Medical Devices - Ancillary - ISO 10993-17

#1
Dear readers,
we have a device which is an adhesive gel that contains Chlorhexidine (CHX) at 0,12% to be applied to an injured wound. The physical barrier is created by the gel and does not allow bacteria to reach the wound. We would like to say that the CHX has antimicrobial properties and reduces risk of infection. However, the % (0,12% used) is also accepted as preservative in cosmetics for instance.

How will this device be classified? if we claim the antimicrobial properties, the device will fall within rule 14? how can we demonstrate that it is a MD and not a drug? should we present any clinical data comparing the gel with vs gel without CHX?

or if we claim that the CHX is preservative, will the device fall under rule 21?

Does ISO 1099317 apply to the CHX? is CHX considered a leachable?

many many thanks!
 
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#3
Dear planB,

thank you very very much for your answer!!!!.

Reading the thread that you provided in your answer, I understand that, if we are able to demonstrate that the CHX acts as a preservative an it is a component of the gel, we will fall under Rule 14.

However, the CHX is likely to "leach" de gel and act on the wound so I think that we are more likely to fall under rule 21. Do you agree?

and hopefully, emphasising that the gel is very important since it acts as a physical barrier to the microorganisms, we hope that the Notified Body will not consider the CHX to have the main action!


thanks again!
marie
 

planB

Trusted Information Resource
#4
marie,

since you described your device forming a stable physical barrier of compromised skin, the device would not be regarded as being absorbed or dispersed in the body, even when CHX quantitatively "leaches" to the patient; thus, Rule 21 would not apply.

Rather Rule 4 applies, presuming that you just claim preservative properties for CHX. Rule 14 would only apply if you additionally claimed therapeutic modes of action for CHX, turning CHX into an ancillary medicinal substance.

You might also want to to re-confirm your classification with your notified body.

Hope this helps,
 
#5
Dear planB,

really appreciate your feedback!

Apologies since I think that I mixed up a bit the classification rules in my last post...

Therefore, I'll summarise your input as follows:

- Rule 4 will apply if we just claim that the CHX has a preservative action. --> class IIa or IIb

-Rule 14 will apply if we claim an ancillary action to the CHX (i.e. antiseptic). Even if CHX is present in the device in a % considered to be preservative, we are claiming an ancillary action, thus rule 14 apply --> class III

-Rule 21 will apply if the device itself (the gel) is absorbed or dispersed. Class IIa will apply since the action takes place in. the mouth/oral cavity. From my understanding, if we want to follow under rule 21, we can't claim any antiseptic/ancillary mode of action to the CHX., is that right?


thank you very much gain, really appreciate your support.

marie
 

planB

Trusted Information Resource
#6
marie,

sorry that I wrongly assumed that your device is non-invasive. Since you clarified that the location of application is the mouth/oral cavity, your device is invasive and thus, either Rule 5 (not Rule 4) / Rule 21 (medical device) apply, or Rule 14 (combination device): You cannot have a purely medical device with a claimed ancillary therapeutic substance.

Hope this helps,
 
#7
perfect, really helpful!!

and releted to the leachables, I understood that in case that CHX leaches de device, yes, it will be considered a leachable.

I was a little bit confuses because the ISOs, when describing leachables, only talk about "chemicals, antioxidants polymers, additives, etc) but never related to medicinal substances. This is why I thought that medicinal substances will not be considered leachables.

thanks!
 
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