| Public Health Service Food and Drug Administration |
| 10903 New Hampshire Avenue Silver Spring, MD 20993 |
Department of Health and Human ServicesAPR 4 2011
WARNING LETTER
VIA United Parcel Service
Dr. Peter Leando
President
Meditherm, Inc.
7404 Dover Lane
Parkland, Florida 33067
Re: Meditherm Med2000 [K003332]
Dear Doctor Leando:
The Food and Drug Administration (FDA) has learned that you are marketing the Meditherm Med2000 for uses that have not received marketing clearance or approval and that you are making false or misleading claims with respect to the Meditherm Med2000, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Under section 201(h) of the Act, 21 U.S.C. § 321(h), the Meditherm Med2000 is a device because it 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. The FDA's Center for Devices and Radiological Health (CDRH) has reviewed your website, at http://www.meditherm.com. and has found that your website promotes the Meditherm Med2000 for uses for which you have not obtained marketing approval or clearance and that your website also makes claims that are false or misleading in violation of the law.
A review of our records indicates that in February, 2001, CDRH cleared the Meditherm Med2000 under section 510(k) of the Act for the following Indications for Use (K003332):
"The Meditherm Med2000 thermal imaging system is a thermal based imaging device intended for viewing and digitally storing thermal panerns generated by the human body in the clinical, hospital, acute care senings, surgery, healthcare practitioner facilities or in any environment where healthcare is provided by a qualified healthcare professional. ..."
"Use of this device is determined by the healthcare professional and is based upon his or her assessment of the patient's medical condition and requirements. The patient populations include all age groups from adult to pediatric and neonatal. The device is for providing thermal images of the human body...."
The original labeling for the Meditherm Med2000 was submitted to CDRH's Office of Device Evaluation (ODE) in response to a request for additional information dated November 17, 2000. Following a review of the proposed labeling, ODE provided you, via facsimile, an annotated copy of the proposed labeling with requested changes and comments. Among the claims in your proposed labeling that ODE determined to be objectionable [as underlined] were: "Breast Screening with Digital Infrared Thermal Imaging;" "For early detection of abnormal changes..."
and, "[i]s a useful complementary procedure...." ODE also noted that there was a lack of data to support claims that thermal imaging with the Meditherm Med2000 "results in greater sensitivity [and] specificity" than other thermal imaging devices. You were asked to strike "screening" and "early detection" and to change "complementary" to "adjunctive." It was also noted that data were needed to support the claims regarding greater sensitivity and specificity. In response to ODE's concerns, you faxed to ODE on February 20, 2001, a corrected version of the proposed labeling that was subsequently reviewed and found to be acceptable.
However, during our review of your web site [accessed October 21, 2010 and January 6, 2011] we found down-loadable brochures that contained claims that represent a major change or modification of the 510(k) cleared intended use of your device, therefore requiring the submission of a new premarket notification. See 21 CFR § 807.81 (a)(3)(ii). Statements in brochures titled: "Meditherm Med2000 Maximizing the potential of thermography" and "Breast Health" that are outside the 510(k) cleared intended uses include:
• "RELIABLE AND ACCURATE information for diagnosis, treatment and prognosis" (emphasis added)
• "DITI's [Digital Infrared Thermal Imaging's] role in breast cancer and other breast disorders is to help in early detection and monitoring of abnormal physiology and the establishment of risk factors for the development or existence of cancer."
• "Increase your chances of detecting breast cancer in its earliest stages"
• "The benefit of DITI testing is that it offers the opportunity of earlier detection of breast disease than has been possible through breast self examination, doctor examination or mammography alone."
In addition, under the section "Business Opportunities" you state, "Opportunities do exist for people...enabling them to practice as independent consultants ...." and list specific clinical applications of Meditherm Med2000, including sports medicine, breast screening, rheumatology and neurology. Other places on your site promote the use of the device as a substitute for venography in diagnosing deep vein thrombosis. In addition, there is a page where you provide "Indications for a Thermographic Evaluation" and list seventy-six specific conditions for which you say your device can be used, many of which are outside the 510(k) cleared intended use.
These include, for example, lower motor neuron disease, neoplasias (melanoma, squamous cell, basal) and nutritional disease (alcoholism, diabetes).
These statements on your website are outside the 510(k) clearance of the device. For this reason, the Meditherm Med2000 is adulterated under section 501(f)(1)(B), 21 U.S.C. § 351(f)(1)(B) of the Act 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. § 360(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360(g), for the new intended uses. Your device is also misbranded under section 502(0) of 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 for the intended uses discussed above, 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 C.F.R. 807.81 (b). The information you need to submit in order to obtain approval or clearance for the new intended uses for this 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 device may be legally marketed.
The Meditherm Med2000 is also misbranded within the meaning of section 502(a) of the Act (21 U.S.C. § 352(a)), in that the statements in the "Breast Health" brochure accessed from your website are misleading under 21 CFR § 807.97, because such statements create an impression of official approval of your device based on the clearance of a premarket notification submission. Specifically, under the "Procedure" section of the "Breast Health" brochure, you state that the device is "F.D.A approved." This device was not approved by the FDA, but was determined to be substantially equivalent within the meaning of section 513(i)(1)(A) of the Act, 21 U.S.C. §360(i)(1)(A).
The device is further misbranded under § 502(a) because there are statements on your website that, under 21 CFR § 801.6, constitute false or misleading representations with respect to another device. The Office of Device Evaluation advised you during the review of your device that your submission did not include the data necessary to demonstrate superior specificity or sensitivity as compared to other thermal imaging products. We are not aware of any new data supporting such claims. However, your website nevertheless states that "[t]hermal mapping is more accurate with the Meditherm Med2000 because it's total range of color and temperature is applied to the patient alone, which results in greater sensitivity and specificity" and that "Meditherm Med2000 maximizes the potential of thermography for the best possible diagnosis and treatment by delivering a higher degree of sensitivity and specificity than other systems." Such claims are false or misleading because data do not demonstrate that the sensitivity or specificity of Meditherm Med2000 is superior to other thermal imaging devices. These claims therefore constitute misleading representations with respect to another device. If you do have data demonstrating that Meditherm Med2000 is more sensitive and specific than other thermal imaging devices, please provide that information to the agency.
The FDA requests that you immediately cease making claims, identical or similar to those described above, for this device. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in the initiation of regulatory action by Food and Drug Administration without further notice. These actions include but are not limited to seizure, injunction and/or civil penalties.
Please submit a written response to this letter within 15 working days from the date you receive this letter, describing your intent to comply with this request. Your response should include a listing of all promotional materials that are the same or similar to those described above and an explanation of your plan for discontinuing the use of such materials. Your response should be sent to Toni Stifano, Office of Compliance, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993-0002, facsimile at (301) 847-8138. We remind you that only written communications are considered official.
The violations described in this letter do not constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for this device comply with each applicable requirement of the Act and FDA implementing regulations.
Sincerely,
/s/
Steven Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health
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