The WALLSTENT® Biliary Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy and an elastomeric polymer. The prosthesis is a braided wire structure. 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 is a 510(k) summary for a medical device called the WALLSTENT® Biliary Transhepatic Endoprosthesis with Unistep™ Plus Delivery System. It describes the device, its intended use, and argues for its substantial equivalence to previously marketed devices.

However, the provided text does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the following information is missing or not applicable based on the provided text:

A table of acceptance criteria and the reported device performance: This document only describes the device and its proposed modifications, but does not present specific performance metrics or acceptance criteria for those metrics.
Sample size used for the test set and the data provenance: No information about a "test set" or its sample size is provided. The document mentions "in vitro and in vivo deployment testing" but gives no details about the size or nature of these tests.
Number of experts used to establish the ground truth... and qualifications: Not applicable, as there's no mention of a ground truth being established by experts for performance evaluation.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not indicated. The document focuses on regulatory approval based on substantial equivalence, not comparative effectiveness.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
The type of ground truth used: Not applicable, as no performance study with ground truth is detailed.
The sample size for the training set: Not applicable, as this is not an AI/machine learning device that would require a "training set."
How the ground truth for the training set was established: Not applicable.

Summary of what is present:

The document describes a modified delivery system for an existing WALLSTENT® Biliary Endoprosthesis. The claim for substantial equivalence is based on:

In vitro and in vivo deployment testing: These tests were performed to demonstrate that "deployment forces and handling characteristics are comparable to the current delivery systems." No specific results, sample sizes, or acceptance criteria for these tests are provided in this summary.
Comparison to predicate devices: The modified system is compared to existing WALLSTENT® models (K923993, K961262, K964119) and the WALLSTENT® Tracheobronchial Endoprosthesis (K980163) for material changes.

In conclusion, the provided text serves as a regulatory submission (510(k) Summary) and focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a study against specific acceptance criteria for performance.

Summary

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2 1998 SEP

16. 510(k) Summary
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Date Prepared	June 4, 1998
Submitter
Address:	Schneider (USA) Inc5905 Nathan LaneMinneapolis, MN 55442
Phone :	(612) 550-5500
Fax :	(612) 550-5771
Contact Person	Ronald W. BennettSenior Regulatory Affairs Specialist

Device Name and Classification
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Trade Name	WALLSTENT® Biliary TranshepaticEndoprosthesis with Unistep™ Plus DeliverySystem
Common Name	Biliary Stent
Classification	Class II
Predicate Devices	WALLSTENT® Biliary TranshepaticEndoprosthesis with Unistep™ Plus DeliverySystem - K923993, K961262, K964119

Device Description

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Indication

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

1982005

Technological Characteristics

The purpose of this 510(k) is to allow an alternate delivery system. Compared to the Unistep™ Delivery System (K961262, K923993), the Unistep™ Plus delivery system allows the user to partially deploy and then reconstrain the stent to facilitate placement. Compared to the present Unistep™ Plus Delivery System (K964119), the modified system has different materials for the outer and inner tubing. This feature is presently available for the 12 mm stent with the change in materials in the WALLSTENT® Tracheobronchial Endoprosthesis with Unistep™ Plus Delivery System (K980163).

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

Summary

In summary Schneider (USA) Inc has demonstrated that the WALLSTENT® Biliary Endoprosthesis with Unister ™ Plus Delivery System with modified delivery system is substantially equivalent based on design, test results, and indications for use to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUM." is arranged in a semi-circle around the left side of the eagle, and the text "SERVICES - USA" is arranged in a semi-circle around the right side of the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 1998 SEP

Mr. Ronald W. Bennett Senior Regulatory Affairs Specialist Schneider (USA) Inc. Pfizer Medical Technology Group 5905 Nathan Lane Minneapolis, MN 55442

Re: K982005

WALLSTENT® with Unistep™ Plus (Biliary Stent and Catheter) Dated: June 4, 1998 Received: June 8, 1998 Regulatory Class: II 21 CFR 876.5010/Procode: 78 FGE

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 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. 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.

If your device is classified (see above) into either class II (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 (OS) 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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/odrh/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

Schneider WALLSTENT® Biliary Endoprosthesis Device Name:

Indications for Use:

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

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)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

David G. Severson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Deyi 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.