HemoSphere Nano Monitor (HSNANO1)

The HemoSphere Nano Monitor is a handheld medical device that measures arterial pressure waveforms from a non-invasive finger cuff and displays blood pressure and derived hemodynamic parameters for up to 10 minutes. It is intended for use by healthcare professionals to evaluate cardiac function parameters in adult patients (≥18 years old) in clinical settings.

The device uses the same ClearSight continuous non-invasive blood pressure monitoring technology based on volume-clamp methodology as the predicate device, with identical measured and derived hemodynamic parameters. The key difference is a smaller, integrated form factor with a rechargeable battery and smaller display that allows handheld use, whereas the predicate is modular and larger. Both use the same Acumen IQ Plus finger cuffs and perform equivalent hemodynamic monitoring functions.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304, IEC 62366, IEC 60601-2-57, ISO 81060-2, and FDA guidance documents on software validation and cybersecurity in medical devices.

The HemoSphere Nano Monitor is substantially equivalent to the HemoSphere Advanced Monitoring Platform (predicate K243781) because both have the same intended use, indications, principle of operation (volume-clamp CNIBP technology), and measured hemodynamic parameters. Although the subject device has a smaller form factor and integrated design, verification testing confirmed that these differences do not adversely affect safety and effectiveness, and all performance specifications remain equivalent.