SafeBeat Rx App

The SafeBeat Rx App is a software-as-a-medical-device that analyzes ECG data from external sources to provide provisional measurements including QT/QTc intervals, QRS duration, heart rate, and RR intervals, with visual display of key waveform features. It is intended for use by qualified healthcare professionals in professional healthcare facilities and optionally for home-based long-term monitoring, but does not provide real-time display, continuous monitoring, or alarm functions.

SafeBeat Rx App uses machine learning-based algorithms for QT interval measurement and includes beat-level feature identification and interval estimation with noise filtering. The predicate (CardioLogs) uses traditional ECG signal processing without machine learning for QT calculation. Both devices provide similar user interfaces for ECG measurement, analysis, and review; both operate as cloud-based software; both support 12-lead and reduced lead set ECG formats.

AAMI ANSI IEC 62304 (software lifecycle), IEC 60601-2-25 (electrocardiograph safety), IEC 60601-2-47 (ambulatory ECG systems), IEC 62366-1 (usability engineering). Testing included validation against CSE and IEC reference databases, cardiologist annotations, beat-segment detection sensitivity/specificity, and heart rate/RR measurements.

SafeBeat Rx App is substantially equivalent because it has the same overall intended use (ECG analysis for healthcare professionals on adult patients) and comparable technological characteristics to the predicate CardioLogs platform. Although SafeBeat uses machine learning for QT measurement (not in the predicate), a reference device (AliveCor QT Service) demonstrates that ML-based QT calculation is well-established in FDA-cleared devices. Comprehensive validation testing shows SafeBeat performs as well as or better than the predicate with no new safety or effectiveness concerns, establishing at least equivalent safety and efficacy.