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510(k) Data Aggregation

    K Number
    K070707
    Device Name
    MICRUS MICROCOIL SYSTEM
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Date Cleared
    2007-04-06

    (23 days)

    Product Code
    HCG
    Regulation Number
    882.5950
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    K063653,K062036,K053160,K033813,K032872
    Why did this record match?
    Reference Devices :

    K063653,K062036,K053160,K033813,K032872

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

    The Micrus MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

    Device Description

    The Micrus MicroCoil System consists of an embolic coil ("MicroCoil") attached to a Device Positioning Unit (DPU) (single use, sterile). An "introducer sheath" covers the microcoil and DPU and is attached to a re-sheathing tool

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about specific acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) premarket notification for the Micrus Microcoil Delivery System, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against predefined acceptance criteria.

    The information provided primarily covers:

    • Device Description and Intended Use: The Micrus MicroCoil Delivery System is for endovascular embolization of intracranial aneurysms.
    • Comparison to Predicate Devices: The submission argues that the device, with its new introducer sheath and re-sheathing tool, is substantially equivalent to previously cleared Micrus Microcoil Systems based on intended use, design, materials, and method of construction.
    • Conclusion: The submission concludes substantial equivalence based on design, materials, function, intended use comparison, and "non-clinical testing." However, the details of this non-clinical testing are not provided.

    Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

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