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510(k) Data Aggregation

    K Number
    K033182

    Validate with FDA (Live)

    Device Name
    PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD
    Manufacturer
    SURGIN SURGICAL INSTRUMENTATION, INC.
    Date Cleared
    2004-01-30

    (121 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    SURGIN'S PRIZM BLADES ARE DESIGNATED AS REPLACEMENT BLADES FOR THE "BECTON DICKINSON BD - 3000 MICRO SURGICAL SYSTEM", TO BE USED FOR LAMELLAR RESECTION OF THE CORNEA

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding the "PRIZM Keratome Blade." This type of document does not contain acceptance criteria or study results for device performance.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It discusses regulatory classifications, general controls, and compliance requirements, but not specific performance metrics or studies.

    Therefore, I cannot provide the requested information from this document. The sections you asked for, such as "A table of acceptance criteria and the reported device performance," "Sample sized used for the test set," "Number of experts used to establish the ground truth," etc., are details typically found in a device's submission dossier, which is not provided here.

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