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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Belmont Instrument Corporation 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

George Hertzlinger, President
Belmont Instrument Corporation
8 Cook Street
Billerica, MA 01821

Refer to CPT1100122 when replying to this letter.

Dear Mr. Hertzlinger:

The Food and Drug Administration (FDA) has learned that your firm is marketing the Belmont Hyperthermia Pump 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 device (K090089) under section 510(k) of the Act, 21 U.S.C. § 360(k), for the following indications: "to raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating warmed sterile solution, according to a protocol to be selected by the physician."

The Office of Compliance, in FDA's Center for Devices and Radiological Health, reviewed your firm's website at http://www.belmontinstrumnent.com/index.php on March 26, 2012. Although the Belmont Hyperthermia Pump is not cleared or approved for the treatment of a specific disease or condition or for use with heated chemotherapy drugs, a video posted on the Belmont Instrument website at http://www.belmontinstrument.com/product.php?id=3 shows the Belmont Hyperthermia Pump being used for the treatment of cancer in the appendix. The video also discusses the use of a chemotherapeutic drug as the solution in the Belmont Hyperthermia Pump.

We are also aware that the website, http://hipecdoctor.com/, which is registered by Belmont Instrument Corporation is presenting information about the Hyperthermic Intraperitoneal Chemotherapy (HIPEC) procedure which is defined as follows: "'Intraperitoneal' means that the treatment is delivered to the abdominal cavity. The term 'Hyperthermic Chemotherapy' means that the solution containing chemotherapy is heated to a temperature greater than normal body temperature."

According to your website, http://hipecdoctor.com/, "[d]uring surgery to remove visible tumors caused by certain types of cancer, a patient's open abdomen is bathed with heated chemotherapy for between 30 and 90 minutes; then drained." On the chemotherapy web page, http://www.hipecdoctor.com/page.php?id=S, there is an image of the Belmont Hyperthermia Pump as well as a paragraph that states in part, "The Chemotherapy used in the HIPEC procedure is a localized approach. During the procedure, the chemotherapy medication is mixed with a Perfusion Fluid and then applied directly to the infected region of a patient's body, commonly the abdominal cavity. Because there is no risk to the unaffected parts of the body, the Chemotherapy dosage can be higher and the results more effective. With HIPEC, oncologists can give doses 80 to 400 times the usual systemic dose, without the risks associated with total-body exposure .... For more information on the equipment used to circulate the chemotherapy bath, please see the Belmont® Hyperthermia Pump website."

The Belmont Hyperthermia Pump, 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 for the intended uses discussed above, as required by section 510(k) of the Act, 21 U.S.C. 360(k) and 21 C.F.R. 807.81(a)(3)(ii). 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 kind of information your firm needs to submit in order to obtain approval or clearance of its device is described on the Internet at http://www.fda.gov/cdrh/deviceadvice/3122.html. The FDA will evaluate the information submitted and decide whether your firm's product may be legally marketed.

The Office of Compliance requests that Belmont Instrument Corporation immediately cease marketing the Belmont Hyperthermia Pump 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and 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 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 response should be sent to:

Terri T. Garvin
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
10903 New Hampshire A venue
W066-3550
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 facility. It is your 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 to bring the product into compliance.

Sincerely yours,

/s/

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