ISO 10993 for Fabric based Electrode - Finding already FDA Approved Materials

M

moe.c.strife

#1
We are planning to use a fabric based electrode in our functional electrical stimulator medical device.

Before we commercially sell it, we need to do more experiments to improve the properties and quality.

We though, it would be necessary to know which materials already have FDA approvals, ISO certifications so we spend less money obtaining approval once the experimentation is done and/or don't waste our time with products which are going to be hard to get approval.

Properties:


  1. Contact: Direct to skin
  2. Material: Nylon, Polyester and Cotton (no metal in direct contact)
  3. Current: Biphasic (similar to the ones used in functional electrical stimulations, 30 Hz, 200 microsec pulse, 5 mA)
  4. Unlike traditional gel electrode or Textronics (FDA approved) Nylon, Polyester, Cotton and Silver threaded electrodes, it must be soaked in water for good conductance

Where should I go from here?

Any help or guidance will be much appreciated.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Re: ISO 10993 for fabric based electrode

Hello and welcome to the cove :bigwave:

A good start would be to ask your material suppliers for any evidence or certification that they have re. meeting the 3 basic ISO 10993 tests: Cytotoxicity, Sensitization & Irritation (assuming your electrode is intended for <24h contact with uncompromised skin only). If they also have master files with the FDA for any of these materials, ask for a letter of authorization (not so much for the authorization, but as proof that the files exist). the ISO 10993 series is harmonized so it should also satisfy the EC requirements in that regard.

You could sometimes get away without the above if necessary (e.g. you need a specific grade that hasn't been tested yet), but as a first choice and to reduce costs and burden the above would be preferred.

Also take a look here:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080735.htm

If you further process the materials from the purchased state / form, you may be required to repeat the tests on finished product, however, the above 3 tests aren't too lengthy / expensive.

Cheers,
Ronen.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Re: ISO 10993 for fabric based electrode

Hello and welcome to the cove :bigwave:

A good start would be to ask your material suppliers for any evidence or certification that they have re. meeting the 3 basic ISO 10993 tests: Cytotoxicity, Sensitization & Irritation (assuming your electrode is intended for <24h contact with uncompromised skin only). If they also have master files with the FDA for any of these materials, ask for a letter of authorization (not so much for the authorization, but as proof that the files exist). the ISO 10993 series is harmonized so it should also satisfy the EC requirements in that regard.

You could sometimes get away without the above if necessary (e.g. you need a specific grade that hasn't been tested yet), but as a first choice and to reduce costs and burden the above would be preferred.

Also take a look here:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080735.htm

If you further process the materials from the purchased state / form, you may be required to repeat the tests on finished product, however, the above 3 tests aren't too lengthy / expensive.

Cheers,
Ronen.
Edit: Testing (if required) may have to be done after soaking with water. I doubt water will materially affect the results, but to be on the safe side better consult a toxicologist experienced with ISO 10993.
 
M

moe.c.strife

#4
Re: ISO 10993 for fabric based electrode

Thanks a lot for the reply Ronen.

I should add that the material I am intending to use for electrical stimulation is actually supplied from a diaper company.

It seems to me, testing would have to include both water and electrical current.

As for toxicologist consultation do you know any good ones, I should be contacting?
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Re: ISO 10993 for fabric based electrode

Thanks a lot for the reply Ronen.

I should add that the material I am intending to use for electrical stimulation is actually supplied from a diaper company.

It seems to me, testing would have to include both water and electrical current.

As for toxicologist consultation do you know any good ones, I should be contacting?
Hi,

You may be right - a conservative approach would include electrical exposure. However, I'm not sure how that would fit in with ISO 10993 standard test methods. An experienced testing toxicologist should be able to properly address this aspect. Alternatively, you might want to show through prior bench testing that the candidate materials are chemically and otherwise stable under the foreseeable worst-case electrical exposure (this may be beneficial regardless of biocompatibility).

For consultation you could approach NAMSA for a USA-based lab, and either MDT or MDS (both in Germany) if you prefer an EC-based one (I am not affiliated with either).

Cheers,
Ronen.
 
M

moe.c.strife

#6
Hi

I was looking up 510k, PMA and every other database on FDA's medical device website.

(FDA >> MedicalDevices >> Device Regulation and Guidance >> Databases, I don't have enough permission to post the link with the complete database listings)

I can't find results with key words like "diaper" or my supplier's company name, there must be some cloth material approval somewhere, or am I even looking up the correct databases.

I am just waiting for replies from the supplier and the toxicologists.

Cheers,

Mohamed
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Hi

I was looking up 510k, PMA and every other database on FDA's medical device website.

(FDA >> MedicalDevices >> Device Regulation and Guidance >> Databases, I don't have enough permission to post the link with the complete database listings)

I can't find results with key words like "diaper" or my supplier's company name, there must be some cloth material approval somewhere, or am I even looking up the correct databases.

I am just waiting for replies from the supplier and the toxicologists.

Cheers,

Mohamed
Hi,

The databases you were searching contain cleared medical devices, classifications etc. I don't think that there's an open-to-public FDA database of approved materials. Many times the materials used are trade secrets.

Collecting existing biocompatibility data for regulatory clearance purposes is one of the trickiest tasks for small start-up companies. You have to be resourceful and persistent, and of course a bit of luck can help too. In simple cases that don't require a lot of testing it may be easier to rely on similar uses (like diapers in your case) and just do the tests.

Cheers,
Ronen.
 

Adele

Involved In Discussions
#8
What you need to find is evidence of FDA clearance of these materials in a medical device that has a similar level of contact.

Also, type the words Nylon, Polyester and Cotton (separately) into the 21 CFR database and see if there are any 21 CFR entries that reference them. It is always very useful and interesting.

My advice would be to contract this evaluation out to a biocompatibility lab to do the whole thing. They have experience preparing biological evaluations which are acceptable to the FDA and will include a toxicologist.
 
J

Jonas Wistrand

#10
Hi,

How did the fabric based electrodes work with FES? I've tried a bunch of these "terry cloth" - electrodes, but they all give a burning feeling.

Also, did you test the materials to see if they comply with ISO 10993?

Regards,
Jonas
 
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