Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050

The Vios Monitoring System Model 2050 is a wireless vital signs monitoring platform for healthcare facilities that continuously tracks 7-lead ECG, heart rate, respiratory rate, pulse rate, blood oxygen saturation, non-invasive blood pressure, patient posture, and activity in adult patients. It includes a wearable chest sensor, finger pulse oximeter adapter, and central monitoring station software that displays patient data and generates alerts for arrhythmias and out-of-range vital signs.

The subject device adds a new blood pressure tracking feature based on Pulse Arrival Time (PAT) derived from ECG and PPG waveforms, requiring calibration with an FDA-cleared oscillometric cuff device. The ECG and PPG sensor components remain unchanged from the secondary predicate K172586, and the PAT-based blood pressure principle is identical to the primary predicate ViSi Mobile (K130709). The central station software is updated only with UI modifications to display the new blood pressure data.

IEC 80601-2-30 (system validation and compliance), ISO 81060-2 (non-invasive blood pressure measurement), IEEE 1708, ISO 81060-3 (invasive reference validation), IEC 60601-1, IEC 60601-1-2, IEC 60601-2-27, IEC 60601-2-49, ISO 10993 (biocompatibility), EN 62304 (software lifecycle), EN 62366 (usability), ISO 14971 (risk management), ISO 80601-2-61 (pulse oximetry), ANSI C63.27 (wireless coexistence), and ASTM D4169-16 (transportation).

The subject device uses the identical PAT-based blood pressure algorithm and calibration methodology as the primary predicate ViSi Mobile (K130709), with no changes to the underlying technological principle. The physical sensors for ECG and PPG acquisition remain unchanged from secondary predicate K172586. Clinical testing using invasive radial artery reference standards demonstrated performance meeting consensus standards with acceptance criteria equivalent to the predicate device. Since the new feature employs proven technology from an existing predicate, the physical components are unmodified, and clinical validation demonstrates equivalent performance, substantial equivalence is established without raising new safety or effectiveness questions.