ProUroCare Medical, a provider of imaging products, has reported that a meeting was held with the FDA on May 19th to review the 510(k) application for the Prostate Mechanical Imaging (PMI) system, also known as the ProUroScan system.
The meeting is to discuss the requirements for filing a reclassification request (a de novo filing) in accordance with Section 513(f)(2) of the Federal Food, Drug and Cosmetic Act.
ProUroCare Medical has filed a de novo application with the FDA for the ProUroScan (PMI) system, on May 21st.
Following the filing of the initial 510(k) application for the PMI system, the FDA issued a letter stating that the PMI system was not ‘substantially equivalent’ to currently marketed devices. As required by the Section 513(f)(2) guidance document, a submission was made on May 19th to request 510(k) clearance under the de novo process.
ProUroCare said that the request asked the FDA to define mechanical imaging systems as devices that are intended to produce an elasticity image of the prostate as an aid in documenting abnormalities of the prostate that are initially identified by digital rectal examination and to be used by physicians as a documentation tool.
The de novo submission also recommended that the classification regulation state that a ‘mechanical imaging system’ device consists of a trans-rectal probe with pressure sensor arrays and a motion tracking system that provides real time images of the prostate. The proprietary components are unique to the ProUroScan system.
The primary benefit of a de novo filing is that it will allow the agency to review and potentially classify mechanical imaging devices, like the ProUroScan, as a Class II device subject to special controls. Once cleared, the PMI may serve as a predicate for future filings and expanded indications for use. The time allowed for review of the de novo application is defined by statue under Section 513(f)(2).
Rick Carlson, CEO of ProUroCare, said: “The FDA meeting was very productive and the agency indicated a willingness to work with us on the review of the de novo filing.”