Perin Health System (PHD80060-2)

The Perin Health System is a wireless remote monitoring platform that enables healthcare professionals to perform spot-check collection of physiological data from adult patients in hospitals, clinics, long-term care facilities, and home settings. The wearable patch measures auscultation sounds, ECG, heart rate, oxygen saturation, respiratory rate, skin temperature, activity level, and body posture, transmitting data via Bluetooth to a mobile application and cloud-based provider portal for storage, analysis, and review.

The subject device performs spot-checking (rather than continuous) monitoring with a 1-channel ECG (versus 2-channel in the predicate), uses dry electrodes instead of wet electrodes, employs a contact acoustic sensor for auscultation data, has a 360-hour wear life, and integrates optional third-party devices for blood pressure and weight data. The device uses BLE 5.4 communication with AES-CTR 256 encryption and includes on-board memory for data storage.

ISO 10993 (biocompatibility), IEC 60601-1/1-2/1-11 (electrical safety and EMC), ISO 80601-2-56 (temperature), ANSI/AAMI/IEC 60601-2-27 and 60601-2-47 (ECG/heart rate), ISO 80601-2-61 (SpO2), ANSI/CTA-2056-A (step count), IEC 60601-1-8 (alarms), IEC 62304 (software lifecycle), and ANSI/IEEE C63.27 (wireless coexistence).

The Perin Health System is substantially equivalent to the UbiqVue 2A (primary predicate) for ECG, skin temperature, respiratory rate, and SpO2 monitoring, and to the Alio Medical system (secondary predicate) for auscultation sound recording. Minor differences—spot-checking vs. continuous monitoring, single vs. dual ECG channels, and dry vs. wet electrodes—represent narrower scope or equivalent performance validated through bench and clinical testing. The device meets all safety and effectiveness requirements demonstrated through comprehensive verification and clinical validation studies.