Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M

The Single Use Cannula V and Single Use 2-Lumen Cannula V PR Series are sterile, single-use endoscopic cannulas designed to inject contrast medium into the biliary or pancreatic ducts during endoscopic retrograde cholangiopancreatography (ERCP). Each device has a handle (proximal portion) and an insertion portion with a distal tip optimized for smooth cannulation of the papilla of Vater or minor papilla, and all models are visible under fluoroscopy.

The subject devices are sterile single-use cannulas offered with and without stylets and fluoroscopic tips, featuring the same distal tip diameters as predicate devices. Key differences from the predicate are: (1) larger maximum insertion portion diameter (2.0–2.5 mm versus 1.8–2.0 mm), and (2) shorter working length (1700–1950 mm versus 1950–3200 mm). Both subject and predicate devices use ethylene oxide sterilization.

ISO 10993-1:2018 (biocompatibility), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (sensitization), ISO 10993-23:2021 (irritation), ISO 10993-11:2017 (acute systemic toxicity), USP <51> (pyrogenicity), ISO 11135:2014 (sterilization validation), ISO 10993-7:2008 (ethylene oxide residuals), ISO 11607-1:2019 and ASTM F1980-21 (packaging and shelf life).

The subject devices share the same intended use, intended patient population (adults), principles of operation, sterilization method, and single-use nature as the predicate ERCP catheters. Although the subject devices have a slightly larger insertion portion diameter and shorter working length, non-clinical mechanical and comparative testing demonstrates these design differences do not raise different questions of safety or effectiveness and do not alter device performance, safety, or efficacy. The devices perform identically in stylet design, tip characteristics, and functional testing (insertion force, contrast infusion, connection strength, visibility).