Respiree Cardio- Respiratory Monitor System

The Respiree Cardio-Respiratory Monitor System is a wearable optical sensor affixed to the chest via adhesive patch that measures respiration rate non-invasively for adult patients in hospitals, hospital-type facilities in non-ICU settings, and home environments. Data is transmitted wirelessly via Bluetooth to a gateway, then uploaded to a cloud server for display on a web dashboard accessible to healthcare professionals for spot-check monitoring.

The device uses a vertical-cavity surface-emitting diode to emit optical light toward skin with an integrated photodetector sensing diffused light, employing adaptive signal processing optimized across different respiratory rate bands. It operates on a 3.7V rechargeable lithium-ion battery, transmits via AES-256 encrypted Bluetooth LE with Wi-Fi/LTE uplink, and measures respiration rates between 5–50 rpm with accuracy <3 rpm. Primary differences from predicate K223681 include extended home-use environment, magnetic charging port instead of micro-USB, polycarbonate casing instead of ABS+polycarbonate, polyurethane/silicone adhesive patch, and cloud-based data processing with web display rather than on-device LCD display.

ISO 10993-5 and -10 (biocompatibility), IEC 60601-1 and 60601-1-11 (electrical safety and home healthcare), IEC 60601-1-2 (electromagnetic compatibility), IEC 62304 (software lifecycle), IEC 62366-1 (usability), IEC 62133-2 and UL 1642 (lithium battery safety), ISO 14971 (risk management), and IEEE C63.27-2021 (wireless coexistence).

The subject device uses identical respiratory rate measurement technology (same sensor units and algorithms) as predicate K223681, an earlier Respiree iteration. Both affix to chest via adhesive patch and measure respiration rate for adult patients with equivalent performance range and accuracy. The addition of home-use environment is supported by predicate K222010 (Biobeat), which demonstrates gateway-based cloud processing and web-platform access in home settings. Non-measurement differences (charging port, casing material, patch adhesive, data display method) do not affect core respiratory measurement function and do not raise new safety or effectiveness questions. Software, biocompatibility, and performance testing confirm the device performs as intended within the expanded use environment.