EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E

K093619 · Cook Ireland, Ltd. · ESW · Jun 17, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K093619
• Device Name: EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E
• Applicant: Cook Ireland, Ltd.
• Product Code: ESW · General, Plastic Surgery
• Decision Date: Jun 17, 2010
• 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 is a flexible, self-expanding nitinol wire stent with a silicone cover. Designed for use in maintaining patency of malignant esophageal strictures and sealing tracheoesophageal fistulas. Stent is mounted on an inner catheter (compatible with 0.035 inch wire guide) and constrained by an outer catheter. Features radiopaque markers for length identification and proximal/distal lasso loops for repositioning. Deployment and recapture are managed via a pistol-grip delivery handle. Operated by clinicians in a clinical setting. Benefits include mechanical support for esophageal patency and fistula closure.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included deployment, dimensional, expansion force, compression force, corrosion, and tensile strength testing.

Technological Characteristics

Nitinol wire stent with silicone cover. Self-expanding. Radiopaque markers. Pistol-grip delivery handle. Compatible with 0.035 inch wire guide. Sterilization method not specified. No software or electronic components.

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

• Evolution™ Esophageal Stent System (K080359)

Submission Summary (Full Text)

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Cook Ireland Evolution™ Esophageal Stent System -Fully Covered

1093619

| Attachment D - 510(k) Summary | JUN 1 7 2010 |
|-----------------------------------------------------|--------------|
| Cook Ireland Ltd | |
| O'Halloran Road | |
| National Technology Park | |
| Limerick, Ireland | |
| [phone] | |
| [phone] | |
| Jacinta Kilmartin, Regulatory Affairs<br>Specialist | |
| Sinead Burke Senior Regulatory Affair<br>Specialist | |
| [phone] | |
| [phone] | |
| November 20. 2009 | |

Attachment D - 510(k) Summary

Evolution™ Esophageal Stent System -Fully Covered

Esophageal Stent

Esophageal Prosthesis (21 CFR 878.3610, Product Code: ESW)

Evolution™ Esophageal Stent System 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, indicating the actual length of the stent at nominal stent diameter. There are lasso loops at both the proximal and distal ends of the

Phone: Fax:

Name: Address:

/

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Contact Persons

Phone: Fax: Date:

Trade Name:

Common Name:

Classification Name:

Legally Marketed Devices: Description of the Device:

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K093619
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Indications for use:

ﺗﺮ

Comparison of Characteristics:

Performance Data:

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 wire guide and is constrained by an outer catheter. A pistol-grip delivery handle allows stent deployment or recapture.

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 device, the Evolution™ Esophageal Stent System, as cleared by K080359.

The risks associated with the modifications to our subject device have been adequately addressed through our Design Control Process. Recommendations as per the FDA guidance document Guidance for Industry -Guidance for the content of Premarket Notifications for Esophageal and Tracheal Prostheses (28-April-1998) with respect to biocompatibility, sterility, labelling and performance testing including deployment testing, dimensional testing, expansion force testing, compression force testing, corrosion testing and tensile strength testing have been applied to the proposed device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G6 Silver Spring, MD 20993-0002

Ms. Jacinta Kilmartin Regulatory Affairs Specialist Cook Ireland Ltd. National Technology Park Limerick IRELAND

## JUN 1 7 2010

· Re: K093619

Trade/Device Name: Evolution™ Esophageal Stent System -- Fully Covered Regulation Number: 21 CFR \$878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: June 10, 2010 Received: June 14, 2010

Dear Ms. Kilmartin:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either 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); medical device reporting of medical device-related

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adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Janine M. Morris

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

Enclosure

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## Indications for Use

K093619 510(k) Number (if known):

Device Name: Evolution™ Esophageal Stent System - Fully Covered

Indications for Use:

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

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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