CardioTag™

The CardioTag is a wearable device that records and displays cardiac vibrations (seismocardiogram), single-channel ECG, and pulse waveforms via photoplethysmography. It measures heart rate, pulse rate, and aortic valve timing. Intended for spot-check measurements of adult patients in clinics or home settings under physician care, with data provided to healthcare professionals as a diagnostic aid.

The CardioTag combines outputs from two predicate devices into one all-in-one wearable solution. Both the subject and primary predicate are reusable, battery-powered, chest-worn devices performing spot-check (non-continuous) measurements with ECG and vibration waveform outputs in reports. The subject and secondary predicate are both battery-powered, reusable spot-check devices outputting PPG waveforms and using PPG for heart rate calculation. Minor technological differences were addressed through risk management, bench-testing, clinical testing, and FDA-recognized standards application.

ISO 10993-1 (Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process); FDA guidance on software content in premarket submissions (November 2021); standards for electrical safety, defibrillation-proof applied parts, and electromagnetic compatibility (EMC) and RF disturbance immunity.

The CardioTag has identical intended use as the predicates and similar technological characteristics as a reusable, battery-powered, chest-worn spot-check device. Bench-testing confirmed ECG, PPG, and SCG functions met specifications; biocompatibility testing (cytotoxicity, sensitization, irritation) passed for limited skin contact; electrical safety and EMC testing complied with applicable standards; and clinical study demonstrated acceptable performance compared to commercially available devices with high accuracy. These comprehensive test results demonstrate that technological differences do not raise new safety or effectiveness questions.