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510(k) Data Aggregation

    K Number
    K043367
    Device Name
    GLAID OCULAR ELECTROPHYSIOLOGY DEVICE
    Manufacturer
    LACE ELECTRONICA S.R.L.
    Date Cleared
    2005-11-17

    (344 days)

    Product Code
    GWE
    Regulation Number
    882.1890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    LACE ELECTRONICA S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The GLAID device is indicated for use in the measurement of visual electrophysiologic potentials, including the electroretinogram (ERG), pattern electroretinogram (PERG), visual evoked potential (VEP) and electrooculogram (EOG), as an aid in the diagnosis and management of Glaucoma when used in conjunction with other established methods of diagnosis and disease management.

    Device Description

    The GLAID Ocular Electrophysiology Device generates a display of photic stimuli which the patient observes as a pattern of alternating dark and white bars or checks. The electrical response of the patients' eye is monitored and recorded. The patients' response is measured using electrodes placed on the patients' face and eye.

    AI/ML Overview

    This 510(k) submission for the GLAID Ocular Electrophysiology Device does not include any information about acceptance criteria or a study that proves the device meets those criteria.

    The document is a summary of the 510(k) submission itself, focusing on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria. The FDA letter confirms the substantial equivalence determination but does not detail a performance study.

    Therefore, I cannot provide the requested information from the given text.

    The provided text only contains:

    • Device Description: The GLAID device generates photic stimuli for patients to observe patterns, and monitors and records the electrical response of the patient's eye using electrodes.
    • Intended Use: Measurement of visual electrophysiologic potentials (ERG, PERG, VEP, EOG) as an aid in diagnosing and managing Glaucoma when used with other established methods.
    • Predicate Devices: Electro-Diagnostic Imaging, Inc. VERIS System, Doran Instruments Inc. Maculoscope, and LKC Technologies Inc. Electroretinograph.
    • Substantial Equivalence Claim: The device has the same intended use and similar technological characteristics to predicate devices, and the differences do not raise new safety or effectiveness questions.
    • FDA Determination: The FDA found the device substantially equivalent to legally marketed predicate devices.
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