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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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ThermaSolutions Incorporated 5/7/12

  

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

Public Health Service
Food and Drug Administration
 

10903 New Hampshire Avenue
Silver Spring, MD 20993

MAY 7, 2012
 

WARNING LETTER

VIA UNITED PARCEL SERVICE

Sidney Geneste
Chief Executive Officer
ThermaSolutions Incorporated
1889 Buerkle Road
Saint Paul, Minnesota 55110
               
Refer to: CPT1100123 when replying to this letter.

Dear Mr. Geneste:

The Food and Drug Administration (FDA) has learned that your firm is marketing the ThermoChem-HT 1000 System (ThermoChem-HT) in the United States. The product is a device within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), 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 to affect the structure or function of the body. As explained below, this device is being marketed without required clearance or approval in violation of the Act. 

Your firm obtained clearance for the ThermoChem-HT System (K993330) under section 510(k) of the Act, 21 U.S.C. § 360(k), for the following indications: “to raise the core temperature of the peritoneum to the desired target temperature by continuously lavaging the peritoneum with circulating warmed Lactated Ringer’s Solution, U.S.P., or another physiologically compatible sterile solution.”

The Office of Compliance, in FDA’s Center for Devices and Radiological Health, reviewed your firm’s website, www.thermasolutions.com, for the ThermoChem-HT on March 26, 2012.  Although the ThermoChem-HT is not cleared or approved for the treatment of a specific disease or condition or for use with heated chemotherapy drugs, your firm states on its homepage that “ThermaSolutions, Inc. is the global leader in hyperthermia medical technology for ovarian, gastric, appendiceal and colorectal cancers . . . . ThermaSolutions manufactures and distributes the ThermoChem HT-1000 and all related disposables.” 

On the “Medical Professionals” section of your firm’s website, accessible at: http://www.thermasolutions.com/www.thermasolutions.com/Medical_Professionals.html, there is a paragraph that states:  “Physicians using the ThermoChem HT-1000 system during a HIPEC [Hyperthermic Intraperitoneal Chemotherapy] procedure use conventional chemotherapy drugs heated to a temperature that kill cancer cells.  By bathing the abdomen with heated chemotherapy immediately following surgery, a higher dose of medication can be used than would normally be tolerated by a patient if given intravenously throughout the body; the traditional way chemotherapy is administered.” 

In addition, throughout your firm’s website, your firm refers visitors to www.hipectreatment.com. On the HIPEC treatment website, there are several videos that demonstrate the HIPEC treatment procedure, including a video showing your firm’s device being used to perform HIPEC procedures:  whttp://www.hipectreatment.com/videos/general/evan_ong.php

Finally, on the “HIPEC on TV” section of your firm’s website, accessible at http://www.thermasolutions.com/www.thermasolutions.com/HIPEC_on_TV.html, there is a television clip from “Grey’s Anatomy,” which features the use of your firm’s device during a HIPEC procedure. The caption next to the video states, “[t]he popular show ‘Grey’s Anatomy’ of ABC featured the Hyperthermic Intraperitoneal Chemotherapy (HIPEC) procedure with ThermaSolutions’ HT-1000 in last year’s episode.  One of our team members participated in the program to make sure the procedure and equipment was used the way our clients do too . . . .”  

We are also aware that on your firm’s Twitter page, accessible at twitter.com/thermasolutions, your firm states that “TSI has the first FDA approved medical device for creating hyperthermia in the abdominal cavity - heating and pumping a chemotherapy solution into the region.”

The ThermoChem-HT 1000 device, with the intended uses described above, is 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 device is also misbranded under section 502(o) of 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, 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 is deemed satisfied when a PMA is pending before the agency, 21 CFR § 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

The Office of Compliance requests that ThermaSolutions, Inc., immediately cease marketing the ThermoChem-HT for unapproved uses such as those 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:

Terri T. Garvin
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
10903 New Hampshire Avenue
WO66-3550
Silver Spring, MD 20993

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. 

Sincerely yours,

/S/

Steve D. Silverman
Director
Office of Compliance
Center for Devices and
  Radiological Health