August 26, 2002
Dr. Steven Binion
Baxter Healthcare Corporation
Route 120 and Wilson Road
Round Lake, IL 60073
Product: Amicus Separator, Concurrent Collection of Red Blood Cells
Date Received: 22-SEP-00
Device Code: GKT
Dear Dr. Binion:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent 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 including requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device has been classified into either class II (Special Controls) or class III (Premarket Approval), (see above), it may be subject to the above and additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note that this response to your Premarket notification submission does not affect any obligation you might have under the Radiation Control for Health and Safety Act of 1968, or other Federal Laws or regulations.
This letter will allow you to begin marketing your device as described. An 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, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. 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.
We acknowledge that you are committed to make the following changes in your SSE, DFU and Operator's Manual:
- Place the statement "Check that the clamps on the lines to the ACD and saline containers are open." on page 5-21 of the Operator's Manual in the Prime Flow Problem corrective action section.
- Place the warning "Platelet products collected during procedures where multiple Inlet Line Occlusion warning alarms occur may result in low-yield products." on Page 8-12 of the Operator's Manual in section 8.7 Safety Sensors
- The SSE, the Operator's Manual and the DFU should state that studies have not been performed to support irradiation or freezing of ACD-A/AS1 RBC products collected on the Amicus System
- In the draft DFU Faxed to CBER on 8/21/02, the statement "or 68 - 72 hours from venipuncture" should be changed to state "or after storage for 68 - 72 hours..."
Mark Weinstein, Ph.D.
Division of Hematology
Office of Blood Research and Review
Center for Biologics Evaluation and Research