AT-Patch (ATP-C130/ATP-C70)
ATsens Co.,Ltd.The AT-Patch (ATP-C130/ATP-C70) is a wearable ECG monitoring device that records cardiac electrical activity for up to 14 or 7 days respectively. It collects ECG data from a patch worn on the patient's torso, which is then analyzed by software algorithms to detect arrhythmias and other cardiac events. A physician reviews this analysis to provide a report to help clinicians diagnose heart conditions, aiding in the management of symptoms like palpitations, dizziness, and fatigue.
Intended Use
The device is intended to measure, analyze, edit and report continuous electrocardiogram (ECG) information for long-term recording by attaching to the patient’s torso. It is used on patients 18 years or older who may be asymptomatic or have transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, fatigue, or anxiety.
Technology
The system includes an ECG recorder patch device (two models ATP-C130 for 14 days and ATP-C70 for 7 days), an analysis software (AT-Report), and an app (AT-Note) used to check device operation. The device records ECG signals via a single channel with a 250 samples/sec sampling rate, stores data internally, and transmits the recording after completion to the analysis software which uses machine learning algorithms for arrhythmia detection. Bluetooth Low Energy (BLE) is used for communication.
Performance
The device underwent electrical safety, EMC, biocompatibility, software validation, cybersecurity, usability, as well as performance testing of arrhythmia detection accuracy using a diverse dataset reflecting the US population demographics. Testing included compliance with IEC and ANSI/AAMI standards for ECG and medical electrical equipment. Accuracy was measured with sensitivity, positive predictive value, and false positive rate metrics. The results support the device's safety and effectiveness in detecting arrhythmias.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/30/2024
8 months - 2
FDA Approval
5/2/2025
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