August 16, 2011
VIA FACSIMILE AND UPS (UNITED PARCEL SERVICE)
Aesthetic Factors, LLC
(Cascade Medical Enterprises, LLC)
20 Greenup Court
Wayne, NJ 07470
20 Greenup Court
Wayne, NJ 07470
Re:Cascade Medical FIBRINET System
Dear Mr. Grippi:
The Office of Compliance and Biologics Quality (OCBQ) in the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has reviewed the Internet websites http://www.ubsaesthetics.com and http://www.Selphyl.com. Through these websites, Aesthetic Factors, LLC and Cascade Medical Enterprises, LLC are marketing Cascade Medical FIBRINET System under the proprietary name Selphyl® System (Selphyl). Your firm, along with UBS Aesthetics Inc., is marketing Selphyl 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). Under section 201(h) of the Act, the Cascade Medical FIBRINET System (a.k.a. Selphyl) is a device because it 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 Cascade Medical FIBRINET System was cleared for marketing under premarket notification (510(k)) submission numbers BK020051 and BK060006. The clearance letters under BK020051 and BK060006 included the following Intended Use statement:
“The Cascade Medical FIBRINET is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP can be mixed with autograft and allograft bone prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements.”
Your websites make claims such as:
- “[Selphyl] is used…to naturally fill skin depressions, acne scars, wrinkles and folds…”
- “…The resulting product (liquid, gel or membrane) can be applied to a treatment area of the face or body to stimulate natural, new tissue growth.”
- “Selphyl prepared PRFM has been shown to increase skin volume and rejuvenation”
Additionally, there are “before” and “after” pictures of patients’ skin that supposedly have benefited from the use of Selphyl.
The intended uses for Selphyl described on your websites represent major changes or modifications to the cleared intended use for this device that significantly could affect its safety or effectiveness. Specifically, the statements on your websites suggest that the output of the Cascade Medical FIBRINET System is safe and effective for clinical indications in the area of cosmetic surgery. However, the clearance letters for BK020051 and BK060006 specifically state that the device is for use only in the “safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP can be mixed with autograft and allograft bone prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements” (emphasis added).
For the above reasons, your Cascade Medical FIBRINET 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 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) for the new intended uses of this device.
Your device also is misbranded under section 502(o) of the Act, 21 U.S.C. §352(o) 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). 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 (See 21 CFR §807.81(b)). Your website promotion of Cascade Medical FIBRINET System for intended uses that are not consistent with those cleared in your 510(k) notifications represent a major change or modification in the intended use that requires the submission of a PMA or a 510(k).
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 you immediately cease marketing the Cascade Medical FIBRINET System and Selphyl for unapproved uses. Please submit a written response within ten (10) business days of receipt of this letter, outlining the specific steps you have taken to correct the violations. Your response should further include a comprehensive plan detailing all steps being taken to address the 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 BK020051 and BK060006. We remind you that only written communications are considered official responses.
Robert A. Sausville
Director, Division of Case Management
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
cc: Glen Faust, CEO, UBS Aesthetics Inc.