Philips Holter Analysis System

The Philips Holter Analysis System is software that analyzes ambulatory ECG recordings from DigiTrak XT recorders to detect arrhythmias, measure QT and ST intervals, assess pacemaker function, and evaluate heart rate variability. It is intended for use by trained clinicians in hospitals, clinics, and diagnostic facilities to evaluate adult patients with suspected rhythm disturbances, assess arrhythmia risk, evaluate antiarrhythmic therapy efficacy, and detect myocardial ischemia. The software generates a preliminary analysis for physician review and requires operator intervention throughout.

The subject device shares the same primary applications, screen views, scan modes, and arrhythmia detection capabilities as the predicate. Key differences include: updated operating system support (Windows 10, 11, Server 2016/2019 versus older systems), upgraded AFIB detection using the ST/AR algorithm with P-wave detection (cleared in K101521), enhanced HRV reporting with nonlinear analysis from PhysioNet, addition of Lorenz plot visualization, and minor report format updates for pacemaker analysis. The EASI-derived 12-lead display function remains unchanged from its K020456 clearance.

IEC 60601-2-47:2012 (ambulatory electrocardiographic systems), AAMI EC57:2012 (cardiac rhythm and ST-segment measurement algorithms), IEC 62366-1:2015/AMD 1:2020 (usability engineering), IEC 62304:2006/A1:2015 and IEC 82304-1:2016 (software lifecycle and health software safety), and ISO 14971:2019 (risk management).

The device is substantially equivalent because it performs the same intended functions as the predicate using the same core Zymed Algorithm, shares identical primary applications and analysis capabilities, maintains the same indications for use (narrowed to adult-only population with specific EASI parameter restrictions for safety), and uses the same ECG input source. All algorithm enhancements are incremental improvements to existing features previously cleared in other 510(k)s (ST/AR AFIB from K101521, EASI display from K020456), and the device underwent equivalent performance testing per recognized standards demonstrating no new safety or effectiveness issues. The operating system and hardware updates address cybersecurity and support modernization rather than functional changes to analysis capability.