WALLSTENT ENTERAL ENDOPROSTHESIS by BOSTON SCIENTIFIC SCIMED, INC.

The WALLSTENT® Enteral Endoprosthesis is comprised of two components: the temporary (short-term) implantable metallic stent and the delivery device. The stent is composed of implant-grade cobalt-base superalloy wire braided in a tubular mesh configuration. The design configuration results in a stent that is flexible, compliant and The stent is available in multiple sizes. Physician preference and self-expanding. individual patient condition and/or anatomy will determine the appropriate size chosen.

AI/ML Overview

This 510(k) submission for the WALLSTENT® Enteral Endoprosthesis does not contain a study that demonstrates the device meets acceptance criteria in the manner typically seen with AI/ML devices or new medical technologies requiring extensive clinical trials for performance validation. Instead, it relies on substantial equivalence to a predicate device and existing clinical literature.

Here's an analysis based on the provided text, addressing your specific points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit)	Reported Device Performance (Implicit)
Mechanical Strength	Fatigue resistance, Corrosion resistance, Relative radial force, Stent deformation.	"The results were all within the expected ranges." (Referring to tests done on the predicate device)
Biocompatibility	Use of implant-grade material (Cobalt-base superalloy).	Device is made of "implant-grade cobalt-base superalloy wire," identical to predicate device. Implies known biocompatibility.
Functionality	Self-expanding deployment, expansion of lumen diameter, palliative treatment of duodenal strictures.	"Allow for self expanding deployment using dynamic radial force to gently and firmly expand the lumen diameter." "Successful in the decompression of a stricture, allowing for immediate relief of gastric outlet obstruction and permitting the patient oral intake of nutrients." (Based on clinical literature for similar stents).
Safety	No new materials, design, or processes compared to predicate.	"Introduces no new materials, design or processes." "Demonstrate that the Schneider WALLSTENT® Enteral Endoprosthesis is equivalent to the predicate device and is therefore safe for its intended use."
Equivalence	Identical technological characteristics to predicate device.	"Has identical technological (materials, construction, processing) characteristics as the predicate device the WALLSTENT® devices."

2. Sample Size for Test Set and Data Provenance

Sample Size: Not applicable in the context of a prospective clinical trial on the new device. The performance validation relies on tests performed on the predicate device and a review of clinical literature.
Data Provenance: The device's performance is supported by:
- Mechanical tests performed on the predicate device.
- A "search of clinical literature" suggesting successful clinical in vivo experience of metal stents in the duodenal area (retrospective, likely international but not specified).

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not applicable. Ground truth, in this context, refers to the established safety and efficacy of the predicate device and general clinical experience with similar devices, not a new clinical evaluation for this specific device.
Qualifications of Experts: N/A for establishing a specific ground truth for a test set of the device itself. The regulatory body (FDA) and the applicant's internal assessments rely on medical and scientific expertise.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The submission does not describe a test set requiring adjudication in the sense of expert consensus on diagnostic or outcome data for the new device. The FDA's review process itself involves expert evaluation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This submission pre-dates widespread AI/ML applications in medical devices and does not involve human readers interpreting data assisted by an AI. The device is a physical stent.

6. Standalone Performance Study (Algorithm Only)

Standalone Performance Study: No. This is a physical medical device (stent), not an algorithm or software-only device.

7. Type of Ground Truth Used

The "ground truth" for this submission is multi-faceted, relying on:

Predicate Device Performance Data: Mechanical test results (fatigue, corrosion, radial force, deformation) on the legally marketed predicate device.
Clinical Outcomes Data (from literature): Successful clinical in vivo experience with similar metal stents in decompressing strictures and relieving gastric outlet obstruction, as reported in published clinical literature.
Engineering Equivalence: The assessment that the new device has identical materials, construction, and processing as the predicate.

8. Sample Size for the Training Set

Sample Size: Not applicable. This is not a machine learning device and therefore does not have a "training set" in that context. The "training" for the device's design and manufacturing comes from the predicate device and established engineering principles.

