(29 days)
These instruments have been designed to be used with Olympus endoscopes to inject contrast media into the biliary or pancreatic tract. They can also be used for retrieval of biliary or pancreatic stones.
The subject device(s) is a balloon catheter that has a triple-lumen catheter and a multiple sizing balloon with pre-measured syringes, to be used in accordance with Intended use of the device. These functions ensure smoother passage of the guidewire and injection of the contrast media without removing the guidewire, and enable to inflate one balloon to 3 different sizes.
The provided document, K033333, is a 510(k) premarket notification for a medical device: the Single Use 3-Lumen Balloon Catheter, Models B-230Q-A and B-230Q-B.
This document does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria. The 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device (B-5/B-7 series Balloon Catheter K962925) based on intended use, method of operation, materials, and design, and explicitly states that no significant changes that could affect safety or effectiveness were made.
Therefore, I cannot provide the requested information in the format specified because the document does not contain the necessary details about performance studies, sample sizes, ground truth establishment, or expert involvement.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.