Power supply - Change From 160 to 300 Watts - Significant change?

Udirn1

Starting to get Involved
Hello All,
I have a class IIb cleared medical device.
I would like to introduce a similar device with same intended use, only with a newer power supply from the same manufacturer and same size.
For example, in current device, the power supply is rated 160W with 24VDC output.
The new power supply is 300W with 24VDC output.

I read in an article that this may be considered a s a significant change since it is a a "change in the source of energy used by the device".
Do you have any insights as of whether its correct, and if yes, what does it mean a change in the source of energy used by the device:
Is it the power feeding the power supply inside the device (the 240V AC source) or its any change related to the internal power supply itself, even though its output stays the same (24V)only its power capabilities increases? (from 160 W to 300W)
Appreciate your input
Udi
 

J0anne

Joanne
Hello All,
I have a class IIb cleared medical device.
I would like to introduce a similar device with same intended use, only with a newer power supply from the same manufacturer and same size.
For example, in current device, the power supply is rated 160W with 24VDC output.
The new power supply is 300W with 24VDC output.

I read in an article that this may be considered a s a significant change since it is a a "change in the source of energy used by the device".
Do you have any insights as of whether its correct, and if yes, what does it mean a change in the source of energy used by the device:
Is it the power feeding the power supply inside the device (the 240V AC source) or its any change related to the internal power supply itself, even though its output stays the same (24V)only its power capabilities increases? (from 160 W to 300W)
Appreciate your input
Udi

A change in the source of supply would be a change from one type to another for example a battery to a mains supply

You could start by looking at the devices predicates to see if any go up to 300W.
If so, it will be substantially equivalent and it's not likely to need a new 510 (k)

But there are still some questions you should ask - Is there no change in performance to the safe use of the device?

Does it improve the effectiveness of the use of the device?

Have you done a risk assessment to see if there are any new risks associated with the use of the new power rating?

Here's a guide and if you read it thoroughly you should be able to determine the correct answer

https://www.fda.gov/media/99812/download
 

primavesvera

Involved In Discussions
From what I gathered from the post, it's a significant change in the case of a device with a CE mark.
There is guidance: DocsRoom - European Commission

Maybe it will help you, it follows a similar approach as one in the FDA guidance, the flowchart approach. However, there are also some additional information for the CE marked devices and maybe it might help you. There is also guidance from NB Team, in case you want to consult that as well: https://www.team-nb.org/wp-content/uploads/2015/05/documents2012andolders/R2_5_2-2_rev7.pdf

And, in the end, the best advice - talk to your notified body and see what they have to say.
 
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