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

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 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.

AI/ML Overview

The provided text is a 510(k) summary and an FDA clearance letter for a medical device called the Evolution™ Esophageal Stent System - Fully Covered. This type of document focuses on establishing substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and a comprehensive report of device performance against those criteria in a clinical or simulated environment.

Therefore, the prompt's request for a table of acceptance criteria and reported device performance from a study proving the device meets the acceptance criteria cannot be fully satisfied with the provided information in the way it would for a performance study.

However, based on the text, we can infer some "acceptance criteria" through the regulatory requirements and testing mentioned:

Inferred Acceptance Criteria and Reported Device Performance (Based on 510(k) Summary):

Acceptance Criteria Category/Type	Reported Device Performance/Evidence from 510(k) Summary
Substantial Equivalence:	The proposed device is substantially equivalent to the currently marketed device, the Evolution™ Esophageal Stent System, as cleared by K080359.
Biocompatibility:	Addressed through the Design Control Process, as per FDA guidance. (Specific results are not provided).
Sterility:	Addressed through the Design Control Process, as per FDA guidance. (Specific results are not provided).
Labeling Requirements:	Addressed through the Design Control Process, as per FDA guidance. (Specific details are not provided).
Deployment Testing:	Applied to the proposed device. (Specific results/metrics are not provided, but implies successful deployment).
Dimensional Testing:	Applied to the proposed device. (Specific results/metrics are not provided, but implies meeting design specifications).
Expansion Force Testing:	Applied to the proposed device. (Specific results/metrics are not provided, but implies meeting required expansion force).
Compression Force Testing:	Applied to the proposed device. (Specific results/metrics are not provided, but implies meeting required compression resistance).
Corrosion Testing:	Applied to the proposed device. (Specific results/metrics are not provided, but implies resistance to corrosion).
Tensile Strength Testing:	Applied to the proposed device. (Specific results/metrics are not provided, but implies structural integrity under tension).
Indications for Use:	Device is used to maintain patency of malignant esophageal strictures and / or to seal tracheoesophageal fistulas, which matches the predicate device.

Study Information (Based on the Provided Text):

The provided text describes a 510(k) premarket notification, which establishes substantial equivalence to a previously cleared predicate device (K080359). It does not present a clinical performance study with human subjects, a test set, expert ground truth, or MRMC analysis in the way typically associated with AI/CADe devices.

Instead, the performance data cited refers to a series of benchtop tests and adherence to regulatory guidance for medical devices, particularly esophageal and tracheal prostheses.

Here's an analysis based on the information provided:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a clinical test set with human data. The 'test set' here refers to physical stents and possibly components used in benchtop testing. The document does not specify the number of stents/components tested for each physical performance criterion (e.g., how many stents were subjected to expansion force testing).
- Data Provenance: The testing was likely conducted in a controlled laboratory environment by Cook Ireland Ltd., as part of their Design Control Process, in accordance with FDA guidance from 1998. The specific country of origin of the physical materials or test environment is not explicitly stated beyond "Cook Ireland Ltd."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a 510(k) for a stent, "ground truth" is typically established by engineering specifications, material science principles, and adherence to recognized performance standards for medical devices, rather than expert clinical consensus on a "test set" of patient data. The "experts" would be the engineers and scientists conducting and reviewing the physical performance tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in image interpretation or clinical diagnosis scenarios, not for the physical performance testing of a medical device like a stent.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI/CADe device. No MRMC study was conducted or is relevant for this type of medical device submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the physical tests (biocompatibility, sterility, deployment, dimensional, expansion force, compression force, corrosion, tensile strength), the "ground truth" or reference criteria would be engineering specifications, material standards, and regulatory performance requirements (e.g., ISO standards, ASTM standards, or internal validated Cook specifications) outlined in the FDA guidance document from 1998 for esophageal and tracheal prostheses.
The sample size for the training set:
- Not Applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established:
- Not Applicable. This is not a machine learning or AI device.

Summary

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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
+353 61 334440
+353 61239293
Jacinta Kilmartin, Regulatory AffairsSpecialist
Sinead Burke Senior Regulatory AffairSpecialist
+353 61 334440
+353 61 239293
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:

Phone: Fax:

Name: Address:

ﻣ

Contact Persons

Phone: Fax: Date:

Trade Name:

Common Name:

Classification Name:

Legally Marketed Devices: Description of the Device:

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K093619
Page 2 of 2

Indications for use:

ﺗﺮ

Comparison of Characteristics:

Performance Data:

stent whose purpose is to reposition the stent as needed.

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 (800) 638-2041 or (301) 796-7100 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 _

· 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.”