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510(k) Data Aggregation

    K Number
    K092009

    Validate with FDA (Live)

    Device Name
    MODIFICATION TO: LEVEEN SUPERSLIM NEEDLE ELECTRODES, MODELS M001262260, M001262270, M001262280, M001262290
    Manufacturer
    Boston Scientific Corporation
    Date Cleared
    2009-11-06

    (123 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Special
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K000032,K982556
    Predicate For
    K113090
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LcVcen SupersSlim Needle Electrode is intended to be used in conjunction with a radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

    Device Description

    The LeVeen SuperSlim Needle Electrode consists of a pre-shaped, multi-armed electrode array which is contained within a delivery cannula. The array is attached to a handle mechanism that deploys the array into targeted tissue. The device is connected to a generator so that RF energy passes from the array to a patient ground pad and heats the tissue surrounding the array.

    AI/ML Overview

    The provided text is a 510(k) summary for the Boston Scientific LeVeen SuperSlim Needle Electrode. It is a submission to the FDA for market clearance, not a study report. As such, it does not contain the detailed information required for a full description of acceptance criteria and the study proving the device meets them.

    Specifically, the document states: "Testing has been completed to demonstrate that the proposed changes do not result in any new issues of safety or effectiveness." and "Boston Scientific Corporation has demonstrated that the proposed changes do not raise any new issues of safety or effectiveness." However, it does not provide any specific performance data, acceptance criteria, study methodologies, or results.

    Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about a study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

    The device described is an electrosurgical electrode for thermal coagulation necrosis, primarily of nonresectable liver lesions. Its purpose is to ablate tissue using radiofrequency energy. Acceptance criteria for such a device would typically involve testing its ability to achieve desired lesion size, temperature profiles, safety against unintended tissue damage, and electrical performance, but no details are given here.

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