K954290 · Boston Scientific Scimed, Inc. · MQR · Jul 10, 1996 · General, Plastic Surgery
Device Facts
Record ID
K954290
Device Name
WALLSTENT ENTERAL ENDOPROTHESIS
Applicant
Boston Scientific Scimed, Inc.
Product Code
MQR · General, Plastic Surgery
Decision Date
Jul 10, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.3610
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Schneider WALLSTENT® Enteral Endoprosthesis is indicated for the palliative treatment of colonic strictures produced by malignant neoplasms.
Device Story
Self-expanding metallic stent; cobalt-base superalloy wire braided in tubular mesh; delivered via specialized delivery device. Used by physicians to open restricted bowel lumens caused by malignant neoplasms. Deployment via dynamic radial force; restores patency to bowel; relieves abdominal distention and discomfort. Clinical benefit: palliative management of obstruction.
Clinical Evidence
No new clinical trials conducted. Evidence based on clinical literature review of in vivo stent performance in enteral indications, demonstrating successful relief of bowel obstruction and associated symptoms. Bench testing (fatigue, radial force) previously established for predicate devices deemed applicable due to identical design and materials.
Technological Characteristics
Implant-grade cobalt-base superalloy wire; braided tubular mesh configuration; self-expanding design. Employs dynamic radial force for lumen expansion. Available in multiple sizes.
Indications for Use
Indicated for palliative treatment of colonic strictures caused by malignant neoplasms in patients requiring relief of bowel obstruction.
Regulatory Classification
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.
Special Controls
The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”
Predicate Devices
WALLSTENT® Esophageal Prosthesis
Submission Summary (Full Text)
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K954290
510(k) Summary
for
The WALLSTENT® Enteral Endoprosthesis
JUL 10 1996
**Date Prepared:** May 15, 1996
**Sponsor:** Schneider (USA) Inc
5905 Nathan Lane
Plymouth, MN 55442
Phone: (612) 550-5500
**Contact:** Kathy Jo Fahey
Regulatory Affairs Specialist
(612) 550-5623
**Device Proprietary Name:** WALLSTENT® Enteral Endoprosthesis
**Classification:** Class III
**Equivalent Devices:** WALLSTENT® Esophageal Prosthesis
**Device Description:**
The WALLSTENT® Enteral Endoprosthesis is comprised of two components: the 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 self-expanding. The stent is available in multiple sizes. Physician preference and individual patient condition and/or anatomy will determine the appropriate size chosen.
**Intended Use:**
The Schneider WALLSTENT® Enteral Endoprosthesis is indicated for the palliative treatment of colonic strictures produced by malignant neoplasms.
**Technological Characteristics:**
The WALLSTENT® Enteral Endoprosthesis has identical technological (materials, construction, processing) characteristics as the predicate devices 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.
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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 enteral area has been successful in opening a bowel obstruction to allow for passage of the bowel’s contents, relieving abdominal distention and discomfort.
Performance testing was done on the predicate devices. Tests included fatigue and radial force testing to assure mechanical strength of the wire. The results were all within the expected ranges. Because the WALLSTENT® Enteral Endoprosthesis introduces no new materials, design or processes of 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.
