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510(k) Data Aggregation

    K Number
    K013813
    Device Name
    MODIFICATION TO:APEX MEDICAL IF-4100
    Manufacturer
    APEX MEDICAL CORP.
    Date Cleared
    2001-12-14

    (28 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    IF4100 is intended to be used in symptomatic relief of chronic intractable pain, posttraumatic and post-surgical pain.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the 510(k) K013813 letter does not contain the detailed information necessary to answer your request. The document is an FDA clearance letter for a medical device (Apex Medical IF 4100) and primarily focuses on its substantial equivalence to a predicate device for marketing purposes.

    It lacks specifics on:

    1. Acceptance criteria and reported device performance: While the indications for use are mentioned, no performance metrics or acceptance criteria are listed.
    2. Study details: There is no description of any clinical or performance studies, including sample sizes, data provenance, expert qualifications, or ground truth establishment.
    3. MRMC comparative effectiveness study or standalone performance: These types of studies are not mentioned.

    Therefore, I cannot extract the requested information from this document.

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