The Cook® Zilver™ Biliary Stent is a self-expanding, nitonol stent designed for superior radial strength and optimal longitudinal flexibility. Constructed from a series of interconnected Z-shaped seqments, 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™ Biliary Stent, along with radiopaque markers on the delivery system, allow precise positioning of the stent. The stent's interconnected Z-shaped segments also keep foreshortening to a minimum.

The Zilver™ Biliary Stent comes preloaded in a 7.0 Fr. (OD) sheath delivery system. The stent is deployed with the use of a simple hand held device. The stent is being made available in unrestrained outer diameters of 12 and 14mm's and in the lengths of 25, 30, 40, 50, 60 and 80mm's

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cook® Zilver™ Biliary Stent:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a list of tests conducted but does not explicitly state specific acceptance criteria (e.g., "stent must deploy within X seconds" or "radial force must be Y Newtons") or quantitative reported device performance values. Instead, it broadly states that the tests provide "reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent."

Test Category	Specific Tests	Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance (Not Explicitly Stated)
1. Deployment	a. Profile	Implicit: Device deploys smoothly without obstruction.	Implicit: Performed reliably according to design.
	b. Deployment accuracy	Implicit: Stent deploys to intended location.	Implicit: Performed reliably according to design.
	c. Stent length and change due to deployment	Implicit: Stent length remains within acceptable parameters post-deployment.	Implicit: Performed reliably according to design.
	d. Stent diameter	Implicit: Stent opens to specified diameter.	Implicit: Performed reliably according to design.
	e. Uniformity of expansion	Implicit: Stent expands uniformly along its length.	Implicit: Performed reliably according to design.
	f. Gold marker diameter and thickness	Implicit: Markers are of specified dimensions and visible.	Implicit: Performed reliably according to design.
	g. Stent integrity	Implicit: Stent remains structurally sound during and after deployment.	Implicit: Performed reliably according to design.
2. Radial Force		Implicit: Stent provides sufficient radial strength to maintain patency.	Implicit: Performed reliably according to design.
3. Finite Element Analysis		Implicit: Modeling confirms structural integrity and performance under simulated conditions.	Implicit: Performed reliably according to design.

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

Sample Size: The document does not specify the sample size used for any of the tests.
Data Provenance: The document does not provide information on the country of origin of the data or whether the tests were retrospective or prospective. Given the nature of a 510(k) summary, these are likely in-house laboratory and engineering tests rather than clinical studies with human patient data.

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

This information is not applicable to the type of testing described in the document. The tests performed are engineering and design verification tests, not clinical studies requiring expert consensus on ground truth. Ground truth in this context would be physical measurements and engineering specifications.

4. Adjudication Method for the Test Set:

This information is not applicable as there is no mention of a human-reviewed test set or "adjudication" in the clinical sense. The tests are physical and analytical.

5. 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:

This is not applicable. The device described is a medical stent, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

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

This is not applicable. The device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the tests described would be the engineering specifications and design requirements for the stent. For example, the specified diameter of the stent, its intended deployment accuracy, and its required structural integrity. The tests verify that the physical device meets these predefined engineering standards.

8. The Sample Size for the Training Set:

This is not applicable as there is no "training set" in the context of this physical device's testing. Training sets are relevant for machine learning models.

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

This is not applicable for the reasons stated above.

Summary

{0}------------------------------------------------

Special 510(k) Premarket Notification Zilver Biliary Stent 12-14 mm COOK INCORPORATED

K031821
page 1 of 2

510(k) Summary

JUL 1 8 2003

Submitted By:

Carol Zwissler Regulatory Affairs Coordinator Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235

June 12, 2003

Device:

Trade Name: Proposed Classification:

Cook® Zilver™ Biliary Stent Biliary Catheter and Accessories

Predicate Devices:

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

Device Description:

{1}------------------------------------------------

cial 510(k) Premarket Notification liary Stent 12-14 mm

KC31821
page 2 of 2

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 devices currently marketed and distributed by Cook Incorporated. This device will undergo sterilization similar to the devices currently marketed and distributed. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.

Test Data:

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

1. Deployment
- a. Profile
- b. Deployment accuracy
- c. Stent length and change due to deployment
- d. Stent diameter
- e. Uniformity of expansion
- f. Gold marker diameter and thickness
- g. Stent integrity
1. Radial Force
Finite Element Analysis 3.

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows a black and white seal. The seal has the words "HEALTH & HUMAN SERVICES USA" written around the edge. In the center of the seal is an image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2003

Ms. Carol Zwissler Regulatory Affairs Coordinator Cook Incorporated 750 Daniels Way P.O. Box 489 BLOOMINGTON, IN 47402-0489

Re: K031821

Trade/Device Name: Cook® Zilver™ Biliary Stent Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: June 12, 2003 Received: June 24, 2003

Dear Ms. Zwissler:

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). You may, therefore, marl:et the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

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

{3}------------------------------------------------

Päge 2 - Ms. Carol Zwissler

Furthermore, the indication for biliary use must be prominently displayed in all labeling, including pouch, box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.

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); 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.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4616. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Daniel G. Schultz, M.D.

Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page 1 of 1

510(k) Number (if known):_K031821

Device Name: Cook® Zilver™ Biliary Stent

FDA's Statement of the Indications For Use for device:

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

Prescription Use _ (Per 21 CFR 801.109) OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Daniel H. Lyman

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.

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.