CloudHRV™ System (100-01-001)

The CloudHRV™ System is an electrocardiograph that acquires approximately 5 minutes of 3-lead ECG data from adult patients (age 22+) with normal sinus rhythm and resting heart rates of 40–110 bpm while supine and at rest. It measures heart rate variability (HRV) using proprietary algorithms and displays results to clinicians; the measurements are not intended for specific clinical diagnosis, and clinical significance must be determined by the physician. The device is indicated for use in healthcare facilities such as physician offices or hospital outpatient clinics, but not in surgical suites or during transport.

Both devices measure HRV from ECG signals using proprietary algorithms and display similar parameters including real-time ECG waveform, heart rate, and HRV indices (SDNN, SDSD, RMSSD, frequency-domain indices). The CloudHRV uses 3-lead (I, II, III) acquisition at 500 samples/sec with 16-bit bipolar sampling and 0.5 Hz to 113 Hz frequency response, compared to the predicate's 12-lead acquisition at 200 samples/sec with 0.5 Hz to 40 Hz response. Both use Class II Type CF device classification and the same AC adapter specifications; CloudHRV stores data in secure cloud infrastructure rather than USB storage.

IEC 60601-1:2005+A1:2012+A2:2020 (general medical electrical equipment safety), IEC 60601-1-2:2014+A1:2020 (electromagnetic disturbances), IEC 60601-2-25:2011/(R2016) (electrocardiographs), IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 (usability), IEC 62366-1:2015+AMD1:2020 (usability engineering), ANSI/AAMI EC57:2012 (cardiac rhythm algorithms), ANSI/AAMI EC53:2013/(R2020) (ECG cables), ASTM D4169-22 (shipping container performance), and IEC 62304:2006+AMD1:2015 (software lifecycle).

The CloudHRV System has the same intended use (acquiring and displaying ECG information to measure HRV for clinical assessment, not diagnosis) and the same regulatory classification (Class II electrocardiograph, DPS product code) as the predicate ANSiscope. Both devices separate sympathetic and parasympathetic components of the autonomic nervous system and display comparable HRV parameters including time-domain and frequency-domain indices. Although CloudHRV uses a different electrode placement (wrists and ankles vs. chest and torso) and higher sampling rate (500 vs. 200 samples/sec), these represent improvements that do not raise new safety or effectiveness questions. The cloud-based data storage and 3-lead versus 12-lead acquisition are design variations that do not change the fundamental safety and performance profile relative to the predicate.