MODIFICATION TO:ZILVER 518 BILIARY STENT

K050698 · Cook, Inc. · FGE · Mar 30, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K050698
• Device Name: MODIFICATION TO:ZILVER 518 BILIARY STENT
• Applicant: Cook, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Mar 30, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Zilver® 581™ Biliary Stent is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Device Story

Zilver® 518™ Biliary Stent is a self-expanding nitinol stent; designed for palliation of malignant biliary strictures. Device features interconnected Z-shaped segments to provide radial strength and minimize foreshortening. Stent is preloaded in a 5 French delivery system; deployed via simple hand-held device. Used by physicians in clinical settings. Stent conforms to biliary system anatomy. Output is physical scaffolding to maintain patency of biliary strictures. Benefits include relief of biliary obstruction caused by malignant neoplasms. Safety/effectiveness for vascular use not established.

Clinical Evidence

Bench testing only. Testing included deployment profile, deployment accuracy, stent length/diameter changes, uniformity of expansion, and stent integrity.

Technological Characteristics

Self-expanding nitinol stent; interconnected Z-shaped segments; 5 French delivery system; available in 4-10 mm diameters and 20-80 mm lengths; radiopaque markers.

Indications for Use

Indicated for palliation of malignant strictures (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.

Submission Summary (Full Text)

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Special 510(k) Premarket Noti Cook Zilver® 518™ Biliary Ste COOK INCORPORATED

MAR 3 0 2005

ouse 1 at 2

32

K050698

#### 510(k) Summary

Submitted By: Stephanie Roberts Requlatory Affairs Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235

March 17, 2005

#### Device:

| Trade Name: | Zilver® 518™ Biliary Stent |
|--------------------------|-------------------------------|
| Proposed Classification: | Catheter, Biliary, Diagnostic |

# Predicate Devices:

The Zilver® 518™ Biliary Stent is similar in terms of intended use, materials of The Zivel - 510 - Billary Ofent is offinal firstics to predicate devices reviewed as construction and toonif malignant neoplasm in the biliary tree.

# Device Description:

The Zilver® 518™ Biliary Stent is a self-expanding, nitinol stent designed for The Zivel - 510 - Dillary Otent is a oth expurching. Constructed from a excellent radial strength and optimations of the stent conforms to the shape of Series of Intercomfected = chaped cogniontial scaffolding throughout the stent's the billary system and provides of our norther Zilver 518" Billiary Stent, length. along with faciopaque manterconnected Z-shaped segments also keep foreshortening to a minimum.

The Zilver® 518™ Biliary Stent comes preloaded in a 5 French delivery system. The stent is deployed with the use of a simple hand held device. The stent is currently available in unrestrained outer diameters of 4, 5, 6, 7, 8, 9 and 10 mm in lengths of 20, 30, 40, 50 and 60 mm. The 80 mm length stent is an addition to this product line.

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KLSK7409 2005-2020

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Special 510(k) Premarket Notification ok Zilver® 518™ Biliary Stent COOK INCORPORATED

### Substantial Equivalence:

This device will be manufactured according to specified process controls and a This do noo will be mogram. This device will undergo packaging similar to the Quality Alourants Programs marketed and distributed by Cook Incorporated. This device will undergo sterilization similar to the predicate devices currently marketed and distributed. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.

# Test Data:

The Zilver® 518™ Biliary Stent was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

- 1. Deployment
- a. Profile
- b. Deployment Accuracy
- c. Stent length and Change due to Deployment
- d. Stent Diameter
- e. Uniformity of expansion
- f. Stent Integrity

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 2005

Ms. Stephanie Roberts Regulatory Affairs Specialist Cook® Incorporated P.O. Box 489 BLOOMINGTON IN 47402-0489

Re: K050698

K050098
Trade/Device Name: Zilver® 518™ Biliary Stent Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: March 17, 2005 Received: March 17, 2005

Dear Ms. Roberts:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(K) prematics from the minent (for the indications for referenced above and have determined the devices marketed in interstate comments, or to devices that use stated in the enclosure) to itgaily many in the Medical Device Amendments, or to devices that proof to May 28, 1976, the enactinent date of the Federal Food, Drug, and Cosmetic have been reclassified in accordance with the prevision to the general controls provisions of the Act (Act). You may, therefore, market the general controls provisions of the Act include Act and the limitations described below. The general velices, 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 he Unice of Device Evanuation has actefficial in the proposed labeling and that such use could cause will be used for an intellucu use not nemained in the Act, the Act, the Act, the following limitation must appear in the Warnings section of the device's labeling:

The safcty 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 Furthermore, the indication for bittlery ass frauve, and other promotional materials, in close pouch, box, and barname, of a similar point size, and in bold print.

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#### Page 2 -- Ms. Stephanie Roberts

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 FDA has made a determination that your device complies with other requirements of the Act or any F Drimal made a dollarions 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 systems (QS) regulation (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 results in a classification for your device and permits your device to proceed to the market. This resure in a cition with 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. Therefore, a new 510(k) is required 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 the regulation entitled, "Misbranding 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 yours,

Dorothy Miller

Donna-Bea Tillman, Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number: K050698

Device Name: Zilver® 518™ Biliary Stent

FDA's Statement of the Indications for Use for device:

The Zilver® 581™ Biliary Stent is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Prescription Use V (Per 21 CFR 801.109) OR

Over-the-Counter Use

cy C. Beadon

(Division Sion-Offi copioductive, Abdominal, Division and Radiological Devices 510(k) Number _