August 15, 2008 - BSD Medical Corp. said it has provided to the FDA additional data requested pertaining to its 510(k) Premarket Notification submission for the MicroThermX-100 Microwave Ablation System.
Clearance from the FDA of the 510(k) Premarket Notification submission is required before a Class II product can be sold commercially in the U.S.
On April 10, 2008, BSD Medical submitted a 510(k) Premarket Notification for the MicroThermX-100 Microwave Ablation System. A 510(k) Premarket Notification includes documentation regarding compliance to applicable standards (UL, IEC, EMC, EMI, etc.), demonstration of substantial equivalence to predicate devices, documentation of required testing -- including biocompatibility, shelf life, sterilization, software, hardware, and other required performance testing and documentation. The company’s 510(k) submission involved 1,251 pages. This week, BSD Medical said it has responded to the eight additional items requested by the FDA regarding the submission that were mentioned in the company’s June 30, 2008 press release. All of these items were technical, not clinical, in nature, said the company.
BSD Medical's product line includes systems that have been strategically designed to offer a range of thermal treatment products using microwave and RF (radiofrequency) technology. BSD is a developer of hyperthermia systems. Hyperthermia is used to treat cancer using heat to increase the effectiveness of companion radiation therapy. The MicroThermX-100 Microwave Ablation System represents an expansion of BSD's products into new applications, as the MicroThermX-100 is designed as a stand-alone therapy that is used to ablate diseased tissue using heat alone. These two approaches to therapy are highly complementary, said the company.
For more information: www.bsdmc.com