Endoscopic Water Pump

The Endoscopic Water Pump is a peristaltic pump that supplies fluid to compatible endoscopes or endotherapy devices for irrigation of the gastric and colonic mucosa during endoscopic or endotherapeutic procedures. It aids in visualization, diagnosis, and treatment. The device comprises a motorized host machine with drive system and peristaltic pump head, operating components (rotatable knob and footswitch), optional hanger assembly, and optional irrigation tube.

The proposed device has a maximum output flow rate of approximately 240–258 ml/min for auxiliary water channel use and 240–258 ml/min for instrument channel flushing (both at flow setting 10, maximum). The predicate device achieves approximately 230 ml/min for auxiliary channels (at setting 9) and 785 ml/min for instrument channels without instruments inserted. The proposed device specifies a 5-year shelf life for the host machine; the predicate's shelf life is unknown. Both use peristaltic pump technology with footswitch operation and front-panel flow control.

IEC 60601 (electrical safety and EMC), ISO 11135 (sterility of irrigation tubes), ISO 10993-5:2009 (biocompatibility—cytotoxicity), ISO 10993-10:2021 (biocompatibility—sensitization and irritation), and ISO 10993-23:2021 (biocompatibility—temporary tissue irritation).

Both devices perform the same intended function—peristaltic pumping of irrigation fluid to endoscopes—using identical technology and operating principles. Although the proposed device achieves higher maximum flow rates than the predicate, the submitter conducted simulation testing demonstrating that the higher flow rates meet clinical requirements without raising safety or effectiveness questions. Material composition and shelf life differ, but biocompatibility testing of the proposed device materials and shelf-life validation studies support equivalence. The differences in optional accessories (water container) and irrigation tube sterilization status do not affect the fundamental safety or effectiveness of the pumping function.