RX HERCULINK™ 14 Biliary Stent System is a balloon-expandable stent pre-mounted onto a rapid exchange (RX) delivery catheter designed to be placed perculaneously into the common bile duct and intended to treat malignant strictures in the biliary tree. The stent is fabricated from a single piece of 316L medical grade stainless steel tubing. The Stent is pre-mounted onto an RX delivery catheter with an integrated shaft system and an of a single have a look balloon bonded at the distal end. The shaft has a combination of a single lumen design at the proximal end and a coaxial lumen at the distal end. The proximal lumen provides for inflation of the balloon with contrast medium. The distal lumen permits use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated.

The balloon, which has 2 radiopaque markers to aid in positioning the balloon in the stenosis, is designed to provide an expandable segment of known diameter and length at specific pressures.

The proximal end of the catheter has a single arm adapter that provides access to the The proximal end of the catherer has a ongro annelly for connection with an inflation device.

The RX HERCULINK™ Biliary Stent System consists of an 18 mm length stent pre-The KA TILICOEINN - Dinary Catheter with balloon diameters of 4.0, 4.5, 5.0, mounted only a 75 cm length don'tory actively Stent System is intended to be delivered and deployed in the biliary tree.

AI/ML Overview

Here's an analysis of the provided text regarding the RX HERCULINK™ 14 Biliary Stent System, focusing on acceptance criteria and supporting studies:

It's important to note that the provided document is a 510(k) summary from 1999 for a medical device (biliary stent), not a diagnostic algorithm or AI system. Therefore, many of the requested categories (like MRMC studies, ground truth for training/test sets, expert adjudication, effect size of human readers with AI assistance) are not applicable to this type of device and submission. The "device" in this context is a physical stent and delivery system.

The "acceptance criteria" for a physical medical device typically revolve around demonstrating substantial equivalence to a predicate device in terms of design, materials, performance, and intended use, rather than meeting specific sensitivity/specificity thresholds. The "study" proving acceptance criteria is often a series of bench tests and analyses to show that the new device performs similarly to the predicate or meets established engineering specifications.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on substantial equivalence to predicate)	Reported Device Performance (as described)
Material Composition	Fabricated from 316L medical grade stainless steel.	Fabricated from a single piece of 316L medical grade stainless steel tubing.
Design Characteristics	Balloon-expandable stent, pre-mounted onto a rapid exchange (RX) delivery catheter, integrated shaft system, single balloon, lumen design for inflation and guidewire, radiopaque markers.	Balloon-expandable stent pre-mounted onto an RX delivery catheter with an integrated shaft system and a single balloon bonded at the distal end. Shaft has a combination of a single lumen (proximal) and coaxial lumen (distal). Balloon has 2 radiopaque markers.
Dimensions/Sizes	18 mm length stent. Delivery catheter lengths, balloon diameters of various sizes.	18 mm length stent pre-mounted onto a 75 cm length delivery catheter with balloon diameters of 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 and 7.0 mm.
Intended Use	Palliation of malignant strictures in the biliary tree.	Indicated for palliation of malignant strictures in the biliary tree. (Matches predicate's intended use)
Method of Delivery	Percutaneous, rapid exchange mechanism.	Designed to be placed percutaneously, rapid exchange (RX) delivery catheter.
Safety and Effectiveness	Demonstrated through in vitro bench tests and analyses.	"The safety and effectiveness of the RX HERCULINK™ 14 Biliary Stent System has been demonstrated through data collected from in vitro bench tests and analyses."
Substantial Equivalence	Similar design, materials, method of deployment, and intended use to Cordis J&J PALMAZ™ balloon-expandable Stent and delivery catheter for the Biliary System (K911581).	States the device "incorporates similar design, components, method of deployment, materials and intended use" to the predicate (K911581).

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

Sample Size: Not specified in terms of number of devices tested for the in vitro bench tests. The document only states "data collected from in vitro bench tests and analyses," implying multiple tests were performed.
Data Provenance: The tests are "in vitro bench tests," meaning they were conducted in a laboratory setting, not on human patients or derived from clinical data. Therefore, there is no country of origin of data or retrospective/prospective classification in the typical sense.

