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510(k) Data Aggregation
K Number
DEN200038Device Name
Gili Pro BioSensor (also known as Gili BioSensor System)
Manufacturer
Date Cleared
2021-04-01
(293 days)
Product Code
Regulation Number
870.2786Why did this record match?
Product Code :
QOK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Gili Pro BioSensor (Gili BioSensor System) includes an optical module that is intended to capture motion-vibration signals from an illuminated surface for assessment of physiological information. Such information, captured during spot-measurement, includes:
- Heart rate ●
- Respiratory rate .
The device is indicated for use by or under the supervision of healthcare professionals for adult patients in a hospital, outpatient, or other medical care settings, or for clinical research purposes.
The device should be used while the subject is seated upright either in a chair or in a bed. The information stored on the system may be reviewed by qualified persons.
Device Description
The Gili Pro BioSensor is an optical system consisting of a sensing unit and a mobile unit with a preinstalled software application. The optical sensing unit is an aluminum enclosure which houses a lithium ion battery, illuminating optics (laser projector and laser pointer), digital image sensor, range meter, and firmware to facilitate data processing. The illuminating optics are based on eye-safe lasers which are compliant with Class I laser product accessible emission limits. The sensing unit is connected via a USB cable to a mobile unit on which the mobile application is installed.
The system illuminates the subject via a low-powered near infra-red (NIR at ~780 nm) light beam while an image sensor module captures the back reflected light pattern by the light sensor. The laser pointer illuminates in the visible spectrum (~650 nm) to facilitate proper positioning of the sensor relative to the subject. Changes in the reflected light pattern are coupled with motions of the illuminated surface, which are affected by heart and breathing motions. Analysis of these patterns through the software application correlate with heart and respiratory rates, as part of vital signs assessment. The heart and respiratory rate values are displayed on the user interface of the mobile unit.
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