Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)

The Aulisa Infant Oximeter Module (2nd Gen.) is a wireless, foot-worn sensor that continuously measures and displays pulse rate and oxygen saturation (SpO2) in infant patients. It transmits data via Bluetooth to a mobile device running Aulisa software for display and review, and is intended for spot-checking or continuous monitoring in hospitals, medical facilities, home care, and subacute environments during non-motion and well-perfused conditions.

The subject device uses red (660 nm) and infrared (905 nm) LED technology, achieving SpO2 accuracy of ±3 digits (70–100%) and pulse rate accuracy of ±3 digits (30–290 bpm). It connects directly to an AC charger via USB Type-C, whereas predicate devices used a charging case. Both subject and primary predicate use Bluetooth only; the secondary predicate adds Wi-Fi. All three measure at the foot and are reusable.

ISO 80601-2-61 (pulse oximeter performance), IEC 60601-1 and IEC 60601-1-11 (electrical safety and home use), IEC 60601-1-2 (EMC), ISO 10993-5/10/23 (biocompatibility), ANSI C63.27 (wireless coexistence), and FDA guidance on pulse oximeters, software V&V, cybersecurity, human factors, and clinical testing.

The subject device has identical indications for use, measurement parameters (SpO2 and pulse rate), measurement sites (foot), use environments, and technology (red/infrared LEDs with Bluetooth transmission) as the predicate devices. Minor differences—such as the 905 nm versus 880 nm infrared wavelength, stricter pulse rate accuracy range (30–290 bpm vs. 30–300 bpm), and direct USB Type-C charging instead of a charging case—do not affect safety or effectiveness. Clinical testing confirmed SpO2 ARMS <3 digits over 70–100%, meeting manufacturer specifications and predicate performance.