The RX HERCULINK ELITE Biliary Stent System features a balloon expandable stent composed of L605 Cobalt Chromium. The stent design is based upon a series of zigzaqqing rings with multiple links per ring. The stent is available in 12mm, 15mm, and 18mm lengths. The delivery system is a rapid exchange, co-axial design with a balloon at the distal end. The proximal lumen provides for inflation of the balloon with contrast medium. The central distal lumen permits use of a guidewire to facilitate advancement of the catheter to and through the stricture to be dilated. The balloon has radiopaque marker(s) to aid in positioning the balloon in the stricture, and is designed to provide an expandable seament of known diameter and length at specified pressures. Markers located on the proximal outer shaft help the physician gauge the dilatation catheter position relative to the guiding catheter tip.

AI/ML Overview

The Guidant RX HERCULINK® ELITE™ Biliary Stent System is intended for palliation of malignant strictures in the biliary tree. The device's substantial equivalence was established through a comparison to predicate devices (HERCULINK® PLUS Biliary Stent System (K010684) and Cordis Palmaz BLUE .018 Transhepatic Biliary Stent System (K040413)) and performance data from in vitro bench tests, analyses, and biocompatibility testing.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria with numerical targets. Instead, it relies on demonstrating substantial equivalence to predicate devices and satisfactory results from bench testing and biocompatibility studies. The device performance is generally stated as meeting requirements for safety and effectiveness without specific metrics.

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance
Device Design	Stent design features (zig-zagging rings, multiple links), material (L605 Cobalt Chromium), available lengths (12mm, 15mm, 18mm), and delivery system (rapid exchange, co-axial, balloon expandable with radiopaque markers) must be suitable for the intended use and comparable to predicate devices.	The RX HERCULINK ELITE Biliary Stent System features a balloon expandable stent composed of L605 Cobalt Chromium. The stent design is based upon a series of zig-zagging rings with multiple links per ring. The stent is available in 12mm, 15mm, and 18mm lengths. The delivery system is a rapid exchange, co-axial design with a balloon at the distal end, with radiopaque markers and a central distal lumen for guidewire advancement. Markers on the proximal outer shaft aid in positioning. The design is described as being in line with predicate devices.
Safety	The device must demonstrate safety through in vitro and biocompatibility testing. It should not pose undue risk in its intended use.	The results of the in vitro bench tests and analyses and biocompatibility testing demonstrated the safety of the RX HERCULINK ELITE Biliary Stent System. The FDA also noted a limitation that the safety and effectiveness for use in the vascular system have not been established, indicating that safety was assessed specifically for biliary use.
Effectiveness	The device must demonstrate effectiveness for the palliation of malignant strictures in the biliary tree through in vitro testing and comparison to predicate devices.	The results of the in vitro bench tests and analyses and biocompatibility testing demonstrated the... effectiveness of the RX HERCULINK ELITE Biliary Stent System. The intended use, which is the palliation of malignant strictures in the biliary tree, is supported by this general statement of effectiveness. The substantial equivalence argument also supports effectiveness by showing similarity to previously cleared effective devices.
Substantial Equivalence	Device must be substantially equivalent to legally marketed predicate devices in terms of intended use, technology, and safety/effectiveness.	The RX HERCULINK® ELITE™ Biliary Stent System is described as substantially equivalent to: HERCULINK® PLUS Biliary Stent System (K010684) and Cordis Palmaz BLUE .018 Transhepatic Biliary Stent System, (K040413). The intended use is identical to the predicates for biliary stricture palliation. The technological characteristics (e.g., balloon-expandable stent, L605 Cobalt Chromium, delivery system features) are presented as comparable.

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

The document states that the performance data was derived from "in vitro bench tests and analyses and biocompatibility testing." No specific "test set" in the context of clinical data (e.g., patient cases) or a defined statistical sample size for such a set is mentioned.

Sample Size: Not applicable/not specified for a clinical test set. Performance data relies on in vitro bench tests and biocompatibility testing, not human subject data.
Data Provenance: Not applicable for a clinical test set. The data originates from internal laboratory (in vitro) testing and biocompatibility studies. No country of origin for clinical data is relevant, and the data is retrospective in the sense of being internal lab testing rather than prospective clinical trials.

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

This information is not applicable to the provided document. The submission relies on engineering bench tests and preclinical biocompatibility studies, not on an expert-adjudicated clinical test set. Therefore, no experts established ground truth in this context.

4. Adjudication Method for the Test Set

This information is not applicable. There was no clinical test set requiring an adjudication method.

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

No, an MRMC comparative effectiveness study was not done. The document describes an in vitro and biocompatibility study, not a clinical study involving human readers or patient cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical medical device (biliary stent system), not an AI algorithm. Its performance is inherent to its physical design, material, and mechanical properties, evaluated through bench testing.

7. The Type of Ground Truth Used

The ground truth used was based on engineering specifications, material science standards, and established biocompatibility testing protocols. For example, the success of a "bench test" would be determined by whether the stent met predefined mechanical tolerances or performance characteristics (e.g., expansion diameter, radial strength, fatigue resistance). Biocompatibility is assessed against recognized standards for materials in contact with the body.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical device submission. The device is designed, manufactured, and tested, not "trained" on data.

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

This information is not applicable. As there is no training set for an AI/ML algorithm, no ground truth was established for it.

Summary

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GUIDANT

MAR 6 2006

K053454
page 1 of 1

Appendix B 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 95054
Telephone:	951-914-2771
Fax:	951-914-2145
Contact Person:	Keith Krohn
Date Prepared:	December 8, 2005
Device Trade Name:	RX HERCULINK® ELITE™ Biliary Stent System
Device Common Name:	Biliary Stent
Device Classification Name:	Biliary Catheter
Device Classification:	Class II

Summary of Substantial Equivalence:

The RX HERCULINK® ELITE™ Biliary Stent System is substantially equivalent to: HERCULINK® PLUS Biliary Stent System (K010684, cleared 4/12/2001); and Cordis Palmaz BLUE .018 Transhepatic Biliary Stent System, (K040413, cleared 6/21/2004)

Device Description:

Intended Use:

The RX HERCULINK ELITE Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

Performance Data:

The results of the in vitro bench tests and analyses and biocompatibility testing demonstrated the safety and effectiveness of the RX HERCULINK ELITE Biliary Stent System.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes extending from its head, symbolizing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 6 2006

Mr. Keith Krohn Manager, Regulatory Affairs Guidant Corporation 26531 Ynez Road TEMECULA CA 92591

Re: K053454

Trade/Device Name: Guidant HERCULINK® ELITE Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: February 15, 2006 Received: February 17, 2006

Dear Mr. Krohn:

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 - Mr. Keith Krohn

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 labeline.

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,

Miriam C. Provost

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

Enclosure

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510(k) Number: K053454

Device Name: Guidant HERCULINK® ELITE Biliary Stent System

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

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

David A. Ingram

(Division Sign-Off) < (Division of Reproductive, Abdominal, and Radiological Devices KOS3454 510(k) Number __

Prescription Use
(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.