ZBPro Diagnostic

ZBPro Diagnostic is a cloud-based software system that analyzes Holter ECG recordings to detect and classify cardiac arrhythmias in adult, non-paced patients. It processes 24–48 hour retrospective ECG data (Lead II, CM5, or Modified-MLII) and provides beat-by-beat analysis including QRS detection, ventricular ectopic beat detection, heart rate measurement, and rhythm classification. The system is intended for use by qualified healthcare professionals as an advisory tool only, not as a sole diagnostic means.

Both ZBPro Diagnostic and the predicate (Cardiologs Holter Platform) are cloud-based ECG analysis systems accessed via secure web browsers with RESTful API integration. Both employ proprietary ECG interpretation algorithms, provide QRS detection, ventricular ectopy detection, R-R interval and heart rate measurement, and rhythm analysis. Key differences are algorithmic implementation details and scope: ZBPro is limited to adult, non-paced Holter ECG data (Lead II, CM5, Modified-MLII) via standard formats (MIT-BIH, EDF, ISHNE), while Cardiologs supports pediatric and paced patients plus event recorders and 12-lead ambulatory ECG. ZBPro is validated for Google Chrome; Cardiologs supports broader cross-platform compatibility.

Performance testing was conducted per AAMI ANSI IEC 62304:2006 (medical device software lifecycle), IEC 62366-1:2015-02 (usability engineering), AAMI ANSI EC57:2012 (cardiac rhythm and ST-segment measurement algorithm performance), and AAMI ANSI IEC60601-2-47:2012 (ambulatory electrocardiographic systems safety and performance). Validation included rhythm classification analysis on an adjudicated database and noise stress testing using the ZBPro Noise Stress Testing (ZNST) database.

ZBPro Diagnostic is substantially equivalent because it shares identical intended use (arrhythmia detection in adult Holter ECG data) and core technological function with the predicate, employing the same well-established signal processing and QRS detection principles. Although ZBPro has narrower patient population and input compatibility than Cardiologs, these are scope-of-validation differences managed through labeling restrictions and do not introduce new safety or effectiveness questions. Both systems provide identical functional capabilities (ECG processing, rhythm analysis, ventricular ectopy detection) and neither is designed for real-time monitoring or life-sustaining applications; both require clinician oversight and are advisory only. The algorithmic and architectural differences (different programming languages and cloud platforms) do not alter the fundamental shared purpose of retrospective Holter ECG analysis and are mitigated by validated performance, labeling, and risk controls.