Grapefruit USA Inc (GPFT)

[IMGGorBust]

You have no idea how many submissions they made before the November 20, 2009 submission. When the DViS gets cleared, it will appear to the public that the application was submitted on April 5, 2010. There will be no reference at all to previous submissions or earlier dates. Each re-submission is essentially a new submission (but for the effect it has on the FDA's internal guidelines for a response).

You can also rest assured that the DViS application uses very similar language about Substantial Equivalence; e.g., the device uses identical sensors to capture images as _ predicate device, it uses identical component parts in the gantry system as _ predicate device, etc., etc., etc. It's noteworthy that in this application, the applicant refers to more than one predicate device to establish substantial equivalence, one for the system itself and another for the type of needles it uses.

The DViS application does the same thing. It refers to different predicate devices for the various functions it performs, and performs in the exact same way except for the ability of its software system to construct the 3D images with less radiation and so much faster than the predicate devices. Speed of a software algorithm is not a function that the FDA is going to balk about. In fact, that is one of the most common uses of a 510(k) application... we have taken predicate device A, and made it function more quickly or more efficiently. We're just as safe, we're just faster. That's the entire purpose of the 510(k) route.