Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered

K163468 · Cook Ireland, Ltd. · MUM · May 4, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K163468
• Device Name: Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered
• Applicant: Cook Ireland, Ltd.
• Product Code: MUM · General, Plastic Surgery
• Decision Date: May 4, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3610
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Evolution® Duodenal Stent System- Uncovered: This device is used for palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms. Evolution® Colonic Stent System- Uncovered: This device is used for palliative treatment of colonic obstruction or colonic strictures caused by malignant neoplasms, and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

Device Story

Self-expanding nitinol stent system for palliative treatment of malignant gastrointestinal obstructions. Stent mounted on inner catheter, constrained by outer catheter; handle allows controlled deployment and recapture. Physician operates system under fluoroscopic guidance using radiopaque markers for placement. Stent provides radial force to maintain patency in duodenal or colonic strictures. Benefits include relief of obstruction and improved patient quality of life. Device is single-use and intended for permanent implantation.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1:2009 (cytotoxicity, irritation, sensitization). Performance testing included simulated use (deployment, recapture, accuracy), dimensional testing, and tensile strength testing.

Technological Characteristics

Self-expanding nitinol wire stent; radiopaque markers for visualization. Introduction system accepts 0.035 inch wire guide. Sterilization via Ethylene oxide (EO). Single-use. Outer catheter material formulation updated from predicate.

Indications for Use

Indicated for palliative treatment of duodenal, gastric outlet, or colonic obstructions and strictures caused by malignant neoplasms; also indicated for relief of large bowel obstruction prior to colectomy in patients with malignant strictures.

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™ Duodenal Stent System (K101530)
• Evolution™ Colonic Stent System (K113510)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

May 4, 2017

Cook Ireland Ltd. Jacinta Kilmartin Regulatory Affairs Manager O'Halloran Road, National Technology Park Limerick Ireland

Re: K163468

> Trade/Device Name: Evolution® Duodenal Stent System - Uncovered, Evolution® Colonic Stent System - Uncovered Regulation Number: 21 CFR§ 878.3610 Regulation Name: Esophageal Prosthesis Regulatory Class: II Product Code: MUM, MQR Dated: April 4, 2017 Received: April 6, 2017

Dear Jacinta 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.

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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 (reporting of medical device-related 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

## 510(k) Number (if known) K163468

Device Name

Evolution® Duodenal Stent System- Uncovered, Evolution® Colonic Stent System - Uncovered

Indications for Use (Describe)

Evolution® Duodenal Stent System- Uncovered: This device is used for palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms.

Evolution® Colonic Stent System- Uncovered: This device is used for palliative treatment of colonic obstruction or colonic strictures caused by malignant neoplasms, and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div> <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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# Section 5: 510(k) Summary

#### I. SUBMITTER

Cook Ireland Ltd. O' Halloran Road National Technology Park Limerick Ireland

Phone: [phone] Fax: [phone]

Contact Persons: Jane Kennedy, Regulatory Affairs Specialist Jacinta Kilmartin, Regulatory Affairs Manager

Phone: [phone] Fax: [phone]

Date Prepared: April 28, 2017

#### II. DEVICE

Trade Name of Device: Evolution® Duodenal Stent System – Uncovered The model numbers are EVO-22-27-6-D, EVO-22-27-9-D, EVO-22-27-12-D Common or Usual Name: Stent, Metallic, Expandable, Duodenal Classification Name: Stent, Metallic, Expandable, Duodenal (21 CFR 878.3610) Regulatory Class: II Product Code: MUM

Trade Name of Device: Evolution® Colonic Stent System – Uncovered The model numbers are EVO-25-30-6-C, EVO-25-30-8-C, EVO-25-30-10-C Common or Usual Name: Stent, Colonic, Metallic, Expandable Classification Name: Stent, Colonic, Metallic, Expandable (21 CFR 878.3610) Regulatory Class: II Product Code: MQR

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#### III. PREDICATE DEVICE

Evolution™ Duodenal Stent System, K101530 cleared March 29, 2011. Evolution" Colonic Stent System, K113510 cleared May 17, 2012.

The predicate devices detailed above have never been subject to a design related recall.

#### IV. DEVICE DESCRIPTION

The same device description applies to both the Evolution® Duodenal Stent System and the Evolution® Colonic Stent System.

Stent Description:

This flexible, self-expanding stent is constructed of nitinol wire. The stent diameter is increased at either end to help provide resistance to migration. The total length of the stent is indicated by radiopaque markers on the inner catheter. indicating the actual length of the stent at the nominal stent diameter.

Introduction 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. The handle allows for desheathing to deploy the stent and resheathing to recapture the stent during stent deployment.

#### V. INDICATIONS FOR USE

Evolution® Duodenal Stent System: This device is used for palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms.

Evolution® Colonic Stent System: This device is used for palliative treatment of colonic obstruction or colonic strictures caused by malignant neoplasms, and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

The intended use of the modified devices and their respective predicate devices are identical.

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### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH A PREDICATE DEVICE

The modified devices are substantially equivalent to the currently marketed predicate devices, the Evolution™ Duodenal Stent System, K101530 cleared March 29, 2011 and the Evolution Colonic Stent System, K113510 cleared May 17, 2012.

In brief, the modified devices are identical to their respective predicate devices with regard to the following:

- । Stent dimensions
- Stent design |
- | Stent materials
- Introduction system dimensions
- -Introduction system materials (excluding outer catheter)
- | Shelf life
- -Sterility (Ethylene oxide, EO)
- -For single use
- For permanent implantation (stent)
- -Principle of operation

The following technological differences exist between the modified device and the currently marketed predicate devices, the Evolution™ Duodenal Stent System (K101530) and the Evolution™ Colonic Stent System (K113510):

- Outer Catheter material formulation change.
#### VII. PERFORMANCE DATA

The biocompatibility evaluation for the material formulation change was conducted in accordance with ISO 10993-1: 2009 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" (June 16, 2016), the following tests were conducted:

- Cytotoxicity
- Irritation ।
- -Sensitization

The device specific guidance document was consulted in preparing this premarket submission, Guidance for the content of premarket notifications for esophageal and tracheal prostheses

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issued April 28th, 1998. Performance testing was performed as per Cook's design control system, the following tests were conducted:

- Simulated Use (Including Deployment, Recapture, Deployment Accuracy) -
- Dimensional Testing -
- Tensile Strength Testing -

#### CONCLUSIONS VIII.

The non-clinical data supports the safety of the modified device and demonstrates that the Evolution® Duodenal Stent System - Uncovered and the Evolution® Colonic Stent System -Uncovered is safe and effective and should perform as intended in the specified use conditions. This non-clinical data supports the substantial equivalence of the Evolution® Duodenal Stent System - Uncovered and the Evolution® Colonic Stent System - Uncovered to their respective predicate devices.