HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)

The HemoSphere Alta Advanced Monitoring Platform is a next-generation cardiac monitoring system that displays hemodynamic and volumetric data for critical care patients in hospital settings. It works with various catheters and sensors (Swan-Ganz, oximetry, pressure cables) to monitor cardiac output, oxygen saturation, blood pressure, and derived hemodynamic parameters in adult and pediatric patients. The system includes new algorithms for right ventricular cardiac output (RVCO), global hypoperfusion index, and hypotension prediction to assist clinicians in hemodynamic assessment.

The subject device uses the same platform hardware as its primary predicate (K232294) but includes new hardware configurations for pressure and AFM cables with modified connectors. Key new features include the RVCO algorithm (a machine-learning algorithm using right ventricular pressure waveforms to calculate continuous cardiac output), integration of previously-cleared algorithms (CAI, Smart Wedge, tHb measurement), updated software supporting integrated algorithms, an updated graphical user interface, and modifications allowing pulse rate as an alternative to heart rate for parameter calculations. The device maintains the same indications and intended use as predicates but expands pediatric applicability to patients ≥12 years of age.

The device complies with 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, and IEC 80601-2-49. Testing included electrical safety, electromagnetic compatibility (EMC), software verification per FDA guidance for software in medical devices, system integration, mechanical testing, human factors usability per FDA guidance, and bench simulation of measured and derived parameters.

The subject device is substantially equivalent because it shares the same fundamental platform, intended use, indications for use, and technological characteristics as the primary predicate (K232294). Technological differences (new RVCO algorithm, updated cables, GUI modifications, integration of previously-cleared algorithms) do not adversely affect safety or effectiveness, as demonstrated by comprehensive verification testing including bench simulation, system integration, mechanical testing, electrical safety, EMC compliance, software verification, and human factors usability studies. The RVCO algorithm is built on the same physiological principles and technologies (RVP and iCO algorithms) already cleared in the predicate, merely combining them through machine learning trained on large-scale clinical data. All new features either reuse existing cleared technologies or have been previously cleared as standalone submissions and are now integrated into this platform.