Disposable Endoscopy Valve Set

The Disposable Endoscopy Valve Set is a collection of sterile, single-use valve components designed to attach to endoscope working channels and ports to control the flow of fluids, gases, and other materials. It comprises four types of valves: Air/Water Valve (controls medical gas and water flow while preventing backflow), Suction Valve (controls suction while preventing air inflow), Biopsy Valve (prevents leakage of gases and body fluids), and Water Jet Adapter (provides irrigation via sterile water supply during GI endoscopic procedures). The device can be configured as a single valve or in combinations up to four valves.

The proposed device has substantially equivalent design, configuration, packaging, fundamental technology, sterilization process (EO sterilization), and intended use compared to the predicate (Disposable Endoscopy Adapter Set, K220210). Materials are silicone rubber, ABS, SUS304, and PC (with the proposed device adding PC to some components). Compatible endoscopes have been expanded from multiple Pentax, Olympus, and Fujifilm series in the predicate to include PENTAX i20 Series for air/water and suction valves. Performance specifications for depression force, suction volume, air feeding, water feeding, sealing, and connection firmness are either equivalent or meet comparable functional requirements.

ISO 10993 (Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing), ISO 11135-1 (Sterilization of Health Care products Ethylene Oxide – Part 1: Requirements for Development, Validation, and Routine Control), and ISO 10993-7 (Biological evaluation of medical devices – Part 7: ethylene oxide sterilization residuals). Bench testing included appearance and physical properties assessments with all results passing.

Substantial equivalence is established because the proposed device and predicate share the same intended use (controlling fluid and gas flow in endoscope channels), regulatory classification (Class II, 21 CFR 876.1500), sterilization method (EO), and fundamental valve technology. Both devices perform identical functions through comparable mechanical designs and materials. Performance testing demonstrates that the proposed device meets equivalent or comparable specifications for critical parameters such as connection firmness, sealing performance, depression force, and suction capability. The material additions (PC in some configurations) are supported by biocompatibility testing. The expanded endoscope compatibility list reflects product line development rather than a fundamental design change, as the valve mechanisms and functional principles remain unchanged.