(300 days)
WALLSTENT® Esophageal Prosthesis
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No
The summary describes a mechanical stent and delivery system with no mention of AI/ML components or functions.
Yes.
The device is indicated for the palliative treatment of colonic strictures produced by malignant neoplasms, which is a therapeutic purpose.
No.
The device is an endoprosthesis (a stent) used for palliative treatment of colonic strictures, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is comprised of an implantable metallic stent and a delivery device, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "palliative treatment of colonic strictures produced by malignant neoplasms." This describes a therapeutic intervention performed within the patient's body to alleviate symptoms, not a test performed outside the body on a sample to diagnose or monitor a condition.
- Device Description: The device is an "implantable metallic stent" and a "delivery device." This is a physical implant designed to be placed inside the colon. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body.
- No mention of in vitro testing: The description focuses on the mechanical properties and implantation of the stent, not on any testing of biological samples.
IVDs are used to examine specimens such as blood, urine, tissue, etc., to provide information for diagnosis, monitoring, or screening. This device is a therapeutic implant.
N/A
Intended Use / Indications for Use
The Schneider WALLSTENT® Enteral Endoprosthesis is indicated for the palliative treatment of colonic strictures produced by malignant neoplasms.
Product codes
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Device Description
The WALLSTENT® Enteral Endoprosthesis is comprised of two components: the implantable metallic stent and the delivery device. The stent is composed of implantgrade 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
colonic
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
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Predicate Device(s)
WALLSTENT® Esophageal Prosthesis
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.”
0
510(k) Summary for The WALLSTENT® Enteral Endoprosthesis
JUL 1 ( JUL 1 0 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 implantgrade 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.
1
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.