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The DEFENDO™ FUJIFILM™ 500/600 Single Use Air/Water Valve is intended to control the air/water function on an endoscope during a GI endoscopic procedure. The DEFENDO™ FUJIFILM™ 500/600 Single Use Suction Valve is intended to control the suction function on an endoscope during a GI endoscopic procedure. The DEFENDO™ FUJIFILM™ 500/600 Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The single use Biopsy Valve provides access for endoscopic device passage and exchange, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The ENDOGATOR™ FUJIFILM™ 500/600 Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures when used with an irrigation pump (or cautery unit).

The Defendo Fujifilm 500/600 Single Use Valves Set, the subject of this 510(k), are a family of ready-to-use, sterile, single use valves designed to be used on the Fujifilm 500/600 series GI endoscopes as accessories. The specific valves include the Defendo Fujifilm 500/600 Single Use Air/Water Valve, the Defendo Fujifilm 500/600 Single Use Suction Valve, the Defendo Fujifilm 500/600 Single Use Biopsy Valve, and the Endoqator Fujifilm 500/600 Single Use Connector. The Air/Water valve allows the end-user to control and maintain air or CO2 insufflation down the endoscope's accessory channel and control the water used to wash the lens of the endoscope during an endoscopic procedure. The Suction valve allows the user to control suction through the endoscope's accessory channel and serves as a fluid-removal conduit to aspirate fluids from the patient. This allows the clinician to remove fluids/soil from the GI tract during an endoscopic procedure. The Biopsy valve allows instruments/devices to be passed through it while maintaining insufflation, allowing suction, and guiding instruments through the biopsy channel during endoscopic procedures. The Connector allows attachment between the irrigation tube set via its luer connection and the compatible endoscope at its dedicated auxiliary water connection. This is sometimes also referred to as the auxiliary water iet valve. These valves are supplied in various kits. The kits are combinations of two or more of the different valves listed above.

The Defendo Pentax Single Use Air/Water Valve is intended to control the air/water function on an endoscope during a GI endoscopic procedure. The Defendo Pentax Single Use Suction Valve is intended to control the suction function on an endoscope during a GI endoscopic procedure. The Defendo Pentax Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The single use Biopsy Valve provides access for endoscopic device passage and exchange, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The Endogator Pentax Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures with an irrigation pump (or cautery unit).

The Defendo Pentax Single Use Valves Set, the subject of this 510(k), are a family of ready-to-use, sterile, single-use valves designed to be used on the Pentax endoscopes as accessories. The specific valves include the Defendo Pentax Single Use Air/Water Valve, the Defendo Pentax Single Use Suction Valve, the Defendo Pentax Single Use Biopsy Valve, and the Endogator Pentax Single Use Connector. The Air/Water valve allows the end-user to control and maintain air or CO2 insufflation down the endoscope's accessory channel and control the water used to wash the lens of the endoscope during an endoscopic procedure. The Suction valve allows the user to control suction through the endoscope's accessory channel and serves as a fluid-removal conduit to aspirate fluids from the patient. This allows the clinician to remove fluids/soil from the GI tract during an endoscopic procedure. The Biopsy valve allows instruments/devices to be passed through it while maintaining insufflation, allowing suction, and guiding instruments through the biopsy channel during endoscopic procedures. The Connector allows attachment between the irrigation tubset via its luer connection and the compatible endoscope at its dedicated auxiliary water connection. This is sometimes also referred to as the auxiliary water jet valve. These valves are supplied in various kits. The kits are combinations of two or more of the different valves listed above.

The Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The Single Use Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The Single Use Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure. The Single Use Suction Valve is intended to be used to control the suction on an endoscope during a GI endoscopic procedure. The Single Use ENDOGATOR™ Connector is intended to be used in conjunction with ENDOGATOR™ Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures when used with an irrigation pump (or cautery unit). The Single Use Cleaning Adapter is intended to be used only to pre-clean the endoscope's air/water channel postprocedure, and not to be used during a patient procedure.

