Claiming Biocompatibility without ISO 10993-1

A

asadr

#1
Hello,

We have a traditional 510k for class 2 device. It is an aesthetic light therapy device and there is patient contact materials which touch patient skin (healthy skin)during treatment schedule is 2x per week for 30min.

1. silicone I have a datasheet that states it is cleared for class II medical device usage. though it is not class 6 material

2. urethane foam topped with acrylic flocking and
a. does not contain levels of materials required to be reported under 29CFR 1910-1200
b. is flammable by definition in OSHA 29 CFR Hazard communications, part 1910-1200 when tested by method described in 16 CFR 1500.44

I plan to submit without getting ISO 10993 certified. These are very low risk materials, and we are unsure if predicates completed biocompability for their plastics.

I am just trying to anticipate the FDA response to this, and improve my chances much as possible if need be, what is yalls experience.

warm
regards
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Re: Claiming Biocompatibilty without ISO 10993-1

Our experience is, no ISO 10993 data, no clearance progress. But, we don't make devices like yours.

G95-1 does create a justification-path for materials with a long history of use. My understanding though is that USFDA wants that history to be well documented, based on numbers of users that create a significantly larger statistical base than your device's use will involve, and in regard to a substantially equal device application.

Note that a "datasheet" isn't evidence. Evidence would be a copy of the original study data underlying the claim made on the datasheet.
 
A

asadr

#3
Re: Claiming Biocompatibilty without ISO 10993-1

Thanks for the input. Pray what device do you work on?

I am trying to get the manufactures test reports/additional info, regarding their CFR conformance, class II eligibility, ect...

anybody else know how to get very low risk materials through without 10993-1?
 
M

MIREGMGR

#4
Re: Claiming Biocompatibilty without ISO 10993-1

We make a wide range of Class II sterile disposables, plus other things.
 

yodon

Staff member
Super Moderator
#5
You might want to have a chat with a test lab like NAMSA (I have no relationship with them other than using them on previous projects). They may be able to define a cost / time -effective path; providing the documentation Miregmgr mentions. Like I said, they did this for us on one project.

Couldn't hurt to have a chat and get their input. They've defined what I always considered a reasonable path with us.
 

somashekar

Staff member
Super Moderator
#6
Re: Claiming Biocompatibilty without ISO 10993-1

Thanks for the input. Pray what device do you work on?

I am trying to get the manufactures test reports/additional info, regarding their CFR conformance, class II eligibility, ect...

anybody else know how to get very low risk materials through without 10993-1?
Also consider answers to open questions about what your process would likely add to the material which makes contact to the healthy skin during the device use ?
The 10993 addresses your finished device that may have undergone your handling and processing / cleaning as necessary and the manufactures test reports/additional info, regarding their CFR conformance, class II eligibility, etc stops at the basic material. Good luck for your project.
 
M

MIREGMGR

#7
Some additional technical points.

(...) it is cleared for class II medical device usage. though it is not class 6 material
As discussed in other threads here, "Class 6" is a materials classification from the obsolete Tripartite materials-classification guidance. Under Tripartite, materials were rated for use in both medical devices and pharmaceutical packaging. In 1995, USFDA split CDRH's materials qualification for medical devices away from CDER's for pharmaceutical packaging by issuing CDRH guidance G95-1. That was the end-point for relevance of "Class 6" as a materials qualification for medical devices.

G95-1 of course replaced the Tripartite "Class 1/2/3/4/5/6" scale, which was based on limited, old-school animal testing, with the much more comprehensive ISO 10993 system.

It's not a good idea to submit a 510(k) containing only a statement of "Class 6" qualification as one's evidence of device-usage materials suitability, because it indicates to FDA that the submitter isn't familiar with the rules.

As to a statement that a material is "cleared for Class II medical device usage", the fact that a material has been allowed in one 510(k) doesn't commit FDA to allowing it in a different 510(k). That decision is based on ISO 10993 qualification relative to each application's context.

does not contain levels of materials required to be reported under 29CFR 1910-1200
Not relevant to USFDA. A material can meet this standard and still be unable to pass ISO 10993, particularly for more-challenging applications.

is flammable by definition in OSHA 29 CFR Hazard communications, part 1910-1200 when tested by method described in 16 CFR 1500.44
Not relevant to biocompatibility qualification. However, disclosure as a part of the materials description might cause the examiner for biocompatibility to cross-communicate with the examiner for the risk analysis, to make sure that materials flammability is addressed in a risk context since the device presumably uses electrical energy.
 
A

asadr

#8
Wow, that was great feedback...

I was citing G95-1 as a reference in my biocompat section but did not fully appreciate that class VI was not my holy grail. Unfortunately, I just received from the manufacturer a test report for UPS plastics biological reactivity for class IV of the material.

Do you think this test report is better than nothing and if explained may support by biocompatibility claim?

I am going to further ask why/how their datasheet claims the device is permitted for class I, II medical devices.

cheers
 
J

Julie O

#10
Belatedly...

I plan to submit without getting ISO 10993 certified.
There is no such thing as ISO 10993 certification that I know of.

If you are talking about submitting to FDA, as far as I know, FDA does not require compliance with ISO 10993 to support a claim of biocompatibility. FDA requires data to support biocompatibility. ISO 10993 simply provides helpful and well-researched guidance on how you might go about collecting those data. Most companies find it easier, quicker, and more cost effective to follow this standard than to try to invent a different wheel to take them to the same place.
 
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