EVOLUTION ESOPHAGEAL STENT SYSTEM

K080359 · Cook Ireland, Ltd. · ESW · May 9, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K080359
• Device Name: EVOLUTION ESOPHAGEAL STENT SYSTEM
• Applicant: Cook Ireland, Ltd.
• Product Code: ESW · General, Plastic Surgery
• Decision Date: May 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3610
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is used to maintain patency of malignant esophageal strictures and / or to seal tracheoesophageal fistulas.

Device Story

Evolution™ Esophageal Stent System; flexible, self-expanding nitinol wire stent with silicone cover; mounted on inner catheter for 0.035 inch guidewire; constrained by outer catheter; includes proximal lasso for repositioning; pistol-grip delivery handle for deployment or recapture; used to maintain patency of malignant esophageal strictures or seal tracheoesophageal fistulas; radiopaque markers on inner catheter indicate stent length; physician-operated in clinical setting.

Clinical Evidence

Bench testing only. Testing included deployment force, expansion force, compression force, dimensional, corrosion, and tensile strength testing to verify safety and effectiveness.

Technological Characteristics

Nitinol wire stent with silicone cover; self-expanding; radiopaque markers; delivery system includes inner catheter (0.035 inch guidewire compatible), outer catheter, and pistol-grip handle; proximal lasso for repositioning.

Indications for Use

Indicated for patients requiring maintenance of patency in malignant esophageal strictures or sealing of tracheoesophageal fistulas.

Regulatory Classification

Identification

An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.

Special Controls

The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”

Predicate Devices

• Esophageal Z Stent with Dua Anti-Reflux Valve (K011591)
• Wallstent II Esophageal Prosthesis (K940395)
• Ultraflex™ Esophageal NG Stent System (K032930)

Submission Summary (Full Text)

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

: .

:

## Company Confidential Pg / of 2-

## 510(k) Summary

. . . . . . . . . .

| Name: | Cook Ireland Ltd | MAY - 9 2008 |
|----------------------------|---------------------------------------------------|--------------|
| Address: | O'Halloran Road | |
| | National Technology Park | |
| | Limerick, Ireland | |
| Phone: | 353 61 334440 | |
| Fax: | 353 61 334441 | |
| Contact Persons: | Emmett Devereux, Quality & Regulatory | |
| | Manager | |
| | Noreen Barry, Regulatory Affairs Specialist | |
| Phone: | 353 61 334440 | |
| Fax: | 353 61 334441 | |
| Date: | May 8, 2008 | |
| Trade Name: | Evolution™ Esophageal Stent System | |
| Common Name: | Esophageal Stent | |
| Classification Name: | Esophageal Prosthesis (21 CFR 878.3610, | |
| | Product Code: ESW) | |
| Legally Marketed Devices: | Esophageal Z Stent with Dua Anti-Reflux | |
| | Valve (K011591) | |
| | Wallstent II Esophageal Prosthesis (K940395) | |
| | Ultraflex™ Esophageal NG Stent System | |
| | (K032930). | |
| Description of the Device: | Stent Description: | |
| | This flexible, self-expanding stent is | |
| | constructed of nitinol wire with a silicone | |
| | cover. The total length of the stent is indicated | |
| | by radiopaque markers on the inner catheter, | |

:

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

2012

indicating the actual length of the stent at nominal stent diameter. There is a lasso at the proximal end of the stent whose purpose is to reposition the stent as needed.

Introducer System Description: The stent is mounted on an inner catheter, which accepts a 0.035 inch guidewire and is constrained by an outer catheter. A pistol-grip delivery handle allows stent deployment or rccapture.

This device is used to maintain patency of malignant esophageal strictures and / or to seal tracheoesophageal fistulas.

The proposed device is substantially equivalent to the currently marketed devices, the Esophageal Z Stent with Dua Anti-Reflux Valve (K011591); the Wallstent II Esophageal Prosthesis (K940395); and the Ultraflex TM Esophageal NG Stent System (K032930).

Non clinical testing was carried out to determine the equivalence of the Evolution™ Esophageal Stent System to the predicate devices and to verify the safety and effectiveness of the device. The following is a summary of the testing carried out: deployment force testing, expansion force testing, compression force testing, dimensional testing, corrosion testing and tensile strength testing.

Indications for use:

Comparison of Characteristics:

Performance Data:

{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 with three lines representing its wings, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The text is in all caps and is written in a sans-serif font. The logo is black and white.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Ms. Noreen Barry Regulatory Affairs Specialist Cook® Ireland Ltd. O'Halloran Road, National Technology Park Limerick IRELAND

Re: K080359

Trade Device/Name: Evolution™ Esophageal. Stent System Regulation Number: 21 CFR \$878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: February 7, 2008 Received: February 11 2008

Dear Ms. Barry:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave reviewed above and have determined the device is substantially equivalent (for the indications for rorerontou as vo allosure) 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 therefore, mance 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your Approval), It they of cally of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "FDA Centennial 1906-2006" in it. The letters "FDA" are in the center of the logo in a bold, stylized font. Three stars are located below the word "Centennial". The logo is surrounded by a circular border with additional text and design elements.

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

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.

Sincerely yours,

Nancy Brogdon

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

Enclosure

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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Evolution™ Esophageal Stent System

Indications for Use:

This device is used to maintain patency of malignant esophageal strictures and / or to seal tracheoesophageal fistulas.

(Division Sign-Off)
ision of Reproductive, Abdominal and
ological Davicos
5.0(k) Number K080359

Prescription Over-The-Counter Use Use AND/OR (Part 21 CFR 801 Subpart D) (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)