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510(k) Data Aggregation

    K Number
    K160103
    Device Name
    Spetzler Malis Dual Illuminating Bipolar Forceps
    Manufacturer
    SYNERGETICS
    Date Cleared
    2016-10-12

    (267 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K962595,K121426
    Why did this record match?
    Device Name :

    Spetzler Malis Dual Illuminating Bipolar Forceps

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

    The Spetzler™-Malis® Dual Illuminating Bipolar Forceps are designed for use with the Malis® Bipolar electrosurgical generators. The disposable Spetzler™-Malis® Dual Illuminating Bipolar Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue and to supply light for surgical procedures.

    Device Description

    The Spetzler™ Malis® Dual Illuminating Bipolar Forceps are sterile, single-use devices for use in electrosurgery. The forceps are a bayonet style and incorporates a twin pin cord in the proximal end for connection to a bipolar electrosurgical generator via a generic twin pin, female socket receptacle cord set. A fiberoptic cable is bonded to each tine and mates to a proprietary connector at the proximal end. The connector mates with an adaptor that is inserted in the illumination port of an endoscopic ligthsource.

    AI/ML Overview

    The provided text describes a 510(k) summary for the Spetzler™ Malis® Dual Illuminating Bipolar Forceps and details non-clinical testing performed to establish substantial equivalence to a predicate device. It does not contain information about an AI/ML device, a multi-reader multi-case (MRMC) comparative effectiveness study, or a standalone algorithm performance study. Therefore, several requested sections cannot be filled from the given text.

    Here's the information extracted and organized based on your request, with "N/A" for unavailable data:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implicitly derived from the comparison to the predicate device and the reference device, aiming for "equivalent" performance.

    ParameterAcceptance Criteria (Implied)Reported Device Performance (Subject Device)
    Non-Stick Coagulation Events (Primary Function)≥ 500+ events (equivalent to predicate)500+
    Illumination Output (Non-Stick Coagulation Testing)N/A (Predicate did not have illumination)200-204 mW
    Beef Liver Steady State Temperature Rise over Ambient (after 30 min. exposure)
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