Sleepiz One+ (2.5)

Sleepiz One+ (2.5) is a contactless radar-based medical device that measures heart rate and respiration rate in resting or sleeping adult patients and detects patient presence and body movements. It consists of a hardware unit positioned near the bed and cloud-based software for data analysis and visualization, intended for use by healthcare professionals in clinical settings or by patients/caregivers at home.

Both subject and predicate devices use radar technology to collect physiological signals transmitted via internet to backend servers. The key difference is the access interface: the predicate provides a dedicated web application while the subject device provides Application Programming Interface (API) links enabling access through third-party systems. Additionally, the predicate is battery-operated while the subject device uses plug-in power, though both require power sources to operate.

Software Verification and Validation per IEC 62304:2006/A1:2015; Electrical Safety per ANSI/AAMI ES60601-1 and ANSI/AAMI HA60601-1-11; Electromagnetic Compatibility Testing per IEC 60601-1-2:2014 + A1:2020.

The subject device has identical intended use, patient population, and monitored parameters as the predicate (K223163). The transition from web-based to API-based interface and the change from battery to plug-in power are minor modifications that do not alter fundamental operation or introduce new safety/effectiveness concerns. Comprehensive verification, validation, and performance testing confirms the subject device performs comparably to the predicate under specified conditions with no new risks or scientific questions.