The Zilver® 518™ Biliary Stent is a self-expanding, nitinol stent designed for excellent radial strength and optimal flexibility. Constructed from a series of interconnected Z-shaped segments, the configuration of the stent conforms to the shape of the biliary system and provides circumferential scaffolding throughout the stent's length. The interconnected Z-shaped segments also keep foreshortening to a minimum. The Zilver® 518™ Biliary Stent comes preloaded in a 5 French delivery system. The stent is deployed with the use of a simple hand held device. The stent is currently available in unrestrained outer diameters of 4, 5, 6, 7, 8, 9 and 10 mm in lengths of 20, 30, 40, 50 and 60 mm. The 80 mm length stent is an addition to this product line.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Cook Zilver® 518™ Biliary Stent. It describes the device, its intended use, and the tests performed to assure its reliable design and performance. However, it does not include the specific details typically found in a clinical study report or a detailed device performance report that would define and then prove acceptance criteria in the way a clinical trial or algorithm validation study would.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices. The "acceptance criteria" discussed here are primarily related to general device performance characteristics and manufacturing control, rather than clinical efficacy or accuracy thresholds for an AI/algorithm.

Here's an analysis based on the information provided, tailored to the requested structure, with explicit notes about what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance
Deployment Performance	a. Profile (of the delivery system and deployed stent)	"The Zilver® 518™ 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... 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."
	b. Deployment Accuracy	As above.
	c. Stent length and Change due to Deployment (e.g., minimal foreshortening)	"The Zilver® 518™ Biliary Stent...interconnected Z-shaped segments also keep foreshortening to a minimum." (This is a design claim rather than a quantifiable test result, but implicitly a performance goal). The deployment test results "provide reasonable assurance...conformance to the requirements."
	d. Stent Diameter (achieving specified unrestrained outer diameters: 4, 5, 6, 7, 8, 9, 10 mm, and the new 80mm length)	"The Zilver® 518™ Biliary Stent... unrestrained outer diameters of 4, 5, 6, 7, 8, 9 and 10 mm in lengths of 20, 30, 40, 50 and 60 mm. The 80 mm length stent is an addition to this product line." The deployment test results "provide reasonable assurance...conformance to the requirements."
	e. Uniformity of expansion	As above.
	f. Stent Integrity (e.g., no breakage, proper structure post-deployment)	As above.
Manufacturing/Compliance	Conformance to specified process controls and a Quality Assurance Program; similar packaging and sterilization to predicate devices.	"This device will be manufactured according to specified process controls and a Quality Assurance Program... undergo packaging similar to the predicate devices... undergo sterilization similar to the predicate devices."
Substantial Equivalence	Similar intended use, materials of construction, and functional characteristics to predicate devices.	"The Zilver® 518™ Biliary Stent is similar in terms of intended use, materials of construction and functional characteristics to predicate devices... 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."
Labeling	Prominently display biliary use; include warning about unestablished vascular system safety/effectiveness.	"the indication for biliary use must be prominently displayed in all labeling... in close proximity to the trade name... and in bold print." and "The safety and effectiveness of this device for use in the vascular system have not been established [must appear] in the Warnings section." (These are conditions of market clearance, not pre-market test results.)
Intended Use	Palliation of malignant strictures (neoplasms) in the biliary tree.	"The Zilver® 581™ Biliary Stent is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree." (This is the declared intended use, which the "Test Data" aims to support as safe and effective compared to predicates.)

The "study" that proves the device meets these criteria is a series of non-clinical bench tests. The document does not describe a clinical trial, and given the 510(k) pathway, a substantial equivalence claim usually relies on comparison to existing predicate devices and extensive bench testing.

Here's the breakdown for the other points, noting where information is not available in the provided text:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for the bench tests. It's common for stent testing to involve multiple units, but the exact number isn't provided.
Data Provenance: Not specified, but generally, bench testing would be conducted within the manufacturer's R&D facilities or accredited testing labs, likely in the US (Cook Incorporated is based in Bloomington, IN).
Retrospective/Prospective: Not applicable, as these are 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 (e.g. radiologist with 10 years of experience)

Not applicable. As this is bench testing of physical device characteristics (profile, deployment accuracy, integrity, etc.), "ground truth" would be established by engineering specifications, measurement equipment, and industry standards, not clinical expert consensus.

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

Not applicable. This is not a clinical study involving human interpretation.

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

Not applicable. This device is a physical medical stent, not an AI/software algorithm.

