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510(k) Data Aggregation

    K Number
    K962087
    Device Name
    SERVOTRONIC EC100 SYSTEM
    Manufacturer
    MEDICON, INC.
    Date Cleared
    1997-04-23

    (330 days)

    Product Code
    HWE
    Regulation Number
    878.4820
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Servotronic EC 100 System is intended to be used for high speed cutting, sawing, drilling, and manipulation of soft tissue and bone in microsurgical procedures including maxillofacial surgery, ENT surgery, orthopedic surgery, and plastic surgery.

    Device Description

    The Servotronic EC 100 System's primary components are: (1) a control unit with irrigation pump; (2) a micromotor; (3) a foot switch for remote control; and (4) various hand pieces and tools. The hand pieces to be used with the Servotronic EC 100 System include the following: (1) Sachse Micro Oscillating Saw; (2) Sachse Micro Osseoscalpel Saw; (3) Micro Compass Saw; (4) Steinhauser Mucotome; (5) Micro Sagittal Saw; and (6) Hauenstein Angular Screwing Instrument.

    The Servotronic EC 100 requires an AC current of 110V or 230/240V. An electrical cord, which is intended to be plugged into a standard electrical outlet, is connected to the back of the control unit. The Servotronic EC 100 has integrated safety and monitoring functions for excess temperature, current limitations within the main supply circuit and within the motor electronics, and a speed-dependent stop used during a change of direction.

    AI/ML Overview

    The provided text describes a 510(k) summary for a medical device called the MEDICON eG'S SERVOTRONIC EC 100. It details the device's intended use, technological characteristics, and principles of operation, and concludes with a summary of the basis for a finding of substantial equivalence to predicate devices.

    However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria. The submission focuses on demonstrating substantial equivalence to existing devices based on intended use and technological characteristics rather than presenting a performance study with detailed acceptance criteria.

    Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided text.

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