The Defendo Fujifilm 700 Single-Use Valves Set consists of a family of ready-to-use, sterile, single-use valves designed to be used on the Fujifilm 700 series GI endoscopes as accessories. The specific valves that are the subject of this 510(k) include the Defendo Fujifilm 700 Single-Use Air/Water Valve, the Defendo Fujifilm 700 Single-Use Suction Valve, the Defendo Fujifilm 700 Single Use Biopsy Valve, the Endogator Fujifilm 700 Connector, and the Defendo Fujifilm 700 Cleaning Adapter.

The ENDOGATOR™ Hybrid Irrigation Tubing (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air (via an air pump) or CO2 (via a CO2 supply) along with sterile water during GI endoscopic procedures when used in conjunction with an irrigation pump or cautery unit.

The ENDOGATOR™ HYBRID Irrigation Tubing device contains a threaded cap and tubeset designed to be attached to sterile water bottles. The proximal end of the irrigation tubing includes the threaded bottle cap for attachment to a sterile water bottle. The bottle cap has three tubes attached, one for receiving CO2 (and air in the case of Pentax SKU's), one coaxial tube which has an inner lens rinsing uptake tube surrounded by an air/CO2 delivery tube, and one for delivering water for irrigation which interfaces with an irrigation pump. The water delivery tubes, both irrigation as well as lens rinsing include backflow check valves.

The Endo SmartCap™ is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

The Endo SmartCap™ supplies sterile water and either air or CO2 to an endoscope during endoscopic procedures when connected to a sterile water source and an air or CO2 source. Two tubes are arranged coaxially; air or CO2 supplied through the outer tube pressurizes the sterile water container, forcing water up through the inner tube and to the endoscope. The proximal end of the tube set includes a bottle cap for attachment to a user-provided sterile water container; the Endo SmartCap™ is compatible with all major brands of sterile water containers. The proximal end of the tube set terminates in a tube weight which keeps the tip of the tubing submerged. A pinch clip prevents water from dripping from the tube's distal end when the device is detached from the endoscope. The distal end of the tube set terminates in a connector which mates with the corresponding brand of endoscope; Endo SmartCap™ models are available for all major brands of endoscopes. The device is provided sterile (EtO). The device is fabricated from metals, plastics, and elastomers. The Endo SmartCap™ is intended for 24 hour multi-patient use and should be discarded daily. No portion of the device comes in direct contact with patients.

SCOPE BUDDY PLUS Endoscope Flushing Aid is an electro-mechanical device intended to pump fluids through the channels of flexible, immersible endoscopes during the manual cleaning process of endoscope reprocessing.

The subject device is intended to provide fluid delivery to endoscope channels in the same manner as a manual syringe would be used during the manual cleaning phase of endoscope reprocessing as defined by the endoscope manufacturer's instructions. The subject device utilizes an external peristaltic pump and 24-hour multi-use connection tubing (tubing used for 24 hours with multiple endoscopes and then discarded) to deliver specific volumes of detergent solution and rinse water to the endoscope channels during the manual cleaning phase. The minimum fluid volumes are defined by the endoscope manufacturer. SCOPE BUDDY PLUS Endoscope Flushing Aid is intended to be used only during the manual cleaning phase of endoscope reprocessing, in conjunction with the instructions and labeling provided by the endoscope manufacturer, to deliver a volume of fluid to the endoscope channels which exceeds the minimum fluid volumes specified by the endoscope manufacturer. The subject device is not an endoscope washer-disinfector and does not bear labeling claims for direct cleaning efficacy or high-level disinfection efficacy for endoscope reprocessing.

Advantage Plus Pass-Thru Endoscope Reprocessing System tests, washes, disinfect and rinses endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus Pass-Thru system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes and related accessories. Manual cleaning of endoscopes is required prior to disinfection in the Advantage Plus Pass-Thru System. The Advantage Plus Pass-Thru Endoscope Reprocessing System uses Rapicide PA High Level Disinfectant to provide high level disinfection of endoscopes when used according to the directions for use. The system uses Intercept Plus Detergent in its washing cycle at a concentration of 0.5%. Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (MRC) of 850 ppm peracetic acid; this ensures that the disinfectant was above MRC during the entire disinfection cycle. Rapicide PA should be used under the following contact conditions -Contact Time: 5 minutes Temperature: 30°C MRC: 850ppm

