Disposable Stone Retrieval Balloon Catheter

The Disposable Stone Retrieval Balloon Catheter is a single-use medical device used for endoscopic removal of stones in the biliary system and for contrast injection. It consists of a latex balloon mounted at the distal end of a Pebax catheter with three internal lumens, radiopaque markers for visualization, and a two-way valve controlling balloon inflation. The device is 2000 mm long with a 2.5 mm outer diameter and offers multiple balloon inflation sizes and exchange methods.

The proposed device shares identical technical principles, structure, and performance characteristics with the predicate Stone Retrieval Balloon (K200173), including the same working length, balloon sizes, exchange methods, and performance specifications. Minor differences exist in material composition (proposed device includes additional materials like Isobornyl acrylate and Poly(acrylic acid)), and catheter outer diameter is 2.5 mm versus 2.4 mm for the predicate, but these do not raise safety or effectiveness concerns.

Biocompatibility testing per ISO 10993-5:2009 (in vitro cytotoxicity), ISO 10993-10:2021 (skin sensitization), ISO 10993-23:2021, and ISO 10993-11:2017; sterility per ISO 11135; and Quality Management System requirements per ISO 13485 and 21 CFR Part 820.

The proposed device is substantially equivalent to the predicate because it employs the same technical principles of operation, has identical structural design and performance characteristics, is indicated for the same clinical use, and demonstrates equivalent safety through biocompatibility testing and non-clinical bench testing despite minor material and dimensional variations that do not affect functionality or safety.