May 2, 2006
Smith & Nephew, Inc
Attn: Kim Kelly
1450 Brooks Road
Memphis, TN 38116
|Product:||Smith & Nephew Platelet Rich Concentrate (PRC) Preparation System|
Dear Ms. Kelly:
We have reviewed your Section S10(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). 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 "Contraindications, Warnings, Precautions" section of the device's labeling:
Efficacy of the biologic product of this device has not been established in any clinical trial.
Please note that the above labeling limitations are required by Section 513(i)(I)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. Thjs letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
If your device is classified (see above) into either class II (Special Controls) or class ill (PMA), it may be subject to 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 deternlination 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.
If you desire specific information about the application of other labeling requirements to your device (21 CPR Part 801), 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" (21 CFR 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.
Jay S. Epstein, M.D.
Office of Blood Research and Review
Center for Biologics
Evaluation and Research
Indications for Use
510(k) Number: BK060004
Device Name: Smith & Nephew Platelet Rich Concentrate (PRC) Preparation System
Indications for Use:
The Smith & Nephew Platelet Rich Concentrate (PRC) Preparation System is intended for the rapid preparation of autologous platelet-rich concentrate (PRC) from a small sample of blood at the patient's point of care. The PRC can be mixed with autograft and allograft bone prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements.