(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.
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K040930 Page 1 of 1
ATTACHMENT F: 510(k) Summary
| SPONSOR: | Wilson-Cook Medical4900 Bethania Station RoadWinston-Salem, NC 27105 |
|---|---|
| CONTACT/SUBMITTER: | Marge Walls-WalkerRegulatory Affairs Specialist[336]-744-0157 Ex.290 |
| DATE OF SUBMISSION: | April 8, 2004 |
| DEVICE: | Zilver Biliary Stent System-USW |
| Trade Name: | Wilson-Cook Zilver Biliary Stent System-USW |
| Common Name: | Expandable Metal Biliary Stent |
| Classification: | Catheter, Biliary, Class II, GU/ 78 FGE21 CFR § 876.5010 |
| PREDICATE DEVICES: | Wilson-Cook Zilver Biliary Stent (K020788) |
| INTENDED USE: | Wilson-Cook's Zilver Biliary Stent System-USWis intended for palliation of malignant neoplasmsin the biliary tree. This device is supplied sterileand intended for single use. |
| DEVICE DESCRIPTION: | The proposed Wilson-Cook Zilver Biliary StentSystem-USW is a catheter within a catheterconfiguration. The pre-loaded (SEMS) ZilverStent is held between the inner and outercatheter by natural expansion force at the distaltip. The inner catheter allows for wire guideaccess when placed through the accessorychannel of an endoscope. The stent is self-expanding to nominal pressures to exert forceon malignant neoplasms in the biliary treeresulting in dilation. It is offered in a variety ofdiameters/lengths to accommodate a range ofbiliary tumors. |
| COMPARISON OF CHARACTERISITICS: | We believe the proposed device to besubstantially equivalent to the named predicatein terms of Intended Use, Indications for Use,performance characteristics tested, stentdiameter and length available andbiocompatibility. |
| PERFORMANCE DATA: | Non-Clinical Testing was performed oncharacteristics of the stent with respect to TheFDA Guidance for the Content of PreMarketNotifications for Metal Expandable Biliary Stentsand additional tests as needed to verify safetyand performance. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing the body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 2 2004
Ms. Marge Walls-Walker Regulatory Affairs Specialist Wilson-Cook Medical GI Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105
Re: K040930
K040930
Trade/Device Name: Wilson Cook Zilver Biliary Stent System USW – Device Modification Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: June 3, 2004 Received: June 4, 2004
Dear Ms. Walls-Walker:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your bection of our production is substantially equivalent (for the indications for referenced above and nave accemines arketed predicate devices marketed in interstate commerce ass stated in the eneround date of the Medical Device Amendments, or to devices that provision way 20, 1970, the chance with the provisions of the Federal Food, Drug, and Cosmetic have been reclassified in accoraanse at the device, subject to the general controls provisions of the Act (Act). Tou may, aleretere, analow. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device I ils Office of De nee Eranance not identified in the proposed labeling and that such use could cause with oc used for an intentation 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
The safety and effectiveness of this device for use in the vascular system have not been established.
Furthermore, the indication for biliary use must be prominently displayed in all labeling, including I urnlermore, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
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Page 2 -- Ms. Marge Walls-Walker
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to additional controls. Existing major regulations affecting your device can be found inay be subject to additional othing Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I rease be devised marr ination that your device complies with other requirements of the Act or any I DA has mude a uctions administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality laboring (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device r he 1 Dr I maning of vice and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. r toast note that are a on the before these limitations are modified in any way or removed from the device's labeling.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4616. Also, please note (21 CFR Part on 1) processions by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International, and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours,
Sincerely, yours,
Donna-Bea Tillman Ph.D Acting Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_1 of 1
510(k) Number: K040930
Device Name: Wilson-Cook Zilver Biliary Stent System USW -- Device Modification
FDA's Statement of the Indications For Use for device:
The Wilson-Cook Zilver Biliary Stent System USE is indicated for the palliation of malignant neoplasms in the biliary tree.
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Nanc Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
§ 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.