MARATHON STENT WITH FUSION TECHNOLOGY

K060624 · Cook Ireland, Ltd. · FGE · Aug 4, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K060624
• Device Name: MARATHON STENT WITH FUSION TECHNOLOGY
• Applicant: Cook Ireland, Ltd.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Aug 4, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended for endoscopic placement of a preloaded biliary stent to drain obstructed biliary ducts and reduce duodenal content reflux. This device is supplied sterile and intended for single use only.

Device Story

Marathon Stent with Fusion Technology; preloaded biliary stent system; 10 Fr diameter; variable lengths (5, 7, 9, 12 cm). Features soft sock attached to proximal end of traditional biliary stent; design reduces duodenal content reflux while maintaining antegrade flow. Used in endoscopic procedures; operated by physicians. Device placed in biliary ducts to drain obstructions. Clinical benefit: effective drainage of obstructed ducts with reduced reflux. Sterile, single-use device.

Clinical Evidence

Prospective, randomized clinical study comparing Marathon Stent with Fusion Technology to standard plastic stent. Results showed device was as effective as standard plastic stent with no new or increased safety risks.

Technological Characteristics

10 Fr biliary stent with proximal soft sock; variable lengths (5-12 cm). Sterile, single-use. Non-clinical testing included endoscope/wire guide compatibility, deployment validation, sock-to-stent security, and antegrade/retrograde flow testing.

Indications for Use

Indicated for patients requiring endoscopic drainage of obstructed biliary ducts and reduction of duodenal content reflux.

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

• Olympus PBD Stents (K933200)
• Wilson-Cook Zimmon Biliary Stent Set (K851962/A)
• Wilson-Cook OASIS Biliary Stent Introduction System (K040151)

Submission Summary (Full Text)

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

K060624 page 1 of 2

## 510(k) Summary

| | AUG -- 4 2006 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name: | Cook Ireland |
| Address: | O'Halloran Road<br>National Technological Park<br>Limerick, Ireland |
| Phone: | 353 61 334440 |
| Fax: | 353 61 334441 |
| Contact Person: | Emmett Devereux, Quality & RegulatoryManager<br>Sinead Burke, Regulatory Affairs Specialist |
| Date: | July 28, 2006 |
| Trade Name: | Marathon Stent with Fusion Technology |
| Common Name: | Stent Introducer with Biliary Stent |
| Classification Name: | Catheter, Biliary, Diagnostic (21 CFR 876.5010<br>Product Code FGE) |
| Legally Marketed<br>Devices: | Olympus PBD Stents (K933200)<br>Wilson-Cook Zimmon Biliary Stent Set (K851962/A)<br>Wilson-Cook OASIS Biliary Stent Introduction<br>System (K040151) |
| Description of the device: | The Marathon Stent with Fusion Technology is<br>designed to place its preloaded biliary stent to drain<br>obstructed biliary ducts and reduce duodenal content<br>reflux. A soft sock is attached to the proximal end of a<br>traditional biliary stent that reduces duodenal content<br>reflux without compromising antegrade flow. The stent<br>is 10 Fr and will be offered in variable lengths of 5, 7, 9<br>and 12 cm between the flaps. |

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

K06024 page 2 of 2

Intended Use:

Comparison of Characteristics: This device is intended for endoscopic placement of a preloaded biliary stent to drain obstructed biliary ducts and reduce duodenal content reflux. This device is supplied sterile and intended for single use only.

We believe the proposed device to be substantially equivalent to currently marketed predicate devices as cleared by K933200, K851962/A and K040151, in terms of intended use, indications for use, performance characteristics, anatomical sites and biocompatibility.

Performance Data:

Non-clinical testing was carried out on the stent to determine the equivalence of the Marathon stent with Fusion Technology to the predicate devices and to verify the safety and effectiveness of the stent. The following is a summary of the testing carried out: verification of Endoscope and wire guide compatibility, validation of stent deployment, sock to stent Security, antegrade flow tests (with simulated bile), retrograde flow tests.

Clinical data in support of the claim of substantial equivalence and the intended use of the Marathon stent with Fusion Technology has been collected and presented within this submission. This prospective, randomized clinical study showed that the Marathon Stent with Fusion Technology was as effective as a standard plastic stent, and no new or increased risks related to safety and effectiveness were likely to be raised when compared to risks experienced with similar marketed devices.

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG - 4 2006

Ms. Sinead Burke Regulatory Affairs Specialist Cook Ireland Ltd. O'Halloran Road National Technology Park Limerick IRELAND

Re: K060624

Trade/Device Name: Marathon Stent with Fusion Technology Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: July 12, 2006 Received: July 17, 2006

Dear Ms. Burke:

We have reviewed your Section 510(k) premarket notification of intent to market the device w & nave reviewed your Doctor on (t) project is substantially equivalent (for the indications for recented in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encreate) to regardy inter of the Medical Device Amendments, or to devices that provision in the provisions with the provisions of the Federal Food, Drug, and Cosmetic have been rochassified in accerantoval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, mainer the device, bagfor to annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket it your device is elassiliar (600 and additional controls. Existing major regulations affecting your Apployal), it may be subject to set Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

Image /page/2/Picture/10 description: The image shows a logo for the FDA Centennial, celebrating 1906-2006. The logo is circular with the letters FDA in the center. The text "Centennial" is below the letters. The text "d Promoting Public Ho" is also visible at the bottom of the image.

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

Page 2 -

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket 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 this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 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/cdrlv/industry/support/index.html.

Sincerely yours,

Nancy Cbrogdon

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

Enclosure

{4}------------------------------------------------

Cook Ireland and Cook Endoscopy Marathon Stent with Fusion Technology

Page 5 of 40

## Indications for Use

510(k) Number (if known): Koleolo24

Device Name: Marathon Stent with Fusion Technology

Indications for Use:

This device is intended for endoscopic placement of a preloaded biliary stent to drain obstructed biliary ducts and reduce duodenal content reflux. This device is supplied sterile and intended for single use only.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Henson

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

510(k) Number

Page 1 of 1