Radius VSM and Accessories

The Radius VSM is a wearable, battery-operated multi-parameter patient monitor for use in hospitals and healthcare facilities. It measures hemodynamic parameters (ECG, arrhythmia detection, blood pressure, SpO₂, pulse rate, PVi, heart rate, temperature), respiratory parameters (respiration rate), and patient orientation/activity in adults.

The subject device adds a Mean Arterial Pressure (MAP) calculation feature using the formula MAP = 1/3×Systolic + 2/3×Diastolic, which automates computation from previously cleared systolic and diastolic measurements. No changes were made to hardware, display, alarms, wireless capabilities, battery, mechanical specifications, or other performance parameters compared to the predicate device K223498.

ISO 81060-2 (blood pressure measurement), ISO 80601-2-56 (thermometer validation), ANSI/AAMI SP10 (NIBP performance), IEC 60601-1 (electrical safety and EMC), and FDA guidance on software device software functions (June 2023).

The subject and predicate devices have identical intended use, principle of operation, mechanism of action, and patient population. The sole difference is the addition of MAP, a derived parameter calculated from pre-cleared systolic/diastolic values using an established standard formula requiring no new hardware. Bench testing validated MAP calculation accuracy, clinical testing compared device-calculated MAP against invasively measured reference values per ISO 81060-2, and software V&V testing supported the feature. These studies demonstrate the MAP feature does not raise different safety or effectiveness questions.