Including a class 1 camera in the 510k application of class 2 therapeutic technology?

#1
Hi everyone,

My company is developing a medical device and is currently drafting our 510k application. The device incorporates a class 2 therapeutic technology subject to a 510k submission, but also a class 1 camera (not therapeutic) that is 510k exempt. The two technologies have two different indications for use.

As far as I can read on FDA's website, the 510k exemption for a class 1 device means that as long as we adhere to the general controls, GMP, etc. we don’t need to submit a 510k application for such a device. However, since we are required to submit a 510k for our class 2 technology anyways, should we still include and compare the class 1 camera in the 510k application, even though it is exempt for this submission type?

To clarify, the two technologies are part of one complete device. Thank you in advance for your time.
 
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Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#4
Is the class I camera provided as a convenience and not required for use of the medical device? Is it a pass-through item to the customer? Do you have control over this class I device in any way or can you access design info about it and testing?
 
#5
The Camera is not required to use the therapeutic function of the device, however, it is required to do a specific measurement after, and arguably unrelated, to the therapeutic function. Or put differently, the therapeutic function has one intended use, and the camera has a different intended use.

The device is to be used by healthcare professionals only, so I suppose it is not a pass-through item - maybe I am mistaken the term you are referring to though.

Yes, we have control over the device in the sense that it is embedded into our medical device. It’s an OEM component and it will be a part of our performance testing anyway.

Hope this clarifies - and thanks!
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#6
Let me rephrase this; Can you describe the safety and effectiveness of your device without relying on Class I Camera? One of the first questions the FDA reviews when looking at a 510(k) is "does the submitter have legal ownership or authority over the submitted device?" If you don't they will reject it back to you unless you are allowed to represent the other company.
 
Last edited:
#7
Yep, we can definitely describe safety and effectiveness without the camera. In some way, you could say that we’re combining two devices into one, but they are not dependant on each other.
 
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