Pulse Oximeter ( PO2, PO2A, PO2B)

The Pulse Oximeter (models PO2, PO2A, PO2B) is a non-invasive finger-ring device that measures and displays functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adults. It is intended for spot-check and/or continuous data collection in sleep labs, long-term care facilities, hospitals, and home use, but not for continuous monitoring.

The subject device uses an integrated SpO2 sensor built into the ring, whereas the predicate (Checkme O2) uses an external detachable sensor with cable. Both employ red (660 nm) and infrared (940 nm) LEDs, have the same ring-type finger application, identical performance specifications (SpO2 accuracy ±2% at 70-100%), OLED displays, Bluetooth connectivity, and lithium rechargeable batteries. The subject device is slightly smaller (38mm × 29mm × 18mm vs. 44mm × 25mm × 15mm).

IEC 60601-1 (Edition 3.2), IEC 60601-1-2 (Edition 4.1), IEC 60601-1-11 (Edition 2.1), ISO 80601-2-61 (Second edition), ISO 10993-5, ISO 10993-10, and ISO 10993-23 for biocompatibility. FDA Guidance on Non-Invasive Pulse Oximeter (March 4, 2013) and FDA Guidance on Software Premarket Submissions were also referenced.

The subject device is substantially equivalent because it uses the same sensing mechanism (red and infrared light absorption), achieves identical SpO2 and pulse rate performance specifications, and conforms to all the same applicable standards as the predicate. Although the subject uses an integrated sensor instead of an external detachable sensor, both sensors maintain the same ring-type design with no changes to LED components, emission power, or finger-pad size. The size difference does not affect performance. Clinical validation demonstrated SpO2 measurement accuracy of 1.77% ARMS, meeting the ≤2% requirement.