How to get an FDA approval before May 2010 - ?Quick and Dirty? FDA Approval

Michael Malis

Quite Involved in Discussions
#11
Re: How to get a FDA approval before May 2010 / “Quick and dirty” FDA approval

Hi all and thanks for the replies!

Ok for the conference: It seems that we don’t need any clearance to exhibit there.We mark the instrument and all our literature as “pending 510(k) clearance”.

Combined with the main medical device (which is a FDA class II device), our equipment (hardware+software) captures, stores and displays images, and calculates physiological parameters from those images. So far we have been acquiring data from patients (in Europe) to establish that the instrument and software are actually doing what they are intended to do. The results are promising and show that the instrument+software can help in the study of diseases.

At the conference we will have a lecture and posters with the results from our instrument. We will also have the instrument+software on display (again, marked as “pending 510(k) clearance”).

For further development we would like to get more involved in clinical testing and have been looking for institutes which are willing to gather further data from patients in the US and Europe.

We would like to send/sell the instrument to research institutions (hospitals) in the US and Europe for more research/investigations. In order to do that, will the US institutions in question have to apply for some research/investigational exception from the FDA?

According to: Displaying Investigational and Unapproved Medical Devices According to FDA Policy

Thanks,
Leifi

Hi Leifi,

You still missing a few points.

Is it a RUO device or something else? Do you have Software validation?

And, you do need to apply for 510(k) clearance...

What does this mean "inst. + software can help in the study of diseases"? What diseases? What type of help? (Find cure for any type of cancer, can see something better, may or may not to do what? Specifically, what the instrument with new software does better/similar to the existing device?

You also mention, "results from the instrument"... What results? For what reason and by doing what we getting those results? Is it a true RUO? Or you what to do something with those results?

You "would like more involved in Clinical testing? What for? What and Whom do you plan to test and why?

You really need to clarify the above, before you will be able to move forward with the submission or "clinicals"

Regards,
Mike
 
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Michael Malis

Quite Involved in Discussions
#12
Re: How to get a FDA approval before May 2010 / “Quick and dirty” FDA approval

Do you plan to attend MDDI in New York in May 2010?

If yes, please be aware that FDA usually attend this meeting "in force" and spend a good deal of time to review posters and booth information...
 
L

Leifi

#13
Re: How to get a FDA approval before May 2010 / “Quick and dirty” FDA approval

[FONT=&quot]We are attending the ARVO ophthalmology conference in Florida in May. [/FONT] [FONT=&quot]

[/FONT] [FONT=&quot]The device which we intend to present measures the oxygen saturation in retinal blood vessels. It is based on a conventional fundus camera (FC). The FC is a Class II device and is used routinely in ophtalmology practise in the USA (and worldwide). [/FONT] [FONT=&quot]Oxygenation of the retina is believed to be disturbed in several diseases, such as retinal vessel occlusions, diabetic retinopathy, glaucoma and age related macular degeneration. However, technology for measuring retinal oxygenation reliably and non-invasively has been lacking. Evidence for disturbances in oxygenation comes from animal studies and limited studies on humans. There is wealth of indirect evidence as well, particularly in vessel occlusions and diabetic retinopathy.[/FONT]
[FONT=&quot]
[/FONT] [FONT=&quot]Our equipment allows non-invasive evaluation of the metabolic state of the retina. First steps are to use it to better understand the diseases in question. In other words, it will be used for clinical studies in the beginning. We anticipate that it will gradually become more useful for evaluation of individual patients but, for the time being, it is not intended to aid in diagnosis in individual patients. [/FONT] [FONT=&quot]The first units will therefore be sold to research institutions (hospitals) and are intended for use in clinical studies.

