Define Energy Used/Delivered - Applicable to Electrical or Mechanical Power or both?

J

jscholen

Can someone define for me what "Energy Used/delivered" means?

Does it apply to electrical or mechanical power or both?
And should it be measured or is it descriptive and measurement is a matter of performance?

I hope that makes sense. I am trying to determine how my device compares to a predicate device for 510k purposes.

Say I'm using hydraulic power to activate a device to perform an intended measurable function. Suppose my device uses less hydraulic power to activate a device and still achieves the same measurable functional output as a predicate device. Can I still claim substantially equivalency, even though I am using less energy?

Thanks.
 
M

MIREGMGR

Re: Define Energy Used/Delivered - applicable to Electrical or Mechanical Power or bo

I wouldn't guess that US FDA would regard a device that uses less energy than, but otherwise is functionally and clinically similar to, its predicate would thereby be disqualified from substantial equivalence.

Their primary focus is on clinical performance. If energy usage affects clinical performance in a significant way, it would matter. Otherwise, I'd think not.

My understanding is that that question is of interest to them because devices that use large amounts of energy might have risks that should be specially reviewed.
 
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