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510(k) Data Aggregation

    K Number
    K022716
    Device Name
    MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB
    Manufacturer
    MED-LOGICS, INC.
    Date Cleared
    2002-10-11

    (57 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB

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

    The Med-Logics 7020CLB microkeratome blades are to be used as replacement blades for the Moria C-B™ microkeratome.

    Device Description

    Microkeratome Blade

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA for a medical device (Med-Logics Model 7020CLB™ Microkeratome Blade). This type of document is an approval letter for a device that has demonstrated substantial equivalence to a predicate device, not typically a report of a new study designed to prove acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria and a study proving the device meets them, especially with details like sample size, ground truth, and expert adjudication, is not present in this document.

    The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976."

    This means the approval is based on demonstrating equivalence, not on a new clinical study with acceptance criteria for device performance as a novel invention.

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

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