(80 days)
Not Found
Not Found
No
The summary describes a mechanical stent and delivery system, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes.
It is indicated for the palliation of duodenal strictures caused by malignant neoplasms, which is a therapeutic purpose.
No
The device is an enteral endoprosthesis (stent) used for palliation of duodenal strictures, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is comprised of a metallic stent and a delivery device, which are physical 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 for the palliation of duodenal strictures caused by malignant neoplasms. This is a therapeutic intervention performed in vivo (within the body) to treat a medical condition.
- Device Description: The device is a metallic stent designed to be implanted in the duodenum. This is a physical device used for treatment, not a test performed on biological samples in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on the analysis of samples
- Reagents, calibrators, or controls
IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic implant.
N/A
Intended Use / Indications for 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.
The Schneider (USA) Inc Enteral Endoprosthesis is indicated for palliation of duodenal strictures caused by malignant neoplasms.
Product codes
78 MUM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
duodenal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
WALLSTENT® Enteral Endoprosthesis
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
APR - 3 1998
| Date Prepared: | January 12, 1998 |
|---|---|
| Sponsor: | Schneider (USA) Inc |
| 5905 Nathan Lane | |
| Plymouth, MN 55442 | |
| Phone: (612)550-5500 | |
| Contact: | Kathy Jo Fahey |
| Sr. Regulatory Affairs Specialist |
Device Proprietary Name: WALLSTENT® Enteral Endoprosthesis
Class III Classification:
Equivalent Devices: WALLSTENT® Enteral Endoprosthesis
(612)550-5623
Device Description:
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.
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.
1
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.
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
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
3
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 _________________________________________________________________________________________________________________________________________________________