Loop System
Spry Health, Inc.The Loop System by Spry Health, Inc. is a prescription-only wearable device designed for adult patients to collect physiological data such as oxygen saturation, heart rate, and respiration rate during resting periods. It passively records data using reflectance-based photoplethysmography from the wrist and uploads the information to a server for remote clinician review, aiding in patient monitoring in home environments.
Intended Use
The Loop System is intended for adult patients in the home environment for passive, non-invasive, intermittent data collection of physiological parameters that will later be transmitted to a web server for remote review by a clinician.
Technology
The Loop System collects reflectance-based photoplethysmogram (PPG) signals from the patient’s wrist using LEDs of varying wavelengths and photodiodes. An accelerometer detects motion to ensure data is collected only during resting periods. Filtering and data processing algorithms are used to remove noise and extract physiological parameters. Data is stored locally and uploaded to a server during charging for clinician access via a web interface.
Performance
Extensive bench and clinical testing demonstrated that the Loop System meets design specifications and is as safe and effective as its predicate device. Clinical studies in healthy adults showed accurate monitoring of respiration rate and pulse oximetry compared to gold standard methods. Testing complied with ISO 80601-2-61 standards and FDA pulse oximeter guidance. Electrical safety, biocompatibility, and shelf life testing also support device safety.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/22/2018
10 months - 2
FDA Approval
3/29/2019
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