated in this summary.

The PreemptiveAI Clinical SDK is substantially equivalent to the predicate device Fibricheck (K232804) because both are software-only, prescription-use devices that perform noninvasive spot-check pulse rate measurement from fingertip PPG video on smartphones, use the same measurement site and approach, operate on the same regulatory classification (21 CFR 870.2920, Class II, Product Code DXH), and both target similar adult user populations for non-critical care monitoring.