myAir

myAir is a mobile app that allows patients with compatible ResMed PAP therapy devices (Air10/Air11) or NightOwl home sleep test sensors to control their devices via Bluetooth, simulate therapy settings, track usage data, and adjust comfort settings. The app serves as a patient engagement and self-monitoring platform for home and hospital use in patients weighing over 66 pounds.

The subject device adds device control functions (starting/stopping therapy and adjusting comfort settings) to the predicate. Both use Bluetooth connectivity, communicate via HTTPS with cloud services, support Test Drive and HST workflows, display on smartphone screens, and connect to ResMed Air11 platform devices and NightOwl HST sensors. The subject device is available on Apple App Store while the predicate was on Google Play Store.

FDA guidance documents on Content of Premarket Submissions for Device Software Functions (June 2023) and Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (September 2023).

The subject device is substantially equivalent because it shares the same intended use (patient control and monitoring of PAP therapy devices), uses identical technological platforms (Bluetooth, cloud connectivity, same target devices), and the addition of device control functions does not raise new safety or efficacy questions since these are comfort adjustments, not therapeutic parameter changes. Non-clinical testing demonstrated the new software functions met all intended performance requirements.