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U.S. Department of Health and Human Services

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Enforcement Actions

Arteriocyte Medical Systems Inc 12/23/09

   

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  Center for Biologics Evaluation and Research
1401 Rockville Pike
Rockville, MD 20852-1448

CBER-10-03


WARNING LETTER

VIA FEDERAL EXPRESS AND FACSIMILE

December 23, 2009

Donald Brown
Chief Executive Officer
Arteriocyte, Inc.
11000 Cedar Avenue, Suite 270
Cleveland, Ohio 44106

Re: Magellan® Autologous Platelet Separator System BK040068

Dear Mr. Brown:

The Office of Compliance and Biologics Quality (OCBQ) in the Food and Drug Administration's Center for Biologics Evaluation and Research (CDER) has reviewed the Internet website http://arteriocyte.com/amsi/Professionals/Product_Magellan_Ordering.asp for Arteriocyte Inc.'s (Arteriocyte) Magellan® Autologous Platelet Separator System, and learned that your firm is marketing the Magellan® Autologous Platelet Separator System in the United States (U.S.) for new intended uses without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). [n addition, a review of your website revealed that your firm is marketing the STEM-PREP and SPORT-PREP products in the United States (U.S.) without marketing clearance or approval, in violation of the Act. Under section 201(h) of the Act, the Magellan® Autologous Platelet Separator System, STEM-PREP, and SPORT-PREP are devices because each is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, which is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body of man or other animals (21 U.S.C. § 321(h)).

The Magellan® Autologous Platelet Separator System was cleared for marketing under premarket notification (510(k)) submission number BK030040 and subsequently modified under BK040068. The device consists of a microprocessor controlled table-top centrifuge and processing disposables designed to allow for safe and rapid automatic separation of plasma and platelets. The clearance letter under BK040068 included the following Intended Use statement:

"The Magellan Autologous Platelet Separator System is designed to be used in the clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of a mixture of blood and bone marrow. The plasma and concentrated platelets produced can be used for diagnostic tests. Additionally, the platelet rich plasma can be mixed with autograft and/or allograft bone prior to application to an orthopedic site."

In clearing your device, the Agency determined that there was a reasonable likelihood that the device would be used for an intended use not identified in the proposed labeling and that such a use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, your clearance letter under BK030040 required that you include the following, on 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."

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."

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."

The intended uses for Magellan® Autologous Platelet Separator System described on your website represent major changes or modifications to the cleared intended uses for this device that could significantly affect its safety or effectiveness. Specifically, under the "Product Ordering Information" section of your website, you list "Magellan® STEM-PREP" and "Magellan® SPORT-PREP," which represents or suggests that the output of the Magellan@ Autologous Platelet Separator System includes the preparation of stem cells or that the output of the device has been evaluated for clinical indications in the area of sports medicine. However, the clearance letter under BK040068 specifically cleared the device for use only in the "safe and rapid preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of a mixture of blood and bone marrow," and required that you only refer to the output of the device as Platelet Rich Plasma or "PRP." The letter also stated that references to the output as anything other than Platelet Rich Plasma or PRP would misbrand your device.

For the above reasons, your Magellan® Autologous Platelet Separator System device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 5I5(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the new intended uses for the device. The device is also misbranded under section 502(0) of the Act, 21 U.S.C. § 352(0), because a notice or other information with respect to the new intended uses for the device was not provided to FDA, as required by section 510(k) of the Act, 21 U.S.C. 360(k). Your website promotion of Magellan® Autologous Platelet Separator System for intended uses that are not consistent with those cleared in your 510(k) notifications represents a major change or modification in the intended use that requires the submission of a PMA or a 510(k). 

Furthermore, a review of our records reveals that you have not obtained marketing approval or clearance before you began offering STEM-PREP and SPORT-PREP for sale, which is a violation of the law. Specifically, STEM-PREP and SPORT-PREP are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351 (f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(0) the Act, 21 U.S.C. § 352(0), because you did not notify the agency of your intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k). is deemed satisfied when a PMA is pending before the agency. 21 CPR 807.81(b).

This letter is not intended to be an all-inclusive list of deficiencies associated with your device. It is your responsibility to ensure that you are in compliance with each requirement of the Act and Federal regulations. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action without further notice to you. These actions may include, but are not limited to, seizure, injunction, and/or civil penalties.

We request that Arteriocyte immediately cease promoting the Magellan® Autologous Platelet Separator System for unapproved uses. Please submit a written response to this letter within ten (10) business days of receipt of this letter, outlining the specific steps you have taken to correct the violations, and how you plan to prevent the violations from recurring. Your response should further include a comprehensive plan detailing all steps being taken to address misleading information currently in the marketplace.

Please direct your response to me at the Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality, HFM-600, 1401 Rockville Pike, Rockville, Maryland 20852-1448. In all future correspondence regarding this matter, please refer to BK040068 and to CBER-l 0-03. We remind you that only written communications are considered official responses.


Sincerely,

/S/
Mary A. Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research