Substantial Equivalence for Laser Wavelength - Class 2 Aesthetic Product

A

asadr

#1
Hello All,

We have a new laser wavelength for a class 2 aesthetic product that we are submitting 510k. Our device is the same laser classification but approximately 20nm from the predicate devices' center wavelength, however we have not completed patient studies, which the predicate did complete.

We justify our substantial equivalence by listing the predicates' studies results and one study for a product that was not FDA cleared.

1. should we exclude the study for the device that was not FDA cleared?
2. should we go into limited/extensive technical discussion for how our wavelength has equivalent efficacy, with citations to studies and research.
there is extensive research unfortunately not single landmark study, so painting a clear technical justification is a bit messy. How much detail do they like/want/need is the question for this approach
3. should we just mention it as a nominal difference and make a simple claim and more on?
4. should we expect it to bounce back with "need clinical studies" because of the vary fact that the predicate had clinical studies?

warm regards
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Hello All,

We have a new laser wavelength for a class 2 aesthetic product that we are submitting 510k. Our device is the same laser classification but approximately 20nm from the predicate devices' center wavelength, however we have not completed patient studies, which the predicate did complete.

We justify our substantial equivalence by listing the predicates' studies results and one study for a product that was not FDA cleared.

1. should we exclude the study for the device that was not FDA cleared?
2. should we go into limited/extensive technical discussion for how our wavelength has equivalent efficacy, with citations to studies and research.
there is extensive research unfortunately not single landmark study, so painting a clear technical justification is a bit messy. How much detail do they like/want/need is the question for this approach
3. should we just mention it as a nominal difference and make a simple claim and more on?
4. should we expect it to bounce back with "need clinical studies" because of the vary fact that the predicate had clinical studies?

warm regards
Can someone help?

Thank you!!

Stijloor.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Hello All,

We have a new laser wavelength for a class 2 aesthetic product that we are submitting 510k. Our device is the same laser classification but approximately 20nm from the predicate devices' center wavelength, however we have not completed patient studies, which the predicate did complete.

We justify our substantial equivalence by listing the predicates' studies results and one study for a product that was not FDA cleared.

1. should we exclude the study for the device that was not FDA cleared?
2. should we go into limited/extensive technical discussion for how our wavelength has equivalent efficacy, with citations to studies and research.
there is extensive research unfortunately not single landmark study, so painting a clear technical justification is a bit messy. How much detail do they like/want/need is the question for this approach
3. should we just mention it as a nominal difference and make a simple claim and more on?
4. should we expect it to bounce back with "need clinical studies" because of the vary fact that the predicate had clinical studies?

warm regards
Hello,

In a nutshell, substantial equivalence is based on similarity in intended use and technological characteristics. Whenever there are differences in technological characteristics, it is up to you to substantiate that these do not pose any new concerns regarding both efficacy and safety.

Whether or not a 20nm difference is significant and/or poses new concerns is up to an expert in the field (hopefully, you; not me) to determine. I'm quite sure (or at least I hope) that when the design decision in that regard was taken good reasons to do so were presented, and the associated risks addressed. So, hopefully, the basic arguments should already be there. It is up to you to now rationalize (in a way as detailed and as elaborated as would be required) and convince that the difference is not significant or that no new concerns are presented. Clinical studies come into play when such new concerns *are* present, to provide evidence that efficacy and safety are not compromised.

Good luck,
Ronen.
 
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