Personalized Therapy Comfort Settings (PTCS)

PTCS is an AI-enabled software accessory for ResMed PAP therapy devices that provides optional, non-prescription comfort setting recommendations (ramp, EPR, AutoSet Response) to support patient therapy engagement during device onboarding and early use. The recommendations are optional and do not automatically adjust prescribed therapy parameters or alter configuration limits.

PTCS uses a machine learning algorithm to generate individualized comfort setting recommendations based on patient-specific input data, unlike the predicate myAir which provides direct user control. Both are Class II software accessories operating within ResMed PAP device systems, but PTCS has no user interface, does not control devices, and communicates via HTTPS and API rather than Bluetooth.

Not stated in this summary. The document references FDA guidance documents including 'Content of Premarket Submissions for Device Software Functions' (June 2023), 'AI-Enabled Device Software Functions: Lifecycle Management' (January 2025), 'Good Machine Learning Practice for Medical Device Development', and 'Cybersecurity in Medical Devices' (March 2024), but does not cite specific consensus standards like ISO or IEC.

PTCS is substantially equivalent to predicate myAir (K250624) because both are optional software accessories for ResMed PAP devices with similar intended use and technological characteristics. The differences—ML-based recommendations versus direct control, no user interface, API communication—do not raise new safety or effectiveness questions since PTCS only recommends existing comfort settings within established device limits and does not alter prescribed therapy.