Grapefruit USA Inc (GPFT)

[BennyJ]

Dominion DVIS is not De-novo review 510k OR PMA process. We have crossed the stage of De-novo review or not. Also we crossed the stage of PMA or not. PMA/DE NOVA(automatic class III designation) is needed or not will be determined earlier stages of 510k process.(That means intended use)

http://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm080252.gif

In the above flow chart we are at number 10

http://www.accessdata.fda.gov/cdrh_docs/pdf5/K050996.pdf

Intended Use is going to be similar to like this:

-Replace the O-Arm to Dominion DVIS
-Replace the 3D imaging to 3D real-time Fluoroscopic
-Add 16 slice CT scan(plenty out there in the market already) - Added funcationaliy for DVIS

Intended Use
The O-ArmnTM Imaging System is designed for 2D Fluoroscopic and 3D imaging for intraoperative applications in surgical theaters, particularly for orthopedic applications. The O-ArmTm Imaging System is compatible with certain Image Guided Surgery Systems.

Similarities and comparison section will be similar to one described in the document(second link above - 2nd link)

Performance data is going to similar to one what they listed in the 510k in the document.(second link above - 2nd link)
(2 Radiologists review comparing the images in different modalities
2D, 3D and CT. )
we all know safety doesn't matter at all( we are far better than industry standard - 50% less to at the max equal to the industry standard)
if the reviewer OK with radiologist review, we will get approval(effectiveness part of it)

IMGG is going to be approved pretty soon.

Original Question asked by IS_GURU:
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Are we under De-novo review 510k process. DVIS is a novel device ...nothing exist in the market..which can be compared with DVIS...but there is very low risk in term s of safety ..low radiation...but ya De-novo take time for review ...and we know that ....

- Dominion has predicate device for CT, 2D & 3D modalities
it does not lack predicate device. for CT - 16 slice & 2D, there are countless devices out there in the market already. for 3D medtronic o-arm imaging system and other 3D system(56 seconds delay) with considerable amount of delay in construction of images out there. Dominion is doing the same construction of images in real-time.
- Dominion has already crossed the safety concern in the 510k regulatory review process.
- Now it is sitting on performance data section. comparision of images. 2 radiologists already given SE and better in their review of images.

The process for Evaluation of Automatic Class III Designation (also known as the de novo classification process) is meant to serve as a regulatory pathway for novel devices that cannot be cleared through the 510(k) process because they lack a clear predicate, but whose risks do not warrant a premarket approval (PMA) level of review. As currently implemented, the de novo classification process tends to be associated with lengthy review timeframes and nontransparent data requirements, making it an impractical path to market for many device developers. The 510(k) Working Group recommends that CDRH make major reforms in our implementation of the de novo process, including steps to streamline the process and clarify the Center’s evidentiary expectations for de novo requests.
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http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM220782.pdf