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510(k) Data Aggregation

    K Number
    K191700
    Device Name
    EyeStat
    Manufacturer
    Blinktbi Inc.
    Date Cleared
    2019-12-09

    (167 days)

    Product Code
    GZP
    Regulation Number
    882.1880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Blinktbi Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EyeStat is intended to measure and display the mechanically induced blink reflex. The device is intended to be used by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under the direct supervision of a medical professional. The device is available for use on any patient as determined by the medical professional including adults and children.
    Device Description
    The operating principle of the EyeStat device is that the application of a light puff of air (sterile food grade CO2) to the outer canthus of the eye acts as a stimulus that elicits a blink reflex. The puff of air is delivered while the patient's eyes are positioned within an eyepiece that allows the movement of the eye lid to be tracked using two high-speed cameras. The device uses software to evaluate the video frames containing the movement of the eyelid of the eye to which the puff of air was applied (ipsilateral) and detect the frame containing the initiation of a blink using image/video processing algorithms. The time associated with the video frame containing the initiation of the ipsilateral blink is then compared to the time associated with the application of the puff of air, and the difference represents the latency.
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