Inspections, Compliance, Enforcement, and Criminal Investigations
Arteriocyte Medical Systems Inc - Close Out Letter 2/17/10
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Center for Biologics Evaluation and
1401 Rockville Pike
Rockville, MD 20852·1448
February 17, 2010
Chief Executive Officer
11000 Cedar Avenue, Suite 270
Cleveland, Ohio 44106
Re: Warning Letter for Magellan® Autologous Platelet Separator System
Dear Mr. Brown:
This is to acknowledge receipt of your January 11, 2010, response (through James R. Ravitz of Arent Fox LLP) to the Office of Compliance and Biologics Quality (OCBQ) in the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER). Your letter was in response to our December 23,2009 Warning Letter regarding false or misleading promotion (Internet website: http://arteriocyte.com/amsi/Professionals/Product Magellan Ordering.asp) for Arteriocyte Inc.' s (Arteriocyte) Magellan® Autologous Platelet Separator System (Magellan). In our letter, we noted that your website promoted Magellan System for new intended uses without marketing clearance or approval.
We have reviewed your response; however, we maintain our position as outlined in our December 23, 2009 letter. Specifically, you state that Stem-Prep and Sport-Prep are "convenience kits" that are comprised of (i) Class II devices that were previously cleared for marketing by FDA through the 510(k) process, (ii) preamendment devices, and (iii) Class I devices that are exempt from premarket notification. You further state that the Stem-Prep Kit consists of a Ratio Dispenser Kit (K041830), a Dual Channel Cannula Tip (K041830), syringes (K980987), a Blood Component Recipient Set (K073339), a preamendment device, and some Class I devices that are exempt from the premarket notification requirements. Additionally, you claim that Sport-Prep is comprised of syringes (K980987), a Blood Component Recipient Set (K073339), a preamendment device, and some Class I exempt devices. We acknowledge that the individual components that make up the kits were cleared for marketing by the FDA, but we are not aware that any of the components were cleared for use in the preparation of stem cells or for use in sports medicine.
Moreover, although these kits are marketed separately, they are marketed in close proximity to the Magellan System. In addition, the kits, as you have stated, are also intended for the collection and mixing of bone marrow and whole blood for further processing in the Magellan System's centrifuge. Thus, we maintain our position that Magellan System was promoted for a new intended use without marketing clearance or approval.
We acknowledge the following corrective actions outlined in your letter:
1. As a precautionary measure, within 24 hours of receipt of the Warning Letter, Arteriocyte removed the two references to "STEM-PREP" and "SPORTS-PREP" from the company's website.
2. Arteriocyte will re-name the kit with product code "STEM-PREP" as the Magellan MAR01. The company will modify its website, all product labeling, and any other promotional materials to reflect this new product code.
3. Arteriocyte will re-name the kit with product code "SPORT-PREP" as the Magellan MAR02. The company will modify its website, all product labeling, and any other promotional materials to reflect this new product code.
4. Arteriocyte will include on its website a link to the Indications for Use as well as the following disclaimers specified in the August 31, 2004 clearance letter for the Magellan System (BK040068): "THE PLATELET RICH PLASMA PREPARED BY THIS DEVICE HAS NOT BEEN EVALUATED FOR ANY CLINICAL INDICATIONS" and "PLATELET RICH PLASMA PREPARED FROM A MIXTURE OF WHOLE BLOOD AND BONE MARROW MAY CONTAIN HIGHER LEVELS OF PLASMA FREE HEMOGLOBIN THAT PLATELET RICH PLASMA PREPARED FROM WHOLE BLOOD."
In light of these corrective actions, we consider this matter closed.
Should you have any questions or concerns involving this matter, please contact Ms. Ele Ibarra-Pratt, RN, MPH, Branch Chief at the Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality, Division of Case Management, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, Maryland 20852-1448. In all future correspondence regarding this matter, please refer to BK040068 and to CBER-10-03.
Director, Division of Case Management
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research