The Zilver® 635 " Biliary Stent is a self-expanding, nitinol stent designed for excellent radial strength and optimal longitudinal flexibility. Constructed from a series of interconnected Z-shaped segments, the stent conforms to the shape of the biliary system and provides circumferential scaffolding throughout the stent's length. Gold radiopaque markers on each end of the Zilver® 635™ Biliary Stent, along with one radiopaque marker at the distal end of the delivery system, allow precise positioning of the stent. The stent's interconnected Z-shaped segments also keep foreshortening to a minimum.

The Zilver® 635" Biliary Stent comes preloaded in a 6 French delivery system. The stent is deployed with the use of a simple hand held device. The stent is available in unrestrained outer diameters of 4, 5, 6, 7, 8, 9 and 10 mm and in lengths of 20, 30, 40, 50, 60 and 80 mm. The 9, 10, 12, and 14 mm diameter stent with a cannula outside diameter of 1.6 mm is an addition to this product line.

AI/ML Overview

The Cook Zilver® 635™ Biliary Stent is a medical device and thus does not involve AI/ML. Much of the requested information (e.g., sample size for training set, number of experts, adjudication method) is not applicable to this type of medical device as it is not an AI/ML device.

Here's a breakdown of the acceptance criteria and study information provided for the Cook Zilver® 635™ Biliary Stent, based on the provided text:

1. Table of acceptance criteria and reported device performance:

The provided text generally describes the types of tests performed rather than specific numerical acceptance criteria or detailed results for each test. The summary states that the results "provide reasonable assurance that the device has requirements for its use as a biliary stent," indicating that acceptance criteria were met.

Acceptance Criteria Category	Reported Device Performance (Summary)
Deployment	Demonstrated reliability
a. Profile	(Implicitly met reliable design)
b. Deployment Accuracy	(Implicitly met reliable design)
c. Stent length and Change due to Deployment	(Implicitly met reliable design)
d. Stent Diameter	(Implicitly met reliable design)
e. Uniformity of Expansion	(Implicitly met reliable design)
Stent Integrity	Demonstrated reliability
Radial Force	Demonstrated reliability

2. Sample size used for the test set and data provenance:

Sample Size: Not explicitly stated for each test. The document mentions "tests" in plural, implying multiple units were tested, but no specific count is given.
Data Provenance: Not specified, but generally, such tests are conducted internally by the manufacturer (Cook Incorporated) as part of their design verification and validation process in a controlled lab setting. It is not patient data.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

Not Applicable. This is a hardware medical device (stent). The "ground truth" for its performance is established through physical and mechanical testing against engineering specifications, not expert consensus on diagnostic images or clinical outcomes in the same way an AI/ML algorithm's ground truth would be established.

4. Adjudication method for the test set:

Not Applicable. As this is a mechanical device, there is no expert adjudication of results in the context of diagnostic interpretation. Results are typically based on objective measurements and established engineering standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This is not an AI/ML diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not applicable.

6. If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done:

Not Applicable. This is a physical medical device. The concept of an "algorithm-only" performance does not apply.

7. The type of ground truth used:

The "ground truth" for this device's performance is based on engineering specifications and performance metrics defined by the manufacturer and relevant industry standards for biliary stents (e.g., measurements of deployment accuracy, radial force, crimped profile).

8. The sample size for the training set:

Not Applicable. This is a hardware medical device. There is no "training set" in the context of machine learning. The device design is based on engineering principles and materials science, not data-driven training.

9. How the ground truth for the training set was established:

Not Applicable. As there is no training set for a machine learning model, this question does not apply. The design of the stent (e.g., Z-shaped segments, nitinol material) is based on established engineering and biomedical knowledge to achieve desired mechanical properties.

