Philips Holter Analysis System
Philips Medizin Systeme Böblingen GmbHThe Philips Holter Analysis System is a standalone software designed to analyze ambulatory ECG recordings collected over extended periods (typically 24 hours to 7 days). It automatically processes ECG data to detect heart rhythm disturbances, arrhythmias, pacemaker function, and myocardial ischemia-related symptoms, providing reports to assist clinicians in evaluating cardiac health. The system enhances arrhythmia detection algorithms and heart rate variability analysis and integrates with clinical information systems for streamlined ECG data management.
Intended Use
The Philips Holter Analysis System provides measurements, data, and reporting of parameters such as normal sinus rhythm, arrhythmias, QT and ST measurements, paced beats analysis and HRV, for evaluation of symptoms that may be related to rhythm disturbances of the heart in adult patients, risk assessment of arrhythmia, efficacy of antiarrhythmic therapy, pacemaker function, and symptoms related to myocardial ischemia.
Technology
A standalone software installed on general purpose PCs that analyzes ambulatory ECG recordings collected from DigiTrak XT recorders (up to 168 hours) using the Zymed Algorithm with enhancements such as improved AFIB detection using Philips ST/AR AFIB algorithm, advanced heart rate variability calculations including nonlinear HRV, and EASI derived 12-lead ECG display for visualization. It supports multiple scan and analysis modes and interoperability with clinical systems.
Performance
The system underwent rigorous non-clinical bench testing for performance and functionality including compliance with IEC 60601-2-47:2012, AAMI EC57:2012, IEC 62304, IEC 62366-1, and IEC 82304-1 standards. Human factors/usability testing and software validation were performed with all tests passed, demonstrating safety and substantial equivalence to the predicate device. No clinical trials were required.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/28/2024
8 months - 2
FDA Approval
3/21/2025
Other devices from Philips Medizin Systeme Böblingen GmbH
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