Airmod

Airmod is an Android-based software application that monitors respiratory rate in sedated or anesthetized adult patients during procedural sedation. It uses acoustic signals from breathing sounds detected by an AccurSound Electronic Stethoscope AS-101 placed on the patient's neck, processes these signals through AI-based algorithms, and displays continuous respiratory rate measurements for use by credentialed healthcare professionals in hospitals and healthcare facilities.

Airmod uses acoustic signal processing from upper airway sounds to calculate respiratory rate, with sensors placed on the patient's neck, whereas the primary predicate uses pulse oximetry with finger-mounted sensors. Both devices are software-based systems providing continuous respiratory rate monitoring with similar accuracy ranges (Airmod: 4-35 ±2.7 breaths/min; predicate: 4-40 ±1 breath/min). Airmod operates as a mobile Android application, while the predicate is integrated software on a patient monitor.

IEC 62304 for software testing; FDA guidance on Content of Premarket Submissions for Device Software Functions; FDA guidance on Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; bench performance testing including active noise cancellation validation.

The intended use is substantially similar: both continuously monitor respiratory rate non-invasively in adult patients in hospital settings. Although Airmod uses acoustic signals instead of pulse oximetry and places sensors on the neck rather than the finger, these technological differences do not present new safety or effectiveness issues because: (1) clinical testing demonstrated non-inferiority to capnography with RMSE of 2.689 BPM, meeting the primary outcome; (2) the reference predicate K120984 (Masimo Acoustic Monitoring) supports acoustic-based respiratory monitoring as an established technology; and (3) the performance characteristics are within the established ranges for respiratory rate monitors.