SANSA HSAT

The SANSA HSAT is a wearable chest patch device that records physiological signals including heart rate, oxygen saturation, chest movement, and breathing patterns to help diagnose sleep apnea in adults. The device analyzes these signals using cloud-based algorithms and provides clinicians with summary metrics and time-series data for review in clinical and home settings under healthcare professional direction.

The subject device uses the same physical components as the predicate (reflective PPG sensor, single-lead ECG, 3-axis accelerometer on chest patch) but adds AI/ML classifiers to distinguish between obstructive and central sleep apnea events and includes REM/NREM sleep stage classification. Performance specifications for heart rate and SpO2 remain identical to the predicate.

Not stated in this summary.

The SANSA HSAT is substantially equivalent to the predicate SANSA HSAT (K244027) because it maintains identical intended use, device placement, sensors, and most output metrics while the new features (central apnea classification and REM/NREM staging) are supported by the legally marketed reference device WatchPAT ONE. Clinical testing of 325 patients demonstrated acceptable performance for the new classifiers compared to polysomnography, with sAHIc sensitivity of 100% and specificity of 98.7%.