ZEUS System (Zio Watch)
iRhythm Technologies, Inc.The ZEUS System (Zio Watch) is a prescription-based wearable device and software system that uses AI to analyze cardiac signals from an ECG and PPG sensor to detect and report atrial fibrillation. It provides clinicians with detailed reports to aid in diagnosing and managing atrial fibrillation in adult patients.
Intended Use
The ZEUS System (Zio Watch), as part of the Zio Watch Service, is intended to process and analyze electrocardiogram (ECG) and photoplethysmogram (PPG) based data to detect and report on the presence of Atrial Fibrillation (AF) over the monitoring period.
Technology
The ZEUS System is a software as a medical device (SaMD) consisting of modules that process ECG and PPG data collected from the Zio Watch wearable device. It uses machine learning algorithms—the ECG Deep Learned (ECGDL) software for ECG analysis and the AF Context Engine (ACE) for PPG data analysis—to generate preliminary findings for clinician reports. Results include AF detection and heart rate measurements, with technician quality review before reporting.
Performance
Performance, verification, and validation testing demonstrated conformance to FDA-recognized standards and that design requirements and intended use were met without raising new safety or efficacy issues. Algorithms were trained on continuous recordings annotated by Certified Cardiographic Technicians and validated on large datasets from ambulatory patients using simultaneous ECG and PPG recordings.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/19/2021
9 months - 2
FDA Approval
7/19/2022
Other devices from iRhythm Technologies, Inc.
- ZEUS System2023 • 510K
- Zio ECG Utilization Software (ZEUS) System2021 • 510K
- Zio XT ECG Monitoring System, Zio AT ECG Monitoring System2019 • 510K
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