Orca Air/Water and Suction Valves

The Orca Air/Water and Suction Valves are endoscopic channel accessories that attach to the air/water and suction ports on an endoscope handle to control air/water flow and suction during gastrointestinal endoscopic procedures. They are single-use, sterile devices supplied as a kit in a tray.

The subject device differs from the predicate in material composition (polycarbonate, ABS resin, thermoplastic elastomers versus stainless steel, ABS resin, thermoplastic elastomers), labeled compatibility (Olympus and Exalt endoscopes versus Olympus only), and packaging (Tyvek lid versus Tyvek/clear polymer peel pack). Mode of operation, intended use, target population, sterility, and sterilization method (EO, SAL 10⁻⁶) remain identical.

Biocompatibility testing followed FDA Blue Book Memorandum #G95-1 and International Standard ISO 10993-1 for biological evaluation of medical devices, including cytotoxicity, sensitization, and irritation testing for tissue contact less than 24 hours.