Huxley SANSA Home Sleep Apnea Test (1000-00)
Huxley MedicalThe Huxley SANSA Home Sleep Apnea Test is a wearable device that records various physiological signals such as oxygen saturation, heart rate, chest movement, snoring, and sleep stages. It uses AI/ML algorithms in a cloud-based platform to analyze these signals and assist healthcare professionals in evaluating sleep-related breathing disorders like sleep apnea, both in clinical and home settings.
Intended Use
The Huxley Home Sleep Apnea Test (SANSA) is a wearable device intended for use in the recording, analysis, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adults suspected of sleep apnea. The device is intended for the clinical and home use setting under the direction of a Healthcare Professional (HCP).
Technology
SANSA collects physiological signals via a chest-worn patch containing reflective PPG sensor, single-lead ECG, and 3-axis accelerometer. Signals are analyzed in a cloud-based algorithm combining signal processing and AI/ML to compute time-series data and clinical summary metrics like apnea hypopnea index and total sleep time.
Performance
Performance testing included comparisons to predicate devices and gold-standard polysomnography (PSG) in a multicenter clinical study with 533 subjects, showing clinically acceptable diagnostic performance for moderate to severe sleep-disordered breathing with sensitivity of 88.2% and specificity of 87.3%. Additional testing includes non-clinical bench tests, biocompatibility, software verification, cybersecurity, and usability testing, all passed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/1/2024
5 months - 2
FDA Approval
7/15/2024
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