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510(k) Data Aggregation
K Number
DEN130051Device Name
PEDIATRIC VISION SCANNER
Manufacturer
Date Cleared
2016-06-08
(908 days)
Product Code
Regulation Number
886.1342Why did this record match?
Applicant Name (Manufacturer) :
REBISCAN, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Pediatric Vision Scanner is intended for the automated detection of misalignment of the visual axes using polarized light. It is indicated for the screening of amblyopia and microstrabismus associated with amblyopia in children age 2 to 8 undergoing evaluation in a professional eye care setting and who are responsive to taking direction and who can pay attention for at least 5 seconds.
Device Description
The Pediatric Vision Scanner (PVS) is a non-invasive, optical instrument intended to be used for ophthalmic diagnostic purposes. The device integrates all hardware components within the plastic enclosure, including the image acquisition optics, the system computer, and visual display. The PVS is to be held with both hands and level to the ground, with the aperture aimed toward the child. The operator positions the PVS in dim light. Prior to each measurement, a background measurement is obtained to minimize signal interference. Rangefinders (laser diode, 650 nm wavelength) allow the proper positioning of the device (~ 0.5 meters) during background measurement and measurement. After the background is obtained, the operator instructs the patient to open their eyes, peer into the lens (with both eyes), and fixate on a target light (red Light-Emitting Diode (LED)) source (in the shape of a "smiley face"). The operator performs the measurement; a spot of near-infrared (laser diode, 830 nm wavelength), polarized light rotates circularly around the fixation target. Based on the polarization characteristics of the received light, the device uses an algorithm to determine whether or not this light is incident on the nerve fibers emanating from the fovea, the central retinal area for normal visual fixation, of each eye. Based upon this analysis and determination, the following output information is presented to the operator: LED outputs (based on binocularity values), "Tries": total number of scans (performed in two sets of 5, a maximum of 10), "Yield": ratio of number of scans that produced a signal to number of tries, "Binoc" / "binocularity": the ratio of scans resulting in bilateral, simultaneous fixation to number of tries. The device has an optical portion and integrated software analysis to administer, interpret, and convey the results of a scan. The optical portion of the device may be divided into two major pathways: Illumination pathway and Viewing pathway.
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