9. How Ground Truth for the Training Set Was Established

How Ground Truth Established: Not applicable. As above, there is no "training set" in the AI/ML sense. The "ground truth" of what constitutes a safe and effective stent for the intended use is established through:
- Years of clinical experience with similar devices.
- Regulatory standards for materials and mechanical performance.
- The proven performance and safety profile of the predicate device.

Summary Explanation:

This 510(k) submission leverages the concept of substantial equivalence. The applicant argues that the WALLSTENT® Enteral Endoprosthesis is equivalent to an already legally marketed device (the WALLSTENT® devices and specifically an existing Enteral Endoprosthesis) because:

It is made of identical materials and has identical construction and processing.
It introduces no new materials, design, or manufacturing processes.
Performance testing conducted on the predicate device demonstrated mechanical strength (fatigue, corrosion, radial force, deformation) within expected ranges, which is considered applicable to this new device due to their identical nature.
A review of clinical literature supports the successful use of metal stents in the duodenal area for the intended palliative treatment of strictures.

Therefore, the "proof" that the device meets acceptance criteria is not a new clinical study directly assessing the performance of this specific device against predefined clinical endpoints. Instead, it's an assertion of sameness to a device already deemed safe and effective, supported by indirect evidence from the predicate and general clinical experience. The FDA's acceptance (indicated by the 510(k) clearance letter) confirms their agreement with this claim of substantial equivalence.

Summary

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510(k) Summary for The WALLSTENT® Enteral Endoprosthesis

APR - 3 1998

Date Prepared:	January 12, 1998
Sponsor:	Schneider (USA) Inc5905 Nathan LanePlymouth, MN 55442Phone: (612)550-5500
Contact:	Kathy Jo FaheySr. Regulatory Affairs Specialist

Device Proprietary Name: WALLSTENT® Enteral Endoprosthesis

Class III Classification:

Equivalent Devices: WALLSTENT® Enteral Endoprosthesis

(612)550-5623

Device Description:

Intended Use:

This device is intended as a for the palliative treatment of duodenal strictures caused by malignant neoplasms. This device is intended as a non-surgical permanent implant as a safe and effective procedure to eliminate gastric outlet obstruction.

Technological Characteristics:

Enteral Endoprosthesis has identical technological (materials, The WALLSTENT construction, processing) characteristics as the predicate device the WALLSTENT® devices. These devices allow for self expanding deployment using dynamic radial force to gently and firmly expand the lumen diameter. The WALLSTENT® Enteral Endoprosthesis will be used to open a pathway through a restricted lumen. The other predicate devices ultimately achieve the same end result.

A search of clinical literature has found that the clinical in vivo experience of a stent within the clinical indication that we are requesting has been successful. In brief a metal stent placement within the duodenal area has been successful in the decompression of a stricture, allowing for immediate relief of gastric outlet obstruction and permitting the patient oral intake of nutrients within several hours to days of the procedure. This procedure eliminates the need for surgical bypass.

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Performance testing was done on the predicate device. Tests included fatigue, corrosion resistance, relative radial force, and stent deformation testing to assure mechanical strength of the wire. The results were all within the expected ranges. Because this is a request for an additional indication and introduces no new materials, design or processes these tests were not repeated.

The results of these tests demonstrate that the Schneider WALLSTENT® Enteral Endoprosthesis is equivalent to the predicate device and is therefore safe for its intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 3 1998

Ms. Kathy Jo Fahey Senior Regulatory Affairs Specialist Schneider, (USA), Inc. 5905 Nathan Lane Minneapolis, MN 55442

Re: K980113

WALLSTENT® Enteral Endoprosthesis and UNISTEPTM Delivery System Dated: January 12, 1998 Received: January 13, 1998 Regulatory Class: III 21 CFR 878.3610/Procode: 78 MUM

Dear Ms. Fahev:

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/cdrh/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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1480113

Page 1 of 1

510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: Schneider WALLSTENT® Enteral Endoprosthesis

Indication for Use:

The Schneider (USA) Inc Enteral Endoprosthesis is indicated for palliation of duodenal strictures caused by malignant neoplasms.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEFDED NEEDED ==============================================================================================================================================================================

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert S. Stling/

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

510(k) Number K980113

Prescription Use
or
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 878.3610 Esophageal prosthesis.

(a)
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”