Existing Device + Existing Device = OK ? New 510(k) required?

T

TJG954 - 2009

#1
Here's the scenario...

Existing x-ray device with older technology receptor is 510k approved.

Existing newer technology receptor is 510k approved.

The x-ray device is upgraded by replacing the older technology with the newer improved receptor.

Other than improving the image and viewing options, nothing else has changed.

Question: Is it necessary to file for a new 510k approval? :confused:

I need opinions from experts from the Cove.
 
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M

MIREGMGR

#2
Re: Existing Device + Existing Device = OK ?

Definitely you must file a new PMN for the system using the new detector. The only question is whether the format should be a Special or a Traditional.

A Special must not have any change to Intended Use (none intended in this case) and must not have any change to the fundamental technology. This latter requirement seems to suggest that a Traditional would be required; however, there are certain exceptions when the new technology itself is already 510(k)ed.

Because this instance is close to that boundary, I suggest you officially inquire with CDRH or DSMICA as to which format to use.
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#3
Re: Existing Device + Existing Device = OK ?

I have moved this post to this forum. Since it is more related to FDA.
 
A

Andrea.Ruth

#4
Re: Existing Device + Existing Device = OK ?

I would disagree that this is definitely a 510(k). I think it could be, it is not a slam dunk either way. I have seen companies with different product families replace old technology with new technology, without changing the regulatory profile of the device, and do it with internal documentation.

You definitely have to ask yourself whether indications for and intended use are changing, whether the new technology add new or different risks to the device, whether the safety and effectiveness profile of the device is changing.

The guidance on the FDA website is a good resource, as is DSMICA (Call them).
 
C

celia4237

#6
Then what about this scenario?
The original device named KD-5961 have already get 510(k) cleared.
Only the appearance of KD-5961 is changed, nothing else changed, which forms a new device, KD-5962.
We all know that the modification of appearance is a very slight change, can we use the K number of KD-5961 for KD-5962 without a 510(k) submission to FDA?
 

Al Rosen

Staff member
Super Moderator
#7
Then what about this scenario?
The original device named KD-5961 have already get 510(k) cleared.
Only the appearance of KD-5961 is changed, nothing else changed, which forms a new device, KD-5962.
We all know that the modification of appearance is a very slight change, can we use the K number of KD-5961 for KD-5962 without a 510(k) submission to FDA?
What did you change? The color. Then I think you can handle it in your internal procedures. A new paint? Maybe not. Look at the http://www.fda.gov/cdrh/ode/510kmod.htmlflowchart.
 
C

celia4237

#8
The modification of appearance brings the change of PCB and the shape of the device.

The question is, if we meet the requirement of the flow chart, but our change has formed a new device, can the new device use the original K number together with the old device?
 
M

MIREGMGR

#9
I hope you recognize that the issues you present, i.e. continued legal marketability of an existing product after changes to that product have been made, should have been addressed when you made those changes... at least if that product is still on the market.

In any case, the bottom line is that you must address the questions in the decision flowchart that Al Rosen linked above.

If the changes to your existing device were "documentation only", then you did not "form a new device". Instead you just created a variant of your already-existing device, and the existing 510(k) would continue to apply.
 
C

celia4237

#10
Oh ,I must have mixed "new device" with "variants of the device".

Thank you and i really learn a lot here.
 
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