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510(k) Data Aggregation

    K Number
    K980838
    Device Name
    REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEM
    Manufacturer
    CERAMOPTEC, INC.
    Date Cleared
    1998-06-02

    (90 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K923953,K943445,K951775,K960413
    Why did this record match?
    Device Name :

    REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEM

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

    The reusable MegaBeam Fiber Optic Delivery System is intended to vaporize, coagulate, and incise and excise tissue. The MegaBeam Fiber Optic Delivery System is also intended to be used in lithotripsy procedures with a Ho:YAG laser system. The reusable MegaBeam Fiber Optic Delivery System is an accessory to a Ho:YAG laser system.

    The reusable MegaBeam Fiber Optic Delivery System is intended for use as an accessory to a Ho:YAG laser system to vaporize, coagulate, and incise and excise tissue, including lithrotripsy. The MegaBeam Fiber Optic Delivery System is also intended to be used in lithotripsy procedures with Ho:YAG laser systems.

    Device Description

    The reusable MegaBeam Fiber Optic Delivery System has similar technological characteristics as its predicate devices. First, CeramOptec's reusable MegaBeam Fiber Optic Delivery System is intended for use with a Ho:YAG laser system. The Coherent SlimLine Delivery System also are intended for use with a Ho:YAG laser, and the company's cleared, disposable fiber optic delivery systems have been cleared for use with 1.44 YAG, Ho:YAG, KTP, Argon and Diode lasers.

    Second, CeramOptec's reusable MegaBeam Fiber Optic Delivery System's fiber optical tip has a similar material composition as its predicate devices. Third, the reusable MegaBeam Fiber Optic Delivery System is available in four sizes: 200 micron, 365 micron, 550 micron and 1000 micron. The cleared Coherent SlimLine Laser Delivery System is available in the identical four sizes, and the cleared disposable MegaBeam Fiber Optic Delivery System is available in sizes ranging from 200 micron to 1200 micron.

    Fourth, the reusable MegaBeam Fiber Optic Delivery System is available in the same tip shapes and handpiece configurations as the company's cleared disposable MegaBeam Fiber Optic Delivery System. Further, both the reusable MegaBeam Fiber Optic Delivery System and the predicate devices are prepackaged sterile and fit lasers which employ SMA 905 connectors or lasers which have suitable adapters to allow SMA 905 connectors to be used.

    Finally, as with the Coherent's SlimLine Laser Delivery System, the reusable MegaBeam Fiber Optic Delivery System can be reused once the optical fiber tip is properly cleaned, inspected, stripped, and cleaved.

    AI/ML Overview

    The provided 510(k) summary for CeramOptec's MegaBeam Fiber Optic Delivery System states "Performance Data: None required."

    This indicates that no specific acceptance criteria or studies demonstrating device performance were deemed necessary for this particular device's clearance. The clearance was based on demonstrating substantial equivalence to predicate devices, rather than on new performance data.

    Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details because these were not part of the submission for this 510(k) clearance.

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