The Advantage Plus Pass-Thru is an electro-mechanical Automatic Endoscope Reprocessor (AER) intended to high-level disinfect pre-cleaned endoscopes and their related accessories by exposing them to a peracetic acid based disinfectant – Rapicide PA disinfectant solution (cleared under 510k – K082988). The subject device is closely related to its predicate the Advantage Plus Endoscope Reprocessing System cleared in 510k – K082988 and K102996 but differs in that it is designed in a "pass-thru" configuration. The subject device is intended to be built into a wall which separates 'clean' and 'dirty' sides. It provides the ability to load an endoscope from the dirty side and unload the disinfected endoscope from the clean side, thus preventing potential mix-up between high level disinfected and contaminated endoscopes. Contaminated endoscopes are placed in the subject device from the 'dirty' side and appropriate connections to the endoscope channels are made. The system is designed to test for proper channel connectivity, channel blockages and leaks in the outer endoscope sheath. After the endoscope passes these tests, the system proceeds to the washing cycle with Intercept Plus detergent, and the highlevel disinfection cycle. In the high-level disinfection cycle, Rapicide PA HLD is diluted by the incoming water to a minimum concentration of 850 ppm of peracetic acid. The system measures and maintains the temperature of this disinfectant solution to ensure that it is above the minimum recommended temperature of 30℃ for Rapicide PA for effective High Level Disinfection to occur. Following the 5 minute disinfectant contact time, the user takes a sample to test for MRC (850 ppm of peracetic acid). Once the MRC test passes, the disinfectant is emptied from basin and drained out of the AER. The endoscope is then rinsed, dried and removed from the 'clean side' of the AER.

Scope Buddy Plus Endoscope Flushing Aid is an electro-mechanical to pump fluids through channels of flexible, immersible endoscopes during the endoscope manual cleaning process.

The subject device is intended to provide fluid delivery to endoscope channels in the same manner as a manual syringe would be used during the manual cleaning phase of endoscope reprocessing as defined by the endoscope manufacturer's instructions. The subject device utilizes an external peristaltic pump and 24-hour multi-use connection tubing (tubing used for 24 hours with multiple endoscopes and then discarded) to deliver specific volumes of detergent solution and rinse water to the endoscope channels during the manual cleaning phase. These fluid volumes are defined by the endoscope manufacturer. Scope Buddy Plus is intended to be used only during the manual cleaning phase of endoscope reprocessing, in conjunction with the instructions and labeling provided by the endoscope manufacturer, to deliver an endoscope manufacturer specified volume of fluid to the endoscope channels. The subject device is not an endoscope washer-disinfector and does not bear labeling claims for direct cleaning efficacy or high-level disinfection efficacy for endoscope reprocessing.

To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following: - Keeping the suitable depth of endoscope's view field - Helping the endoscope with being inserted into the gastrointestinal tract

The subject device is a sterile, single use, disposable medical device. It is designed to be placed on the distal end of an endoscope during endoscopic procedures to improve the physician's ability to visualize and examine the mucosa. AmplifEYE is made of injection molded polymer and consists of a main body tube with flexible wings arranged in a single row around one end of the main body tube. In a standard colonoscopy procedure, the endoscope is intubated through the rectum and advanced forward through the length of the colon. The endoscope is then retracted while the physician visually examines the colon mucosa for polyps or other abnormalities. The AmplifEYE wings fold down during intubation and movements that advance the endoscope forward so that forward movement is not hindered. During endoscope withdrawal, the wings open and fold outward to keep the depth of the endoscope's view field by manipulating the colonic folds and stabilizing the position of the endoscope within the intestinal lumen, thus aiding in the physician's ability to visualize and examine the mucosa.

The Rapicide PA High-Level Disinfectant Test Strips are used as a chemical indicator after the disinfection cycle to ensure that the Rapicide PA High-Level Disinfectant Solution is above minimum recommended concentration (850ppm peracetic acid); this ensures the disinfectant was above MRC during the entire disinfection cycle.

Rapicide PA High-Level Disinfectant Test Strips have the ability to measure the disinfectant use solution concentration above 850ppm PAA. This is the minimum recommended concentration (MRC) of PAA for Rapicide PA high level disinfectant. If the solution is at or below MRC, the test strip pad will indicate a failure by turning dark grey, violet grey, light grey, or white (no change in color). A passing result will be indicated by the test strip pad turning solid black color.