TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING

K040129 · Wilson-Cook Medical, Inc. · GCA · Feb 27, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K040129
• Device Name: TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: GCA · Gastroenterology, Urology
• Decision Date: Feb 27, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Wilson-Cook's Tri-Ex Extraction Balloon with Multiple Sizing is for endoscopic removal of stones in the biliary system and for contrast injection.

Device Story

Tri-Ex Extraction Balloon is a biliary catheter used during endoscopic procedures. Device facilitates stone removal from biliary system and allows for contrast injection. Operated by physicians in clinical settings. Device is supplied sterile for single use. Modification of existing Wilson-Cook extraction balloons.

Clinical Evidence

Bench testing only.

Technological Characteristics

Biliary catheter; single-use; sterile; multiple sizing capability. No specific materials or software algorithms described.

Indications for Use

Indicated for endoscopic removal of biliary stones and contrast injection in patients requiring biliary intervention.

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 Triple Lumen Balloon Stone Extractor (k953951)

Submission Summary (Full Text)

{0}------------------------------------------------

FEB 27 2004

## 510(k) Summary of Safety and Effectiveness: k040129

| SPONSOR: | Wilson-Cook Medical 4900 Bethania Station Road Winston-Salem, NC 27105 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Marge Walls-Walker Regulatory Affairs Specialist [336] 744-0157 Ex.290 |
| DATE OF SUBMISSION: | February 13, 2004 |
| DEVICE: | Tri-Ex Extraction Balloon with Multiple Sizing |
| Trade Name: | Tri-Ex Extraction Balloon with Multiple Sizing |
| Common Name: | Extraction Balloon |
| Classification: | Catheter, Biliary, Surgical, Class II 21 CFR § 876.5010 78 GCA |
| PREDICATE DEVICES: | Wilson-Cook Triple Lumen Balloon Stone Extractor (k953951) |
| INTENDED USE: | Wilson-Cook's Tri-Ex Extraction Balloon with Multiple Sizing is for endoscopic removal of stones in the biliary system and for contrast injection. |
| DEVICE DESCRIPTION: | The proposed Extraction Balloon is a modification to existing extraction balloons currently marketed by Wilson-Cook. The Tri-Ex Extraction Balloon with Multiple Sizing is supplied sterile and intended for single use only. |
| COMPARISON OF CHARACTERISITICS: | We believe the proposed device to be substantially equivalent to currently marketed Wilson-Cook biliary extraction balloons as cleared by k953951 |
| PERFORMANCE DATA: | We believe the proposed device to be substantially equivalent to the named predicate in terms of Intended Use, performance characteristics tested and biocompatibility. |

:

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 27 2004

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

Re: K040129

Trade/Device Name: Wilson-Cook Tri-Ex Extraction Balloon with Multiple Sizing Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 GCA Dated: February 13, 2004 Received: February 17, 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 commerce prior to 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see 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 or any Federal statutes and regulations 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.

{2}------------------------------------------------

Page 2

This letter will allow you to begin marketing your device as described in your Section S10(k) I mis lotter notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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 contact the Office of Compliance at one of the following numbers, based 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 advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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,

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

{3}------------------------------------------------

510(k) Number (if known): _KO40129

## Device Name: Wilson-Cook Tri-Ex Extraction Balloon with Multiple Sizing

## Indications for Use:

The Tri-Ex Extraction Balloon with Multiple sizing is used for endoscopic removal of stones in the biliary system and for contrast injection.

(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

Over-the-Counter

Nancy broadon

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