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

Not applicable. This device is a physical medical stent, not an AI/software algorithm.

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

For the bench tests, the "ground truth" would be the engineering specifications and established measurement methods for properties like stent diameter, length change, and deployment accuracy. The goal is to demonstrate that the device performs according to its design specifications. For the overall submission, the "ground truth" for its clinical utility is established by its substantial equivalence to legally marketed predicate devices with proven safety and effectiveness for the same intended use.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning algorithm.

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

Not applicable. This is a physical device, not a machine learning algorithm.

Summary of what the document focuses on:

The Zilver® 518™ Biliary Stent gained 510(k) clearance by demonstrating substantial equivalence to existing predicate devices. The "study" referenced is a series of non-clinical bench tests designed to ensure the physical device characteristics (deployment, profile, accuracy, diameter, expansion uniformity, integrity) meet internal specifications and are consistent with safe and effective performance for a biliary stent. The letter from the FDA also specifies important labeling requirements as conditions of clearance, specifically limiting the stated indication to biliary use and requiring a warning about unestablished vascular use.

Summary

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Special 510(k) Premarket Noti Cook Zilver® 518™ Biliary Ste COOK INCORPORATED

MAR 3 0 2005

ouse 1 at 2

K050698

510(k) Summary

Submitted By: Stephanie Roberts Requlatory Affairs Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235

March 17, 2005

Device:

Trade Name:	Zilver® 518™ Biliary Stent
Proposed Classification:	Catheter, Biliary, Diagnostic

Predicate Devices:

The Zilver® 518™ Biliary Stent is similar in terms of intended use, materials of The Zivel - 510 - Billary Ofent is offinal firstics to predicate devices reviewed as construction and toonif malignant neoplasm in the biliary tree.

Device Description:

The Zilver® 518™ Biliary Stent is a self-expanding, nitinol stent designed for The Zivel - 510 - Dillary Otent is a oth expurching. Constructed from a excellent radial strength and optimations of the stent conforms to the shape of Series of Intercomfected = chaped cogniontial scaffolding throughout the stent's the billary system and provides of our norther Zilver 518" Billiary Stent, length. along with faciopaque manterconnected Z-shaped segments also keep foreshortening to a minimum.

The Zilver® 518™ Biliary Stent comes preloaded in a 5 French delivery system. The stent is deployed with the use of a simple hand held device. The stent is currently available in unrestrained outer diameters of 4, 5, 6, 7, 8, 9 and 10 mm in lengths of 20, 30, 40, 50 and 60 mm. The 80 mm length stent is an addition to this product line.

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KLSK7409 2005-2020

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Special 510(k) Premarket Notification ok Zilver® 518™ Biliary Stent COOK INCORPORATED

Substantial Equivalence:

This device will be manufactured according to specified process controls and a This do noo will be mogram. This device will undergo packaging similar to the Quality Alourants Programs marketed and distributed by Cook Incorporated. This device will undergo sterilization similar to the predicate 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® 518™ 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

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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 2005

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

Re: K050698

K050098
Trade/Device Name: Zilver® 518™ Biliary Stent Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: March 17, 2005 Received: March 17, 2005

Dear Ms. Roberts:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(K) prematics from the minent (for the indications for referenced above and have determined the devices marketed in interstate comments, or to devices that use stated in the enclosure) to itgaily many in the Medical Device Amendments, or to devices that proof to May 28, 1976, the enactinent date of the Federal Food, Drug, and Cosmetic have been reclassified in accordance with the prevision to the general controls provisions of the Act (Act). You may, therefore, market the general controls provisions of the Act include Act and the limitations described below. The general velices, 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 I he Unice of Device Evanuation has actefficial in the proposed labeling and that such use could cause will be used for an intellucu use not nemained in the Act, the Act, the Act, the following limitation must appear in the Warnings section of the device's labeling:

The safcty 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 Furthermore, the indication for bittlery ass frauve, and other promotional materials, in close pouch, box, and barname, of a similar point size, and in bold print.

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Page 2 -- Ms. Stephanie Roberts

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 F Drimal made a dollarions 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 resure in a cition with 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,

Dorothy Miller

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

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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number: K050698

Device Name: Zilver® 518™ Biliary Stent

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

The Zilver® 581™ Biliary Stent is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Prescription Use V (Per 21 CFR 801.109) OR

Over-the-Counter Use

cy C. Beadon

(Division Sion-Offi copioductive, Abdominal, Division 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.