(84 days)
The Wilson-Cook Zilver Biliary Stent System USE is indicated for the palliation of malignant neoplasms in the biliary tree.
The proposed Wilson-Cook Zilver Biliary Stent System-USW is a catheter within a catheter configuration. The pre-loaded (SEMS) Zilver Stent is held between the inner and outer catheter by natural expansion force at the distal tip. The inner catheter allows for wire guide access when placed through the accessory channel of an endoscope. The stent is self-expanding to nominal pressures to exert force on malignant neoplasms in the biliary tree resulting in dilation. It is offered in a variety of diameters/lengths to accommodate a range of biliary tumors.
The provided text describes a 510(k) submission for the "Wilson-Cook Zilver Biliary Stent System-USW" and its modification, but it does not contain information about specific acceptance criteria, device performance metrics (e.g., sensitivity, specificity), or a study detailing how the device meets such criteria.
The document refers to "Non-Clinical Testing" being performed "with respect to The FDA Guidance for the Content of PreMarket Notifications for Metal Expandable Biliary Stents and additional tests as needed to verify safety and performance." However, it does not elaborate on what these tests involved, what the acceptance criteria for those tests were, or what the reported performance was.
Therefore, most of the requested information cannot be extracted from this document.
Here's what can be gathered, highlighting the missing information:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Clinical Performance (e.g., efficacy, patency rates) | Not specified in the document | Not specified in the document |
| Mechanical Performance (e.g., radial force, fatigue resistance, deployment accuracy) | Not specified in the document. Reference to FDA Guidance for Metal Expandable Biliary Stents, but no specific criteria listed. | Not specified in the document. |
| Biocompatibility | Not specified in the document. | Mentioned as tested and believed to be substantially equivalent to predicate, but no specific results reported. |
| Sterility | Not specified in the document. | Mentioned as supplied sterile, but no testing details or performance reported. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified in the document.
- Data Provenance: Not specified in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable as the document does not describe a study involving expert-established ground truth for a test set. This device is a medical device, not an AI/diagnostic tool, so this type of evaluation is generally not performed in the same manner.
4. Adjudication method for the test set
- Not applicable for the reasons stated above.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a medical device (stent), not an AI/diagnostic tool that would involve human reader interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (stent), not an algorithm.
7. The type of ground truth used
- Not applicable, as there is no mention of a diagnostic study requiring ground truth in this context. The "performance data" refers to non-clinical testing of the stent's physical characteristics and biocompatibility.
8. The sample size for the training set
- Not applicable, as this is a medical device (stent), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable for the reasons stated above.
§ 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.