RTMsense Respiratory Monitoring System

The RTMsense Respiratory Monitoring System is a wearable acoustic monitoring device that continuously measures respiratory rate by analyzing tracheal airflow sounds during breathing. It consists of a single-use wearable trachea sound sensor adhered to the patient's neck, wirelessly transmitting data to a Lenovo tablet for real-time display and analysis. It is intended for use by healthcare professionals in post-operative care and general ward settings to monitor breathing in adults aged 22 years and older, with measurements serving as an adjunct to other clinical information.

The subject device uses acoustic signals from the proximal trachea (versus the upper airway in the predicate), includes wireless Bluetooth transmission capability (predicate is software-only), and is battery-powered rather than AC-powered. Both devices provide continuous, non-invasive respiratory rate monitoring using proprietary software algorithms analyzing acoustic signals, display results graphically against time, and apply sensors at the neck. The subject device has a narrower respiratory rate range (8–22 ± 1 BPM versus 4–35 ± 2.7 BPM) and lacks alarm functionality present in the predicate.

ISO 10993-1, ISO 10993-5, and ISO 10993-10 for biocompatibility; IEC 60601-1 and IEC 60601-1-2 for electrical safety and electromagnetic compatibility; IEEE ANSI C63.27-2021 for wireless coexistence; IEC 62366-1 for usability; ISO 14971 for risk management; and FDA guidance documents on device software and cybersecurity.

Both the subject and predicate devices provide continuous, non-invasive respiratory monitoring in adult patients using acoustic analysis of airflow in the upper airway/trachea, with graphical display and proprietary algorithms. Performance and safety testing—including connection/transmission, signal output, adhesion, battery functionality, and clinical validation studies comparing accuracy to gold-standard capnometry (44 subjects, 150+ breath samples, mean absolute error <3%, no statistically significant difference)—demonstrated that technical differences (wireless capability, battery power, narrower RR range, proximal versus upper airway monitoring) do not raise new safety or effectiveness concerns. The narrower clinical use environment (post-operative/general wards versus procedural sedation) and absence of alarms are supported by the adjunctive-use indication, making the subject device substantially equivalent to the Airmod predicate.