EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D

K101530 · Cook Ireland, Ltd. · MUM · Mar 29, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K101530
• Device Name: EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D
• Applicant: Cook Ireland, Ltd.
• Product Code: MUM · General, Plastic Surgery
• Decision Date: Mar 29, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3610
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is used for palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms.

Device Story

The Evolution™ Duodenal Stent System is a self-expanding nitinol wire stent designed for palliative treatment of malignant duodenal or gastric outlet obstructions. The stent features end flanges and is mounted on an inner catheter, constrained by an outer catheter. A pistol-grip delivery handle allows for controlled stent deployment or recapture. The system is compatible with a 0.035-inch wire guide. Radiopaque markers on the inner catheter indicate the stent length at nominal diameter. The device is intended for use by clinicians in a clinical setting to relieve obstructions, potentially improving patient quality of life by restoring luminal patency.

Clinical Evidence

Bench testing was performed to verify safety and effectiveness, including deployment force, expansion force, compression force, dimensional, corrosion, tensile strength, and MRI testing. The document mentions that clinical testing was carried out, but does not provide specific clinical study results or metrics.

Technological Characteristics

Self-expanding nitinol wire stent with end flanges. Delivery system includes inner/outer catheters and a pistol-grip handle. Compatible with 0.035-inch wire guide. Radiopaque markers for visualization. Non-clinical testing included deployment, expansion, compression, corrosion, tensile strength, and MRI compatibility.

Indications for Use

Indicated for palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms.

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

• Boston Scientific Wallstent® Enteral Endoprosthesis with Unistep™ Delivery System (K991056)
• Boston Scientific WallFlex™ Enteral Duodenal Stent System with Anchor Lock Delivery System (K062750)

Submission Summary (Full Text)

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K101530

## Section 5.0 510(k) Summary

MAR 2 9 2011

| Name: | Cook Ireland Ltd |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | O'Halloran Road |
| | National Technology Park |
| | Limerick, Ireland |
| Phone: | 353 61 334440 |
| Fax: | 353 61 239293 |
| Contact Persons: | Jacinta Kilmartin, Regulatory Affairs Specialist |
| | Emmett Devereux, Director Quality &<br>Regulatory Affairs |
| Phone: | 353 61 334440 |
| Fax: | 353 61 239 293 |
| Date: | March 24, 2011 |
| Trade Name: | Evolution™ Duodenal Stent System |
| Common Name: | Stent, Metallic, Expandable, Duodenal |
| Classification Name: | Stent, Metallic, Expandable, Duodenal (21 CFR<br>878.3610, Product Code: MUM) |
| Predicate Devices: | Boston Scientific Wallstent® Enteral<br>Endoprosthesis with Unistep™ Delivery System<br>(K991056) |
| | Boston Scientific WallFlex™ Enteral Duodenal<br>Stent System with Anchor Lock Delivery System<br>(K062750) |
| Description of the Device: | Stent Description: |
| | This flexible, self-expanding stent is constructed<br>of nitinol wire. The total length of the stent is<br>indicated by radiopaque markers on the inner |
| | catheter, indicating the actual length of the stent at<br>nominal stent diameter. The stent has flanges at<br>both stent ends. |
| | Introducer System Description:<br>The stent is mounted on an inner catheter, which<br>accepts a 0.035 inch wire guide and is constrained<br>by an outer catheter. A pistol-grip delivery<br>handle allows stent deployment or recapture. |
| Indications for use: | This device is used for palliative treatment of<br>duodenal or gastric outlet obstruction and<br>duodenal strictures caused by malignant<br>neoplasms. |
| Comparison of Characteristics: | The Evolution™ Duodenal Stent System is<br>substantially equivalent to the currently marketed<br>predicate devices, the Boston Scientific<br>Wallstent® Enteral Endoprosthesis with<br>Unistep™ Delivery System (K991056), and the<br>Boston Scientific WallFlex™ Enteral Duodenal<br>Stent System with Anchor Lock Delivery System<br>(K062750). |
| Performance Data: | Performance (bench and clinical) testing was<br>carried out to determine the equivalence of the<br>Evolution™ Duodenal Stent System to the<br>predicate devices and to verify the safety and<br>effectiveness of the device. The following bench<br>tests were carried out: deployment force testing,<br>expansion force testing, compression force<br>testing, dimensional testing, corrosion testing,<br>tensile strength testing and MRI testing. |

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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 figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The text is arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

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

MAR 2 9 201

. Re: K101530

Trade/Device Name: Evolution™ Duodenal Stent System Regulation Number: 21 CFR 8878,3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: MUM Dated: February 14. 2011 Received: February 16, 2011

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 v 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/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 vours.

Hubert Lemon MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section 4.0 Indications for Use

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Device Name: Evolution™ Duodenal Stent System

Indications for Use:

This device is used for palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms.

Prescription Use V 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)

Helen Klemm

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K101530

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