Extraction Basket

The Extraction Basket is a sterile, single-use endoscopic accessory for removing stones and foreign bodies from the biliary system. It comes in two types: Type 1 works through a duodenoscope channel with X-ray guidance, while Type 2 works through a choledochoscope channel with direct visualization.

The proposed device has the same intended use, operating principles, configuration (basket assembly, sheath, handle), main materials (metal wires), sterilization method (EO), and packaging as the predicate. The primary differences are in dimensions (basket diameter 10-30mm vs. predicate's 15-30mm; outer tube diameter 3-7Fr vs. predicate's 5.5-10Fr) and shelf life (1 year for Type 1, 3 years for Type 2 vs. predicate's single shelf life), which the submitter states do not affect safety and effectiveness.

ISO 10993-1:2009 for biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity); ISO 11135:2014+A1:2018 for ethylene oxide sterilization validation; ASTM F1980-21 and ISO 11607-1:2019 and ISO 11607-2:2019 for shelf-life and packaging integrity testing. Performance testing included dimension, connection force, simulated-use, stone capture and durability, and for Type 1 only, injection, Luer, and X-ray detectability testing.

The Extraction Basket is substantially equivalent because it shares identical intended use (endoscopic stone and foreign body removal from biliary tract), the same fundamental design, materials, sterilization process, and operational principles as the cleared predicate Memory Eight Wire Baskets. Dimensional and shelf-life variations are minor and have been demonstrated through testing not to affect safety or effectiveness. All biocompatibility, performance, and sterilization validation testing confirm the device works as intended with compatible endoscopes.