510k file requirements for non-sterile medical device accessories

J

justjat

I have a device that is 510k cleared and we would like to market extra cartridges in a separate box of ten cartridges. These cartridges have no function other than collecting samples. They are non-sterile and do not require to be sterilized. Do we need to notify the FDA of this separate "product"? If so, under what pathway?

Thanks!
 
mihzago

mihzago

Trusted Information Resource
Have the same or similar cartridges been cleared with the parent device? Can these cartridges be used only with the parent device or will this be marketed as a generic accessory?
If it was already cleared with the parent device then just repackaging it should not require additional submission. If this is a modification to the cleared cartridge then depending on the modification you may be able to just file as an LTF (letter to file) against the parent file, or a special 510(k) for significant changes.
 
M

MIREGMGR

I agree with Mihzago's analysis.

Of course, there are a few Product Codes for which dependent components and accessories have separate Product Codes. If that were the case for your parent and child products, you might need to consider whether separately marketed cartridges would need to have their own classification so as to be properly Listable.
 
M

Mark Meer

Trusted Information Resource
Of course, there are a few Product Codes for which dependent components and accessories have separate Product Codes. If that were the case for your parent and child products, you might need to consider whether separately marketed cartridges would need to have their own classification so as to be properly Listable.
Click to expand...

Question: is this applicable even if the accessories are exclusively intended to be used with the parent device? ...or is a separate classification only necessary in cases of "generic" accessories?
 
J

justjat

Thanks, all.

It is the same accessory that is previously cleared and can only be used with that device.

Regarding your Listable comment - if I want to list this as a separate SKU, I will need to do a separate file?
 
M

mogluk

I would not think that you need to file, as long as you document required activities in engineering release process you should be fine. most product do not need an additional listing for an addition sku that is quantity based.
 
M

MIREGMGR

Mark Meer said:
Question: is this applicable even if the accessories are exclusively intended to be used with the parent device? ...or is a separate classification only necessary in cases of "generic" accessories?
Click to expand...

There's no uniform answer to that question. FDA over the years unfortunately has not been at all consistent in regard to Product Codes, guidances and 510(k) approaches. Each product context needs to be reviewed by a person with comprehensive knowledge of the applicable regulatory situation.
 
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