(129 days)
The Atrium Advanta™ T-Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Insufficient data is available at this time to support Atrium Advanta™ T-Graft use in aortocoronary bypass applications or for use as a patch.
Not Found
This document is a 510(k) premarket notification decision letter from the FDA to Atrium Medical Corporation regarding their Atrium Advanta™ T-Graft. It does not contain primary study data or detailed acceptance criteria for the device's performance.
Therefore, I cannot provide the requested information, which includes:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, and adjudication methods for a test set.
- Information on multi-reader multi-case studies or standalone algorithm performance.
- Type of ground truth used.
- Sample size and ground truth establishment for a training set.
This document merely confirms that the FDA has reviewed the 510(k) submission and determined the device to be substantially equivalent to legally marketed predicate devices for the stated indications for use. It lists the regulation number, regulation name, and product code, and outlines general regulatory provisions. It does not disclose the specific studies or data submitted to demonstrate substantial equivalence or the acceptance criteria used in those studies.
{0}------------------------------------------------
::
Image /page/0/Picture/2 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular and contains the department's logo, which is a stylized caduceus. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the top of the circle.
SEP 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen Hall Director RA/OA Atrium Medical Corporation 5 Wentworth Drive Hudson, NH 03051
Re: K051332
Atrium Advanta™ T-Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis 6mm and greater diameter Regulatory Class: Class II (two) Product Code: DSY Dated: July 21, 2005 Received: July 25, 2005
Dear Ms. Hall:
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.
{1}------------------------------------------------
Page 2 - Ms. Karen Hall
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), please contact the Office of Compliance at (240) 276-0120. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Duna R. Vachner
Image /page/1/Picture/5 description: The image shows a signature. The signature is in black ink and appears to be stylized. The signature is difficult to read, but it appears to have a loop on the top and a line on the bottom.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
KOS1332 p. Loft
Indications for Use
510(k) Number (if known):
Device Name: Atrium Advanta™ T-Graft
Indications For Use:
The Atrium Advanta™ T-Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Insufficient data is available at this time to support Atrium Advanta™ T-Graft use in aortocoronary bypass applications or for use as a patch.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Vochner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K 0 5 / 33 2
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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.”