OASIS BILIARY STENT INTRODUCTION SYSTEM

K040151 · Wilson-Cook Medical, Inc. · FGE · Feb 20, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K040151
• Device Name: OASIS BILIARY STENT INTRODUCTION SYSTEM
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Feb 20, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Wilson-Cook's OASIS Biliary Stent Introducer System is for endoscopic biliary stent placement to drain obstructed bile ducts. The OASIS Biliary Stent Introduction System is intended for endoscopic biliary stent placement to drain obstructed bile ducts. The device is supplied sterile and intended for single use only.

Device Story

The OASIS Biliary Stent Introduction System is a sterile, single-use catheter system used by physicians during endoscopic procedures to facilitate the placement of biliary stents for the drainage of obstructed bile ducts. The device functions as an introducer to guide and position the stent within the biliary tree. It is a modification of existing Wilson-Cook stent introduction systems. The device is operated by a physician in a clinical setting; the output is the successful deployment of a biliary stent, which relieves ductal obstruction and improves patient biliary drainage.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Catheter-based biliary stent introducer; sterile, single-use. Design is a modification of existing Wilson-Cook biliary stent introduction systems. No specific materials or software algorithms described.

Indications for Use

Indicated for patients requiring endoscopic biliary stent placement to drain obstructed bile ducts. Prescription use only.

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

• Zimmon Endoscopic Biliary Stent Sets (k851962/A)

Submission Summary (Full Text)

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FEB 2,0 2004

K040151 Page 1 of 1

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## ATTACHMENT F: 510(k) Summary of Safety and Effectiveness

| 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: | January 22, 2004 |
| DEVICE: | OASIS Biliary Stent Introduction System |
| Trade Name: | OASIS Biliary Stent Introduction System |
| Common Name: | Stent Introducer |
| Classification: | Catheter, Biliary, Surgical, Class II<br>21 CFR § 876.5010 78 FGE |
| PREDICATE DEVICES: | Zimmon Endoscopic Biliary Stent Sets<br>(k851962/A) |
| INTENDED USE: | Wilson-Cook's OASIS Biliary Stent Introducer<br>System is for endoscopic biliary stent placement<br>to drain obstructed bile ducts |
| DEVICE DESCRIPTION: | The proposed Stent Introduction system is a<br>modification to Stent Introduction systems<br>currently sold by Wilson-Cook. The OASIS Stent<br>Introduction system is supplied sterile and<br>intended for single use only. |
| COMPARISON OF CHARACTERISITICS: | We believe the proposed device to be<br>substantially equivalent to the currently<br>marketed Wilson-Cook biliary stent introduction<br>systems as cleared by k851962/A |
| PERFORMANCE DATA: | We believe the proposed device to be<br>substantially equivalent to the named predicate<br>in terms of Intended Use, performance<br>characteristics tested and biocompatibility. |

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2004

Ms. Marge Walls-Walker Regulatory Affairs Specialist Wilson-Cook Medical GI Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105

Re: K040151

Trade/Device Name: Wilson-Cook OASIS®-Onc Action Stent Introduction System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: January 22, 2004 Received: January 23, 2004

Dear Ms. Walls-Walker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass battled in the May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou more s provisions of the Act include requirements for annual registration, listing of general connects production practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (sec above) into cither 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 that 1 Dr its al statutes and regulations administered by other Federal agencies. You must or uny I outher banate and 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k)
The all and the more of the first of substantial equivalence of your device to a This letter will allow you to begin matketing your actives of your device of your device to a legally
premarket notification. The FDA indines from for your device and thus premarket notification. The FDA inding of substantial equivations of your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our laboling regarders, based on the regulation number at the top of the letter:

| 8xx. Ixxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your devices, please contact the Additionally, for questions on the promotion and are mote the regulation entitled, "Misbranding
Office of Compliance at [phone]. Increase note the regulation of ther s Office of Compliance at [phone]. Also, products and obtain. Other general
by reference to premarket notification" (21CER Part 807.97) you may obtain. Other program by reference to premarket nouncation (21C) it it its of the Schained from the Division of Small
information on your responsibilities under the Act may be obtained from the Un information on your responsibilities and its the result-free namber [phone] or
Manufacturers, International and Colsum Assistance at its toll-free managemann html. Manufacturers, International and Colisumer Fisistance at to 10
[phone] or at its Internet address http://www.fda.gov/odrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(核(Number (if known): K040151

## Device Name: Wilson-Cook OASIS- One Action Stent Introduction System

## Indications for Use:

The OASIS Biliary Stent Introduction System is intended for endoscopic biliary stent placement to drain obstructed bile ducts.

The device is supplied sterile and intended for single use only.

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E

Prescription Use Only (Per 21 CFR § 801.109

OR

Over-the-Counter

Gevid h. Llymm

(Division Sign-Off) Abdominal Division of Reproductive and Radiological Devices 510(k) Number