List all 510K numbers on predicate for 510K?

B

Bruce Banner

#1
If I am filing a traditional 510K that is intended to work with another device and that device has multiple 510K for different models.
The same exact product but been through changes, but each one is the same product but with a different aspect.
Example: a bike with spring suspension, sold as Huffy A1: Bike with a hydraulic suspension, Huffy Super A2: Bike with gas shocks: Huffy G1 etc...

For example, maybe not the best example in the world)
I want to file a 510K for a mobile swing arm xray to attach to an existing device like a patient bed. The patient bed has multiple 510k's cause it has different models. Lets say 6 models, so 6 different 510k numbers, same device, just different models.
What is the best way to say in my submission that my swing arm xray attaches to these 6 beds. All 6 beds are basically the same thing, they one may have a heating option so it has its own 510K, the other may have a hydarulic actuator so it has its own 510k etc...
Do I need to mention each 510K number constantly, or can I mention on a top level the model name and it's subsequent models?
Bearing in mind the manufacturer of these beds is somebody else
 
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M

MIREGMGR

#2
It seems that your post title refers to how to define and describe your identified predicate, i.e. an already cleared device to which your device is similar, but your post body discusses how to define and describe your intended use.

It's possible to state more than one predicate when a composite of features from already-cleared similar devices is the best basis for your product's similarity, but the number should be minimized to simplify your interactions with FDA.

I don't see any downside in stating all involved devices in regard to your intended use, other than the requirement for more writing. To the contrary, I'd think it's usually essential that you do so.
 
B

Bruce Banner

#3
Sorry for the title and content confusion. I didn't know how to change the topic title after I made it.
In involving all the devices I intend to use in conjunction with, It would be quite a mouthful to list 6 K numbers and full product names, since all 6 are essentially the same device, but slightly different. Would FDA look at it weird if I were to say something like the HUFFY bike, in all variations and configurations?
 
M

MIREGMGR

#4
Would FDA look at it weird if I were to say something like the HUFFY bike, in all variations and configurations?
My guess is that they'll accept efficient language as long as the resulting document is fully self-explanatory without external research by the reader.

I'd think you might want to fully and precisely define the bounds of your intended use once, then refer thereafter to that full description using a shorthand term.
 
B

Bruce Banner

#5
My guess is that they'll accept efficient language as long as the resulting document is fully self-explanatory without external research by the reader.

I'd think you might want to fully and precisely define the bounds of your intended use once, then refer thereafter to that full description using a shorthand term.
Where would be the best place to make the abbreviation statement in the submission?
 
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