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    K Number
    K081634
    Device Name
    CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL
    Manufacturer
    CONMED CORPORATION
    Date Cleared
    2008-06-25

    (14 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K982309,K791137
    Why did this record match?
    Device Name :

    CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL

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

    The Gold Vac pencils, when used with an effective smoke evacuation system, removes smoke plume from the surgical site. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgioal effect.

    Device Description

    The CONMED GoldVac "Integrated Smoke Evacuation Pencils a sterile, single use integrated electrosurgical pencil and smoke evacuation handpiece. The device is intended for general electrosurgical applications and when used in conjunction withan effective smoke evacuation system, for removing smoke generated by electrosurgery. The integration of the pencil and the smoke attachment allows a single device to be used. The device is constructed of themoplastics well known throughout the industry in the manufacture of medical devices. The device won known integratival pencil with an integrated pathway for smoke removal. This pathway forms an airway from the tip to the rear of the pencil. The pencil is connected to tubing which will be attached to the rear of a variety of smoke evacuation systems. The smoke is then filtered by smoke evacuation system preventing personnel exposure to this surgical smoke. The device will be packaged singly for sterile distribution. The CONMED GoldVac "Integrated Smoke Evacuation Pencil incorporates an extendable "smoke tube" which is housed within the electrosurgical pencil. The pencil is connected to the 10 feet of tubing which connects the pencil to the smoke evacuation system.

    AI/ML Overview

    The provided text describes the CONMED® GoldVac™ Integrated Smoke Evacuation Pencil, an electrosurgical pencil with integrated smoke evacuation. The information focuses on its substantial equivalence to predicate devices rather than a detailed study proving performance against specific acceptance criteria for a novel AI/software device. Therefore, many of the requested categories are not applicable to this submission.

    Here's a breakdown of the available information and areas where the requested details are not present:

    Acceptance Criteria and Device Performance

    The submission focuses on establishing substantial equivalence to predicate devices rather than defining and meeting specific analytical or clinical performance acceptance criteria for a new type of device. The "performance testing" section describes general bench testing.

    Acceptance CriteriaReported Device Performance
    Electrosurgical Function: No effect or changes to the function of the electrosurgical pencil."tests conducted with the device have shown no effect or changes to the function of the electrosurgical pencil."
    Smoke Removal: Removal of smoke similar to predicate devices."The removal of smoke was similar to that of the two independent devices."
    Design does not impede electrosurgical function: No obstruction of the electrosurgical function by the smoke intake nozzle."The nozzle or intake portion of the device has been designed so as to not impede the operation of the electrosurgical function of the pencil and provides for intake of the surgical smoke for filtering."
    Compliance with standards: ANSI/AAMI HF-18, IEC 60601-2-2, ISO 14971, ISO 10993."The device has been designed to comply with the applicable sections of ANSI/AAMI American National Standard for Electrosurgical Devices HF-18, the International Electrotechnical Commission Standard for Electrosurgical Devices, 60601-2-2, Risk Management ISO 14971 and Biocompatibility ISO 10993." (This indicates design intent and compliance, not necessarily specific test results for each standard in this summary.)

    Study Information (Not Applicable for this type of submission)

    The provided document describes a 510(k) submission for an electrosurgical pencil, a hardware device, not an AI or software device. Therefore, information regarding sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details are not included and are not expected for this type of medical device submission.

    1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a hardware device submission focused on substantial equivalence. Performance testing mentioned is "bench testing" without details on sample size or data provenance.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
    3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Bench testing" on the device was performed to confirm its function.
    7. The sample size for the training set: Not applicable.
    8. How the ground truth for the training set was established: Not applicable.
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