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510(k) Data Aggregation

    K Number
    K112548
    Device Name
    ALTOMEC ARTHROSCOPE
    Date Cleared
    2012-08-15

    (349 days)

    Product Code
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALTOMEC ENDOSCOPY INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended Use: Arthroscopes are rigid endoscopic devices introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. Arthroscopes are indicated for use in arthroscopic procedures performed in the hip, knee, shoulder, wrist (carpel tunnel syndrome), temporal mandibular joint, ankle, elbow, and feet (plantar fascia release).
    Device Description
    Altomec Arthroscopes are Non-deflectable rigid endoscopic devices, introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. The Altomec Rigid Arthroscope is a long tube containing a series of lenses. At the distal end, an objective lens captures the image of the object. Lens along the rod relay the image. At the proximal end, a proximal coupling lens relays the image to a CCD (Camera). The Altomec Arthroscope has 140mm working length with an outside diameter of 4.0mm. The inner or optical tube that holds the optical system has a diameter of 3.25mm. The Altomec Arthroscope has a 105 degree field of view and 30 degree direction of view. The direction of view enables viewing of different parts. Operating site is magnified two to five times of its actual size, depending on the distance between the tip of the endoscope and the object that is inspected. Magnified image is viewed on a monitor by connecting device's eyepiece to a video coupler of a camera monitor system. Image size on the monitor also depends on the type of video coupler used with camera system. Image can be recorded in a variety of formats depending on the camera system used. Light is transmitted through glass fibers running between inner and outer tubes from distal end to the light post. Light transmission is achieved by connecting one end of a light source and other end to the light post of the device. Device has no working channel. Sheaths with locking mechanism identical to predicate device, are used for irrigation.
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