(52 days)
Not Found
Not Found
No
The device description focuses on the physical structure and deployment mechanism of a self-expanding stent, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended for the palliative treatment of strictures and fistulae of the esophagus due to malignant processes, indicating a therapeutic purpose to alleviate symptoms and improve quality of life.
No
The device is an esophageal endoprosthesis intended for palliative treatment of strictures and fistulae, not for diagnosing conditions.
No
The device description clearly describes a physical, implantable medical device (a stent) and its associated delivery system, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Description: The description clearly states that the Flamingo™ WALLSTENT® Esophageal Endoprosthesis is a self-expanding prosthesis that is placed inside the body (in vivo) to treat strictures and fistulae in the esophagus. It is a physical implant, not a test kit or analytical instrument.
Therefore, based on the provided information, this device falls under the category of an implantable medical device used for therapeutic purposes, not an IVD.
N/A
Intended Use / Indications for Use
The Flamingo™ WALLSTENT® Esophageal Endoprosthesis is intended to be used for the - palliative treatment of strictures of the esophagus, - including cardia, due to a malignant process - palliative treatment of tracheo-esophageal fistulae due to a malignant process.
Product codes
ESW
Device Description
The Flamingo™ WALLSTENT® Esophageal Endoprosthesis is a self expanding prosthesis constructed of biomedical superalloy with an elastomeric polymer covering. The prosthesis is a braided wire structure which is covered with elastomeric polymer over approx. 75 % of it's length. The outward radial force, the conical shape of the stent along with the ends of the device serve to stabilize the placed. The stent's purpose is to increase or maintain the inner lumenal diameter of the esophageal passage or to close tracheo-esophageal fistulae.
The stent is placed by means of a delivery system. The delivery system is a coaxial tubing assembly which constrains the prosthesis until it is released in a controlled manner. The release of the stent is accomplished by the sliding of the outer coaxial tube. The prosthesis is packaged constrained on the delivery system ready for placement. The system is sterile and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus, cardia
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
984068
JAN 7 1999
510(k) Summary Flamingo™ WALLSTENT® Esophageal Endoprosthesis
General Information
| Date Prepared: | November 11, 1998 |
|---|---|
| Classification: | Class III |
| Trade Name: | Flamingo™ WALLSTENT® Esophageal Endoprosthesis |
| Submitter: | Schneider (Europe) GmbH |
| Ackerstrasse 6, CH-8180 Bülach, Switzerland | |
| Tel. ++41 872 11 11; Telefax ++41 862 05 04 | |
| Contact: | Thomas Thaler, Ph. D. |
| Director, Clinical and Regulatory Affairs | |
| Predicate Device: |
Device Description:
The Flamingo™ WALLSTENT® Esophageal Endoprosthesis is a self expanding prosthesis constructed of biomedical superalloy with an elastomeric polymer covering. The prosthesis is a braided wire structure which is covered with elastomeric polymer over approx. 75 % of it's length. The outward radial force, the conical shape of the stent along with the ends of the device serve to stabilize the placed. The stent's purpose is to increase or maintain the inner lumenal diameter of the esophageal passage or to close tracheo-esophageal fistulae.
The stent is placed by means of a delivery system. The delivery system is a coaxial tubing assembly which constrains the prosthesis until it is released in a controlled manner. The release of the stent is accomplished by the sliding of the outer coaxial tube. The prosthesis is packaged constrained on the delivery system ready for placement. The system is sterile and intended for single use only.
In summary, Schneider (Europe) GmbH believes the above listed predicate devices and the Flamingo™ WALLSTENT® Esophageal Endoprosthesis are substantially equivalent based on design, materials, methods of fabrication and indications for use.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 7 1999
Thomas Thaler, Ph.D Director, Clinical and Regulatory Affairs Schneider (Europe) GmbH Ackerstrasse 6, P.O. Box CH-8180 Bülach, Switzerland
K984068 Trade Name: Flamingo Wallstent Esophageal Endoprostheses Regulatory Class: III Product Code: ESW Dated: November 12, 1998 Received: November 16, 1998
Dear Dr. Thaler:
Re:
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 (Special Controls) or class III (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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
Image /page/1/Picture/9 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized eagle with three lines representing its wings.
2
Page 2 - Dr. Thomas Thaler
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) 594-4595. 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/dsmamain.html".
Sincerely yours,
~Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K9840668
Premarket Notification for the Flamingo™ WALLSTENT® Esophageal Endoprosthesis
510(k) number (if known):
Device name:
Indications for Use:
Flamingo™ WALLSTENT® Esophageal Endoprosthesis
The Flamingo™ WALLSTENT® Esophageal Endoprosthesis is intended to be used for the - palliative treatment of strictures of the esophagus,
- including cardia, due to a malignant process
- palliative treatment of tracheo-esophageal fistulae due to a malignant process.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
X
Prescription
OTC
lo.colle
(Division) Sign-Off Division of General 510(k) Number