*****FDA MOST LIKELY TO DENY BIEL BASED ON......HUGE*****A__MUST__READ
Dont assume these are getting approved any time soon.
I received another email, and not good about BIEls recent reply about the FDAs requirements. This will never see FDA "approval", and will require a whole new filing, adding a lot more time, and shares.
I was asked if Id share on here. SO here you go...
Here is why ActiPatch will most likely NOT be cleared by the FDA
Class II or Class III doesn't matter with the most recent 510(k) because BIEL is still trying to use the ActiBand as the Predicate Device.
BIEL tried to use the ActiBand as the Predicate Device in their previous ActiPatch 501(k) and the FDA said "NSE." The indication for use (IFU) statement for the ActiBand device is “for the treatment of edema following Blepharoplasty.” edema means SWELLING and blepharosty is a very specific indication. The ActiBand is not cleared by the FDA for any of BIEL's claims about the ActiPatch so the FDA is going to say "NSE" again.
BIEL will have to amend the 510(k) or submit a new 510(k) naming a different device that is Substantially Equivalent. The ActiBand is NOT going to work for this. What device is SE? I have no idea. I'm not aware of one.
I think they are going to have to submit a PMA for a Class II device. Anyone who disagrees needs to either name the Predicate Device that will work in a 510(k) or do a little DD on the FDA process for clearing devices and realize their mistake. I think it's the latter. I think a symptom of the ignorance here is the continued use of the word "approved" instead of "cleared." The ActiPatch is a DEVICE and devices get CLEARED, not APPROVED, and the 510(k) process requires that someone in the past has gone through the effort of filing a PMA for a similar device that subsequent 510(k)'s can name as the Predicate Device.
So yes, the ActiPatch is Class II. That isn't enough to get the thing cleared by the FDA in a 510(k). The FDA needs to agree on a Predicate Device which clearly they will NOT do with ActiBand... and then the FDA needs to accept BIEL's evidence, which at the moment consists mainly of testimonials and surveys.
BIELS IR P. Knopick told me that the ActiBand is the predicate device they claimed in their 2010 510(k) and the predicate device they are claiming in this 510(k).
But I think that anyone who actually cares about a discussion of this issue needs to contact Knopick and get the answers themselves
1. What predicate device is BIEL claiming for the ActiPatch in the recent 510(k)?
2. If it is the same predicate device they claimed for the previous 510(k), why does BIEL think the FDA will make a decision other than NSE this time?
I asked those two questions, and Knopick answered to my satisfaction. Based on those answers, I think the FDA is going to say NSE again.
Maybe there have been secret discussions between BIEL and the FDA and maybe there is something about the 510(k) we don't know. I would highly doubt this as the FDA is transparent, and pretty cut and dry, in these matters.
Many say "By moving to Class II it allows for Actiband to be the predicate." I disagree. The ActiBand would have to be cleared for treatment of pain or edema caused by something other than Blepharoplasty in order for it to be the predicate. BIEL is trying to get the Actipatch cleared for OTC treatment of pain and/or edema caused by something other than Blepharoplasty.
The ActiBand was cleared as a Class III device. I hope many are aware of this. 510(k) number K022404. I found that on the FDA site..
The ActiPatch was not rejected in the previous 510(k) on the grounds that ActiPatch was Class III and ActiBand was Class II, in other words. Changing the ActiPatch to Class II does not make it SE to ActiBand.
That 2012 Warning Letter didn't pull any punches, and that is on the FDA site. What I find striking is: BIEL received NSE decisions for their devices and marketed the devices anyway, forcing the FDA to act. I am having trouble believing that the FDA now loves BIEL and will make an exception to their 510(k) rules to grant clearance for the ActiPatch based on this recent 510(k).
Everyone should be prepared to embrace full denials again from the FDA, based on these very real facts.
