ProUroScan - Regulatory Status


The ProUroScan System is not currently marketed or sold and has not yet been cleared for marketing by the FDA. Our initial goal was to have the ProUroScan System regulated by the FDA as a Class II device and approved under a 510(k). In a 510(k) application, applicants must demonstrate that their device is substantially equivalent to an existing approved product, or “predicate device.” Products that are new or novel technologies, and those in which no comparable predicate device is found, can be cleared for marketing under Section 513(f) of the Federal Food, Drug, and Cosmetic Act (“FDCA”). This path, referred to as a “de novo” application.

In November 2009, a 510(k) application for market clearance was filed with the FDA that incorporated a basic imaging and documentation claim. From that submission, the FDA determined that the ProUroScan System was not substantially equivalent to a device currently being marketed. As required by Section 513(f)(2) of the FDCA Act, a submission was made in May 2010 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 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 FDA is currently reviewing the de novo application and we have supplied answers to questions they have recently asked. We continue to be engaged in active dialog with FDA review personnel with a goal to accelerate the review process. Although the exact nature of the response from the FDA cannot be determined prior to formal notification, we are optimistic that the submission will be viewed favorably and that the labeling claim is well supported by the clinical study data submitted.

Not available for Sale in the United States.
CAUTION – Investigational device.  Limited by Federal law to investigational use.