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510(k) Data Aggregation

    K Number
    K081475

    Validate with FDA (Live)

    Device Name
    ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]
    Manufacturer
    MEDTRONIC XOMED, INC.
    Date Cleared
    2008-10-17

    (143 days)

    Product Code
    HBE,HBC,HRX,HWE
    Regulation Number
    882.4310
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K073255,K935567,K012453,K012456,K012457,K002523
    Predicate For
    K111520,K121264,K130755,K132264,K133061,K141122,K160713,K163565,K170312,K193630,K233958
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Electric Drill System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General Surgical Procedures.

    Device Description

    The electric drill system consists of a power console, footswitches, connection cables, irrigation / cooling tubing sets, a remote irrigation control unit, and assorted handpieces to drive various burs, blades, drills, rasps, and saw blades. The system can also function as an endoscope lens cleaning system.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. The document is a 510(k) summary for an Electric Surgical Drill/Saw System, focusing on its classification, equivalence to predicate devices, and intended use for regulatory approval.

    Therefore, I cannot provide the requested table or answer the specific questions about studies, sample sizes, ground truth, or adjudication methods.

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