The RX HERCULINK™ 14 Biliary Stent System is a balloon-expandable stent premounted onto a rapid exchange (RX) delivery catheter designed to be placed percutaneously 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 XCELON™ 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 inflation lumen. It is designed with a luer-lock fitting for connection with an inflation device. The RX HERCULINK™ Biliary Stent System consists of either a 13 mm or 18 mm length stent pre-mounted onto a 75 cm length delivery catheter with balloon diameters ranging from 4 - 7 mm depending on stent length. The RX HERCULINK™ 14 Biliary Stent System is intended to be delivered and deployed in the biliary tree.

AI/ML Overview

The provided document, K993588, is a 510(k) submission for a medical device (RX HERCULINK™ 14 Biliary Stent System) and focuses on demonstrating substantial equivalence to a predicate device. It primarily details device description, intended use, and technological characteristics.

Crucially, this document does not describe acceptance criteria for algorithmic performance, nor does it present a study proving a device meets such criteria, because a device like a biliary stent system is not typically evaluated using those metrics. The "Performance Data" section states that safety and effectiveness were demonstrated through "in vitro bench tests and analyses," which are engineering and biocompatibility tests, not studies of AI algorithm performance.

Therefore, most of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance simply does not apply to this type of medical device submission.

Here's how to interpret the request in the context of the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a mechanical stent system, acceptance criteria would be related to physical properties, durability, deployment success, biocompatibility, and sterilization effectiveness. These are not explicitly detailed as "acceptance criteria" with numerical values in the provided summary, but rather implied through the statement:

Acceptance Criteria (Implied for a Mechanical Stent)	Reported Device Performance (as stated in the document)
Substantial Equivalence: Design, materials, method of delivery, and intended use as compared to a predicate device.	"The design, materials, method of delivery and intended use features of RX HERCULINK™ 14 Biliary Stent System with the 13 mm length stent are substantially equivalent with regard to these features in the predicate device, the RX HERCULINK™ 14 Biliary Stent System with the 18 mm length stent (K990867)."
Safety and Effectiveness: Demonstration through relevant testing.	"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."
Technological Characteristics: Materials, biocompatibility, performance properties, sterilization, packaging.	"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."

2. Sample size used for the test set and the data provenance

Not applicable for an AI algorithm performance study. The device is a physical stent.
The "test set" would refer to the samples used in the "in vitro bench tests and analyses," but their number and specifics are not provided in this summary. Data provenance would be from laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device does not involve expert-labeled data for "ground truth" in the way an AI algorithm does. Evaluation would involve engineering and material science experts for bench testing.

4. Adjudication method for the test set

Not applicable. This concept relates to conflicting expert opinions in AI ground truth establishment.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, this is not an MRMC study. MRMC studies are used to evaluate diagnostic performance of imaging devices or algorithms with human readers. This is a physical interventional device.

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

Not applicable. This device does not have an "algorithm-only" performance component.

7. The type of ground truth used

For this device, "ground truth" would be established through objective physical measurements (e.g., stent dimensions, radial force, fatigue resistance during bench tests) and biocompatibility assessments (e.g., compliance with ISO standards, cell culture tests). The document refers to "in vitro bench tests and analyses."

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable. No training set exists for this type of device submission.

Summary

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K993588

NOV 1 7 1999

510(k) SUMMARY

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

Submitter's Name:	Guidant CorporationAdvanced Cardiovascular Systems, Inc.
Submitter's Address:	3200 Lakeside DriveSanta Clara, CA 95052
Telephone:	408-845-3000
Fax:	408-845-3743
Contact Person:	Sandra Sundell
Date Prepared:	October 21, 1999

Device Trade Name: RX HERCULINK™ 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 with the 13 mm length stent are substantially equivalent with regard to these features in the predicate device, the RX HERCULINK™ 14 Biliary Stent System with the 18 mm length stent (K990867).

Device Description:

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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 inflation lumen. It is designed with a luer-lock fitting for connection with an inflation device.

The RX HERCULINK™ Biliary Stent System consists of either a 13 mm or 18 mm length stent pre-mounted onto a 75 cm length delivery catheter with balloon diameters ranging from 4 - 7 mm depending on stent length. The RX HERCULINK™ 14 Biliary Stent System is intended to be delivered and deployed in the biliary tree.

Intended Use:

The RX HERCULINK™ 14 Biliary 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 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 Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 17 1999

Ms. Sandra Sundell Senior Regulatory Affairs Coordinator Guidant Corporation Vascular Intervention Group 3200 Lakeside Drive Santa Clara, California 95054

Re: K993588

Guidant RX HERCULINK™ 14 Biliary Stent System Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: October 21, 1999 Received: October 22, 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.

Phing Plunzi

Feigal, Jr., M.D., M.P.H. David V Acting 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): K993588

Device Name: Guidant RX HERCULINK™ 14 Biliary Stent System

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

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

Prescription Use __ OR (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

David A. Syner

tive. Abdominal. El

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.