HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)
Edwards LifeSciencesThe HemoSphere Alta Advanced Monitoring Platform is an advanced medical monitoring system used primarily in critical care for adult and pediatric patients. It combines data from various catheters and sensors to continuously measure cardiac output, pressures, blood oxygenation, and derived hemodynamic parameters. The system provides clinicians with insights about cardiac function and patient status through integrated algorithms and a user-friendly interface, supporting decision-making in complex clinical scenarios.
Intended Use
The HemoSphere Alta Advanced Monitoring Platform is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is intended for use with compatible Edwards Swan-Ganz/Swan-Ganz Jr/Swan-Ganz IQ catheters and oximetry catheters, FloTrac/FloTrac Jr sensors, Acumen IQ sensors, TruWave DPTs, ForeSight /ForeSight Jr sensors/ForeSight IQ sensor, Acumen IQ fluid meter and ClearSight/ClearSight Jr/Acumen IQ finger cuffs.
Technology
The device uses an integrated platform with hardware and software that collects hemodynamic data from catheters and sensors including pressure cables and oximetry sensors. It incorporates multiple algorithms such as Right Ventricular Cardiac Output (RVCO), Cerebral Adaptive Index (CAI), Smart Wedge, and Acumen Hypotension Prediction Index (HPI) to process physiological signals and provide continuous monitoring of cardiac and hemodynamic parameters. The GUI is updated to support these algorithms and user convenience.
Performance
The device underwent usability studies following FDA guidance, bench simulation testing for measured and derived parameter validation, system integration and mechanical testing, electrical safety and EMC testing, and comprehensive software verification with all tests passing successfully. No new clinical trials were conducted, but clinical waveform data supported algorithm validation. The device is deemed substantially equivalent to predicate devices with confirmed safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/16/2024
3 months - 2
FDA Approval
12/9/2024
Other devices from Edwards LifeSciences
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.