Disposable Stone Extraction Basket

The Disposable Stone Extraction Basket is a single-use endoscopic device consisting of a stainless steel/nitinol basket at the distal end of a polytetrafluoroethylene catheter sheath with a handle. It is used for endoscopic removal of biliary stones and foreign bodies in the biliary system and is indicated for adult patients only.

The proposed device differs from the predicate in basket length (25mm/34mm/42mm/50mm vs 20mm/40mm/50mm), insert portion maximum width (1.8mm, 2.4mm vs 2.0mm, 2.8mm, 3.7mm), and materials (adds ABS, PVC, and silica gel to the nitinol and stainless steel). The fundamental principle of operation remains the same.

ISO 10993-5:2009 (in vitro cytotoxicity), ISO 10993-10:2021 (skin sensitization and intracutaneous reactivity), ISO 10993-23:2021, ISO 10993-11:2017 (biocompatibility), and ISO 11135 (sterility). Non-clinical bench testing included appearance, size, connecting performance, smoothness, Luhr joint performance, flexibility, and stone capture performance.

The proposed device is substantially equivalent because it has the same intended use and fundamental principle of operation as the predicate device. Differences in basket length, insert width, and materials are acceptable and were evaluated through bench testing and biocompatibility studies, which demonstrate the device meets performance criteria and does not raise questions regarding safety and effectiveness.