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510(k) Data Aggregation

    K Number
    K980389
    Device Name
    MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLES
    Manufacturer
    CERAMOPTEC, INC.
    Date Cleared
    1998-07-29

    (177 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K923953,K943445,K946336,K960032
    Why did this record match?
    Reference Devices :

    K923953, K943445, K946336

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

    Intended to be used as a fiber optic delivery system handpiece with the capability to be reused with a disposable optical fiber.

    Device Description

    The MegaBeam Reusable Fiber Optic Handpiece and Needles are designed to be used with the company's cleared disposable MegaBeam Fiber Optic Delivery Systems which are intended to vaporize, coagulate, incise and excise tissue and which are designed for any indication for which compatible laser systems have been cleared by FDA. The needle is available with 0°, 15°, 30° and 70° angles. They are designed to fit 400 micron, 600 micron, 800 micron and 1000 micron disposable optical fibers. The labeling includes instructions for sterilizing the devices using EtO or steam. The needle is attached to the handpiece by a threaded connector. The fiber optic is then threaded through the handpiece and needle. At the end of the procedure, the fiber optic is discarded and the handpiece and needle are reusable.

    AI/ML Overview

    The provided text is a 510(k) summary for the CeramOptec's MegaBeam Reusable Fiber Optic Handpiece and Needles. It describes the device, its intended use, technological characteristics, and substantial equivalence to predicate devices. However, it explicitly states:

    "Performance Data: None provided."

    Therefore, based on the input text, there is no information available regarding:

    1. Acceptance criteria and reported device performance.
    2. Sample size used for the test set and data provenance.
    3. Number of experts used to establish the ground truth for the test set and their qualifications.
    4. Adjudication method for the test set.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study.
    6. Standalone (algorithm-only) performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How the ground truth for the training set was established.

    The 510(k) cleared the device based on its substantial equivalence to predicate devices, rather than on new performance data demonstrating meeting specific acceptance criteria through a study.

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