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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK040068 Letter

November 9, 2004

Medtronic Sofamor Danek
Attention: Dr. Richard Treharne
1800 Pyramid Place
Memphis Tennessee 38132

Re:BK040068
Product:Magellan Autologous Platelet Separator System
Date Received:31-AUG-04
Classification:II
Device Code:JQC

Dear Dr. Treharne:

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 and the limitations described below. 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.

The Office of Blood Research and Review has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the device's labeling:

  1. The device must be labeled as follows:
    "The Platelet Rich Plasma prepared by this device has not been evaluated for any clinical indications."

    This labeling must follow the regulations for prominence of required label statements as set forth in Title 21 CFR 801.15, including placement in the instructions for use. Please submit copies of all labeling to FDA prior to marketing of your device.

  2. The device must be labeled as follows:

    "Platelet Rich Plasma prepared from a mixture of whole blood and bone marrow may contain higher levels of plasma free hemoglobin than Platelet Rich Plasma prepared from whole blood."

    This labeling must follow the regulations for prominence of required label statements as set forth in Title 21 CFR 801.15, including placement in the instructions for use. Please submit copies of all labeling to FDA prior to marketing of your device.

  3. All labeling and promotional material will refer to the output of the device as Platelet Rich Plasma or "PRP". If the output of the device is referred to as anything but Platelet Rich Plasma or "PRP", it will be considered to be misbranded under Title 21 CFR 801.

If your device has been 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 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 on promotional labeling and advertisement for your device, please contact our Advertising and Promotional Labeling Staff (HFM-602) at (301) 827-3028. 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) 835-4709 or (301) 827-1800 or at its Internet address: http://www.fda.gov/cber/smlbus.htm.

Sincerely yours,

/signature/

Basil Golding, M.D.
Director
Division of Hematology
Office of Blood Research and Review
Center for Biologics Evaluation and Research