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The device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

The Fujinon G5 Duodenoscopes are medical endoscopes used for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

The G5 Duodenoscopes are offered in a 200 and 400 series. The ED-250XT5 represents the G5 Duodenoscope 200 series and the ED-450XT5 represents the G5 Duodenoscope 400 series.

The G5 Duodenoscopes include minor changes that improve the useability, ergonomics, and cleaning of the devices. The G5 scopes do not have an L-Port. The L-port functioned as a lens wash port. Doctors had the option to take a syringe to inject a fluid to use it as a high pressure wash for the lens. This function was eliminated because demand was low and it was rarely used by the surgeons.

A G5 forceps inlet port was modified. The new port is smaller and comes with a rubber cap. The new design helps increase suction and reduces leakage.

The jet wash line check valve was removed. Internal check valves were removed to eliminate the potential for clogging and to facilitate cleaning, disinfection. The valves are now external and removable.

The suction and air/water cylinders and valves were upgraded. They were updated to accommodate the new valves. The function of the valves is the same.

The G5 Duodenoscopes also feature the addition of the FOV, which is the rubber forceps inlet valve cover. This helps create a watertight seal when the endoscope is used. Upgrade to CA-500 cleaning adaptor. The cleaning adaptor allows the scope to be connected to tubes for cleaning.

The G5 Duodenoscopes are used with the same processors, monitors, hard copy units, and carts as the predicate devices. Each Duodenoscope is packaged in a protective carrying case with lens cleaner, silicon oil, forceps valve, waterproof cap, S connector cap, protective cap, adapters, valves, and the Operation Manual.

The Fujinon G5 Duodenoscopes are used in conjunction with other peripherals specified in the Operation Manual such as:

• Light Source
• Processor
• Cart
• Data Keyboard
• Foot Switch
• Monitor
• Video Printer
• Camera and Hard Copy Unit
• VCR
• ElectroSurgical Instruments

The provided document is a 510(k) summary for the Fujinon G5 Duodenoscopes, which discusses minor design changes and compares them to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through testing or clinical trials.

The document states:

• "The subject device has been subjected to and passed EMC testing requirements." - This is a general statement about electromagnetic compatibility testing, not a detailed performance study related to the device's primary function (visualization, diagnosis, endoscopic treatment).
• "The patient contact materials in the Duodenoscopes are identical to the materials used in the predicate device." - This is about material equivalence, not performance.
• "We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate devices." - This is a conclusion based on the minor nature of the changes and substantial equivalence to existing devices, not on a new study demonstrating specific performance metrics.

Therefore, I cannot provide the requested table or information regarding a study proving the device meets acceptance criteria, as such details are absent from the provided text. The submission relies on demonstrating substantial equivalence to predicate devices for its safety and effectiveness claims, rather than presenting a de novo performance study with defined acceptance criteria.

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