Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)

The Aulisa Oximeter Module (2nd Gen.) is a wireless, wrist-worn sensor that continuously measures and displays a patient's pulse rate and oxygen saturation (SpO2) using red and infrared light technology. It transmits data via Bluetooth to a commercial mobile device running an Aulisa-developed application for display and review. It is indicated for spot-checking and/or continuous monitoring of SpO2 and pulse rate in adult and pediatric patients during non-motion and well-perfused conditions in hospitals, medical facilities, home care, and subacute environments.

The subject device uses identical red (660 nm) and infrared (905 nm) wavelengths as the predicate devices and achieves the same measurement accuracy (SpO2 ±3 digits, pulse rate ±3%). It differs primarily in charging method—using a Type C connector for direct charging rather than a charging case—and in use environment scope, as the primary predicate was limited to hospitals while the subject device covers multiple settings like the secondary predicate.

Testing referenced ISO 80601-2-61 (pulse oximeter performance), IEC 60601-1 and IEC 60601-1-11 (electrical safety and home healthcare), IEC 60601-1-2 (electromagnetic compatibility), ISO 10993-5/10/23 (biocompatibility), ANSI C63.27 (wireless coexistence), and FDA guidance documents on pulse oximeters, software validation, cybersecurity, usability, and human factors.

The device is substantially equivalent because it maintains identical intended use (measuring SpO2 and pulse rate wirelessly), identical technology (red/infrared wavelengths), identical measurement specifications and accuracy (±3 digits SpO2, ±3% pulse rate), identical patient populations (adult/pediatric), identical measurement site (finger), and identical wireless communication method (Bluetooth). Minor differences in charging mechanism and expanded use environments do not affect safety or effectiveness, and performance testing confirmed compliance with the same standards as the predicate devices.