The Belmont Hyperthermia Pump provides high speed, rapid perfusion of warmed fluid to the thoracic or peritoneal cavity by continuously lavaging the cavity with circulating warmed sterile solution.
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| Belmont Hyperthermia Pump |
In Jun 2007, FDA approved Belmont (stated in the Premarket Notification 510k Summary) as substantially equivalent to ThermoChem-HT System which received FDA 510k to market in Dec 1999.
In May 2012, FDA sent a warning letter to the President of Belmont Instrument Corporation, that FDA has learned that the Hyperthermia Pump, is marketed without the required clearance or approval of the Federal Food, Drug, and Cosmetic Act and in violation of the Act.
FDA as explained in the warning letter, mentioned that website, http://hipecdoctor.com/, which is a registered Belmont website is presenting information about Hyperthermia 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."
The warning further stated that Belmont did not have an approved application for premarket approval (PMA) or an approved application for investigational device exemption and that Belmont did not notify the agency (FDA) of its intent to introduce the device into commercial distribution for the intended used mentioned above. FDA therefore requires Belmont to submit PMA for evaluation and approval of the product to be marketed.
FDA Office of Compliance requests Belmont to immediately cease marketing the Belmont Hyperthermia Pump for unapproved uses (HIPEC) as that described above.
In summary, the Belmont Hyperthermia Pump is not approved for HIPEC use and will need FDA to evaluate after PMA is filed with FDA.
Ref: FDA 510k #K070654; FDA Inspection, Compliance, Enforcement and Criminal Investigation
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