The Evolution® Esophageal Stent System - Partially Covered consists of a self-expanding metal stent and a stent introduction system. The stent is provided pre-loaded in the introduction system. The handle allows for desheathing to deploy the stent and resheathing recapturing the stent during stent deployment. The stent is woven from nitinol wire. The stent is formed with a flange at either end. The increased diameter of the stent at the stent ends helps provide resistance to migration. A silicone membrane applied to the stent covers the complete body of the stent along with part of both flanges. The covering is intended to reduce the risk of tissue ingrowth and provides a seal for tracheoesophageal fistulas. To aid in visibility under fluoroscopy there are four bands at either end of the stent. The stent has a lasso loop which can be used to reposition the stent during the initial placement procedure if desired. The device is supplied sterile, intended for single use only and is available for prescription use only.

AI/ML Overview

This document describes the Cook Ireland Ltd. Evolution® Esophageal Stent System - Partially Covered and its substantial equivalence to predicate devices, but does not contain any information about acceptance criteria, device performance metrics, or study results related to an AI/Machine Learning device or software.

Therefore, I cannot fulfill the request to provide:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance.
Number of experts and their qualifications for ground truth.
Adjudication method.
MRMC comparative effectiveness study results.
Standalone performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The provided text pertains to a traditional medical device (an esophageal stent) and focuses on its physical characteristics, materials, and non-clinical performance testing (biocompatibility, simulated use, corrosion, etc.) to demonstrate substantial equivalence for regulatory clearance. It does not involve any AI/ML components or studies that would involve performance metrics like sensitivity, specificity, or reader studies with AI assistance.

Summary

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

December 21, 2016

Cook Ireland Ltd. Jane Kennedy Regulatory Affairs Specialist O'halloran Road, National Technology Park Limerick Ireland

Re: K162717 Trade/Device Name: Evolution® Esophageal Stent System - Partially Covered Regulation Number: 21 CFR§ 878.3610 Regulation Name: Esophageal Prosthesis Regulatory Class: II Product Code: ESW Dated: October 4, 2016 Received: October 6, 2016

Dear Jane Kennedy:

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely,

Joyce M. Whang -S

for

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)

K162717

Device Name

Evolution® Esophageal Stent System - Partially Covered

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5: 510(k) Summary

I. SUBMITTER

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

Phone: +353 61 334440 Fax: +353 61 239293

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

Phone: +353 61 334440 Fax: +353 61 239293

Date Prepared: December 05, 2016

II. DEVICE

Trade Name of Device: Evolution® Esophageal Stent System – Partially Covered The model numbers are EVO-20-25-8-E, EVO-20-25-10-E, EVO-20-25-12.5-E and EVO-20-25-15-E.

Common or Usual Name: Esophageal Stent

Classification Name: Esophageal Prosthesis (21 CFR 878.3610)

Regulatory Class: II

Product Code: ESW

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III. PREDICATE DEVICE

Primary Predicate: Evolution™ Esophageal Stent System, K080359 cleared May 09, 2008. Second Predicate: Evolution™ Esophageal Stent System - Fully Covered, K093619 cleared on June 17th, 2010.

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

DEVICE DESCRIPTION IV.

The stent is woven from nitinol wire. The stent is formed with a flange at either end. The increased diameter of the stent at the stent ends helps provide resistance to migration. A silicone membrane applied to the stent covers the complete body of the stent along with part of both flanges. The covering is intended to reduce the risk of tissue ingrowth and provides a seal for tracheoesophageal fistulas. To aid in visibility under fluoroscopy there are four bands at either end of the stent. The stent has a lasso loop which can be used to reposition the stent during the initial placement procedure if desired. The device is supplied sterile, intended for single use only and is available for prescription use only. Use of this device is restricted to a trained healthcare professional.

V. INDICATIONS FOR USE

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

The intended use of the subject and predicate devices are identical.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH A VI. PREDICATE DEVICE

The subject device is substantially equivalent to the currently marketed devices, the Evolution® Esophageal Stent System, K080359 cleared May 09, 2008 and the Evolution™ Esophageal Stent System – Fully Covered, K093619 cleared on June 17th, 2010.

In brief, the subject device is identical to/ within the range of the Evolution® Esophageal Stent System, K080359, primary predicate device, and the Evolution™ Esophageal Stent System -Fully Covered, K093619, with respect to the following:

। Stent material
Stent dimensions ।
। Stent function
-Introduction system dimensions
-Introduction system materials
। Shelf life
-Principle of operation
-For professional use
For single use
-Sterility (Ethylene oxide, EO)

The following technological differences exist between the subject device and the Evolution Esophageal Stent System, K080359, primary predicate device, and the Evolution™ Esophageal Stent System - Fully Covered, K093619:

। Materials and configuration of the stent lasso loop.
MRI Information ।

PERFORMANCE DATA VII.

The biocompatibility evaluation for the Evolution® Esophageal Stent System - Partially Covered 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 -
Acute Systemic Toxicity -

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-Implantation (with Histopathology Report)
The device specific guidance document was consulted in preparing this premarket submission, Guidance for the content of premarket notifications for esophageal and tracheal prostheses issued April 28th, 1998, the following tests were conducted for the subject device:
Simulated Use (Including Deployment, Repositioning, Dimensional) -
। Corrosion Testing
-Tensile Strength Testing
Shelf Life Testing (Visual Inspection, Radial Force, Simulated Use, Tensile Strength) |
-Visual Inspection
Torque Testing -
-MR Compatibility Testing

CONCLUSIONS VIII.

The non-clinical data supports the safety of the subject device and demonstrates that the Evolution® Esophageal Stent System - Partially Covered 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® Esophageal Stent System – Partially Covered to the predicate devices.

Regulation Number and Section

§ 878.3610 Esophageal prosthesis.

(a)
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.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”