The OMNILINK® .035 Biliary Stent System is a balloon-expandable stent compused of .16L medical grade stainless steel. The stent is pre-mounted onto an over-the-wire (OT)N) lefivery catheter. The OMNILINK® .035 Biliary Stent System consists of a dual stent design, fabricated from a single piece of 316L medical grade stainless steel tubing. The stent designs are based on a series of zigzagging rings with multiple articulations per ring. The stents are available in two designs which primarily differ in strut width and the length of the basic cell. One design is used for stent sizes 5.0mm -- 7.0mm and the other for stent sizes 8.0mm -- 10.0mm. The delivery system is an over-the-wire, co-axial design with a balloon at the distal end. The delivery catheter's central lumen is designed to permit the use of a 0.035" guide wire to facilitate advancement of the catheter to and through the stricture to be dilated. Once the delivery system is placed in the desired location, the stent expands upon inflating the balloon with contrast medium. The balloon provides an expandable segment of known diameter and length at specific pressures. In addition, the balloon has two radiopaque markers to aid in stent positioning. The stent is designed to remain in the biliary duct as a permanent implant. The subject device OMNILINK® .035 Biliary Stent System consists of stent sizes of diameters ranging from 5.0mm - 10.0mm with stent lengths of 12, 16, 18, 28, 38, 58mm and delivery system length of 80 and 135cm. The stent and delivery system are supplied sterile and is intended for single use only.

AI/ML Overview

The provided text is a 510(k) summary for a medical device, the OMNILINK® .035 Biliary Stent System. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study proving the device meets specific acceptance criteria through performance data.

Therefore, many of the requested elements (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not detailed in this type of regulatory submission.

Here's an analysis based on the information provided:

Acceptance Criteria and Device Performance

The provided document does not contain a table of specific quantitative acceptance criteria or corresponding reported device performance metrics from a study. As a 510(k) summary, its primary purpose is to establish substantial equivalence to predicate devices, not to present novel performance data against defined acceptance criteria.

The submission states: "No performance standards have been established for Biliary Stents under Section 514 of the Food, Drug and Cosmetic Act." This indicates that there are no government-mandated acceptance criteria, and the document itself does not specify internal company acceptance criteria for a new performance study.

Absence of a Comprehensive Study Description

The document indicates that studies validating the performance of this specific iteration of the device against new, defined criteria were likely not conducted or, if they were, the details are not included in this summary. The "Performance Data" section simply states, "No performance standards have been established for Biliary Stents under Section 514 of the Food, Drug and Cosmetic Act."

The changes described for this 510(k) (optimized manufacturing parameters, revised test methods, addition of process monitoring, updates to product labeling, and related updates to product specification) suggest modifications to an existing device rather than a new device requiring extensive clinical trials to establish de novo performance.

Given this, the following points cannot be answered from the provided text:

Sample sizes used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
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: Not applicable (this is a physical medical device, not an AI system).
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not mentioned.
The sample size for the training set: Not applicable (not an AI system).
How the ground truth for the training set was established: Not applicable.

Summary

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GUIDANT

120 12

K053459
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Appendix A 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:	951-914-4412951-914-0214
Contact Person:	Sylvia Hernandez
Date Prepared:	December 12, 2005
Device Trade Name:	OMNILINK® .035 Biliary Stent System
Device Common Name:	Biliary Stent
Device Classification Name:	Biliary Catheter
Device Classification:	Class II

Summary of Substantial Equivalence:

The OMNILINK® .035 Biliary Stent System, subject device of this 510(k), is substantially similar in materials, design and intended use to the predicate devices, OTW MEGALINK® SDS Biliary Stent System (K992319), and the OMNILINK® .035 Biliary Stent System (K011506 and K032530). The changes described herein involve optimized manufacturing parameters, revised test methods, addition of process monitoring, updates to the product labeling and related updates to the product specification.

Device Description:

The OMNILINK® .035 Biliary Stent System is a balloon-expandable stent compused of .16L medical grade stainless steel. The stent is pre-mounted onto an over-the-wire (OT)N) lefivery catheter.

The OMNILINK® .035 Biliary Stent System consists of a dual stent design, fabricated from a single piece of 316L medical grade stainless steel tubing. The stent designs are based on a series of zigzagging rings with multiple articulations per ring. The stents are available in two designs which primarily differ in strut width and the length of the basic cell. One design is used for stent sizes 5.0mm -- 7.0mm and the other for stent sizes 8.0mm -- 10.0mm.

CONFIDENTIAL

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K053459
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The delivery system is an over-the-wire, co-axial design with a balloon at the distal end. The delivery catheter's central lumen is designed to permit the use of a 0.035" guide wire to facilitate advancement of the catheter to and through the stricture to be dilated. Once the delivery system is placed in the desired location, the stent expands upon inflating the balloon with contrast medium. The balloon provides an expandable segment of known diameter and length at specific pressures. In addition, the balloon has two radiopaque markers to aid in stent positioning. The stent is designed to remain in the biliary duct as a permanent implant.

The subject device OMNILINK® .035 Biliary Stent System consists of stent sizes of diameters ranging from 5.0mm - 10.0mm with stent lengths of 12, 16, 18, 28, 38, 58mm and delivery system length of 80 and 135cm. The stent and delivery system are supplied sterile and is intended for single use only.

Intended Use:

The OMNILINK® .035 Biliary Stent System is indicated for palliation of malignant strictures in the biliary tree.

Technological Characteristics:

Similar to the predicate devices, the subject device OMNILINK® .035 Biliary Stent System is comprised of a 316L stainless steel balloon-expandable stent pre-mounted onto an over-thewire, co-axial design delivery catheter with a balloon bonded at the distal end. The catheter shaft with a co-axial lumen provides a conduit for contrast medium to inflate the balloon. Upon balloon inflation with contrast medium, the stent expands to a specific diameter. The stent is a permanent implant. The system is designed for single use.

Performance Data:

No performance standards have been established for Biliary Stents under Section 514 of the Food, Drug and Cosmetic Act.

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Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is written in a simple, sans-serif font. The words are arranged horizontally, with 'Public' and 'Health' on the first line and 'Service' on the second line.

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure with three heads, symbolizing health, services, and people. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure.

APR 1 2 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mara Caler Regulatory Affairs Guidant Corporation 26531 Ynez Road TEMECULA CA 92591

Re: K053459

Trade/Device Name: Guidant OMNILINK® .035 Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: February 21, 2006 Received: February 23, 2006

Dear Ms. Caler:

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:

This device is not intended for any vascular indications. The safety and effectiveness of this device for use in the vascular system has not been established and could result in serious harm and/or death.

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. Mara Caler

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.

J.M. Hall

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

Enclosure

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510(k) Number: K053459

Device Name: Guidant OMNILINK® .035 Biliary Stent System

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

The Guidant OMNILINK® .035 Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

Prescription Use (Pcr 21 CFR 801.109)

Over-the-Counter Use ------

David A. Syverson

(Division Sign-Off) (Division Sign-On)
Division of Reproductive, Abdominal, and Radicio as a Devilo 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.