myAir

myAir is a mobile application that allows patients prescribed compatible ResMed therapy devices (PAP, NIV) and NightOwl home sleep apnea test devices to control their devices via Bluetooth, simulate therapy settings, and track device usage. The app serves as a patient self-monitoring and engagement platform for managing sleep-disordered breathing and respiratory impairment in home and hospital settings.

myAir differs from the predicate (EasyCare Online) in several implementation aspects: it uses Bluetooth connectivity instead of cloud infrastructure, runs on smartphone displays rather than webpages, targets patients as end-users rather than healthcare specialists, and adds compatibility with NIV therapy devices and NightOwl HST sensors. The underlying clinical purpose and operating principles remain the same—transferring, displaying, and using data from compatible ResMed therapy devices to support patient care.

Not stated in this summary. The document references FDA guidance documents including 'Content of Premarket Submissions for Device Software Functions' (June 2023) and 'Cybersecurity in Medical Devices' (March 2024), and indicates compliance with ISO 13485 quality management system requirements, but specific test standards or consensus standards are not cited.

The subject device myAir is substantially equivalent to the predicate EasyCare Online because both share the same general intended use (supporting management of sleep-disordered breathing through data transfer and display from compatible ResMed devices), similar technological characteristics and operating principles, and the identified differences relate only to implementation and workflow (Bluetooth vs. cloud, mobile vs. web interface, patient vs. clinician end-user) rather than intended use or safety/effectiveness. Non-clinical testing demonstrated the device meets acceptance criteria and does not raise new safety or effectiveness questions.