(33 days)
The EndoGl S-Path Biliary Stent System is intended for delivery of stent(s) to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
The revised EndoGI S-Path System incorporates one preloaded stent which has a straight body and one end incorporating a 65° bend (duodenal bend). The stent is identical to the previously cleared EndoGI stent and is comprised of a biocompatible radiopaque plastic which allows visualization of the stent post deployment.
The EndoGI S-Path System is available 10 Fr and includes a single preloaded stent available in three lengths (80, 110 and 140 mm). The system is compatible with a guidewire of up to 0.035".
The provided text is a 510(k) summary for the EndoGI S-Path Biliary Stent System. It primarily focuses on demonstrating substantial equivalence to a predicate device based on intended use, technology, and performance data from mechanical, dimensional, biocompatibility, and sterilization tests. It does not contain information about clinical study acceptance criteria or the specifics of a clinical study aimed at proving device performance against such criteria.
Therefore, I cannot provide the requested information from the given text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample size for a test set or its provenance.
- Number or qualifications of experts used for ground truth.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for a training set.
- How ground truth for a training set was established.
The document discusses "performance data" in a general sense within Section 7, referring to mechanical performance, dimensional testing, and kink tests, as well as biocompatibility and sterilization tests to support modifications made to the delivery system. These are typically engineering and laboratory tests, not clinical performance studies with human subjects or expert readers that would generate the kind of data requested in the prompt.
§ 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.