FDA WARNING_LETTER - ThermaSolutions Incorporated

The FDA issued a Warning Letter to ThermaSolutions Incorporated for marketing the ThermoChem-HT 1000 System (ThermoChem-HT) with uncleared and unapproved indications. The device, cleared under K993330 for raising peritoneal core temperature with warmed sterile solution, is being promoted for treating specific cancers (ovarian, gastric, appendiceal, colorectal) and for use with heated chemotherapy drugs in Hyperthermic Intraperitoneal Chemotherapy (HIPEC) procedures.

The FDA's Office of Compliance reviewed the firm's website (www.thermasolutions.com), the linked www.hipectreatment.com, and the firm's Twitter page. These platforms explicitly state the device's use in HIPEC with heated chemotherapy for cancer treatment, feature videos of HIPEC procedures using the device, and reference its use on "Grey's Anatomy" for HIPEC. The firm's Twitter page also claimed FDA approval for heating and pumping chemotherapy solution into the abdominal cavity.

These promotional claims constitute new intended uses for which the device lacks required clearance or approval. Consequently, the ThermoChem-HT 1000 is deemed adulterated under section 501(f)(1)(B) of the Act for not having an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE). It is also misbranded under section 502(o) for failure to submit a 51