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510(k) Data Aggregation

    K Number
    K030118
    Device Name
    RAPID PROGRAMMAR
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Date Cleared
    2003-03-11

    (57 days)

    Product Code
    GZB
    Regulation Number
    882.5880
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ANS Neurostimulation system is indicated for Spinal Cord Stimulation (SCS) in the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.

    The Rapid Programmer is intended to assist clinicians in determining the optimum performance while automatically logging procedures data. Rapid Programmer also allows the clinician to optimize performance by leading the patient through a series of device parameter combinations and recording the stimulation effects. This system uses a touch screen computer to program the stimulator to the required waveforms and electrode configurations and to log the information derived.

    Device Description

    This system uses a touch screen computer to program the stimulator to the required waveforms and electrode configurations and to log the information derived.

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the "Rapid Programmer" device. It is a regulatory document and does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter confirms substantial equivalence of the device to a predicate device for its stated indications for use, but it doesn't detail performance metrics, study designs, or ground truth establishment.

    Therefore, I cannot extract the requested information from the provided text.

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