The Guidant MEGALINK™ Biliary Stent is a balloon-expandable stent 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 Guidant MEGALINK™ Biliary Stent is designed to be hand crimped onto a PTA balloon delivery catheter and expanded by balloon inflation. Two crimping 0.87 mm (0.035") and 0.35mm (0.014") are included to provide innuel member support of the delivery catheter during stent crimping. Once the Guidant MEGALINK™ Biliary Stent is mounted onto the PTA balloon delivery catheter it is intended to be delivered and deployed in the biliary tree.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Guidant MEGALINK™ Biliary Stent. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive new clinical studies with established acceptance criteria and performance metrics.

Therefore, much of the information requested in your prompt (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, MRMC study details, training set details) is not applicable or explicitly provided in this type of regulatory document.

Here's a breakdown based on the available information:

1. A table of acceptance criteria and the reported device performance

Not Applicable / Not Provided: The document does not specify quantitative acceptance criteria or detailed reported device performance for clinical outcomes. The regulatory pathway here is a 510(k), which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy against defined metrics through a de novo study. The "Performance Data" section states that safety and effectiveness were demonstrated through "nonclinical bench tests and analyses," but specific criteria and results are not detailed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided: No clinical "test set" from human data is described in this 510(k). The performance data cited is from "nonclinical bench tests and analyses."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable / Not Provided: As there is no clinical "test set" described, there is no mention of experts establishing ground truth for such a set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not Provided: No clinical test set or adjudication method is described.

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 / Not Provided: This device is a physical medical implant (a stent), not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.

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

Not Applicable / Not Provided: This device is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable / Not Provided for clinical data: For "nonclinical bench tests and analyses," the "ground truth" would typically relate to engineering specifications, material properties, and mechanical performance (e.g., expansion diameter, radial strength, fatigue resistance). The document does not elaborate on these specifics.

8. The sample size for the training set

Not Applicable / Not Provided: There is no mention of a "training set" as this is not an AI/algorithm device submission.

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

Not Applicable / Not Provided: There is no mention of a "training set."

Summary of Relevant Information from the Document:

Study That "Proves" Device Meets Criteria: The document states, "The safety and effectiveness of the Guidant MEGALINK™ Biliary Stent has been demonstrated through data collected from nonclinical bench tests and analyses." This is the "study" referred to, though no specific details of these tests are provided beyond their nonclinical nature.
Acceptance Criteria & Performance (Implicit): The primary "acceptance criteria" for a 510(k) submission is demonstrating substantial equivalence to a predicate device. The performance is implicitly accepted if it is deemed equivalent to the predicate.
- Predicate Device: JJIS PALMAZ™ balloon-expandable Stent for the Biliary System (K905720 and K911581).
- Basis for Equivalence: "The design, materials, method of delivery and intended use features of the Guidant MEGALINK™ Biliary Stent are substantially equivalent with regard to these features in the predicate device... The Guidant MEGALINK™ Biliary Stent incorporates similar design, components, method of deployment, materials and intended use of the predicate device..."
Intended Use/Indication: Palliation of malignant strictures in the biliary tree.
Technological Characteristics: Range of expanded lengths (18 to 38 mm) and diameters (6 to 10 mm).
FDA's Determination: The FDA reviewed the 510(k) notification and determined the device is "substantially equivalent" for the stated indications for use, subject to specific labeling limitations (regarding vascular use and prominent display of biliary use).

Summary

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3/3/99

510(k) SUMMARY

K983-75

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Submitter's Name:	Guidant CorporationAdvanced Cardiovascular Systems, Inc.
Submitter's Address:	3200 Lakeside DriveSanta Clara, CA 95052
Telephone:	408-235-3000
Fax:	408-235-3743
Contact Person:	Sandra Sundell
Date Prepared:	September 1, 1998

Device Trade Name: Guidant MEGALINK™ Biliary Stent

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 the Guidant MEGALINK™ Biliary Stent are substantially equivalent with regard to these features in the predicate device, the JJIS PALMAZ™ balloon-expandable Stent for the Bliary. System (K905720 and K911581).

Device Description:

Intended Use:

The Guidant MEGALINK™ Biliary Stent is indicated for palliation of malignant strictures in the biliary tree.

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K983075

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Technological Characteristics:

The Guidant MEGALINK™ Biliary Stent incorporates similar design, components, method of deployment, materials and intended use of the predicate device, the JJIS PALMAZ™ balloon-expandable Stent for the Biliary System (K905720 and K911581). The Guidant MEGALINK™ Biliary Stent is provided in a range of expanded lengths from 18 to 38 mm and in a range of expanded diameters from 6 to 10 mm.

Performance Data:

The safety and effectiveness of the Guidant MEGALINK™ Biliary Stent has been demonstrated through data collected from nonclinical bench tests and analyses.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 1099

1999

Ms. Sandra Sundell Senior Regulatory Affairs Coordinator Guidant Corporation P.O. Box 58167 Santa Clara, California 95052

Re: K983075 Guidant MEGALINK™ Biliary Stent Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: December 14, 1998 Received: December 15, 1998

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 (1 remaxer ipps of the cound 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

Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known):

Guidant MEGALINK™ Biliary Stent Device Name:

Indications for Use:

ﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬ

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The Guidant MEGALINK™ Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K983075 / S⁰⁰¹

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.