WILOSN-COOK BILIARY DILATION BALLOON

K040800 · Wilson-Cook Medical, Inc. · FGE · Jun 25, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K040800
• Device Name: WILOSN-COOK BILIARY DILATION BALLOON
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Jun 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Wilson-Cook's Biliary Dilation Balloon is intended to dilate strictures in the biliary tree. This device is supplied sterile and intended for single use

Device Story

Triple lumen catheter with balloon mounted on distal tip; used for biliary stricture dilation. One lumen provides wire guide access; two lumens facilitate balloon inflation/deflation with water. Device inserted through endoscope accessory channel; physician-operated. Balloon inflation exerts radial force on strictures to achieve dilation. Offered in various diameters to accommodate different stricture sizes. Single-use, sterile device.

Clinical Evidence

Bench testing only. Performance characteristics of the balloon were evaluated in accordance with FDA Guidance for Urological Balloons and additional safety/performance verification tests.

Technological Characteristics

Triple lumen catheter; balloon inflation via water; various diameters available. Single-use; sterile. No specific materials or software algorithms described.

Indications for Use

Indicated for the dilation of strictures in the biliary tree. Intended for single use.

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 Quantum T.T.C. Dilation Balloon (k935094)
• Microvasive RX Biliary Balloon Dilation Catheter (K001338)

Submission Summary (Full Text)

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JUN 2 5 2004

K040800

Page 1 of 1

## ATTACHMENT E: 510(k) Summary

| SPONSOR: | Wilson-Cook Medical<br>4900 Bethania Station Road<br>Winston-Salem, NC 27105 |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Marge Walls-Walker<br>Requlatory Affairs Specialist<br>[336] -744-0157 Ex.290 |
| DATE OF SUBMISSION: | March 25, 2004 |
| DEVICE: | Biliary Dilation Balloon |
| Trade Name:<br>Common Name:<br>Classification: | Wilson-Cook Biliary Dilation Balloon<br>Biliary Dilation Balloon<br>Dilator, Esophageal, Class II 78 KNQ<br>21 CFR § 876.5365 |
| PREDICATE DEViCES: | Wilson-Cook Quantum T.T.C.Dilation Balloon<br>(k935094)<br>Microvasive RX Biliary Balloon Dilation Catheter<br>(K001338) |
| INTENDED USE: | Wilson-Cook's Biliary Dilation Balloon is<br>intended to dilate strictures in the biliary tree.<br>This device is supplied sterile and intended for<br>single use |
| DEVICE DESCRIPTION: | The proposed Wilson-Cook Biliary Dilation<br>Balloon is a triple lumen catheter with a balloon<br>mounted on the distal tip. The three lumens<br>allow one lumen for wire guide access and two<br>lumens for inflation/deflation of the balloon when<br>placed through the accessory channel of an<br>endoscope. The balloon is inflatable with water<br>to nominal pressures to exert force on biliary<br>strictures resulting in stricture dilation. It is<br>offered in a variety of diameters to<br>accommodate a range of biliary strictures |
| COMPARISON OF CHARACTERISITICS: | We believe the proposed device to be<br>substantially equivalent to the named predicates<br>in terms of Intended Use, Indications for Use,<br>performance characteristics tested, balloon<br>diameter and length available and<br>biocompatibility. |
| PERFORMANCE DATA: | Non-Clinical Testing was performed on<br>characteristics of the balloon with respect to The<br>FDA Guidance for Urological Balloons and<br>additional tests as needed to verify safety and<br>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 features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 5 2004

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

Re: K040800

Trade/Device Name: Wilson-Cook Biliary Dilation Balloon Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: March 25, 2004 Received: March 29, 2004

Dear Ms. Walls-Walker:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed your becasin 3 re(s) press.
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 use stated in the endobure) to regard comment date of the Medical Device Amendments, or to commerce prior to may 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices mat have occh rochasined in avee approval of a premarket approval application (PMA). and Cosmetic Act (10t) that do not request to the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the fiest labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), if your device is classified (500 a0070) in Friday major regulations affecting your device can be it may of Subject to adultional controlians, 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 ITTCase oc actived that I Dr Srissantes or our device complies with other requirements of the Act mat IDA has made a determination administered by other Federal agencies. You must of any Federal statures and roganders including, but not limited to: registration and listing Comply with an the Act 5 requirement Part 801); good manufacturing practice requirements as set (21 CFR Part 607), lubonus (21 CFR Part 820); and if applicable, the electronic forth in the quanty by stolins (QB) rog (sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k)
The are and and and and finding of substantial equivalence of vour device to a This letter will allow you to begin matkenes your active of your device of your device to a legally
premarket notification. The FDA includification for vour device and thus, premarket notification. The FDA inding of substantial ogardents 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 (2) CFR Part 801), please
r and the may of the following for fith of the following numbers, based on If you desire spective advice for your device on our lasting of your and on the regulation number at the top of the letter:

| 8xx. 1xxx | [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 advice, please contact the Additionally, for questions on the promotion and the regulation entitled, "Missionaling
Office of Compliance at [phone]. Association may obtain . Other general Office of Compliance at [phone]. Assistence of Commary obtain. Other general by reference to premarket notificans under the Act may be obtained from the Division of Small
information on your responsibilities under the Act may be rits toll fire number information on your responsibilités mire Assistance at its tall-free murber [phone] or
Manufacturers, International and Consumer Assistance at its toll-free managemana Manufacturers, International and Collistation and Collist.
[phone] or at its Internet address http://www.fda.gov/cdrl/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(k) Numbêr (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Wilson-Cook Biliary Dilation Balloon

indications for Use:

The Wilson-Cook Biliary Dilation Balloon is intended to dilate strictures of the biliary tree. This The Wilson Ocon Sterile and intended for single use only.

## (Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE-IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Only
(Per 21 CFR § 801.109)

OR

David A. Legnon

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

Over-the-Counter______________________________________________________________________________________________________________________________________________________________