WatchPAT400 (WP400)

The WatchPAT400 (WP400) is a non-invasive home sleep apnea diagnostic device worn on the wrist with a finger probe and chest sensor. It detects sleep-related breathing disorders, measures respiratory disturbance index (pRDI), apnea-hypopnea index (pAHI), and provides sleep staging, snoring level, and body position data for patients aged 12 and older (pAHIc for 17+). The device transmits data wirelessly via Bluetooth to a mobile app and cloud storage for clinician analysis.

The WP400 combines a reusable wrist-worn housing design from the WP300 with wireless Bluetooth connectivity from the WP1 predicate. Core hardware includes an optical PAT finger probe, actigraph, chest sensor, microphone, and accelerometer—all identical to predicate devices. Signal acquisition and processing algorithms are unchanged; the device uses a single AAA battery and transmits data real-time via Bluetooth, distinguishing it from the WP300 which used USB data transfer.

Electrical safety and electromagnetic compatibility testing per IEC 60601-1:2005 (AMD1:2012, AMD2:2020), IEC 60601-1-11:2015 (AMD1:2020) for home healthcare, and IEC 60601-1-2:2014 (AMD1:2020). FCC compliance testing for wireless communications. SpO2 accuracy validated per ISO 80601-2 and FDA's Pulse Oximeters guidance (March 4, 2013) using CO-Oximetry reference with 24 subjects across varying skin tones (Monk Skin Tone scale).

The WP400 shares identical intended use (home sleep apnea screening), core PAT technology, sensor components, and clinical algorithms with predicate WP1. The only substantive differences—reusable housing and wireless connectivity—were independently cleared in reference device WP300, so they do not introduce new safety or effectiveness concerns. Comprehensive performance testing demonstrates SpO2 accuracy (ARMS 2.0%, 95% CI 2.08%) with non-disparate performance across skin tones, meeting all established electrical and software safety standards, thereby raising no new questions relative to WP1.