(28 days)
The EndoGI 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 EndoGI S-Path Biliary Stent System consists of a stent and stent delivery catheter. The EndoGI S-Path Biliary Stent System catheter is 10 Fr in diameter and includes a single preloaded stent available in three lengths (80, 110 and 140 mm). The delivery catheter is compatible with a guidewire of up to 0.035". EndoGI S-Path Biliary System stents have a straight body and one end incorporating a 65° bend (duodenal bend). Stents are comprised of a biocompatible radiopaque plastic which allows visualization of the stent post deployment.
This document is a 510(k) Summary for the EndoGI S-Path Biliary Stent System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and expert involvement is not available in the provided text.
Based on the information provided, here's what can be extracted:
Acceptance Criteria and Reported Device Performance (as inferred from the context of a 510(k) for device modification):
The document primarily states that "repeat bench testing demonstrated that the system functions as intended and yielded substantially equivalent results to the results obtained with the predicate." It also notes that "the results of the validation testing demonstrated that the EndoGI S-Path system is as safe and effective as its predicate and that the modifications to the system did not raise new questions of safety and effectiveness."
While specific numerical acceptance criteria are not presented, the implicit acceptance criterion is that the modified device's performance is substantially equivalent to the predicate device for a set of defined performance tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: Equivalent to predicate device | Repeat bench testing demonstrated the system functions as intended and yielded substantially equivalent results to the predicate. Validation testing confirmed the system is as safe and effective as its predicate. |
| Dimensional Performance: Equivalent to predicate device | Repeat bench testing demonstrated the system functions as intended and yielded substantially equivalent results to the predicate. Validation testing confirmed the system is as safe and effective as its predicate. |
| Kink Resistance: Equivalent to predicate device | Repeat bench testing demonstrated the system functions as intended and yielded substantially equivalent results to the predicate. Validation testing confirmed the system is as safe and effective as its predicate. |
| Flow Rate: Equivalent to predicate device | Repeat bench testing demonstrated the system functions as intended and yielded substantially equivalent results to the predicate. Validation testing confirmed the system is as safe and effective as its predicate. |
| Safety and Effectiveness: No new questions raised by modifications | The modifications to the system did not raise new questions of safety and effectiveness. The system is as safe and effective as its predicate. |
Missing Information (Not provided in the document):
- Sample size used for the test set and the data provenance: Not mentioned. The document only refers to "bench testing" and "validation testing" without detailing the number of units tested or if any clinical data was used (which is unlikely for a 510(k) for minor modifications).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not mentioned. The testing described appears to be bench testing of physical properties, not a clinical trial requiring expert ground truth establishment.
- Adjudication method for the test set: Not applicable/Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document describes a physical medical device (biliary stent system), not an AI-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used: For physical performance tests, the "ground truth" would be established by validated measurement standards and physical testing methodologies. No human-expert derived ground truth is applicable here.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Study Description (as inferred from the 510(k) Summary):
The "study" or rather, the performance evaluation, was a bench testing validation study. It was conducted to demonstrate that the modified EndoGI S-Path Biliary Stent System (which includes new stent sizes and minor delivery system improvements) performs as intended and is substantially equivalent to its predicate device (EndoGI Biliary Stent System, K202477).
The modifications included two new stent sizes (80mm and 140mm) and an extended overall system length.
The specific tests performed were:
- Mechanical testing
- Dimensional testing
- Kink resistance testing
- Flow rate testing
The conclusion was that these repeat performance tests demonstrated that the modified system functions in an equivalent manner to the predicate and that the modifications did not raise new questions of safety or efficacy. The data provenance is implied to be from the manufacturer's internal testing.
§ 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.