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510(k) Data Aggregation

    K Number
    K083528
    Device Name
    SMITH & NEPHEW BIPOLAR ADAPTER CABLE, MODEL 72200022
    Manufacturer
    SMITH & NEPHEW, INC.
    Date Cleared
    2009-01-28

    (61 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K052878,K061660
    Predicate For
    K111262
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Smith & Nephew Adaptor Cable is intended for connecting a Smith & Nephew Radiofrequency Denervation Probe to Smith & Nephew RF Lesion Generators.

    Device Description

    The Smith & Nephew Adaptor Cable has been designed as an accessory device to the Smith & Nephew Electrothermal Spine System and will provide the option of bipolar energy distribution. The subject device is designed to be used with Smith & Nephew Electrothermal generators, Radiofrequency (RF) denervation probes, and cannulae to create RF heat lesions for the treatment of pain. This configuration eliminates the need of a grounding pad, allowing for return of the delivered energy via a secondary non-active RF probe.

    AI/ML Overview

    This is a 510(k) summary for a medical device that is an adaptor cable, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable to this submission.

    The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on design features and intended use, rather than clinical performance or AI/ML model metrics.

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