(28 days)
Not Found
Not Found
No
The summary describes a vascular graft made of ePTFE and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for "replacement or bypass of diseased vessels" for various conditions, which directly addresses disease and restores normal physiological function.
No
Explanation: The device is a vascular graft, intended for replacement or bypass of diseased vessels, not for diagnosing medical conditions.
No
The device description clearly states it is composed of expanded polytetrafluoroethylene (ePTFE) and is a physical vascular graft, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "replacement or bypass of diseased vessels" and other vascular procedures. This describes a surgical implant used directly within the body to treat a physical condition.
- Device Description: The description details a physical graft made of ePTFE, designed to be implanted into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. IVDs typically involve reagents, analyzers, or test kits used in a laboratory or point-of-care setting.
Therefore, this device falls under the category of a surgical implant or medical device used for vascular repair, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
GORE TEX Vascular Grafts and GORE-TEX Stretch Vascular Grafts are intended for use for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requireing vascular replacement, or for other vascular procedures.
Product codes
DSY
Device Description
GORE-TEX® Vascular Grafts and GORE-TEX® Stretch Vascular Grafts are composed of expanded polytetrafluoroethylene (ePTFE), and utilize an ePTFE basetube radially reinforced with a thin layer of ePTFE film wrapped around the basetube circumference. The device modification that is the subject of this Special 510(k) involves an alternative thin ePTFE film wrapped around the basetube circumference for use on vascular grafts configured for pediatric shunt.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels
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)
Not Found
Reference Device(s)
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
§ 870.3450 Vascular graft prosthesis.
(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”
0
KU 13250
OCT 2 6 2001
Attachment IV
Page 1 of 2
Special Premarket Notification Summary of Safety and Effectiveness
Applicant:
W.L. Gore & Associates, Inc. 3450 West. Kiltie Lane P.O. Box 500 Flagstaff, AZ 86002-0500
Contact
Timothy J. Rynn
Date Prepared
24 October 2001
Trade or Proprietary Name
GORE-TEX® Vascular Graft; GORE-TEX® Stretch Vascular Graft
Common or Usual Name
Vascular Graft Prosthesis
Classification Name
Vascular Graft Prosthesis
Device Predicates
GORE-TEX® Vascular Grafts and GORE-TEX® Stretch Vascular Grafts
Device Description
GORE-TEX® Vascular Grafts and GORE-TEX® Stretch Vascular Grafts are composed of expanded polytetrafluoroethylene (ePTFE), and utilize an ePTFE basetube radially reinforced with a thin layer of ePTFE film wrapped around the basetube circumference. The device modification that is the subject of this Special 510(k) involves an alternative thin ePTFE film wrapped around the basetube circumference for use on vascular grafts configured for pediatric shunt.
Statement of Intended Use
GORE TEX Vascular Grafts and GORE-TEX Stretch Vascular Grafts are intended for use for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requireing vascular replacement, or for other vascular procedures.
1
Summary of Safety and Effectiveness
Page 2 of 2
Substantial Equivalence
The applicant device is substantially equivalent in design, materials, and intended use to currently marketed ePTFE vascular grafts prostheses. No new types of safety and effectiveness issues are raised by the proposed modification.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle, with its wings spread and its head turned to the left.
OCT 2 6 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tomothy J. Rynn Regulatory Affairs W.L. Gore & Associates, Inc. 3450 West Kiltie Lane P.O. Box 500 Flagstaff, AZ 86002-500
Re: K013250
Trade Name: Gore-Tex® Vascular Graft; Gore-Tex® Stretch Vascular Graft Regulation Number: 21 CFR 870.3460 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II (two) Product Code: DSY Dated: September 27, 2001 Received: September 28, 2001
Dear Mr. Rynn:
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 application (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 such 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.
3
Page 2 - Mr. Tomothy J. Rynn
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 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 begin 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
James E. Dillard III
Director
Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment II
Indications For Use Statement
Page _ of _
510(k) Number (if known) K013250
Device Name: GORE-TEX® Vascular Graft; GORE-TEX® Stretch Vascular Graft
INDICATIONS FOR USE:
GORE TEX Vascular Grafts and GORE-TEX Stretch Vascular Grafts are intended for use for GORE TEX Vascular Grans and CONE TEX Suffering occlusive or aneurysmal diseases, in teplacement or bypaos of alsociation replacement, or for other vascular procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Division of Cardiovascular & Respiratory Devices | |
| 510(k) Number | KO 13250 |
| Prescription Use (per 21 CFR 801.109) | X | OR | Over-The-Counter Use ____ |
|---|---|---|---|
| --------------------------------------- | --- | ---- | --------------------------- |
(Optional Format 1-2-96)