This flexible, self-expanding stent is constructed of nitinol wire. 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. The stent has flanges at both stent ends. The stent is provided with a body diameter of 25mm and flange diameters of 30mm and is provided in three lengths 6cm, 8cm and 10cm. 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. The introducer system diameter is 10 Fr and working length is 230cm.

AI/ML Overview

The provided text describes the Cook Ireland Evolution® Colonic Stent System and its performance testing. However, it does not explicitly define acceptance criteria in a quantifiable manner, nor does it present the study results in a way that directly maps to specific performance metrics with clear pass/fail thresholds. The information provided is more descriptive of the types of tests conducted and the general outcomes.

Therefore, I will extract relevant information that implies acceptance criteria and describe the study in the best way possible given the available text.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category (Implied)	Reported Device Performance
Bench Testing:
Deployment Functionality	"deployment testing was successfully completed." "Results of the testing provide reasonable assurance that the Evolution® Colonic Stent System will function as intended."
Expansion Force	"expansion force testing was successfully completed."
Compression Force	"compression force testing was successfully completed."
Dimensional Accuracy	"dimensional testing was successfully completed."
Corrosion Resistance	"corrosion testing was successfully completed."
Tensile Strength	"tensile strength testing was successfully completed."
MRI Compatibility	"MRI testing was successfully completed."
Biocompatibility	"Biocompatibility testing in compliance with ISO 10993-1 and FDA's Guidance... supports the safety of the Evolution® Colonic Stent."
Clinical Performance:
Technical Success	"The data demonstrate acceptable technical success... were achieved."
Clinical Success	"The data demonstrate acceptable... clinical success... were achieved."
Acute Procedural Success	"The data demonstrate acceptable... acute procedural success were achieved."
Symptom Relief	"The data demonstrate acceptable... symptom relief."
Absence of Device Malfunction Related Adverse Events	"Importantly, no adverse events were associated with device malfunction."
Absence of Device Complication Related Deaths	"no deaths were considered to be caused by a device complication."

Important Note: The document states that the bench testing was "successfully completed" and provided "reasonable assurance" and that clinical data demonstrated "acceptable" levels of success. This suggests that certain pre-defined thresholds were met, but the specific numerical acceptance criteria (e.g., a specific percentage for technical success or a specific force measurement range) are not explicitly stated in this summary.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: 80 patients
Data Provenance: The study was a "registry study," implying real-world data collection, but no specific country of origin is mentioned beyond "Cook Ireland Ltd" being the manufacturer. It's prospective in the sense that data was collected during the use of the device in these patients with follow-up, suggesting it's not purely retrospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the given text.

4. Adjudication Method for the Test Set:

This information is not provided in the given text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance:

This information is not applicable as the device is a physical medical stent, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable as the device is a physical medical stent, not an AI algorithm.

7. The Type of Ground Truth Used:

For the clinical study, the "ground truth" was established by clinical observation and assessment of patient outcomes. This included:

Technical success of the stent placement.
Clinical success in achieving palliation or relief of obstruction.
Acute procedural success.
Symptom relief.
Reporting and assessment of adverse events (perforation, migration, obstruction, and their association with device malfunction or complication).

8. The Sample Size for the Training Set:

This concept is not applicable to this type of device and study. The "training set" is generally used for machine learning models, which is not what is being described here. The clinical study involved 80 patients who received the device, and their outcomes informed its effectiveness.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as there is no "training set" in the context of an AI/algorithm. For the clinical study, the "ground truth" (i.e., the actual clinical outcomes and adverse events) was established through direct patient follow-up and medical assessment.

