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The endoscope system is used to examine body cavities, hollow organs and canals, specifically the lower GI tract (colon) only, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The endoscope system includes the endoscope with control head, a disposable assembly, an imaging system, and a fluid and air system. The endoscope system features: 1) a smooth control head containing a minimal number of outside angles and joint crevices, 2) a single use disposable system encompassing all of the inner passage channels that start at the manifold, continue through the endoscope cavity, and seal onto the outside of the rigid distal tip, 3) a pneumatically driven air and fluid system eliminating the need for mechanical valves in the contamination path, and 4) a lavage function that provides a bolus of water through the working channel to loosen and flush debris from the field of view as the insertion tube advances through the colon.

The proposed VSI Model S-V200 Color Video Sigmoidoscope is intended for use to examine the lower bowel tract, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The VSI Model S-V200 Color Video Sigmoidoscope with Disposable EndoSheath consists of a reusable video sigmoidoscope with a D-shaped cross section containing fiberoptic illumination and imaging bundles and a sterile, disposable, protective sheath containing the air, water and suction/biopsy channels. The sheath is removed and disposed of following each procedure.

The EndoSheath provides a sterile, disposable protective covering for the scope to be used during endoscopic examination of the sigmoid colon.

The EndoSheath for use with the VSI Model S-F100 and S-V100 Sigmoidoscopes consists of a sterile, disposable, protective sheath which covers the pation of the scope during a clinical procedure. The sheath is removed and disposed of following each procedure.

The EndoSheath provides a sterile, disposable protective covering for the scope to be used during endoscopic examination of the sigmoid colon.

The SS-F32 EndoSheath for use with the VSI Model S-F100 Sigmoidoscope consists of a sterile, disposable, protective sheath which covers the pation of the scope during a clinical procedure. The sheath is removed and disposed of following each procedure.

The ES-3840, Video Sigmoidoscope, is intended to provide visualization (via a video monitor) of, and therapeutic access to, the Lower Gastrointestinal Tract. The Lower Gastrointestinal Tract includes, but is not restricted to, the organs; tissues; and subsystems: Rectum and Sigmoid Colon. The instrument is introduced per rectally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.

The ES-3840, Video Sigmoidoscope, must be used with a Video Processor (a software controlled device). The endoscope has a flexible insertion tube, and umbilicus. The umbilicus provides connection to the video processor. The control body includes controls for up/ down/ left/ right angulation, air/water delivery, suction, Forward Water Jet, 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.

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.

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.