MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)

The MoMe ARC® is a wireless ambulatory ECG monitoring system that detects cardiac arrhythmias in patients with suspected arrhythmias, including those with transient symptoms, requiring drug monitoring, or recovering from cardiac surgery. It consists of a body-worn sensor pod, leads or patch, a gateway mobile app, and a cloud-based software platform that analyzes ECG data and flags abnormalities for physician review. The device is non-invasive, uses standard ECG electrode technology, and is intended for outpatient use only—not for life-threatening arrhythmias requiring hospitalization.

The subject device uses a rechargeable lithium-ion sensor (59×39×11 mm) acquiring 1–2 ECG channels via single patch or 3 disposable electrodes, transmitting via Bluetooth to a handheld gateway with cellular module, then to a cloud-based server. It differs from the predicate in size (smaller sensor, predicate size included gateway) and patient-contacting materials, but both employ identical wireless transmission (Bluetooth/4G cellular), proprietary server-side arrhythmia detection algorithms, and conform to IEC 60601-2-47 ambulatory ECG standards.

ANSI/AAMI ES 60601-1:2005, ANSI/AAMI IEC 60601-1-2:2014, ANSI/AAMI/IEC 60601-2-47:2012, IEC 60601-1-11:2015, IEC 60601-4-2:2016, ISO 10993 series (1, 2, 5, 10, 12, 23), ANSI/AAMI EC57:2012 cardiac rhythm and ST-segment algorithms, IEEE C63.27-2021 wireless coexistence, and FIRST CVSS v4.0 vulnerability assessment.

The subject device has identical intended use (ECG reporting and arrhythmia detection in non-life-threatening cases) and substantially equivalent indications for use as the predicate K230265. Both employ the same technological approach: body-worn sensor, handheld gateway with cellular module, Bluetooth transmission, 4G connectivity, proprietary server-side detection algorithms, and compliance with IEC 60601-2-47. Physical differences (sensor size, materials) do not introduce new safety or effectiveness questions because they reflect normal design iteration on existing ECG technology. Clinical testing on 87 subjects demonstrated sensitivity and positive predictivity meeting predefined acceptance criteria, with heart-rate accuracy within ±0.247 bpm, confirming performance equivalent to the predicate.