Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K951577
    Date Cleared
    1996-03-21

    (352 days)

    Product Code
    Regulation Number
    876.1500
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    ES-3800, VIDEO SIGMOIDOSCOPE

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

    The ES-3800, Video Sigmoidoscope, is intended to provide optical visualization of, and therapeutic access to, the Lower Gastrointestinal Tract (extent of exam, sigmoid colon). The Lower Gastrointestinal Tract includes, but is not restricted to, the organs; tissues; and subsystems; Large Bowel. The instrument is introduced per rectally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.

    Device Description

    The ES-3800, Video Sigmoidoscope, must be used with a Video Processor (a software controlled device) The endoscope has a flexible insertion tube, a control body, and umuilicus. The umbilicus provides connection to the video processor. The control body includes controls for up/ down/ left/ right angulation, air/water delivery, suction, CO2 delivery, and an accessory inlet port. The device contains light carrying bundles, to illuminate the body cavity, and a charge couple device (CCD) to collect image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced (the instrument is supplied with two biopsy forceps). The Video Processor contains a 300 watt xenon lamp which provides white light that is filtered, via a Red, Green, Blue color wheel, and is focused at the connected video endoscope lightguide prong. The endoscope light carrying bundles present the color strobes to the body cavity and the CCD collects image data for each strobe of color. The video processor stores the CCD information until all three color strobes are completed and a full color frame is compiled. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to fulfill your request. The document describes a medical device, its intended use, and a comparison to predicate devices, but lacks details about acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot generate the table and descriptive points you've requested.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1