HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)

The HemoSphere Alta Advanced Monitoring Platform is a next-generation hemodynamic monitoring system that displays cardiac output, oxygen saturation, pressure, and derived hemodynamic parameters on a screen. It integrates multiple monitoring technologies including Swan-Ganz catheters, oximetry cables, pressure sensors, and noninvasive finger cuffs for use in critical care settings, operating rooms, and emergency departments in adult and pediatric patients.

The subject device uses the same hardware platform as the predicate (K242451). Key differences include updated software supporting a new Smart Pressure Controller and Acumen IQ Plus finger cuff, an enhanced graphical user interface accommodating new features like Oxygen Delivery/Consumption trending screens and Cerebral Autoregulation Index secondary screens, and cybersecurity updates. The device maintains identical core technological elements and design principles as the predicate.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304, IEC 62366-1, IEC 60601-2-34, IEC 60601-2-57, IEC 60601-2-49, IEC 60529-1, and IEC 80601-2-49. Testing also followed FDA guidance on human factors and usability engineering and software verification for medical devices.

The subject device is substantially equivalent to predicate K242451 because it maintains the same core technology, hardware platform, and intended use for hemodynamic monitoring in critical care. Although software enhancements and a new accessory were added, comprehensive verification testing including usability, system integration, electrical safety, EMC, and software verification demonstrated no adverse effects on safety or effectiveness. The device does not raise new questions of safety or effectiveness.