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The ED-3490TK, Video Duodenoscope, is intended to provide optical visualization (via a video monitor) of, and therapeutic access to the Biliary Tract via the Upper GI Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophogus, Stomach, Duodenum, Common Bile, Hepatic, and Cystic Ducts. This instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric populations.

The ED-3490TK, Video Duodenoscope, must be used with a Video Processor (software controlled device). The endoscope has a flexible insertion tube, a control body 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 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 Video Processor, EPK-i, contains a 300 watt short Arc Xenon lamp which provides white light that is focused at the connected video endoscope lighteuide prone. The endoscope light carrying bundles present the light to the body cavity and the CCD collects image data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.

The provided text does not contain information about acceptance criteria and a study proving device performance for the PENTAX ED-3490TK, Video Duodenoscope.

The 510(k) summary explicitly states: "The substantial equivalence is not based on an assessment of clinical performance data." This indicates that no clinical study was conducted to demonstrate the device's performance against specific acceptance criteria. The submission for substantial equivalence relied on comparisons to a predicate device, specifications, and system performance testing (which typically refers to non-clinical tests like electrical safety, biocompatibility, and mechanical performance, not clinical outcome or diagnostic accuracy).

Therefore, I cannot provide the requested information.

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