Replies to post #32746 on Grapefruit USA Inc (GPFT)

[KingKong_Guru]

It wasn't only FDA fault ..There were many mistake from Dean part also.
I always believed DVIS technology ...but there was something which use to worry me about Dean's ability to write 510k application single handed... The first time Deans made me worry ..when in one of the CC .he said "I never heard of radiologist review in 510k application " ..but actually in 510k process performance data submission is very common ...that showed Deans lack of knowledge in 510k process ...

NSE decision obviously surprised me..based on the my research , discussion with radiologist and technical expert in medical imaging ..I always found DVIS SE .....

So why NSE ?

IMGG part:
1) Not a neat and tidy 510k application. Many small mistakes ..could have been avoided if we would have used 510k expert writer.

2) Dean should have submitted Financial information ..as it is integral part of 510k whenever a third party reviewer involved in the process. Missing financial information makes radiologist review suspicious.

3) Submitting TIF format images looks lil unprofessional ...DICOM is the standard medical imaging format.

4) Should have used cadavers for radiologist review ..just like Breakaway imaging ...phantom data look lil unprofessional.

FDA:

1) FDA reviewer works on strict template and checklist. Sometime review is very robotic without any brain.

2) Sometime FDA issues NSE to reset their clock ..instead of giving AI.

3) Many NSE letter looks like AI letter. This is known fact for many 510k experts.

4) FDA posted October 510k clearance data on their website on 23rd of Nov..which is very unusual ..normally it used to be before 10th of every month.

Next step:

Based on the technical aspect of DVIS and the available information from the industry 510k/medical imaging expert ..I highly doubt that DVIS is PMA.

10% of 510k application requires clinical data to support substantial equivalence (bench , animal or human).

Human clinical trial are required , whenever there is major safety or efficacy concern...

To me most likely outcome of MWE discussion will be refile 510k application with additional data ..may be using cadavers or in worst case animal trial (not costly and expensive).

If IMGG re-submits 510k application under MWE supervision ..without human clinical trial ...It will be a HUGE BUY signal...


KKG