The Zilver® 518 " Biliary Stent is a self-expanding, nitinol stent designed for superior 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® 518 " Biliary Stent, along with radiopague markers on the delivery system, allow precise positioninq of the stent. The stent's 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 available in unrestrained outer diameters of 4, 5, 6, 7, 8, and 9 mm and in lengths of 20, 30, 40, 50 and 60 mm.

AI/ML Overview

Here's an analysis of the provided text regarding the Zilver® 518™ Biliary Stent, focusing on acceptance criteria and study details.

Based solely on the provided text, the document primarily describes the device, its intended use, and substantial equivalence to predicate devices, along with the types of tests performed. It does not provide specific acceptance criteria values or detailed performance results in the format typically requested for AI/device performance studies. The document is a 510(k) summary for a medical device approval, which focuses on demonstrating substantial equivalence, and not on detailed performance metrics as would be found in a clinical trial report.

Therefore, many of the requested fields cannot be filled with specific data from this document. I will extract what is present and explicitly state when information is not available.

Description of Acceptance Criteria and Study:

The Zilver® 518™ Biliary Stent was subjected to a series of tests to assure reliable design and performance. These tests were comprised of:

Deployment:
- Profile
- Deployment Accuracy
- Stent length and Change due to Deployment
- Stent Diameter
- Uniformity of expansion
- Stent Integrity
- Ease of Deployment
Radial Force
Finite Element Analysis
Biocompatibility - ISO 10993-1

The document states that "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." However, the specific quantitative acceptance criteria (e.g., "Deployment Accuracy must be within X mm") and the reported device performance metrics (e.g., "Deployment Accuracy was Y mm") are not detailed in this summary.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric (as implied)	Acceptance Criteria (Specific Value/Range)	Reported Device Performance (Specific Value/Range)
Deployment	Profile	Not specified in document	Not specified in document
	Deployment Accuracy	Not specified in document	Not specified in document
	Stent length change	Not specified in document	Not specified in document
	Stent Diameter	Not specified in document	Not specified in document
	Uniformity of expansion	Not specified in document	Not specified in document
	Stent Integrity	Not specified in document	Not specified in document
	Ease of Deployment	Not specified in document	Not specified in document
Mechanical Properties	Radial Force	Not specified in document	Not specified in document
Simulation	Finite Element Analysis	Not specified in document	Not specified in document
Biocompatibility	ISO 10993-1 Compliance	Compliance with ISO 10993-1 standards	Device was subjected to and presumably met, as approval was granted.

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 for Test Set: Not specified in the document. The tests listed are primarily bench/engineering tests, and the "sample size" would refer to the number of stents or components tested under each condition. This information is not provided.
Data Provenance: Not specified. As these are bench tests for a medical device manufacturer (Cook Incorporated, Bloomington, Indiana, USA), it can be inferred the tests were likely conducted internally or by contracted labs, presumably within the US or a region adhering to similar standards. The data is likely prospective for these specific tests as they were performed to support the 510(k) submission.

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)

This question is more applicable to clinical studies or studies involving human interpretation (e.g., imaging devices). The listed tests are primarily physical and chemical performance tests of the device itself. Therefore, "ground truth" would be established by validated test methodologies and instrument calibration, not by human expert consensus in the typical sense.
The "experts" would be the engineers, scientists, and technicians performing and validating the tests, but no specific number or qualifications are provided here.

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

Not applicable to the types of engineering and laboratory tests described. Adjudication methods are typically used in clinical studies or human-reader performance evaluations to resolve discrepancies in diagnoses or assessments.

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. An MRMC comparative effectiveness study was not done. This document describes the approval of a physical medical device (a stent), not an AI algorithm or an imaging diagnostic tool that would involve human readers or AI assistance.

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

No. This is not an algorithm, but a physical medical device. Therefore, a standalone algorithm performance study is not applicable.

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

For the physical and chemical tests listed, the "ground truth" is based on objective measurements obtained from validated testing equipment and adherence to relevant industry standards (e.g., ISO 10993-1 for biocompatibility). It is not pathology, outcomes data, or expert consensus in a clinical diagnostic sense. For example, stent length change would be measured directly, and the true value is the measured value from the test instrument.

8. The sample size for the training set

Not applicable. This document describes the approval of a physical medical device, not an algorithm that requires a training set. The device design and presumably iterative testing inform product development, but this is not analogous to an algorithm's training set.

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

Not applicable. As a training set is not relevant to this type of device approval, the establishment of its ground truth is also not applicable.

Summary

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DEC 1 5 2003

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510(k) Summary

Submitted By:

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

October 17, 2003

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 constructions and technological characteristics to predicate devices reviewed as devices for palliation of malignant neoplasms in the biliary tree.

Device Description:

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 available in unrestrained outer diameters of 4, 5, 6, 7, 8, and 9 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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K033348
Page 2 of 2

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

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® 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
- g. Ease of Deployment
1. Radial Force
Finite Element Analysis ന
Biocompatibility- ISO 10993-1 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 biliary 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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 2003

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

Re: K033348

Trade/Device Name: Cook Zilver® 518TM Biliary Stent Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: November 19, 2003 Received: November 21, 2003

Dear Ms. Keyt:

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, market 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.

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.

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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 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 C. Schultz, M.D.

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: K033348

Device Name: Cook Zilver® 518TM Biliary Stent

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

The Zilver® 518™ Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.

David A. Seemann

Division Sign-Off) Tivision of Reproductive, Abdominal, nd Radiological Device RO33348 10(k) : Jumber

Prescription Use ﻠ (Per 21 CFR 801.109)

Over-the-Counter Use

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.