Medical Device Resource Corp 10/9/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone: (510) 337-6700
VIA UNITED PARCEL SERVICE
October 9, 2012
Melbourne Kimsey II
Medical Device Resource Corporation
5981 Graham Court
Livermore, California 94550
Dear Mr. Kimsey:
During an inspection of your firm located in Livermore, California, on March 26, 2012, through April 9, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Aquavage Model AV2000 and 1200 Systems. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices, because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. As explained below, these devices are being marketed without required clearance or approval in violation of the Act.
Our records show your firm submitted a premarket notification submission under section 510(k) of the Act, 21 U.S.C. § 360(k), for the Aquavage Models AV2000 and 1200 (K092284). FDA cleared the Aquavage Systems "for use in aspirating subcutaneous fatty tissue including autologous fat collection.” However, your firm promotes and distribute its device for uses for which it does not have FDA clearance. Specifically,your firm’s websites (www.mdresource.com and www.aquavage.com) make numerous claims for the Aquavage Systems that are not covered by the above-identified 510(k). Examples include:
1. “The Aquavage is a highly versatile fat grafting system for high and low volume autologous fat transfer. Designed for liposculpture, body contouring, buttock and breast augmentation and stem cells derived from adipose tissue.”
2. “A high volume harvester such as the Aquavage, on the other hand, can harvest up to 2000cc in less than half and hour, often concurrently with liposuction to dramatically reduce time in surgery. Cosmetic surgery is not the only application for high volume fat harvesting. Fat cells are an abundant and readily accessible source of stem cells.”
3. “The MD Resource Aquavage is for sterile fat collection, in 1, 2, and 3 liter volumes; meeting the needs of the surgeon performing autologous fat transfer for full body sculpting or:
- Breast reconstruction
- Enhancement of male pectorals
- Rejuvenation of the face
- Enhancement of the shape of the buttocks
- And as an alternative to silicon breast implants”
4. “Fat Grafting: The Aquavage is a highly versatile fat grafting system for high and low volume autologous fat transfer. Designed for liposculpture, body contouring, buttock and breast augmentation and SVF/ADRC from adipose tissue.”
5. “The Aquavage is truly a volume system, optimizing volumes from 100cc to 3000cc, and is designed to work with all types of tissue and to maintain the highest cell viability possible.”
Promotion or labeling of the device for use in buttock, breast, or pectoral augmentation, facial rejuvenation, high-volume fat harvesting, or as a source of stem cells represent a new intended use and requires a premarket notification submission under section 510(k) of the Act, 21 U.S.C. § 360(k), per 21 CFR 807.81(a)(3). Additionally, comparative claims regarding the speed of the procedure or processing require clinical data and a new 510(k) submission.
In light of these findings, the Aquavage Model AV2000 and 1200 Systems are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution in that a notice or other information respecting the new intended use of the device was not provided to the FDA as required by section 510(k), 21 U.S.C. § 360(k), and 21 C.F.R. 807.81(a)(3)(ii).
Our office requests that Medical Device Resource Corporation immediately cease the use and dissemination of objectionable labeling and promotional materials for the Aquavage Model AV2000 and 1200 Systems device as described above.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to: Lawton W. Lum, Director of Compliance. Refer to the Unique Identification Number (328258) when replying. If you have any questions about the contents of this letter, please contact: Aleta T. Flores at (510) 337-6821.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the product into compliance.
Barbara J. Cassens