(58 days)
The Wilson-Cook Modified Zilver Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.
Used to maintain patency of malignant biliary strictures.
The Wilson-Cook Zilver Biliary Stent is indicated for use in the palliation of malignant neoplasms in the biliary tree.
The Wilson-Cook Modified Zilver Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree. This device and its introduction system are supplied sterile and intended for single use only.
The modification of the Zilver Biliary Stent includes a change to the introduction system only. The stent itself is identical to the predicate Cook Zilver Biliary Stent (K010242) in configuration and materials of construction, and the intended use for both the predicate and modified device are also the same. However, since the predicate introduction system is utilized for percutaneous biliary stent placement and the modified Wilson-Cook Metal Biliary Stent introduction system is used for endoscopic placement, the introduction system of the modified device is longer (200 cm) than that of the predicate device (80 cm).
These devices also operate in the same manner; the main difference being the method utilized in order to gain access to the placement site. The predicate device is used for percutaneous placement, while the modified Wilson-Cook Biliary Stent is placed endoscopically.
The document provided is a 510(k) summary for the Wilson-Cook Modified Zilver Biliary Stent. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and the study that proves the device meets those criteria.
Specifically, the document states:
- "All results obtained during our Design Verification met our predetermined acceptance criteria for this product line." (Page 2, "Design Control/Risk Analysis/Design Verification" section).
- It also mentions "dimensional and functional testing to ensure the performance and design integrity of this product line."
However, the document DOES NOT provide:
- The actual acceptance criteria themselves (the specific numerical or qualitative targets).
- The detailed results of these tests.
- Information about sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for these tests.
- Any information regarding a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study, as this is a medical device, not an AI/software device.
Given the information provided in the 510(k) summary:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document (e.g., specific dimensions, deployment force, patency duration, biocompatibility test results, etc.) | "All results obtained during our Design Verification met our predetermined acceptance criteria for this product line." (Successful performance in dimensional and functional testing, and biocompatibility has been established.) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in the document.
- Data Provenance: Not specified in the document. The tests seem to be internal design verification and functional testing conducted by the manufacturer, Wilson-Cook Medical Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of information is generally not applicable to a physical medical device's design verification and functional testing, which relies on engineering specifications and laboratory measurements, not expert review of images or data. Therefore, this information is not present in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this is a physical medical device, not an AI/software device requiring human adjudication for test set ground truth.
5. 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:
- No. This is a physical medical device (biliary stent and introducer), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device. This type of study is not applicable.
7. The type of ground truth used:
- For the device's design verification and functional testing, the "ground truth" would be established by the engineering specifications and performance requirements defined by the manufacturer based on regulatory standards, industry best practices, and the intended use of the device. Biocompatibility was established through "history of use in similar patient-contacting medical devices and as applicable biocompatibility test results."
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning algorithm.
9. How the ground truth for the training set was established:
- Not applicable. This is a physical medical device, not a machine learning algorithm.
In summary, the provided 510(k) indicates that design verification and functional testing were performed and met pre-determined acceptance criteria. However, it does not detail those criteria or the specifics of the testing as would be expected for an AI/software device. The questions related to experts, adjudication, MRMC studies, and training/test sets for AI are not applicable to this type of medical device submission.
§ 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.