Inspections, Compliance, Enforcement, and Criminal Investigations
Medical Device Resource Corporation 21-Dec-07
Department of Health and Human Services
Public Health Service
San Francisco District
VIA FEDERAL EXPRSS
December 21, 2007
Melbourne Kimsey II, President
Medical Device Resource Corporation
23392 Connecticut Street, Unit 1
Hayward, California 94545
Dear Mr. Kimsey:
The Food and Drug Administration (FDA) has learned that your firm is marketing the LS2 and the LS2DP Liposuction Systems in the United States (U.S.) 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 LS2 and the LS2DP Liposuction Systems 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 we intended to affect the structure or function of the body, 21 U.S.C. 321(h). The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.
An inspection of your firm located in Hayward, California; from August 15 through August 29, 2007, and a review of our records revealed that you have not obtained marketing approval or clearance before you began offering your products for sale, which is a violation of the law. Your products are not covered by the 510(k) for the LS1000 Surgical Aspirator II, K854844 (cleared February 12, 198b). This 510(k) applies only to devices "intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system," 21 CFR 878.4780, whereas you offer the LS2 and the LS2DP Liposuction Systems for a new intended use --use in suction lipectomy. A review of your product labeling for the LS2 and the LS2DP Liposuction Systems and your internet website, www.mdresource.com reveals that you are promoting these devices for use in lipectomy. Because of this new intended use, the products are not covered by your existing 510(k) and require their own marketing approval or clearance.
Specifically, the LS2 and LS2DP Liposuction Systems are adulterated under section 501(f)(l)(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(o) the Act, 21 U.S.C. 352(o), because a notice or other information respecting the new intended use of the devices was not provided to the FDA as required by section 510(k), 21 U.S.C. 360(k), and 21 CFR 807.81(a)(3}(ii). For devices 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 CFR 807.81(b)). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product maybe legally marketed.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please let this office know in writing what steps you have taken to correct the problem within fifteen (15) working days from the date you received this letter. We also ask that you explain how you plan to prevent this from happening again. If you need more time, let us know why and when you expect to complete your correction. Please direct your response or any questions you may have to: Lawton W. Lurn, Compliance Officer, United States Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502, at 510-337-6792, Fax# 510-337-6703.
Finally, you should understand that there are many FDA requirements pertaining to the manufacture and marketing of devices. This letter pertains only to the issue of premarket review for your devices and does not necessarily address other obligations you have under the law.
Barbara J. Cassens
San Francisco District