A strange question about predicate device selected in 510(k) submission

Ashley Fu

Starting to get Involved
Hello all, recently I come across a puzzling question about the predicate device.
That is, whether a device with different product code but same regulation number could be selected as a predicate device? you know, some product codes may point at specific loction of body, so the predicate device 's product code is definitely difficient with the subject device.
:unsure::unsure:Did somebody ever have similar consideration about this question? or do you think this predicate device could be available for 510(k)?
 

Swimming In The Soup

Involved In Discussions
From my experience. The challenge is showing Significant Equivalence. The further you deviate from equivalence, the more difficult it will be to get agreement from FDA.
 

yodon

Leader
Super Moderator
I'm not a regulatory expert but we've worked with companies whose regulatory consultants cited multiple predicates, ostensibly to cover where the first one did not.
 

Swimming In The Soup

Involved In Discussions
Hello all, recently I come across a puzzling question about the predicate device.
That is, whether a device with different product code but same regulation number could be selected as a predicate device? you know, some product codes may point at specific loction of body, so the predicate device 's product code is definitely difficient with the subject device.
:unsure::unsure:Did somebody ever have similar consideration about this question? or do you think this predicate device could be available for 510(k)?

Funny thing about product codes, they are the initials of the FDA person assigned to oversee the submission of a De Novo. They guide the creation of the risk classification and any special controls for that product code.
 

mihzago

Trusted Information Resource
A predicate with a different product code may not work as your main predicate, depending on the differences, but it may be appropriate if you're trying to expand the indications of your device to the new product code, or it may be useful as a reference device.

There are a lot of factors.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
There is a struggle at FDA with AI and predicate. How machine learning occurs is fundamentally similar across modalities. There are various methods but they rely on large volumes of data and parameters and outcomes to learn how best to see patterns and predict outcomes; often outside the realm of human understanding on specific outcomes. If a company submits an AI-based device for ECG and outcomes is the new part the AI or the entire product?

Historically, if a product code did not exist it would probably be De Novo.

Best of luck,

Ed
 

Ashley Fu

Starting to get Involved
Luckily, I find some 510(k) summaries where the subjects' product codes are different from their's predicate device. So, the examples that different product code with predicate device is really exist and available.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Luckily, I find some 510(k) summaries where the subjects' product codes are different from their's predicate device. So, the examples that different product code with predicate device is really exist and available.


Can you share this? Which review area of FDA?
 
Top Bottom