The RX and OTW MEGALINK™ SDS Biliary Stent Systems are comprised of a bailoon-expandable stent pre-mounted onto either a rapid exchange (RX) or an over-thewire (OTW) 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 premounted onto either an RX or an OTW delivery catheter with an integrated shaft system and an XCELON™ (nylon blend) balloon bonded at the distal end. The RX 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 stricture to be dilated. The OTW shaft has a coaxial dual lumen extending the entire length of the catheter. The outer lumen provides for inflation of the balloon with contrast medium. The central lumen permits use of a guide wire to facilitate advancement of the catheter to and through the stricture to be dilated. The balloon, which is identical on both RX or OTW configurations, has 2 radiopaque markers to aid in positioning the balloon in the biliary duct, and is designed to provide an expandable segment of known diameter and length at specific pressures. The proximal end of the RX catheter has a single arm adapter that provides access to the inflation lumen. The proximal end of the OTW catheter has a dual arm adapter, one for the guide wire lumen and the other for access to the inflation lumen. The adapter arm used to access the inflation lumen is designed with a luer-lock fitting for connection with an inflation device. The RX and OTW MEGALINK™ SDS Biliary Stent Systems consists of an 28 mm length stent pre-mounted onto 75 cm length delivery catheters with balloon diameters of 6.0, 7.0, 8.0, 9.0, and 10.0 mm. The RX and OTW MEGALINK™SDS Biliary Stent Systems are intended to be delivered and deployed in the biliary tree.

AI/ML Overview

The provided document is a 510(k) premarket notification summary for the RX and OTW MEGALINK™ SDS Biliary Stent Systems. It details the device's description, intended use, and substantial equivalence to predicate devices. However, it does not contain information on acceptance criteria for device performance, nor does it describe a study specifically designed to prove the device meets such criteria.

The document states:

"The safety and effectiveness of the RX and OTW MEGALINK™ SDS Biliary Stent Systems have been demonstrated through data collected from in vitro bench tests and analyses."

This indicates that the safety and effectiveness were established through laboratory testing rather than clinical trials with human subjects. The details of these bench tests, including specific acceptance criteria and the results, are not provided in this summary.

Therefore, I cannot populate the table or answer most of the questions you've posed based on the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not provided in the document.	Not provided in the document.

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

Sample size: Not provided for in vitro bench tests.
Data provenance: "in vitro bench tests and analyses." This implies laboratory data, not human patient data, so country of origin and retrospective/prospective status are not applicable in the human study sense.

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

Not applicable and not provided. Since it was in vitro bench testing, ground truth would likely be established by engineering specifications and measurements, not expert clinical consensus from images.

4. Adjudication method for the test set:

Not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical data.

5. 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:

No. This is a medical device for treating malignant strictures, not an AI diagnostic tool. MRMC studies are not relevant here.

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

Not applicable. This isn't an algorithm. It's a physical stent and delivery system.

7. The type of ground truth used:

Not explicitly stated, but implicitly based on engineering specifications and physical properties. For in vitro bench tests, ground truth would be determined by precise measurements and adherence to design parameters (e.g., stent expansion diameter at specific pressures, material integrity, delivery system functionality).

8. The sample size for the training set:

Not applicable and not provided. This refers to in vitro bench testing, not a machine learning model.

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

Not applicable and not provided.

In summary, the provided 510(k) summary focuses on establishing substantial equivalence based on design, materials, and intended use compared to predicate devices, and refers to "in vitro bench tests and analyses" for demonstrating safety and effectiveness. It does not include the detailed performance data, acceptance criteria, or specifics of the studies that would be required to answer your questions in the context of, for example, a diagnostic AI device.

Summary

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8 1999

992319 H-2 1/2

510(k) SUMMARY

Submitter's Name:	Guidant CorporationAdvanced Cardiovascular Systems, Inc.
Submitter's Address:	3200 Lakeside DriveSanta Clara, CA 95052
Telephone:	408-845-3000
Fax:	408-845-4278
Contact Person:	Sandra Sundell
Date Prepared:	July 9, 1999
Device Trade Name:	RX MEGALINK™ SDS Biliary Stent SystemOTW MEGALINK™ SDS 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 and OTW MEGALINK™ SDS Biliary Stent Systems are substantially equivalent with regard to these features in the predicate devices, the MEGALINK™ Biliary Stent (K983075), the Cordis J&J PALMAZ™ balloon-expandable Stent and delivery catheter for the Biliary System (K911581) and the Cordis PERFLEX™ Balloon Expandable Stent and Delivery System for the Biliary System (K980653).

Device Description:

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The balloon, which is identical on both RX or OTW configurations, has 2 radiopaque markers to aid in positioning the balloon in the biliary duct, and is designed to provide an expandable segment of known diameter and length at specific pressures.

The proximal end of the RX catheter has a single arm adapter that provides access to the inflation lumen. The proximal end of the OTW catheter has a dual arm adapter, one for the guide wire lumen and the other for access to the inflation lumen. The adapter arm used to access the inflation lumen is designed with a luer-lock fitting for connection with an inflation device.

The RX and OTW MEGALINK™ SDS Biliary Stent Systems consists of an 28 mm length stent pre-mounted onto 75 cm length delivery catheters with balloon diameters of 6.0, 7.0, 8.0, 9.0, and 10.0 mm. The RX and OTW MEGALINK™SDS Biliary Stent Systems are intended to be delivered and deployed in the biliary tree.

Intended Use:

The RX and OTW MEGALINK™ SDS Biliary Stent Systems are indicated for palliation of malignant strictures in the biliary tree.

Technological Characteristics:

The RX and OTW MEGALINK™ SDS Biliary Stent Systems incorporate similar design, components, method of deployment, materials and intended use of the predicate devices, Cordis J&J PALMAZ™ balloon-cxpandable Stent and delivery catheter for the Biliary System (K911581) and the Cordis PERFLEX™ Balloon Expandable Stent and Delivery System for the Biliary System (K980653). The RX and OTW MEGALINK™ SDS Biliary Stent Systems consist the 28 mm length MEGALINK™ Stent (K983075) pre-mounted onto 7.5 cm length delivery catheters with balloon diameters of 6.0, 7.0, 8.0, 9.0 and 10.0 mm.

Performance Data:

The safety and effectiveness of the RX and OTW MEGALINK™ SDS Biliary Stent Systems have 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 consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the upper portion of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1999 OCT

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

K992319 Re:

RX MEGALINK™ SDS Biliary Stent System OTW MEGALINK™ SDS Biliary Stent System Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: July 9, 1999 Received: July 12, 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)(I) 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.

Ame Alfert

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): K992319

Device Name: _RX MEGALINK™ SDS Biliary Stent System and OTW MEGALINK™ SDS Biliary Stent System

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

The RX and OTW MEGALINK™ SDS Biliary Stent Systems are indicated for the palliation of malignant strictures in the biliary tree.

Prescription Use V OR (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

David A. Segarra

(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological Devig 902319 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.