ProUroCare Medical Announces Filing of Request to Classify the Prostate Mechanical Imager ("PMI") as a Class II Device
Published: May 25, 2010
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. This 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. These 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).
"The FDA meeting was very productive and the agency indicated a willingness to work with us on the review of the de novo filing," said Rick Carlson, CEO of ProUroCare.
About ProUroCare Medical, Inc.
ProUroCare Medical, Inc. is a publicly traded company engaged in the business of creating innovative medical imaging products. The company's current focus is the ProUroScan prostate imaging system, which is used to map abnormalities of the prostate detected by DRE. Based in Minneapolis, Minn., ProUroCare is traded on the OTCBB.
Safe Harbor Statement
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SOURCE ProUroCare Medical, Inc.