(77 days)
To preserve patency of the common duct and to ensure drainage of bile out of the body until edema in the common duct has subsided enough for bile to drain into the duodenum normally. The T-Y Drainage Tube is also allowed for flush in the common duct.
All Silicone T-Drainage Tube w/wo Eyes All Silicone Y-Drainage Tube All Silicone T-Y Drainage Tube
The provided text is a 510(k) premarket notification letter from the FDA. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or detailed methodologies for establishing ground truth or conducting comparative effectiveness studies.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This means the device was approved based on its substantial equivalence to a predicate device, rather than through a new clinical performance study demonstrating fulfillment of specific acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
To be able to answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data, a clinical study report, or a detailed submission document that outlines the device's technical specifications and the studies conducted for its clearance.
§ 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.