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510(k) Data Aggregation

    K Number
    K033888
    Device Name
    MSI MODEL S-500 RF GENERATOR
    Manufacturer
    MEDSPHERE INTERNATIONAL, INC
    Date Cleared
    2004-04-02

    (108 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K963772
    Predicate For
    K041980
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Indicated for coagulation of soft tissue
    These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

    Device Description

    MSI S-500 RF Generator

    AI/ML Overview

    The provided text is related to a 510(k) submission for the "MSI S-500 RF Generator," an electrosurgical device. Based on the content, this submission is for a medical device that performs electrosurgical cutting and coagulation, not an AI/ML-driven device.

    Therefore, the document does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert involvement typically associated with a study proving an AI/ML device meets acceptance criteria.

    The submission focuses on establishing substantial equivalence to a predicate device (Somnus Model 225 Electro Surgical Generator K963772) based on intended use and technological characteristics. It mentions "Performance testing was done to validate its intended use," but provides no details about this testing, its criteria, or results.

    Since the device is an electrosurgical generator, the "performance testing" likely refers to electrical and safety standards, functional verification of coagulation, and perhaps some bench testing or animal studies, rather than clinical trials with human readers and ground truth data as one would expect for an AI/ML diagnostic or assistive device.

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