(88 days)
The Ultramax™ Woven Velour Vascular Graft is indicated for surgical repair, bypass or replacement of damaged vessels of the abdomen in cases of aneurysmal or occlusive disease.
Not Found
The provided document is an FDA 510(k) clearance letter for the Ultramax™ Woven Velour Vascular Graft. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods.
This letter is a regulatory document stating that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It refers to the "indications for use stated in the enclosure" and general controls provisions but does not elaborate on the specific technical performance or clinical study details that would typically be contained within the 510(k) submission itself.
Therefore, I cannot fulfill your request for the detailed information as it is not present in the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 5 2002
Mr. Joseph P. DePaolo Sponsor for B. Braun Surgical GmbH Director of Regulatory Affairs Atrium Medical Corporation 5 Wentworth Drive Hudson, NH 03051
Re: K013577
Trade/Device Name: Ultramax™ Woven Velour Vascular Graft (abdominal location) Regulation Number: 21 CFR 870.3460 Regulation Name: Prosthesis, Vascular Graft Regulatory Class: II (two) Product Code: DSY Dated: October 24, 2001 Received: October 29, 2001
Dear Mr. De Paolo:
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.
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
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Page 2 - Mr. Joseph P. DePaolo
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) 594-4586. 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,
Deata Willn
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_ 1_of_1__
510(k) Number (if known):__K013577
Device Name: Ultramax™ Woven Velour Vascular Graft
Indications For Use: The Ultramax™ Woven Velour Vascular Graft is indicated for surgical repair, bypass or replacement of damaged vessels of the abdomen in cases of aneurysmal or occlusive disease.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Danke Tilh
Division of Cardiovascular & Respiratory Devices
510(k) Number K013577
(Optional Format 3-10-98)
Prescription Use
(Per 21 CFR 801.109)
§ 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.”