The DYNALINK™ .018 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 0.018" 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. The distal end of the delivery system includes the DYNALINK™ Biliary Self-Expanding Stent held in its constrained state by the stent-restraining sheath, a soft, low profile tip, and two radioopaque markers to indicate the proximal and distal ends of the stent. At the proximal end of the delivery system, the user interface is composed of a pull-back handle attached to the OM, a shaped housing that allows the handle to slide axially, and a luer fitting that is rigidly fixed to the shaped housing. The DYNALINK™ Biliary Self-Expanding Stent is fabricated from superelastic nickel-titanium (nitinol). The DYNALINK™ Biliary Self-Expanding Stent is comprised of a series of serpentine rings that are aligned along a common longitudinal axis. The stent is laser cut from a tube of superelastic nitinol. All of the stent diameters are cut with similar stent patterns, and the stent is expanded and heat-treated to be stable at the desired final diameter. The stents are electropolished to obtain a smooth finish with a thin layer of titanium oxide on the surface.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the DYNALINK™ .018 Biliary Self-Expanding Stent System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with detailed acceptance criteria and standalone performance studies.

Therefore, much of the requested information regarding acceptance criteria, specific study design (test/training sets, expert consensus, MRMC studies, effect sizes), and detailed performance metrics is not explicitly present in the provided document. The submission relies on "in vitro bench tests and analyses" and comparison to a predicate device.

Here's an attempt to extract and infer information based on the provided text, while also explicitly stating what is not available.

1. Table of Acceptance Criteria and Reported Device Performance

As per the given document, detailed acceptance criteria with specific numerical targets and corresponding performance reports are not provided. The submission focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific performance criteria against a predefined standard. The document only generally states:

Criterion/Feature	Reported Device Performance (or Claim)
Technological Characteristics	Substantially equivalent to predicate device (materials, biocompatibility, performance properties, sterilization, packaging).
Safety and Effectiveness	Demonstrated through data collected from in vitro bench tests and analyses.
Design Modification	The only reported modification compared to the predicate is the "length of the stent."

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

Sample Size for Test Set: Not specified. The document mentions "in vitro bench tests and analyses" but does not provide any sample sizes for these tests.
Data Provenance: The data is from "in vitro bench tests and analyses." There is no mention of human subject data, retrospective or prospective studies, or country of origin.

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

Not applicable/Not specified.
Since the document describes "in vitro bench tests and analyses," there is no mention of human experts providing ground truth for a test set in the context of diagnostic or clinical accuracy.

4. Adjudication Method for the Test Set

Not applicable/Not specified.
As there's no mention of expert labeling or human performance evaluation in a test set, an adjudication method is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No.
The document does not mention an MRMC comparative effectiveness study. This type of study is typically used for diagnostic imaging devices to assess the impact of AI on human reader performance, which is not relevant for a self-expanding stent system.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable/Not specified in detail.
This device is a physical stent system, not an algorithm. The "performance data" refers to the physical and functional performance of the device (e.g., expansion, material properties) as assessed by "in vitro bench tests and analyses." There is no "algorithm only" performance reported.

7. The Type of Ground Truth Used

Not explicitly defined as "ground truth" in the diagnostic sense.
For "in vitro bench tests and analyses," the "ground truth" would likely be established engineering specifications, material standards, and performance metrics for mechanical properties (e.g., expansion force, radial strength, durability, patency in a simulated environment) that the device is tested against. The document does not elaborate on these specific metrics or how they were established.

8. The Sample Size for the Training Set

Not applicable/Not specified.
This device is a physical stent system, not an AI model that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not specified.
As there is no "training set" for an AI model, this question is not relevant to the provided text.

Summary of Study Type:

The study described is a premarket notification (510(k)) that relies on in vitro bench tests and analyses to demonstrate substantial equivalence to an existing predicate device (DYNALINK™ Biliary Self-Expanding Stent System, K002143). The focus is on comparing the technological characteristics of the new device to the predicate, with the main difference being the length of the stent. Specific performance metrics and human-centric studies are not detailed as part of this submission process.

Summary

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K014007

510(k) SUMMARY

2007

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 03, 2001
Device Trade Name:	DYNALINK™ .018 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™ .018 Biliary Self-Expanding Stent System are substantially equivalent with regard to these features in the predicate device, the DYNALINK™ Biliary Self-Expanding Stent System (K002143, October 12, 2000).

Device Description:

The DYNALINK™ .018 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 0.018" 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.

The distal end of the delivery system includes the DYNALINK™ Biliary Self-Expanding Stent held in its constrained state by the stent-restraining sheath, a soft, low profile tip, and two radioopaque markers to indicate the proximal and distal ends of the stent. At the proximal end of the

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K07 4007

delivery system, the user interface is composed of a pull-back handle attached to the OM, a shaped housing that allows the handle to slide axially, and a luer fitting that is rigidly fixed to the shaped housing.

The DYNALINK™ Biliary Self-Expanding Stent is fabricated from superelastic nickel-titanium (nitinol). The DYNALINK™ Biliary Self-Expanding Stent is comprised of a series of serpentine rings that are aligned along a common longitudinal axis.

The stent is laser cut from a tube of superelastic nitinol. All of the stent diameters are cut with similar stent patterns, and the stent is expanded and heat-treated to be stable at the desired final diameter. The stents are electropolished to obtain a smooth finish with a thin layer of titanium oxide on the surface.

Intended Use:

The DYNALINK™ .018 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™ .018 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 seal for the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

JAN - 7 2002

Ms. Saba Modiarrad Regulatory Associate II Guidant Corporation 3200 Lakeside Drive Santa Clara, California 95054

Re: K014007

Trade/Device Name: DYNALINK™ .018 Biliary Self-Expanding Stent Sytem Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: December 4, 2001 Received: December 5, 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,

L. W. T. Jen

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

Enclosure

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Page 1 of 1

510(k) Number (if known): K014007

Device Name: DYNALINK™ .018 Biliary Self-Expanding Stent System

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

The DYNALINK™ .018 Biliary Self-Expanding Stent System is indicated for the palliation of malignant strictures in the biliary tree.

Prescription Use V OR (Per 21 CFR 801.109)

Over-The-Counter Use

Yancy C. Borden

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K014007

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.