I think what they are saying is that it is both (PEMF and thermal). I don't believe BIEL ever stated that no heat was emitted, just that because of the nature of PEMF you do not get that heat buildup, thus it is not noticible. This is in the literature.
Skirting the regs? The CFR is not clear on if you have to feel the 'heat' for the product to be classified as thermal. Just that the device provides deep heat therapy (or whatever the exact wording is).
And you're right, the previous device, all the way up to the NSE letter, was PEMF only. However, BIEL realized that if they ever wanted to get Class II status without going thru PMA, they were going to have to add the thermal element and go for the IMJ classification. That is exactly what they did. The original device did generate heat; however not enough to be physiologically meaningful. The new device that was submitted for De Novo was more powerful and did, according to BIEL, supply heat that was over the meaningful threashold.
Just because the heat cannot be felt doesn't mean it's not there. That's the entire arguement for BIEL. If I was their lawyer, I'd ask FDA to point to the reg in the CFR which explictly states that in order for a device to be classified as IMJ, the device must product heat that is noticible to the patient. It does not state that - however the regs are open to interpretation, particularly at the level they are written for this specific issue.
There are arguements on both sides. If I cannot feel the heat working, then how do I know it's 'working'? Also, kid you are correct in that they are stating that the primary mode of operation is heat. PEMF is not heat, but does generate heat.
The other side is that the IMJ product code is silent on PEMF - but does state the requirement for heat therapy (in a general sense). Did BIEL meet that threshold? The device produces more heat (but with no build up) then previously cleared devices at the low level. But is build up the key?
And where does the PEMF fall? Well, Those are class III, by the same reg in the CFR. So, if the only difference is thermal, and all things being equal, that is the tie-breaker (PEMF devices are categorized under the same CFR section, just a different class), then the decision basically comes down to the interpretation of 'thermal'. Can deep heat therapy be obtained without heat build up?
It should be interesting to see what happens from here.
Heck if I know.
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