Avidhrt Sense SpO2

The Avidhrt Sense SpO2 is a handheld, spot-checking oximeter that measures functional oxygen saturation of arterial hemoglobin (SpO2) and pulse waveform via pulse oximetry. It is intended for non-invasive spot checking in adult patients in the home environment during stationary conditions and is not for continuous monitoring, use during motion, or in patients with low perfusion.

Both the Avidhrt Sense SpO2 and predicate device use pulse oximetry to measure SpO2. The primary technological difference is the measurement method: Avidhrt uses reflectance pulse oximetry while the Masimo MightySat Rx uses transmittance. Both devices measure SpO2 and pulse rate; the predicate also measures respiration rate, which the subject device does not include.

ISO 80601-2-61 (pulse oximetry), IEC 60601-1 and IEC 60601-1-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), ANSI C63.27 (wireless coexistence), ISO 10993-1 (biocompatibility), and IEC 80601-2-61 (clinical performance including hypoxia study).

Avidhrt has the same intended use as the predicate—noninvasive spot-checking of SpO2 in adults—but for a narrower patient population and use environment (home, no motion, well-perfused only). The technological difference in pulse oximetry method (reflectance vs. transmittance) does not raise different safety or effectiveness questions because both methods employ the same pulse oximetry principle. Performance testing per ISO 80601-2-61 demonstrated equivalent accuracy across SpO2 ranges, meeting prespecified criteria and confirming the device performs as intended with no new safety concerns.