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.
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.