From: Doug Sutherland (wearable_at_earthlink.net)
Date: 2001-12-18 15:54:39
Yaniv,
> can we get this device out without fda and for what
> purpose (personal , clinical)?
Brainmaster has been for sale for several years. If
you look at the following page you will see that it
received FDA approval in May 1999.
http://www.fda.gov/cdrh/510k/summay99.html
Here is the FDA 510(k) summary for brainmaster
http://www.fda.gov/cdrh/pdf/k990878.pdf
Some interesting facts:
- It lists Lexicor NRS-2D and Stoelting AT62 EEGs
as predicate device information. These are also
low-cost EEGs.
- It lists BOTH software and hardware, and the
software is split into clinical version and a
version for education/research.
- Intended use is listed as relaxation training
using alpha EEG biofeedback. That's interesting
since it's clearly being used for other clinical
treatments like ADD/ADHD.
- Testing was conducted in accordance with the FDA
1993 Draft "Reviewer Guidance for Premarket
Notification Submissions", DCRND. This is what we
need to look at for electrical, mechanical, and
environmental requirements.
- Testing was conducted by a contract testing lab
to prove IEC 60601-1 (electrical isolation)
compliance.
- Radiated and conducted electromagnetic energy
and magnetic field testing per the 1993 Draft.
- Conclusion is that this device is equivalent to
the predicate EEGs (NRS-2D and AT62). Interesting.
So if you want the FDA approval we could do the
same thing as long as we meet the standards.
- You should take a look at the letter granting the
approval, it talks about marketing in interstate
commerce.
> assuiming that personal use don't reuire fda, still
> if want to make it avail to professionals, we need
> fda clearance, and that's one big question
Brainmaster was for sale and (I think) was in use by
some practitioners prior the FDA approval of May 99.
There has always been two versions, clinical and
non-clinical. As I mentioned before, only recently
has a new policy showed up on the brainmaster site
that says "The BrainMaster is approved by the FDA
(K990538) for clinical biofeedback applications.
When used for this purpose, federal law restricts
its sale to or on the order of a biofeedback
practitioner. I see the same note on the altered
states company web site in NZ that sells brainmaster.
http://www.altered-states.co.nz/brainmaster/what.htm
So, my observations so far are:
- HAL-4 was sold (as a kit) to the public with no
FDA approval.
- Brainmaster was sold to the public prior to its
receiving FDA approval.
- Now that brainmaster has FDA approval, there are
restrictions on its sale, when used for clinical
purposes.
- The altered states NZ site says that there is a
non-clinical version, but interestingly I don't
see that same note on the brainmaster site.
- Obviously Lexicor and Stoelting also have FDA
approval for low-cost EEGs.
The following interesting info is in the mind
machine FAQ http://www.mind-gear.com/faq.htm
Before you understand the legal status of mind machines,
you need to understand the prejudices of the United
States' Food & Drug Administration. The FDA takes the
following principles for granted, and will not consider
any evidence that contradicts them:
1.Anything that alters body or brain function is a
medical treatment.
2.Medical treatments can and should only be used to
cure disease.
3.Only medical treatments which have been clinically
proven and widely accepted to be both safe and
reliably effective in curing disease should be used.
4.Being normal is not a disease. Anything that promises
to enhance normal human function is at best making a
fraudulent medical claim, and at worst promoting drug
abuse.
It is the opinion of this author that all four of those
statements are false and incorrect. Nevertheless, these
are the prejudices of the top several levels of the FDA
and much of Congress, and much of what has happened in
mind machines, vitamins, dietary supplements, and
alternative medicine can only be understood once you
understand these prejudices.
And this is VERY KEY:
Section 510 of the Pure Food & Drug Act, the law that
created the FDA, specifically says that they can't ban
anything that was already in use prior to 1976. And in
one primitive form or another, practically all of these
technologies existed prior to 1976.
Now if you look at the letter of approval from FDA for
brainmaster, it talks about this 1976 thing!
This page about procomp says the following:
Our implementation of these protected pin connectors
preceded the adoption of new safety specifications by
regulatory bodies, such as the FDA, requiring that all
medical products for physiological monitoring be
manufactured with electrode leads that have no exposed
metal surfaces.
http://www.thoughttechnology.com/procomp.htm
This American Biotec Newsletter says
5. USING EQUIPMENT WHICH HAS NOT GONE THROUGH PROPER FDA
SCRUTINY. This is in violation of federal law, and might
be used as a loophole by some insurance companies,
enabling them to nullify malpractice insurance in the
event of a lawsuit. Besides, it is irresponsible. It is
not that difficult to satisfy FDA requirements for those
serious about producing clinical grade equipment. There
is something wrong with a company that tries to tell you
that it doesn't matter that they have not satisfied FDA
regulations. Of course, we should also mention that to
our knowledge there has never been a dollar paid out in
a Biofeedback malpractice judgment.
http://www.mindfitness.com/newslet4.htm
> especially because of testing. it might be expensive.
> on hint i got on this issue is that if you can prove
> that you design is safe , testing won't be needed.
Better check that FDA draft. I think testing is needed.
> don't you think prototype or everyboard would need
> safety testing? that's the biggest question.
Yes. I think every unit that gets sold must go through
some testing, and the overall design needs to go through
the isolation testing to meet FDA standards.
> but still about isolation , assuming we can isolate
> with something that people can know without a doubt
> it's isolated, with very little or none addup to cost,
> and small working time
I think we should read the IEC 60601-1 standard for
electrical isolation and shoot for compliance.
> i don't understand something. assumoing you use
> rechargable batteries, and charge them in an external
> device, i don't see any problem , and why people
> won't use them, if we explain that this kind of
> setting makes the machine safer? i believe, but maybe
> i'm wrong that most people wouldn't mind this little
> hassle so much that they would pay $1000-$4000 for
> compatible machine from other company.
You may be right. I am just tossing ideas around here.
Convenience is important to people. Brainmaster is
very convenient because of its built-in charging.
> if you're going to buy all the parts for your design,
> can you post price list ? if possible for 20-50 qty ?
> it could be helpfull to estimate mfr price in usa .
Yes, I will post the prices, but I'm not ordering all
of the resistors and capacitors. Digikey includes the
price for single, 25, and 100 units on their web site.
I will at least provide a cost summary for everything
but the DC/DC converter and the resistors/capacitors
for 1/25/100 units.
Hope this helps.
-- Doug
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