Belun Sleep System BLS-100
Belun Technology Company LimitedThe Belun Sleep System BLS-100 is a wearable device designed for adult patients suspected of sleep apnea. It consists of a sensor ring worn on the user's index finger overnight to collect biophysical signals such as oxygen saturation and pulse, which are then analyzed by AI-powered software to help healthcare professionals assess the severity of sleep-related breathing disorders in both clinical and home settings.
Intended Use
The Belun Sleep System BLS-100 is a wearable device intended to record, analyze, display, export, and store biophysical parameters to aid in evaluating moderate to severe sleep-related breathing disorders of adult patients suspected of sleep apnea. The device is intended for use in clinical and home settings under the direction of a Healthcare Professional (HCP).
Technology
The system includes a wearable sensor ring placed on the proximal phalanx of the index finger that records photoplethysmography (PPG) signals and accelerometer data overnight. The collected data is stored on the device and then exported to standalone AI software (Belun Sleep AI) which processes signals to calculate the apnea-hypopnea index (bAHI) and sleep stages (bSTAGES). The device uses optical plethysmography and accelerometry sensors, utilizes deep learning for signal analysis, and is battery powered by a 3.7V Lithium battery.
Performance
Performance testing included non-clinical safety and electromagnetic compatibility tests per IEC standards, biological evaluation per ISO standards, and clinical studies comparing device output to polysomnography (PSG) in 106 patients. The device demonstrated comparable accuracy, sensitivity, and specificity for apnea-hypopnea index and sleep stage classification relative to PSG, with accuracies over 87% for AHI and sleep stages.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/25/2022
6 months - 2
FDA Approval
2/23/2023
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