Grapefruit USA Inc (GPFT)

[KingKong_Guru]

Benny..

Great DD as always ...
...

Approval is near ...read on..

1) DVIS is a perfect example of HW/SW co-design. FDA has to determine SE for DVIS Hardware and S/W.

2) Is hardware SE : Hardware is SE without any doubt , there are multiple predicate device with similar H/W ..O-Arm , fluoroscopy .., flat X-ray screen etc.

3) Is intended use SE: Yes DVIS will be used for existing procedure performed by other predicate devices.

4) Is S/W SE : Hmmm this is the million $ question. Certainly FDA is not interested in S/W algorithm used , SW package/language , S/W complexity On2 or nLOGn ..which DSP process , etc ..Only thing matters for FDA is the final outcome of 3d S/W ..i.e Image quality to perform claimed procedure.

In the last submission FDA was not able to determine whether images are substantially equivalent to images from predicate device ..because DVIS generate images in real time 3d.

The best way for FDA to determine image equivalence is to get opinion from radiologist ..Same thing happened to Meditronic O arm also.

Now If radiologist rubber stamped (which I strongly believe) image equivalence ..then FDA finds DVIS 3d S/W SE.

DVIS HW (SE) + DVIS SW (SE) = DVIS (SE)


IS_guru