(79 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical characteristics and equivalence to predicate devices, with no mention of AI or ML.
Yes
The device is indicated for the treatment of tracheobronchial strictures caused by malignant neoplasms, which is a therapeutic purpose.
No
The device description clearly states it is a self-expanding implantable endoprosthesis for the treatment of tracheobronchial strictures. This indicates a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "self-expanding implantable endoprosthesis" and describes physical components like a "fluoropolymeric tube with a nitinol structure" and a "catheter delivery system," indicating it is a hardware device, not software-only.
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).
- VIATORR Endoprosthesis Function: The VIATORR Endoprosthesis is an implantable device designed to be placed inside the tracheobronchial tract to treat strictures. It is a physical device that provides structural support, not a test performed on a sample.
The description clearly indicates it's a self-expanding implantable endoprosthesis used for treatment within the body, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The VIATORR® Endoprosthesis is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.
Product codes
JCT
Device Description
The VIATORR Endoprosthesis is a self-expanding implantable endoprosthesis that is compressed and secured on the distal end of a catheter delivery system. The catheter delivery system provides a means for implanting the endoprosthesis at a target location within the tracheobronchial tract. The endoprosthesis consists of a fluoropolymeric tube with a nitinol structure located over its external surface and radiopaque markers. The catheter delivery system is configured with radiopaque markers and is designed for use with guidewires.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tracheobronchial tract
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
A variety of tests, assessments, and comparisons demonstrate that the VIATORR Endoprosthesis is substantially equivalent to the cited predicates in terms of composition, design, intended use, and performance attributes.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
VIABAHN™ Endoprosthesis, Ultraflex™ Tracheobronchial Stent System, WALLGRAFT® Tracheobronchial Endoprosthesis with Unistep Plus Delivery System
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3720 Tracheal prosthesis.
(a)
Identification. The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image contains the text "Public Health Service". The text is written in a simple, sans-serif font. The words are arranged on a single line, with "Public" and "Health" being slightly larger than "Service".
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
NOV , 3 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
W.L. Gore & Associates, Inc. % Mr. Timothy W. Capehart Regulatory Affairs Associate 3450 West Kiltie Lane P.O. Box 2400 Flagstaff, Arizona 86003
Re: K024178
Trade/Device Name: VIATORR® Endoprosthesis Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: JCT Dated: December 16, 2002 Received: December 18, 2002
Dear Mr. Capehart:
This letter corrects our substantially equivalent letter of March 7, 2003.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
1
Page 2 - Mr. Timothy W. Capehart
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Melk
N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
2
510(k) Number (if known) :
K024178
Device Name :
VIATORR® Endoprosthesis
Indications for Use:
The VIATORR® Endoprosthesis is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE)
V Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) Division of General, Restorative Counter Use _________________________________________________________________________________________________________________________________ and Neurological Devices
510(k) Number
3
024178 p. 1 of 2
W.L. Gore & Associates, Inc. December 2002
VIATORR Endoprosthesis Premarket Notification
Premarket Notification Summary
-
- Applicant Name, Address:
W.L. Gore & Associates, Inc. 3450 W. Kiltie Lane P.O. Box 500 Flagstaff. AZ 86002-0500
- Applicant Name, Address:
Contact Person:
Date of Summary:
December 16, 2002 Revised August 28, 2006
Tracheobronchial stent
Timothy W Capehart
(928)864-3719
- Tracheal prosthesis Classification Name: 2.
Common or Usual Name:
VIATORR™ Endoprosthesis Trade or Proprietary Name:
- Device Predicates: VIABAHN™ Endoprosthesis, Ultraflex™ 3. Tracheobronchial Stent System, and WALLGRAFT® Tracheobronchial Endoprosthesis with Unistep Plus Delivery System.
- Device Description: The VIATORR Endoprosthesis is a self-expanding 4. implantable endoprosthesis that is compressed and secured on the distal end of a catheter delivery system. The catheter delivery system provides a means for implanting the endoprosthesis at a target location within the tracheobronchial tract. The endoprosthesis consists of a fluoropolymeric tube with a nitinol structure located over its external surface and radiopaque markers. The catheter delivery system is configured with radiopaque markers and is designed for use with guidewires.
4
Ko241178 p. 2 of 2
W.L. Gore & Associates, Inc. December 2002
VIATORR Endoprosthesis Premarket Notification
- Intended Use: The VIATORR Endoprosthesis is indicated for the 5. treatment of tracheobronchial strictures produced by malignant neoplasms.
- Substantial Equivalence: A variety of tests, assessments, and 6. comparisons demonstrate that the VIATORR Endoprosthesis is substantially equivalent to the cited predicates in terms of composition, design, intended use, and performance attributes.