iBSM

The iBSM is a wireless patient monitoring system for general care hospital patients (18+ years) that continuously displays ECG waveforms, heart rate, respiratory rate, SpO2, skin temperature, blood pressure, body position, and fall detection. It is not intended for critical care, home use, ICU/CCU, or surgery rooms, and operates through wearable sensors paired with a tablet application that transmits data to an external server.

The iBSM uses third-party FDA-cleared wearable sensors (ANNE Chest and ANNE Limb from Sibel Health) paired with an iBSM View application running on Android 12 tablets with a docking station. It communicates internally via Bluetooth LE and externally via WiFi LAN. Performance specifications match the predicate: HR range 30–270 bpm (±5 bpm or ±10%), RR 8–35 brpm (±3 brpm), SpO2 70–100% (±3% ARMS), temperature 73.2–109.4°F (±0.54°F), NIBP 0–300 mmHg (±3 mmHg).

IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-1-2:2014, IEC 60601-1-6:2010, IEC 60601-1-8:2006, IEC 60601-2-27, IEC 60601-2-47, IEC 80601-2-30, IEC 80601-2-49, ISO 80601-2-56:2017, ISO 80601-2-61:2017, IEC 62304:2015, ANSI C63.27, ISO 10993-5:2009, ISO 10993-10:2021, and ASTM D4169.

iBSM is substantially equivalent to ANNE One (K223711) because it measures identical physiological parameters (ECG, HR, RR, SpO2, temperature, body position, fall detection) using the same type of third-party FDA-cleared sensors with matching performance specifications and accuracy ranges. Both are Class II devices regulated under 21 CFR 870.2910, use identical wireless communication (Bluetooth LE and WiFi), undergo the same safety and performance testing standards, and are designed for general care patient monitoring in hospital settings. The primary difference—iBSM restricts use to healthcare settings only while ANNE One permits home use—does not alter the fundamental technology or safety profile of the monitoring function itself.