MODIFICATION TO EPTFE GRAFT by VASCUTEK LTD.

The document is a letter from the FDA to Vascutek Ltd. acknowledging the review of their 510(k) premarket notification for the "Vascutek ePTFE Wrapped ePTFE Vascular Prosthesis." It states that the device is substantially equivalent to legally marketed predicate devices.

Specifically, the document does not include:

A table of acceptance criteria and reported device performance.
Details about sample sizes for test sets, data provenance, or training sets.
Information on the number or qualifications of experts used to establish ground truth.
Adjudication methods.
Results of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes.
Results of a standalone algorithm performance study.
The type of ground truth used.
How ground truth for a training set was established.

This document is primarily an approval letter and an "Indications for Use" statement, not a detailed study report. To find the information you're looking for, you would typically need to consult the actual 510(k) submission summary or associated clinical/technical reports, which are not provided in this excerpt.

Summary

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three parallel lines curving upwards and to the right, creating a sense of movement or progress.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 2004

Vascutek Ltd. c/o Mr. Steven Arick Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor, MI 48103-9300

Re: K041528

Vascutek ePTFE Wrapped ePTFE Vascular Prosthesis Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II (two) Product Code: DSY Dated: June 3, 2004 Received: June 8, 2004

Dear Mr. Arick:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your becaller of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enolosure) is regars the Medical Device Amendments, or to conninered provided to may 20, 1978, in accordance with the provisions of the Federal Food, Drug, devices mat have been roomsomed in avere approval of a premarket approval application (PMA). and Cosmetic Trol (110) market the device, subject to the general controls provisions of the Act. The I ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions 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 If your device is classified (600 world) als. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ourcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean i loase oc advised that I Dr unation that your device complies with other requirements of the Act that I Dri has made a cond regulations administered by other Federal agencies. You must or any 1 coolar statuates and states and the mot limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFA in the quality systems (DS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality byections (Sections 531-542 of the Act); 21 CFR 1000-1050. product lastiall control probegin marketing your device as described in your Section 510(k) I ms letter will and w yours of substantial equivalence of your device to a legally premaince notification. The Pressession 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 If you desire specific acripliance at (301) 594-4648. Also, please note the regulation entitled, Connact the Office of Count of Court (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miorination of your corporation in its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address

(301) +45-0597 of arts international dsmamain. html

Sincerely yours,

Duura R. Vochner

(A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):___KOY / 528

VASCUTEK ePTFE WRAPPED ePTFE VASCULAR Device Name:__________________________________________________________________________________________________________________________________________________________________ PROSTHESES

Indications For Use:

SUBCUTANEOUS OF CREATION CONDUITS FOR BLOOD ARTERIOVENOUS ACCESS, BYPASS OR RECONSTRUCTION OF OCCLUDED OR DISEASED ARTERIAL BLOOD VESSELS.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Duma R. Schmer

Page 1 of 1_

(Division Sign-Off) Division Orginal Cardiovascular Devices

510(k) Number_K041528

Regulation Number and Section

§ 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.”