Going from push buttons to touchscreen -> Is a new 510(k) needed?

D

drill

#1
Hi all,

I have a device that already has a 510(k), but I want to update it to make it more modern. It currently has push buttons to control assorted functions, and I would like to migrate them to a touchscreen. Would this require a new 510(k)?

I've looked through the FDA guidance and some of their categories are unclear. I'm don't think it would be considered a change to operating principle or control mechanism, but I'm not completely confident in that given how vague the FDA wording is. Additionally, from the standpoint of the ergonomics of the patient/user interface part of the flowchart, it looks to not require a new 510(k) for that part.

I figure some people are likely to have dealt with this before -- and was hoping some of you may be able to help. Thanks!
 
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regork

Starting to get Involved
#2
drill,
changing from the push buttons to touch screen is a control mechanism change to the ergonomics of a patient/user interface that (I'm assuming) involves a change to the software/firmware and you would need to look closely @ B8.3.

The justification will depend on the type, class of device, what the UI is actually doing / controlling, and a good hazard analysis and FMEA.

more info on the device and change would be helpful to have us provide you a more complete answer.
 
D

drill

#3
regork,

I've looked closely through the B8.1/B8.2/B8.3 path, and I'm not particularly concerned about those (the buttons involved don't affect safety or effectiveness) -- it's just the vagueness of the term "control mechanism" (B1) that has me caught up as to what falls under that term. It's a class 2 device, but the UI isn't controlling anything that impacts safety and effectiveness.
 

regork

Starting to get Involved
#4
Drill,
Yes the definition of control mechanism is very vague by design.
I start by assuming yes, and justify back to a no position.
You may be surprised by how the subtle change may have unintended effects on S&E of the overall device operation such as the SW change impacting the functional sw of the device, environmental concerns (EMC, ESD), change in physical characteristics is the touch screen bigger / smaller than the button design.

I recommend that you contact the office of device evaluation for your device and ask them. If you contact DICE they can look up the contact info of who evaluated your original 510K.

Good luck let me know if you have any questions.
 

Mark Meer

Trusted Information Resource
#5
It's a class 2 device, but the UI isn't controlling anything that impacts safety and effectiveness.
Just curious: what is the UI controlling? Can the device be used in the absence of the buttons?
 
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