Summary

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MAY 17 2012

K113510; Cook Ireland Evolution® Colonic Stent System

・

	Section 5.0 510(k) Summary
Name:	Cook Ireland Ltd
Address:	O 'Halloran RoadNational Technology ParkLimerick, Ireland
Phone:	353 61 334440
Fax:	353 61 239293
Contact Persons:	Jacinta Kilmartin, Regulatory Affairs SpecialistEmmett Devereux, Director Quality & Regulatory Affairs
Phone:	353 61 334440
Fax:	353 61 239 293
Date:	April 25, 2012
Trade Name:	Evolution® Colonic Stent System
Common Name:	Stent, colonic, metallic, expandable
Classification Name:	Stent, colonic, metallic, expandable(21 CFR 878.3610, Product Code: MQR)
Predicate Devices:	Boston Scientific Wallstent® Enteral Endoprosthesis withUnistep™ Plus Delivery System (K000281)Boston Scientific WallFlex™ Enteral Colonic Stent withAnchor Lock Delivery System (K061877)Cook Evolution® Duodenal Stent System (K101530)

Page 1 of 4

3 1 of 4

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K113510
pg2064

Description of the Device:

Stent Description:

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. The introducer system diameter is 10 Fr and working length is 230cm.

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 Evolution® Colonic Stent System is substantially equivalent to the currently marketed predicate devices, the Boston Scientific Wallstent® Enteral Endoprosthesis with Unistep™ Plus Delivery System (K000281), the Boston Scientific WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System (K061877) and the Cook Evolution® Duodenal Stent System (K101530). The proposed device shares many technological characteristics with at least one of the predicate devices (or fall within the range of the predicates) in terms of the following:

. Stents:
Dimensions (Diameter & Length), ୍

Materials (i.e. nitinol), o

O Self Expanding Stent,

Indications for use:

Comparison of Characteristics:

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K113510
pg 3 of 4

o Braided Stent Construction,
o Number of Expanded Ends.
Introduction System:
- Materials of construction, o
- Working length dimensions, o
- o Allows stent deployment and recapture.
- o Supplied with a preloaded stent,
- o Allows placement using fluoroscopic techniques,
- Compatibility with an endoscope o
Intended use .
All are intended for single use, are supplied sterile and . are not intended to be removed.

Performance (bench and clinical) testing was carried out to determine the equivalence of the Evolution® Colonic Stent System to predicate devices and to verify the safety and effectiveness of the device.

Performance Testing-Bench:

The bench testing was conducted in accordance with various applicable ASTM standards and in accordance with FDA's Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses. In the absence of specific colonic stent guidance this guidance was considered relevant to colonic stents. The following bench tests were carried out: deployment testing, expansion force testing, compression force testing, dimensional testing, corrosion testing, tensile strength testing and MRI testing. The bench testing was successfully completed. Results of the testing provide reasonable assurance that the Evolution® Colonic Stent System will function as intended.

Biocompatibility:

Biocompatibility testing in compliance with ISO 10993-1 and FDA's Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses supports the safety of the Evolution® Colonic Stent

Performance Data:

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K113510
pg 4 of 4

System.

Performance Testing-Clinical:

A 80 patient registry study was conducted to compile clinical data on use of the Evolution® Colonic Stent System for palliation of symptoms due to colonic obstruction or stricture caused by malignant neoplasms, and as a "bridge to surgery" to relieve large bowel obstruction prior to potential colectomy in patients with malignant strictures. Data on clinical success, technical success, acute procedural success, implant duration, symptoms at follow-up, and adverse events were collected. Follow-up occurred to 6 months or death. The data demonstrate acceptable technical success, clinical success, acute procedural success were achieved, and symptom relief. Adverse events included perforation, migration, and obstruction. Importantly, no adverse events were associated with device malfunction and no deaths were considered to be caused by a device complication.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or other bird.

Public Health Service

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

Ms. Jacinta Kilmartin Regulatory Affairs Speacialist Cook Ireland Ltd. O' Halloran Road, National Technology Park LIMERICK IRELAND

MAY 1 7 2012

Re: K113510

Trade/Device Name: Evolution® Colonic Stent System Regulation Number: 21 CFR& 878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: MQR Dated: April 25, 2012 Received: April 30, 2012

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 (reporting of medical

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Page 2 -

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 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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

Sincerely yours,

Benjamin R. Eick

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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Section 4.0 Indications for Use

5510

510(k) Number (if known): __

Device Name: Evolution® Colonic Stent System

Indications for Use:

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

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)

Dorat M. Why

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K113510

Page 1 of 1

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.”