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 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" 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" Biljary Stent comes prefoaded 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 and 60 mm.

AI/ML Overview

This device is a medical implant, and the provided text describes its 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than a study against a pre-defined acceptance criteria for diagnostic/AI performance. The information you requested, particularly regarding acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert involvement, and comparative effectiveness studies, is not typically part of a 510(k) submission for this type of device (a biliary stent).

However, I can extract the relevant information pertaining to the device's functional performance testing as described in the submission.

Here is the information based on the provided text, heavily inferring where direct answers to your questions are not present due to the nature of the submission (device not AI/diagnostic):

1. Table of Acceptance Criteria (Inferred Functional Performance) and Reported Device Performance

Acceptance Criteria Category (Inferred)	Specific Test	Device Performance (Reported as assurance of reliable design and performance)
Deployment	a. Profile	Assured reliable design and performance
	b. Deployment Accuracy	Assured reliable design and performance
	c. Stent length and Change due to Deployment	Assured reliable design and performance
	d. Stent Diameter	Assured reliable design and performance
	e. Uniformity of Expansion	Assured reliable design and performance
	f. Stent Integrity	Assured reliable design and performance
	g. Ease of Deployment	Assured reliable design and performance
Mechanical Properties	Radial Force	Assured reliable design and performance
	Finite Element Analysis	Assured reliable design and performance
	Tensile Testing	Assured reliable design and performance

Note: The submission states "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." This implies that the device met the pre-defined acceptance criteria for each of these functional tests, without detailing the specific numerical thresholds for those criteria in this summary.

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

Sample Size: Not specified in the provided text.
Data Provenance: Not applicable in the context of device functional testing described. These are laboratory/bench tests, not clinical data.

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

Not applicable. Ground truth, in the diagnostic sense, is not established for these functional device performance tests. These tests are based on engineering specifications and measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This concept pertains to expert review in diagnostic studies, not functional device testing.

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:

No. This is a medical device (stent), not an AI/diagnostic software.

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

No. This is a medical device (stent), not an AI/diagnostic software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the functional tests described, the "ground truth" would be the engineering specifications and established test methodologies (e.g., measuring stent diameter, deployment accuracy against a defined target, tensile strength against a known material property standard). It's based on physical measurements and material science, not clinical ground truth.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device. The design and manufacturing processes are likely informed by engineering principles and previous device designs, but there isn't a "training set" in the AI sense.

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

Not applicable. See point 8.

Summary

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510(k) Summary

K040505
page 1 of 2

Submitted By:

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

February 26, 2004

Device:

Trade Name:	Zilver® 635TM Biliary Stent
Proposed Classification:	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:

The Zilver® 635" Biljary Stent comes prefoaded 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 and 60 mm.

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

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67 K040505
page 2 of 2

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 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:

1. Deployment
- a. Profile
- b. Deployment Accuracy
- c. Stent length and Change due to Deployment
- d. Stent Diameter
- e. Uniformity of Expansion
- f. Stent Integrity
- g. Ease of Deployment
1. Radial Force
1. Finite Element Analysis
Tensile Testing 4.

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 biliarv stent.

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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 stylized caduceus, which is a symbol featuring a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 6 2004

Ms. Leland Keyt Regulatory Affairs Coordinator Cook Incorporated 750 Daniels Way, P.O. Box 489 BLOOMINGTON IN 47402

Re: K040505

Trade/Device Name: Cook Zilver® 635TM Biliary Stent Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: February 26, 2004 Received: February 27, 2004

Dear Ms. Keyt:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have tenced your booksh or only promised is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the enerosure) to regairy and of the Medical Device Amendments, or to devices that provision in the provisions with the provisions of the Federal Food, Drug, and Cosmetic nave been rolumnited in assore, market the device, subject to the general controls provisions of the Act (Fee). Tou may, mercerere, thelow. The general controls provisions of the Act include Act and the inmual 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 Tile Office of De Hoo Eranance not identified in the proposed labeling and that such use could cause will be assed for an mecason with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labcling:

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, including r annerher of 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.

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Page 2 - Ms. Leland Keyt

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 I toast of a rised made a determination that your device complies with other requirements of the Act or any I DA mas made a doceminations 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 clectronic 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 The I Dri Indialis of succeantial squarterice and permits your device to proceed to the market. This resure in a classination on 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 (21 CFR Part 807,9 provided whis 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

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Page 1 of 1

510(k) Number: K040505

Device Name: Cook Zilver® 635TM Biliary Stent

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

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

Prescription Use /
(Per 21 CFR 801.109)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Carolyn Y. Newland for NBC.

luctive, Abdominal 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.