Disposable Distal Cap

The Disposable Distal Cap is a single-use accessory that attaches to the distal end of a cholangioscope to maintain an appropriate endoscopic field of view during procedures. It is available in two types: cylinder and taper configurations, each with one specification, totaling two specifications. The device is sterilized to achieve a Sterility Assurance Level of 10^-6 and has a shelf life of one year.

The proposed device incorporates the same sterilization method, material, chemical composition, principle of operation, and substantial equivalence design as the predicate device Disposable Distal Cap (K243388). Both devices are designed for use with cholangioscopes, though the proposed device is specifically intended for various cholangioscope models in biliary systems, while the predicate was designed for gastrointestinal endoscopes.

ISO 10993-1 (Biological Evaluation of Medical Devices), ASTM F1980 (Accelerated Aging of Sterile Barrier Systems), ISO 11135 (Sterilization of Health Care Products – Ethylene Oxide), and ISO 13485 (Quality Management System Regulation).

The proposed device is substantially equivalent to predicate K243388 because it uses identical sterilization methods, materials, chemical composition, and operational principles. Performance testing confirmed the device works as intended with compatible cholangioscopes and is as safe and effective as the predicate. Although the intended use differs (cholangioscope vs. gastrointestinal endoscope), adequate risk analysis and mitigation measures were implemented to demonstrate safety and effectiveness.