The 'Intended Use Statement' is a driver in the 510(k) process for determining substantial equivalence. But to prove safety, it doesn't necessarily mean you have to have another cytokine filter to compared it to. You (most likely, again the FDA is it's own beast with individuals who have differing opinions) need to prove the primary mode of action is equivalent. i.e. Blood filtration of a component. FDA thinks in terms of: primary mode of action, e.g. filtration vs chemical bonding vs chemical breakdown etc., power source: battery vs ac in wall, etc and population for which it is proved safe and effective. (e.g. This works for Females aged 8-18)
Many companies will have a new product that no one else has done, but the primary mode of action will be equivalent enough. in this case blood filtration for a component. I've seen plenty of comparisons in products that seem completely different but the primary mode of action is close enough.
btw: the 'Intended use statement' is an important aspect of any medical device. Not to be confused with the 'indications for use'
Typically the Intended use is higher level 'This product filters cytokines from the blood' and the 'Indications for use' is the subpopulation the device has validation data. 'This product is for females aged 5-50' (there is a little more to it than that but in general)
For the 510(k)s ive done, typically is 6-12 3" binders of data. For perspective, a PMA would be a pick up truck of binders.
I just want to emphasize, a 510(k) on a product such as this, is not a slam dunk nor simple. They already have a lot of data though for their CE marking which should be able to be use in the 510(k) submission. Plus they should already have an ISO13485 accredited QMS (Quality Management System) in place. These will go a long way for data to go into the submission.
Ok, I got to get to my own job and dealing with my own regulatory issues. :)
