The WALLSTENT® Biliary Endoprosthesis is intended for use in the treatment of biliary strictures produced by malignant neoplasms.
The Wallstent® Biliary Endoprosthesis is indicated for the palliation of malignant neoplasms in the biliary tree.

Device Description

The WALLSTENT® Biliary Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy and an elastomeric polymer. Smaller diameter models may utilize a radiopaque core. The prosthesis is a braided wire structure that may be covered with an elastomeric polymer in selected models. The outward radial force along with the ends of the device serve to stabilize the prosthesis after implanted. The stent's purpose is to increase or maintain the inner lumen diameter of the biliary duct.
The stent is placed by means of a delivery system. The delivery system is a coaxial tubing assembly that constrains the prosthesis until it is released in a controlled manner. The release of the stent is accomplished by retracting the outer sheath. The prosthesis is packaged constrained on the delivery system ready for placement. The system is sterile and intended for single use only.

AI/ML Overview

This document (K993232) is a 510(k) premarket notification for a modified medical device delivery system, not an AI/ML powered device. Therefore, the questions related to AI/ML specific aspects (like training/test sets, ground truth methodology, expert consensus, MRMC studies, standalone performance) are not applicable.

The submission focuses on demonstrating substantial equivalence of a new delivery system for an existing product (WALLSTENT® Biliary Endoprosthesis). The acceptance criteria and the study to prove it are based on in vitro testing comparing the new delivery system to the predicate device's delivery system.

Here's an interpretation of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred from "substantially equivalent")	Reported Device Performance	Study Type
Deployment Forces	Comparable to current delivery systems	Demonstrated to be comparable	In vitro testing
Handling Characteristics	Comparable to current delivery systems	Demonstrated to be comparable	In vitro testing
Reduced Profile	Smaller French size than predicate device's delivery system	Achieved reduced profile	Design comparison

Explanation:
The core acceptance criterion for this 510(k) is that the new Unistep™ Plus Delivery System with a reduced profile is "substantially equivalent" to the previously cleared Unistep™ Plus Delivery System (K964119). This substantial equivalence is specifically assessed in terms of deployment forces and handling characteristics. The reduced profile itself is a design change, and the 510(k) aims to show this change doesn't negatively impact performance.

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

Sample Size: Not explicitly stated in the provided text. The document only mentions "results of in vitro testing."
Data Provenance: In vitro testing. This means the testing was conducted in a laboratory environment, not on human or animal subjects. Details on the specific country of origin are not provided, but it would have been conducted by Boston Scientific Corporation.
Retrospective or Prospective: Not applicable as it's in vitro testing.

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

This question is not applicable. The "ground truth" for in vitro testing of a physical device is typically based on engineering specifications, industry standards, and measurable physical properties, not expert human interpretation in the way AI/ML ground truth is established.

4. Adjudication Method for the Test Set

This question is not applicable. As it's in vitro testing, there would be no subjective adjudication of results by human experts in the way AI/ML studies require. Test results would be objectively measured and compared against predefined engineering tolerances or equivalence criteria.

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

This question is not applicable. This is not an AI/ML device; it's a physical medical device delivery system.

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

This question is not applicable. This is not an AI/ML device.

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

This question is not applicable in the context of AI/ML ground truth. For this device, the "ground truth" for the in vitro testing would be the performance characteristics of the predicate delivery system (K964119) and established engineering/design specifications for safe and effective device function. The new delivery system's performance needed to fall within acceptable parameters defined by these benchmarks to be considered substantially equivalent.

8. The Sample Size for the Training Set

This question is not applicable. This is not an AI/ML device, so there is no training set in the AI/ML sense.

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

This question is not applicable. As there is no AI/ML training set, there is no ground truth established for it.

Summary

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		K993232
DEC 30 1999		Premarket Notification for the WALLSTENT® Biliary EndoprosthesisWith Unistep™ Plus Delivery System1 of 2
16. 510(k) Summary
Date Prepared		September 24, 1999
Submitter	Address:	Boston Scientific CorporationPlymouth Technology Center5905 Nathan LaneMinneapolis, MN 55442
	Phone:Fax:	(612) 694-5500(612) 694-5858
Contact Person		Ronald W. BennettRegulatory Affairs Project Manager
Device Name and Classification
	Trade Name	WALLSTENT® Biliary Endoprosthesiswith Unistep™ Plus Delivery System
	Common Name	Biliary Stent
	Classification	Class II
Predicate Devices		WALLSTENT® Biliary Endoprosthesis

Device Description

with Unistep™ Plus Delivery System - K964119

The stent is placed by means of a delivery system. The delivery system is a coaxial tubing assembly that constrains the prosthesis until it is released in a controlled manner. The release of the stent is accomplished by retracting the outer sheath. The prosthesis is packaged constrained on the delivery system ready for placement. The system is sterile and intended for single use only.

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Indication

The WALLSTENT® Biliary Endoprosthesis is intended for use in the treatment of biliary strictures produced by malignant neoplasms.

Technological Characteristics

The purpose of this 510(k) is to allow an alternate delivery system. Compared to the present Unistep™ Plus Delivery System (K964119), this version of the Unistep™ Plus delivery system has a reduced profile, that is smaller French size.

The alternate delivery system can be found substantially equivalent based on the results of in vitro testing that demonstrates the deployment forces and handling characteristics are comparable to the current delivery systems.

Summary

In summary Boston Scientific Corporation has demonstrated that the WALLSTENT® Biliary Endoprosthesis with Unistep™ Plus Delivery with reduced profile for the delivery system is substantially equivalent based on design, test results, and indications for use to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an image of a bird in flight, with three wavy lines representing the bird's wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 3 0 1999

Mr. Ronald W. Bennett Regulatory Affairs Project Manager Plymouth Technology Center Boston Scientific Corporation 5905 Nathan Lane Plymouth, MN 55442

Re: K993232 Wallstent® Biliary Endoprosthesis Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: September 24, 1999 Received: September 27, 1999

Dear Mr. Bennett:

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 - Mr. Ronald W. Bennett

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 Cover Cood 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 he 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.

Lumber C. Richter for

David W. Feigal, Jr., M.D., M.P.H. Acting Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _ l of 1

510(k) Number (if known): K993232

Device Name: Wallstent® Biliary Endoprosthesis________________________________________________________________________________________________________________________________

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

The Wallstent® Biliary Endoprosthesis is indicated for the palliation of malignant neoplasms in the biliary tree.

(Division of Recording Abdominal, ENT, Division ( ... .. .. .. .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ...

510(k) Number --

Prescription Use_L/ OR (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.