(25 days)
Not Found
Not Found
No
The summary describes a physical implantable device and its delivery system, with no mention of software, algorithms, or data processing that would suggest AI/ML.
Yes
The device is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms, which is a therapeutic purpose.
No
The device is described as an implantable endoprosthesis for treating strictures, not for diagnosing them. Its function is interventional (treatment), not diagnostic.
No
The device description clearly describes a physical, implantable endoprosthesis and a catheter delivery system, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of tracheobronchial strictures. IVDs are used for the diagnosis of diseases or conditions.
- Device Description: The device is an implantable endoprosthesis, a physical device used to treat a condition. IVDs are typically reagents, kits, or instruments used to analyze samples from the body (like blood, urine, or tissue).
- Anatomical Site: The device is implanted within the tracheobronchial tract, which is an internal anatomical site. While some IVDs might involve collecting samples from internal sites, the device itself is not used for analysis of these samples.
This device is a therapeutic device, specifically an implantable medical device used for treatment.
N/A
Intended Use / Indications for Use
The GORE VIABAHN® Endoprosthesis is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.
Product codes (comma separated list FDA assigned to the subject device)
JCT
Device Description
The VIABAHN™ 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 within the factor over its external surface. 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 (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.
The information provided lists "VIABAHN™ Endoprosthesis" under "Device Predicates" but does not give a K/DEN number for a predicate device.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with three curved lines representing its wings or body. The bird is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the circumference of the circle.
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: K023811
Trade/Device Name: The GORE VIABAHN'" Endoprosthesis Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: JCT Dated: November 14, 2002 Received: November 15, 2002
Dear Mr. Capehart:
This letter corrects our substantially equivalent letter of December 10, 2002.
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.
Reto Thumme
rk N lelker Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
2
510(k) Number (if known) : K023811
The GORE VIABAHN® Endoprosthesis Device Name :
Indications for Use:
:
The GORE VIABAHN® 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)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
(Division Sign-Off)
| Division of General, Restorative | Counter Use __________ |
|---|---|
| and Neurological Devices |
| 510(k) Number | LC 023511 |
|---|---|
| --------------- | ----------- |
3
Tab D Premarket Notification 510(k) Summary
Summary of Safety and Effectiveness
Page 1 of 2
Applicant:
W.L. Gore & Associates, Inc. 3450 West. Kiltie Lane P.O. Box 500 Flagstaff, AZ 86002-0500
Contact
Timothy W Capehart
Date Prepared
November 13, 2002 Rev: August 28, 2006
Trade or Proprietary Name
VIABAHN™ Endoprosthesis
Common or Usual Name
Tracheal Endoprosthesis
Classification Name
Tracheal Prosthesis
Device Predicates
VIABAHN™ Endoprosthesis
Device Description
The VIABAHN™ 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
VIABAHN™ is a Trademark of W.L. Gore & Associates.
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023811 p. 20+2
Summary of Safety and Effectiveness
Page 2 of 2
Device Description (cont'd)
within the tracheobronchial tract. The endoprosthesis consists of a fluoropolymeric tube with a within the factor over its external surface. The catheter delivery system is configured with radiopaque markers and is designed for use with guidewires.
The device has been modified in several particulars in order to improve manufacturability. The I he device has been mountented. The fundamental scientific principles underlying its function remain unchanged.
Statement of Intended Use
The VIABAHN™ Endoprosthesis is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.
Substantial Equivalence
A variety of tests, assessments, and comparisons demonstrate that the VIABAHN™ Endoprosthesis is substantially equivalent to its predicate in terms of composition, design, intended use, and performance attributes.