Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)

The Disposable Balloon Catheter (B5-2Q, B7-2Q, B7-2LA) is designed for use with Olympus endoscopes to inject contrast medium into the biliary or pancreatic tract during endoscopic retrograde cholangiopancreatography (ERCP) procedures. The device can also be used for retrieval of biliary or pancreatic stones. It consists of an inflatable balloon, tube, branch, injection port, air feeding port, and stopcock that is inserted through the endoscope channel, inflated at the target site, and then deflated and removed after the procedure.

The subject device shares identical or nearly identical specifications with the predicate device across insertion diameter, working length, compatible guidewires, and endoscope compatibility. However, due to a change in the Natural Rubber Latex balloon material manufacturer, the subject device holds increased maximum air volume (B5-2Q: 2.2 ml vs. 1.6 ml; B7-2Q: 2.4 ml vs. 1.8 ml; B7-2LA: 2.6 ml vs. 2.0 ml). Both devices are single-use and sterilized by ethylene oxide (ETO).

ISO 10993-1 (Biological evaluation of medical devices); ISO 14971:2019 (Risk management). Biocompatibility testing included cytotoxicity, intracutaneous irritation, sensitization, pyrogen, and acute systemic toxicity studies per ISO 10993-1.