EGIS Biliary Double Bare Stent (BDB080405)

The EGIS Biliary Double Bare Stent is a medical device made of nitinol wire with a double-layer structure (inner and outer stents physically fixed with medical sutures) designed to relieve malignant strictures blocking the biliary tract. It is classified as a Class II device and is intended for palliative use only in the biliary system.

The device features a straight, round cylinder form with a double-layer construction created by overlapping two separately manufactured stents. Key specifications—including stent diameter, stent length, deployment system diameter, crossing profile, radial outward force, radial compression force, foreshortening, and bond strength—are equivalent to the predicate device. The double-layer design offers improved conformability and smaller cell size compared to the single-layer predicate.

ISO 10993-3 (genotoxicity—Ames and chromosomal aberration), ISO 10993-4 (hemolysis), ISO 10993-5 (cytotoxicity), ISO 10993-6 (implantation), ISO 10993-10 (sensitization and intracutaneous reactivity), ISO 10993-11 (acute/subchronic/chronic toxicity and pyrogenicity). Bench testing included foreshortening, stent integrity, dimensional verification, radial forces, corrosion, deployment, catheter bond strength, radiopacity, and magnetic resonance compatibility.

The EGIS Biliary Double Bare Stent is substantially equivalent to the predicate EGIS Biliary Single Bare Stent because both share the same intended use (palliation of malignant biliary strictures), identical design principles, and equivalent mechanical specifications. The minor modifications—addition of polymer sutures and conversion to double-layer structure—do not alter the fundamental function or safety profile; bench testing and biocompatibility evaluation confirmed performance equivalence across all critical parameters, including the critical force specifications at magnetic field conditions.