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510(k) Data Aggregation

    K Number
    K072462
    Device Name
    WIDE SPACED QUATTRODE LEADS
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Date Cleared
    2007-10-11

    (41 days)

    Product Code
    GZB,GZF
    Regulation Number
    882.5880
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    WIDE SPACED QUATTRODE LEADS

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

    The ANS Neurostimulation Systems are indicated for spinal cord stimulation (SCS) in the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. ANS Percutaneous Leads model number 3066, 3161, 3163, 3166, 3169, extension model numbers 3382, 3383, 3341, 3342, 3343, and receiver model number 3408, transmitter model number 3508, and antenna model numbers 1220 and 1230 are also indicated to stimulate electrically peripheral nerves to relieve severe intractable pain.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for "Wide Spaced Quattrode Leads." It confirms the device's substantial equivalence to a predicate device and outlines regulatory requirements.

    This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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