AI-ECG Tracker
Shenzhen Carewell Electronics Co., Ltd.AI-ECG Tracker is software designed to assist healthcare professionals in hospitals by automatically analyzing ambulatory ECG data to detect and assess cardiac arrhythmias in adults. It processes ECG waveforms, detects specific ECG features like QRS complexes and ectopic beats, measures intervals and heart rate, and provides advisory interpretations to support clinical diagnosis of arrhythmias, but not as the sole diagnostic tool.
Intended Use
The AI-ECG Tracker is intended to be used by qualified healthcare professionals in hospitals and healthcare facilities for the assessment of arrhythmias using ECG data acquired from adults (age 22 and older) without pacemakers.
Technology
The device is a distributed ECG auto analysis system using AI (convolutional neural network) for beat classification of ECG waveform data uploaded by users. The AI model is locked post-development and does not self-learn. The software provides automated interpretation results and ECG measurements which can be reviewed and modified by physicians. It is developed in C# and C/C++ using Microsoft .Net framework and accessed through an API.
Performance
Bench testing demonstrated the device meets all design specifications and complies with IEC 60601-2-25, AAMI/ANSI EC57, IEC 60601-2-47, IEC 62304 software lifecycle, and ISO14971 risk management standards. Testing showed substantial equivalence to the predicate Monebo Automated ECG Analysis and Interpretation Software Library.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/8/2020
2 months - 2
FDA Approval
3/20/2020
Other devices from Shenzhen Carewell Electronics Co., Ltd.
- AI-ECG Platform2018 • 510K
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