VitalSigns 1-Lead Holter (VSH101)

The VitalSigns 1-Lead Holter (VSH101) is a wearable ECG recorder that captures single-channel electrocardiogram data via a chest electrode patch and transmits it wirelessly over Bluetooth to a mobile iOS app (VSHealth) for storage and display. It is intended for use by healthcare professionals, patients with known or suspected cardiac conditions, and health-conscious individuals, with ECG data serving as supplementary patient information for manual interpretation only, not automated analysis.

The VSH101 uses a rechargeable lithium battery (3.7V/160mAh/0.59Wh) and a proprietary VS Electrode Patch composed of 3M medical tape and AmGel AG600 hydrogel, compared to the predicate's coin-cell battery and standard attachable electrodes. Both devices record one ECG channel via Bluetooth Low Energy (2402–2480 MHz) and display data on mobile apps. The VSH101 provides 24-hour data storage capability, whereas the predicate's storage was not specified.

ISO 10993-1 (biocompatibility), IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-2-47 (ECG monitors), IEC 60601-1-11 (home use), IEC 62304 (software lifecycle), ISO 14971 (risk management), IEC 62366-1 (usability), ANSI/AAMI EC12 (ECG electrodes), IEEE/ANSI C63.27 (RF immunity), and FDA guidance on biocompatibility, cybersecurity, and software in medical devices.

The VSH101 shares the same regulatory classification (Class II), product code (DXH), indications for use, single-channel ECG technology, Bluetooth transmission, and mobile app viewing platform as the predicate eCordumTM Cardiac Monitor. Although the battery type and electrode design differ, the applicant demonstrated through performance testing (including IEC 60601-2-47 compliance) that these differences do not affect safety or effectiveness. The rechargeable battery and improved electrode composition were validated to meet performance criteria without raising new safety concerns, and all software, EMC, and biocompatibility testing confirmed functional equivalence.