Do we have to submit a new 510(k) for a device with a new MCU?

C

celia4237

#1
Dear all:

We produce blood pressure monitor, and it has get the K number, now we want to change its MCU, so we will do the design modification verification on the new device, and i know that maybe it don't need to submit a new 510(k), according to the guidance document < Deciding when to submit new 510(k) for a change to the existing device>. However, at the same time, we don't want to discard the old design specification. Because the customer may ask for the device with the old MCU, do we have to submit a new 510(k) for the device with a new MCU?
 
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G

gar4guv

#2
i am guessing that MCU means microcontroller. i don't know too much about blood pressure monitors, but it sounds like the MCU is kind of like the CPU of a personal computer.

if that is the case, then i believe installing a new MCU would require a new 510k. my reasoning is this, if you look at flowchart B in the guidance document you mentioned, the first diamond asks if there is a control mechanism change, and the second diamond asks if there is an operating principle change. i am guessing that a new MCU would fall under one of these categories. therefore any of these types of changes would need the submission of a new 510k.
 

Stijloor

Staff member
Super Moderator
#3
Dear all:

We produce blood pressure monitor, and it has get the K number, now we want to change its MCU, so we will do the design modification verification on the new device, and i know that maybe it don't need to submit a new 510(k), according to the guidance document < Deciding when to submit new 510(k) for a change to the existing device>. However, at the same time, we don't want to discard the old design specification. Because the customer may ask for the device with the old MCU, do we have to submit a new 510(k) for the device with a new MCU?
MCU means what?

Stijloor.
 
C

celia4237

#5
thank you all.


Please look at this question:we don't want to discard the old design specification.

Let imagine that this kind of modification don't need a new 510(k), but if we want to keep the old design specification. Does it make any difference? Because it seems that if the old specification is kept, it is not a design change anymore, it sounds like a "new device" is created, because it has the entire design file. Do we have to submit a new 510(k) for this device? After all, this "new device" is a little different, isn't it?
 
G

gar4guv

#6
if you conclude that this design change does not need a new 510k, then i believe you can reference the original K number for both the original model and the new model with the updated MCU.

i see no reason for you to discard the old specifications (unless there is a safety or effectiveness issue). both product lines would still have market approval under the same 510k.

with that said, you should be very certain that this change does not require a new submission. should the agency disagree with you, the new model could be the subject of an expensive recall.
 
Last edited by a moderator:
W

wangyang

#7
if you conclude that this design change does not need a new 510k, then i believe you can reference the original K number for both the original model and the new model with the updated MCU.
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I want to know it is a rare thing, or everybody follow it?
 
I

icare2much

#9
What is the difference between the new MCU and the old one? THis is significant. For example - often times a microprocessor is discontinued but the model is superceded by a new device that may have extended capability (that you don't need to use) but is fully backward compatible.

Similarly, is embedded software the same or did it change?

If the new processor is a simple drop in replacement, I think an argument can easily be made that no significant control changes were made.
 
W

wangyang

#10
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I want to know it is a rare thing, or everybody follow it?
-----------------------------------------------------

I have just got a FDA's response about this question.

You may only market one version or model of the subject device under the current 510(k) clearance. You may market the "old device" using the existing 510(k) clearance and the "new or modified device" using a separate FDA clearance.
 
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