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510(k) Data Aggregation

    K Number
    K112214
    Device Name
    OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Date Cleared
    2011-11-17

    (107 days)

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

    OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS

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

    St. Jude Medical Neuromodulation Division percutaneous trial leads and compatible accessories are indicated for spinal cord stimulation in the management 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.

    OctrodeX™ and QuattrodeX™ trial leads and their accessories are intended to be used during a spinal cord stimulation trial period for a maximum of 30 days.

    Device Description

    OctrodeX TM, IntrodeX™, Epidural Needle, Stylets

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for St. Jude Medical Neuromodulation devices. This document does not contain any information about acceptance criteria, study details, or device performance against such criteria.

    The letter confirms that the FDA has determined the devices (OctrodeX™, QuattrodeX™, IntrodeX™, Epidural Needle, Stylets) are substantially equivalent to legally marketed predicate devices. It lists the indications for use but does not provide any clinical study results or performance data.

    Therefore, I cannot fulfill your request for the detailed table and study information as the necessary data is not present in the provided input.

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