ZILVER BILIARY STENT SYSTEM USW

K040930 · Wilson-Cook Medical, Inc. · FGE · Jul 2, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K040930
• Device Name: ZILVER BILIARY STENT SYSTEM USW
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Jul 2, 2004
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Wilson-Cook's Zilver Biliary Stent System-USW is intended for palliation of malignant neoplasms in the biliary tree. This device is supplied sterile and intended for single use.

Device Story

Self-expanding metal biliary stent (SEMS) system; catheter-within-a-catheter configuration. Stent pre-loaded between inner and outer catheters; held by natural expansion force at distal tip. Deployed via endoscope accessory channel; inner catheter provides wire guide access. Stent self-expands to nominal pressure to exert radial force on malignant biliary neoplasms; results in dilation. Used in clinical settings by physicians. Benefits patient by palliating biliary obstructions caused by tumors.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Self-expanding metal biliary stent; catheter-based delivery system. Dimensions vary by diameter and length. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for the palliation of malignant neoplasms in the biliary tree.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Wilson-Cook Zilver Biliary Stent (K020788)

Submission Summary (Full Text)

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K040930 Page 1 of 1

## ATTACHMENT F: 510(k) Summary

| SPONSOR: | Wilson-Cook Medical<br>4900 Bethania Station Road<br>Winston-Salem, NC 27105 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Marge Walls-Walker<br>Regulatory Affairs Specialist<br>[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 FGE<br>21 CFR § 876.5010 |
| PREDICATE DEVICES: | Wilson-Cook Zilver Biliary Stent (k020788) |
| INTENDED USE: | Wilson-Cook's Zilver Biliary Stent System-USW<br>is intended for palliation of malignant neoplasms<br>in the biliary tree. This device is supplied sterile<br>and intended for single use. |
| DEVICE DESCRIPTION: | The proposed Wilson-Cook Zilver Biliary Stent<br>System-USW is a catheter within a catheter<br>configuration. The pre-loaded (SEMS) Zilver<br>Stent is held between the inner and outer<br>catheter by natural expansion force at the distal<br>tip. The inner catheter allows for wire guide<br>access when placed through the accessory<br>channel of an endoscope. The stent is self-<br>expanding to nominal pressures to exert force<br>on malignant neoplasms in the biliary tree<br>resulting in dilation. It is offered in a variety of<br>diameters/lengths to accommodate a range of<br>biliary tumors. |
| COMPARISON OF CHARACTERISITICS: | We believe the proposed device to be<br>substantially equivalent to the named predicate<br>in terms of Intended Use, Indications for Use,<br>performance characteristics tested, stent<br>diameter and length available and<br>biocompatibility. |
| PERFORMANCE DATA: | Non-Clinical Testing was performed on<br>characteristics of the stent with respect to The<br>FDA Guidance for the Content of PreMarket<br>Notifications for Metal Expandable Biliary Stents<br>and additional tests as needed to verify safety<br>and performance. |

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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 [phone]. 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 [phone] or [phone] 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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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 _