510k: What to include if your own device is the predicate

SSchoepel

Involved In Discussions
#1
If we are using our own device as our predicate, what reference information do we need to include? (When we used a different device I included some marketing literature and was able to get a table of contents from their user manual.) Do I need to do anything other than reference our previous 510k? I want to make sure I'm including the appropriate amount of information.
 
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Watchcat

Trusted Information Resource
#2
I don't do 510(k)s, but I will ask the question anyway:

Which of these two approaches do you think is going to lead to a faster review?
1) you include the relevant information about your predicate device in the 510(k.
2) you just reference your 510(k), so that the reviewer has to go get it?
 

SSchoepel

Involved In Discussions
#4
I don't do 510(k)s, but I will ask the question anyway:

Which of these two approaches do you think is going to lead to a faster review?
1) you include the relevant information about your predicate device in the 510(k.
2) you just reference your 510(k), so that the reviewer has to go get it?
Precisely. That's why my preference/strategy is the first one, but I was just wondering if there was an "etiquette" I was not aware of for it.
 

nvquality

Starting to get Involved
#5
Sharing my experiences, I've always included everything (regarding the predicate) in the submission to do a complete package. The other submissions I've seen were also done this way, I would think it makes it so much easier for FDA to reference things in their review.

I have used supporting reference predicates (not the main predicate), where you just list the 510(k) number.
 
#6
If we are using our own device as our predicate, what reference information do we need to include? (When we used a different device I included some marketing literature and was able to get a table of contents from their user manual.) Do I need to do anything other than reference our previous 510k? I want to make sure I'm including the appropriate amount of information.
Dear SSchoepel,

I´ve done several 510(k)s before and have to say, you´re in a comfortable situation when using one of your own devices as a predicate!
Oftenly it´s hard to find all data related to a predicate - But you should have everything available.

Compare both devices as it would not be one of your own ones, you still have to show that it´s a valid/suitable predicate.
As always, provide the 510(k) number of the predicate and present documents where you derived that data.

Kind regards,
thinqbetter
 
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