SANSA HSAT

The SANSA HSAT is a wearable chest patch device that records physiological signals including oxygen saturation, heart rate, chest movement, snoring, body position, respiratory effort, sleep staging, and ECG to aid clinicians in evaluating sleep-related breathing disorders in adults suspected of sleep apnea. The device is used in clinical and home settings under healthcare professional direction, with data analyzed on a cloud-based platform.

The subject device adds cellular (LTE-M) wireless data transfer capability to the predicate device. All other aspects remain identical: same chest-worn sensor architecture (PPG sensor, single-lead ECG, 3-axis accelerometer), identical physiological channels, identical analysis outputs (sAHI, total sleep time, heart rate, SpO2), identical performance specifications, and identical cloud-based analysis platform. Data can fall back to USB transfer if cellular connectivity fails.

IEC 62304 (Medical device software lifecycle processes); FDA Guidance on Device Software Functions (June 14, 2023); FDA Guidance on Cybersecurity in Medical Devices (September 27, 2023); FCC 47 CFR Parts 15, 24, and 27 (wireless emissions); FCC 47 CFR Part 2 (SAR testing); AAMI TIR 69 (no coexistence testing required due to negligible risk).

The subject device demonstrates substantial equivalence because it maintains identical indications for use, target population, intended use environment, sensor placement, device channels, analysis outputs, and performance specifications (Heart Rate ≤3 bpm arms, SpO2 ≤3% arms, 88.2% sensitivity/87.3% specificity for moderate-to-severe OSA) as the predicate. The only change is the addition of cellular data transfer capability, which does not alter the clinical functionality, safety profile, or diagnostic accuracy of the device. Software and cybersecurity testing confirmed no regression and data integrity preservation during the wireless upload process.