Inspections, Compliance, Enforcement, and Criminal Investigations

Eclipse Aesthetics LLC 10/27/15

  

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

Public Health Service
Food and Drug Administration
 Silver Spring, MD  20993 

 

CBER-16-01
 
WARNING LETTER
 
 
VIA FEDERAL EXPRESS AND FACSIMILE
 
 
October 27, 2015
 
Tom O’Brien
Chief Executive Officer
Eclipse Aesthetics, LLC.
13988 Diplomat Drive, Suite 160
Dallas, Texas 75234
 
Re:   TropoCells Autologous Platelet Preparation Kit
         BK110035
 
Dear Mr. O’Brien:
 
The Office of Compliance and Biologics Quality (OCBQ) in the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has reviewed your Internet website http://eclipseaesthetics.com/ and learned that your firm is marketing TropoCells Autologous Platelet Preparation Kit (TropoCells) under the proprietary name Eclipse PRPTM 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 TropoCells Autologous Platelet Preparation Kit (Ecplise PRPTM) 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 TropoCells Autologous Platelet Preparation Kit was cleared for marketing under premarket notification (510(k)) submission number BK110035. The device is a self-contained disposable kit containing two sterile blood separating vacuum tubes, two sleeve filters, various needles and a transferring device. The clearance letter under BK110035 included the following Intended Use statement:
 
“The TropoCells Autologous Platelet Preparation Kit is intended 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 is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.”
 
On your website, in conjunction with the caption, “Dr. Tess on San Diego 6 Featuring Eclipse MicroPen, Eclipse PRP & Skinfinity RF” you present a video that makes claims such as:
  • “How would you like to look ten to twenty years younger?”
  • “We did a combination procedure where we used laser skin resurfacing, platelet rich plasma, a few fillers.”
  • “The middle picture is just ten days after and you can see already dramatic improvement.”
  • “We truly are permanently reversing and taking your skin to a younger state.”
  • “You can look natural. You can look younger. Ten, twenty years younger.”
  • “No need to go under the knife.” 
The video also features a woman, with “before’ and “after” pictures, who has supposedly benefited from the procedure that features the Eclipse PRPTM. Additionally, on May 11, 2015 at 1:22 PM, Eclipse (@EclipseAesth) tweeted (https://mobile.twitter.com/EclipseAesth/status/597859409860153345),  “If you have hair loss, you might want to look at what one doctor is doing to help people. youtu.be/tW4dxnUFk1E?a.” The link directs potential patients to a YouTube video where a physician uses PRP to help treat hair loss. 
 
The intended uses for Eclipse PRPTM 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, the statements on your website suggest that the output of the Eclipse PRPTM is safe and effective for clinical indications in the area of cosmetic dermatology and treatment of hair loss. However, the letter under BK110035 specifically cleared the device 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 is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.”  The cleared indications for use do not encompass the new, unapproved indications for use because the areas of cosmetic dermatology and treatment of hair loss differ from the area of bone graft handling. 
 
The information on your website is false or misleading.  For example, your website lacks adequate descriptions of the risks, warnings, and contraindications of your product. Risks associated with this use of the product include, but are not limited to pain, irritation, or infection at the injection site. Furthermore, the claims for the unapproved uses are unsubstantiated, and you do not disclose this lack of substantiation. FDA has conducted a literature review to assess support for your claims regarding the efficacy of Eclipse PRPTM in aesthetic application and hair growth. The relevant articles FDA has located do not support the efficacy of Eclipse PRPTM in these applications.  Notably, you have not submitted any data to FDA to support such claims. 
 
For the above reasons, your Eclipse PRPTM 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 for the device. 
 
The device is also misbranded under 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1), because the device fails to bear adequate directions for its intended use(s), and 502(a) of the Act, 21 U.S.C. § 352(a), to the extent applicable, because the information on your website is false and misleading. 
 
The device is also 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 internet promotion of Eclipse PRPTM for intended uses that are not consistent with those cleared in the 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 promoting Eclipse PRPTM 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, 10903 New Hampshire Ave., WO71-G112, Silver Spring, MD 20993-0002. In all future correspondence regarding this matter, please refer to BK110035 and to CBER-15-03. 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
 
cc:
Aaron Esteron, Chief Executive Officer
Irving L. Wiesen, Esq.

Page Last Updated: 01/15/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English