The Circadia C300 System (C300)

The Circadia C300 System is a contactless radar-based monitor that measures respiratory rate and heart rate in adult patients in clinical settings like skilled nursing and long-term care facilities. It does not provide real-time alarms and is not intended for active monitoring of acute life-threatening situations or patients with arrhythmias.

The C300 uses an FMCW radar operating at 58.0–61.5 GHz (compared to the predicate's 6.4–7.8 GHz UWB radar), with identical measurement ranges (respiratory rate 7–38 breaths/minute, heart rate 40–140 beats/minute) and the same contactless radar-based sensing principle. Both devices detect micromotions from respiration and heartbeat, monitor patient motion, and detect patient presence/absence.

IEC 62304:2006/A1:2015 (software verification and validation), IEC 60601-1:2005 + A1:2012 + A2:2020 (electrical safety), IEC 60601-1-2:2014 + A1:2020 (EMC), AIM 7351731 Rev. 3.00, IEEE/ANSI C63.27-2021 (wireless coexistence), and 2022 FDA EMC guidance.

The C300 is substantially equivalent to the predicate C200 System because it has identical intended use, indications, physiological parameters, and sensing principle. Although the radar frequency differs, clinical testing demonstrated equivalent performance (RR accuracy within ±3 breaths/minute, HR within ±5 beats/minute). All modifications underwent full software verification, bench testing, and clinical validation without raising new safety or effectiveness questions.