Summary

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Special 510(k) Premarket Notification Cook Zilver® 635™ Biliary Stent COOK INCORPORATED

510(k) Summary

JUL 1 2 2005

53
KC51124
Page 1 of 2

Submitted By:

Stephanie Roberts Regulatory Affairs Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235

Mav 2, 2005

Device:

Trade Name: Proposed Classification: Zilver® 635" Biliary Stent Catheter, Biliary, Diagnostic

Predicate Devices:

The Zilver® 635™ Biliary Stent is similar in terms of intended use, materials of construction and technological characteristics to predicate devices reviewed as devices for palliation of malignant neoplasm in the biliary tree.

Device Description:

Substantial Equivalence:

This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging similar to the

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Special 510(k) Premarket Notification Cook Zilver® 635™ Biliary Stent COOK INCORPORATED

54 K051124
Page 2 of 2
s

predicate devices currently marketed and distributed by Cook Incorporated. This predicate devices carrerilization similar to the predicate devices currently device will andergo otonilea.org similar with respect to indications for use, materials and distribution "Boing online and predicate devices, this device meets the requirements for section 510(k) substantial equivalence.

Test Data:

The Zilver® 635™ Biliary Stent was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

Deployment 1.
- a. Profile
- b. Deployment Accuracy
- c. Stent length and Change due to Deployment
- d. Stent Diameter
- e. Uniformity of Expansion
- Stent Integrity ﮩﻨ
1. Radial Force

The results of these tests provide reasonable assurance that the device has The results of these tests provide reaconaments for the requirements for its use as a biliary stent.

. . . -

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 12 2005

...

Ms. Stephanie Roberts Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way P.O. Box 489 BLOOMINGTON IN 47402-0489

Re: K051124

K031124
Trade/Device Name: Cook® Zilver® 633TM Biliary Stent Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: July 5, 2005 Received: July 6, 2005

Dear Ms. Roberts:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(t) promatic is substantially equivalent (for the indications
referenced above and have determined the device is subsessmarketed in interstat referenced above and have delemined the device to redicate devices marketed in interstate for use stated in the enclosure) to regally manced promoted Device American so to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the chaodinene with the provisions of the Federal Food, Drug, devices that have been reclassified in accounted the device, subject to the general controls provisions of the and Cosmetic Act (Act). You may, therefore, therefore, The general controls provisions of the provisions of the Act and the immantous described of devices, good manufacturing practice, Act merude requireme against misbranding and adulteration.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this The Office of Device Evaluation has decemined that the proposed labeling and that such use device will be used for an mended use not neith Section of S(i)(L)(E) of the Act, the following Could Cause nami. "Therefee, Warnings section of the device's labeling:

The safety and effectiveness of this device for use in the vascular system have not been established.

Furthermore, the indication for biliary use must be prominently displayed in all labeling, Furthermore, the Includion for othary use must of promotions for use, and other promotional materials, in metuding pouch, box, and carvone, of a similar point size, and in bold print.

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Page 2 – Ms. Stephanie Roberts

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Please note that the a00ve tabeling innitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate THE IDA Iniding of substantial equirae and permits your device to proceed to the device results in a classification for your device as described in your Section market. This letter will anow you to eventimation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (000 above) and stations affecting your device can be it may be subject to additional controliations, 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 Please be advised that FDA s issumes of a bacements of the requirements of the Act that I DA has made a decormination administered by other Federal agencies. You must or any irederal statutes and regalations and limited to: registration and listing (21 comply with an the Act 3 requirements, morading, can manufacturing practice requirements as set CFK Fart 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

If you desire specific information about the application of other labeling requirements to your II you desire specific information acourt the Office of Compliance at (240) 276-0115. Also, uevice (21 CFRT an 001), preference to premarket notification' (21 please note the regulation onlines and information on your responsibilities under the CITY att 807.77). Tou may obtain official general, and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours

Donna-Bea Tillman, Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K051124

Device Name: Cook® Zilver® 635™ Biliary Stent

Indications For Use:

The Cook® Zilver® 635™ Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C brogdon

Division Sign-Off Division of Reproductive, Abdor and Radiological De 510(k) Number

Page 1 of 1

Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.