ISO 10993-1: External Communicating Device biocompatibility test requirements

[snakepitt]

Our medical device has two basic components: A disposable catheter-type device that goes into the blood stream for treatment, and a separate disposable control module held and manipulated by the physician.

We are trying to determine the biocompatibility test requirements, if any, for the control module. I have access to the device categorization test matrix table from ISO 10993-1, and it seems that the best fit might be "external communicating device, blood path indirect". I suspect that these are defined in ISO 10993-1 but unfortunately I do not have ready access to the standard (working on it), and internet searches for explanation have come up empty.

Is someone able to elaborate on possible examples of an external communicating device and blood path indirect, or point me in the right direction?

Thanks

 

[Ronen E]

Our medical device has two basic components: A disposable catheter-type device that goes into the blood stream for treatment, and a separate disposable control module held and manipulated by the physician.

We are trying to determine the biocompatibility test requirements, if any, for the control module. I have access to the device categorization test matrix table from ISO 10993-1, and it seems that the best fit might be "external communicating device, blood path indirect". I suspect that these are defined in ISO 10993-1 but unfortunately I do not have ready access to the standard (working on it), and internet searches for explanation have come up empty.

Is someone able to elaborate on possible examples of an external communicating device and blood path indirect, or point me in the right direction?

Thanks

Normally, IV sets fall under that category.

it's a bit difficult to be specific without knowing that control module and the nature of it's contact with the patient. If it stays outside the body but contacts in vivo body fluids either directly or indirectly (e.g. via saline), I'd venture to say that you picked the right category. If you contact me in a PM and provide details or direct me to a website, I might be able to verify that.

If you contact NAMSA (or similar) they will be able to help you with both classification and actual testing.

Cheers,
Ronen.

 

[snakepitt]

Hi Ronen,
Thanks very much for the reply. I thought I responded to you a couple weeks ago with additional information, but in looking at the thread just now I do not see it. Anyway, I will try again.

To elaborate on our device: The catheter-type device is a platinum coil attached to the distal end of a 2 meter long pusher, and housed within a retractable introducer sheath. The coil and distal portion of the pusher are inserted into an artery and advanced to an aneurysm to be treated. The pusher does not contain a fluid channel. The pusher is like a guide wire in that regard. When the coil is in position, the proximal end of the pusher is then connected to the control module. The control module is not intended to contact the patient directly or indirectly.

Pushing a button on the control module produces a small electrical current (isolated from the patient) which causes the coil to detach from the pusher, and stay within the aneurysm. The pusher is then removed.

Attached is a Use guide from a company called Terumo, which produces a product along the lines to the one we are developing. The green “detach controller” in the Use guide is what I am referring to as control module.
A colleague pointed me to a nice pamphlet produced by a company Pacific Biolabs, which contains a device category and example table, I believe excerpted from ISO 10993 (page 13 of the PDF file).

After reviewing this table, I am of the opinion that our coil is an Implant, pusher is an External Communicating Device, Circulating Blood; and that the control module does not fit into any of these categories. I think such a device is called Non-Contact. If correct, would that mean no biocompatibility testing required?

I will appreciate your further analysis and feedback.
Thanks,
Jeffrey

 

[Ronen E]

I am of the opinion that our coil is an Implant, pusher is an External Communicating Device, Circulating Blood; and that the control module does not fit into any of these categories. I think such a device is called Non-Contact.

Hi,

Thanks for the additional information.

I mostly agree with your analysis, though I think it won't be unreasonable to expect the outer shell of the control module to occasionally briefly contact the patient's skin (going by Terumo's brochure which you attached). Under this scenario it would be a Skin, Limited Duration Contact device, per ISO 10993-1.

The pamphlet which you referred to, showing the device categories and examples, was not attached to your post. I assume it is that one. The contents in p. 13 of the PDF (p. 12 of the document) are taken directly from ISO 10993-1.

Cheers,
Ronen.

 

[snakepitt]

Thanks again Ronen for your feedback. Yes, the pamphlet you attached is the one to which I was referring. To your point about possible occasional skin contact, the patient is fully covered under sterile drapes, so likelihood is minimal. However, to be conservative it might be prudent to treat the controller as you suggest.

Take care,
Jeffrey