RhythmStar System (SL)

The RhythmStar SL is a portable, wearable cardiac monitor that continuously records ECG data for up to 30 days. It detects arrhythmias (bradycardia, tachycardia, atrial fibrillation) via an embedded algorithm and automatically transmits recorded data to a cloud server for retrospective review by medical professionals at a monitoring center. The device does not provide real-time monitoring, alarms, therapy delivery, or diagnostic interpretation.

The RhythmStar SL is nearly identical to the predicate device (RhythmStar RS-10003, K233584) with one key difference: the distance between electrodes is reduced from 7.5" to 5.5". Both devices feature a 2-lead analog ECG front-end, accelerometer, 256 Hz sampling rate, 4G LTE wireless transmission, rechargeable 3.7V lithium-ion battery (72-hour life), identical dimensions (59×50×15 mm), and the same arrhythmia detection algorithm.

ISO 14971:2019 (risk management), IEC 62304 (software life cycle), ISO 10993-1 (biocompatibility), ANSI/AAMI EC57 (performance testing standard), ANSI/AAMI EC53 and EC12 (ECG device requirements), and FDA Cybersecurity Guidance (penetration and vulnerability testing).

Substantial equivalence is demonstrated because the RhythmStar SL has an identical intended use (continuous ECG monitoring and arrhythmia detection) and equivalent technological characteristics to the predicate device. The electrode spacing reduction does not affect device performance, as confirmed by additional performance testing showing identical beat detection and algorithm performance using the new lead placement in real-world clinical datasets.