[/FONT]
[FONT=&quot]The results have been obtained with a prototype and are so far promising. The results show that it is sensitive to changes in oxygen saturation and are reproducible. The prototype has been used to measure abnormal retinal oxygenation in patients as well as normal physiological changes. This has been published in several peer-reviewed papers. [/FONT]

[FONT=&quot]The software does not control the FC in any way. It grabs the images from the FC+accessory and [/FONT] [FONT=&quot]estimates [/FONT][FONT=&quot]the oxygen saturation in retinal vessels. The estimation is based on the fact that the color of blood changes with oxygen saturation. Our accessory and software simply analyze the traditional retinal images. [/FONT] [FONT=&quot]The examination is identical to traditional fundus photography for both the photographer and the patient[/FONT]
[FONT=&quot]
[/FONT]
[FONT=&quot]For software validation, we have followed "Agile software development", we use Trac, Tickers and Unit testing on all features. If this is not what you were thinking of please clarify.

I hope I have cleared things a little better.
Leifi[/FONT]
 
M

MikeEmergo - 2010

#14
Re: How to get a FDA approval before May 2010 / “Quick and dirty” FDA approval

I can write and submit an FDA 510k, and have received clearance in 3 months from the FDA on some product... but that was for devices that had good predicates (other devices that are exactly like the one being submitted).

It takes about 30 days to write a 510k, and then the FDA has 90 days to reply. It's IMPORTANT to make sure you have everything included. That software needs verification and validation. That must be done first. Have the 510k or preparation done, then submit.

I would suggest Googling for a good FDA consultant. ;)
If you have everything in place IT CAN be done..

g/l
 

Michael Malis

Quite Involved in Discussions
#15
Re: How to get a FDA approval before May 2010 / “Quick and dirty” FDA approval

[FONT=&quot]We are attending the ARVO ophthalmology conference in Florida in May. [/FONT] [FONT=&quot]

[/FONT] [FONT=&quot]The device which we intend to present measures the oxygen saturation in retinal blood vessels. It is based on a conventional fundus camera (FC). The FC is a Class II device and is used routinely in ophtalmology practise in the USA (and worldwide). [/FONT] [FONT=&quot]Oxygenation of the retina is believed to be disturbed in several diseases, such as retinal vessel occlusions, diabetic retinopathy, glaucoma and age related macular degeneration. However, technology for measuring retinal oxygenation reliably and non-invasively has been lacking. Evidence for disturbances in oxygenation comes from animal studies and limited studies on humans. There is wealth of indirect evidence as well, particularly in vessel occlusions and diabetic retinopathy.[/FONT]
[FONT=&quot]
[/FONT] [FONT=&quot]Our equipment allows non-invasive evaluation of the metabolic state of the retina. First steps are to use it to better understand the diseases in question. In other words, it will be used for clinical studies in the beginning. We anticipate that it will gradually become more useful for evaluation of individual patients but, for the time being, it is not intended to aid in diagnosis in individual patients. [/FONT] [FONT=&quot]The first units will therefore be sold to research institutions (hospitals) and are intended for use in clinical studies.

[/FONT]
[FONT=&quot]The results have been obtained with a prototype and are so far promising. The results show that it is sensitive to changes in oxygen saturation and are reproducible. The prototype has been used to measure abnormal retinal oxygenation in patients as well as normal physiological changes. This has been published in several peer-reviewed papers. [/FONT]

[FONT=&quot]The software does not control the FC in any way. It grabs the images from the FC+accessory and [/FONT] [FONT=&quot]estimates [/FONT][FONT=&quot]the oxygen saturation in retinal vessels. The estimation is based on the fact that the color of blood changes with oxygen saturation. Our accessory and software simply analyze the traditional retinal images. [/FONT] [FONT=&quot]The examination is identical to traditional fundus photography for both the photographer and the patient[/FONT]
[FONT=&quot]
[/FONT]
[FONT=&quot]For software validation, we have followed "Agile software development", we use Trac, Tickers and Unit testing on all features. If this is not what you were thinking of please clarify.

I hope I have cleared things a little better.
Leifi[/FONT]
Sorry - I was away...
Your information helps a lot.

First, you need to validate your software and this will take time. If you have everything in place, - start with Software...

Second, in my opinion your technology is new and will require Clinicals. See latest FDA guidelines of how clinical evaluation needs to be conducted.

Third, you need to evaluate your claims and comparision. In other words, which device do you plan to use as a predicate device in your submission and what do you really can claim?

Good Luck!
 
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