The FDA has rejected ProUroCare Medical's 510(k) premarket application (PMA) for its prostate imaging system because it couldn’t identify an appropriate predicate device.
According to Eden Prairie, Minn.-based ProUroCare, it received a letter from the FDA on March 29 informing the company that it “noted the lack of a comparable predicate device for use as an aid in visualizing and documenting abnormalities of the prostate detected by digital rectal examination."
ProUroCare said it plans on communicating to the FDA why it believes there is a suitable predicate. The company also said that if the prostate imaging system is not found to be substantially equivalent because a suitable predicate can’t be identified the FDA can still indicate that the product is appropriate for a de novo or risk-based classification.
“We remain optimistic about the regulatory status of the system,” said ProUroCare CEO Rick Carlson, “and believe the FDA will recognize the ProUroScan as a low-risk device that can be cleared under either the 510(k) application or the de novo process.”