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

Not Applicable. For a physical device like a stent, "ground truth" isn't established by expert consensus on clinical findings in the same way it would be for an AI diagnostic algorithm. Performance is typically measured against engineering specifications, material properties, and mechanical test standards. The "experts" involved would be engineers, material scientists, and quality assurance personnel performing the bench testing, not clinicians establishing clinical ground truth.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies among multiple human readers when establishing ground truth for diagnostic studies. This is not relevant for in vitro bench testing of a physical medical device.

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

Not Applicable. This is a physical medical device (stent), not an AI algorithm. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Engineering Specifications / Performance Standards: The "ground truth" for this device's performance would be adherence to established engineering specifications, material standards (e.g., for 316L stainless steel), and mechanical performance metrics (e.g., expansion diameter at certain pressures, stent integrity, delivery system functionality). The bench tests verify that the device meets these pre-defined physical and mechanical properties.

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device, not an AI algorithm that requires a "training set" of data.

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

Not Applicable. As there is no training set for a physical device, this question does not apply.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets its acceptance criteria is described as "in vitro bench tests and analyses." These tests are designed to demonstrate the "safety and effectiveness" of the stent system by verifying its physical, mechanical, and material characteristics against predetermined specifications and in comparison to the predicate device. The ultimate acceptance criterion for a 510(k) summary is "substantial equivalence" to a legally marketed predicate device (in this case, the Cordis J&J PALMAZ™ balloon-expandable Stent, K911581). This substantial equivalence is established by showing that the new device has similar designs, materials, methods of deployment, and intended use as the predicate, which the bench testing would support.

Summary

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K990867 p. 1/2 H-2

SEP 2 1999

510(k) SUMMARY

Submitter's Name:	Guidant Corporation
Submitter's Address:	Advanced Cardiovascular Systems, Inc.3200 Lakeside DriveSanta Clara, CA 95052
Telephone:	408-235-3000
Fax:	408-235-3743
Contact Person:	Sandra Sundell
Date Prepared:	March 15, 1999
Device Trade Name:	RX HERCULINK TM 14 Biliary 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 RX HERCULINK™ 14 Biliary Stent System are substantially equivalent with regard to these features in the predicate device, the Cordis J&J PALMAZ™ balloon-expandable Stent and delivery catheter for the Biliary System (K911581).

Device Description:

The balloon, which has 2 radiopaque markers to aid in positioning the balloon in the stenosis, is designed to provide an expandable segment of known diameter and length at specific pressures.

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The proximal end of the catheter has a single arm adapter that provides access to the The proximal end of the catherer has a ongro annelly for connection with an inflation device.

Intended Use:

The RX HERCULINK™ 14 Biliary Stent System is indicated for palliation of malignant strictures in the biliary tree.

Technological Characteristics:

The RX HERCULINK™ 14 Biliary Stent System incorporates similar design, components, method of deployment, materials and intended use of the predicate device, Cordis J&J PALMAZ™ balloon-expandable Stent and delivery catheter for the Biliary System (K911581). The RX HERCULINK™ 14 Biliary Stent System consists of an 18 mm length stent pre-mounted onto a 75 cm length delivery catheter with balloon diameters of 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 and 7.0 mm.

Performance Data:

The safety and effectiveness of the RX HERCULINK™ 14 Biliary 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 shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized bird with three curved lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 1999 SEP

Ms. Sandra Sundell Senior Regulatory Affairs Coordinator Guidant Corporation Advanced Cardiovascular Systems P.O. Box 58167 Santa Clara, California 95052-8167

Re: K990867 RX HERCULINK™ 14 Biliary Stent System Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: July 1, 1999 Received: July 2, 1999

Dear Ms. Sundell:

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. Sandra Sundell

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Susan Alpert, Ph.D., 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 (if known): K990867

Device Name: RX Herculink™ 14 Biliary Stent System

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

The RX Herculink™ 14 Biliary Stent System is indicated for the palliation of malignant neoplasms in the biliary tree.

Prescription Use / OR Over-The-Counter Use _____

(Per 21 CFR 801.109)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number	K9908627
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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.