The DYNALINK™ .035 Biliary Self-Expanding Stent System is a catheter designed to deploy a self-expanding nickel titanium (Nitinol) stent into the biliary tree.

The catheter body is constructed from two coaxial members. The inner member (IM) is compatible with a .035" guide wire in an over-the-wire configuration. The outer member (OM) is composed of a distal sheath that constrains the unexpanded stent, an outer shaft over most of the catheter length, and a proximal handle used to retract the assembly.

AI/ML Overview

The acceptance criteria and the study proving the device meets these criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Performance Metric)	Device Performance as Reported in the Submission
Safety and Effectiveness	Demonstrated through data collected from in vitro bench tests and analyses.
Technological Characteristics	Substantially equivalent to currently marketed predicate devices (K011881) in terms of materials, biocompatibility, performance properties, sterilization, and packaging.

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

The document does not detail specific sample sizes for a "test set" in the context of clinical or human data. The performance data primarily relies on "in vitro bench tests and analyses." Therefore, information on data provenance (e.g., country of origin, retrospective/prospective) for a test set of human data is not applicable here.

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

This information is not provided. Since the performance data is based on in vitro bench tests, the concept of establishing ground truth by medical experts in the way it applies to clinical studies is not relevant.

4. Adjudication Method for the Test Set:

This information is not provided. As the performance data is from in vitro bench tests, adjudication methods typically used for interpreting human data are not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was mentioned. The device is a physical medical device (a biliary stent system), not an AI-assisted diagnostic or interpretative tool. Therefore, this type of study is not relevant to this submission.

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

This is not applicable as the device is a physical stent system.

7. The Type of Ground Truth Used:

The ground truth for demonstrating safety and effectiveness was based on the results of in vitro bench tests and analyses. This would involve engineering specifications, material properties, mechanical testing results, and other laboratory-based evaluations.

8. The Sample Size for the Training Set:

This information is not provided. The concept of a "training set" in the context of developing an algorithm or AI model for diagnostic or predictive purposes is not applicable to this physical medical device. The "training" for such a device would typically involve engineering design, prototyping, and iterative bench testing.

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

This information is not explicitly detailed. For a physical device like a stent, "ground truth" during development (analogous to a training set for algorithms) would be established through engineering design specifications, materials science principles, and iterative bench testing to ensure the device met predetermined performance criteria (e.g., expansion force, radial strength, fatigue resistance, biocompatibility). These criteria would be based on established industry standards and clinical needs for biliary stent functionality.

Summary

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'JAN 1 8 2002

510(k) SUMMARY

The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92

Submitter's Name:	Guidant Corporation
Submitter's Address:	3200 Lakeside DriveSanta Clara, CA 95052
Telephone:Fax:	408/845-1067408/845-3743
Contact Person:	Saba Modjarrad
Date Prepared:	December 17, 2001
Device Trade Name:	DYNALINK™ .035 Biliary Self-Expanding Stent System
Device Common Name:	Biliary Stent
Device Classification Name:	Biliary Catheter
Device Classification:	Class II

Summary of Substantial Equivalence:

The design, materials, method of delivery and intended use features of DYNALINK™ .035 Biliary Self-Expanding Stent System are substantially equivalent with regard to these features in the predicate device, the DYNALINK™ .035 Biliary Self-Expanding Stent System (K011881, July 18, 2001).

Device Description:

The DYNALINK™ .035 Biliary Self-Expanding Stent System is a catheter designed to deploy a self-expanding nickel titanium (Nitinol) stent into the biliary tree.

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Intended Use:

The DYNALINK™ .035 Biliary Self-Expanding Stent System is indicated for palliation of malignant strictures in the biliary tree.

Technological Characteristics:

Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties, sterilization and packaging are substantially equivalent to the currently marketed predicate devices. The design modification of the new biliary stent system compared to that of the predicate biliary stent system is the length of the stent.

Performance Data:

The safety and effectiveness of the DYNALINK™ .035 Biliary Self-Expanding Stent System has been demonstrated through data collected from in vitro bench tests and analyses.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol associated with the department.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 8 2002

Ms. Saba Modjarrad Regulatory Associate II Guidant Corporation 3200 Lakeside Drive SANTA CLARA, CA 95054-2807

Re: K014184

Trade/Device Name: DYNALINK™ .035 Biliary Self-Expanding Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: December 17, 2001 Received: December 20, 2001

Dear Ms. Modjarrad:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. Saba Modjarrad

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 above is added to your labeling, as described.

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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification''(21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Bernard Hestet

Bernard E. Statland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K014184

Device Name: DYNALINK™ .035 Biliary Self-Expanding Stent System

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

The DYNALINK™ .035 Biliary Self-Expanding Stent System is indicated for the palliation of malignant strictures in the biliary tree.

Prescription Useレ OR (Per 21 CFR 801.109)

Over-The-Counter Use __

Thurc Brandon
Division Sign-Off
Division of Remediation Division

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.