ISO 10993-1: 2009 Annex A Biological Evaluation Tests

Hi All,

We manufacture syringes that are used for the delivery of anaesthesia after the orthopedics surgery, the common administration of anesthesia is around the knees. We only supply the syringes. The needles are selected by the surgeons. As such the device is registered as Syringe without the needle.

I needed to draw a report on biological evaluation tests and just wondering if someone assist me to identify the catagory of the device in conformance with ISO 10993-1: 2009 Annex A 'Biological Evaluation tests'. I am in two minds where to catagorise device;
1. Surface Device A limited i.e. less than 24h
or
2. External communicating Device- Tissue/bone/dentin A limited contact duration

Your comments will be great help to me.

Thanks

 

Hi,

By "surface device" I assume you refer to the sub-category "skin".

In most cases the classification into either of the two options you highlighted would lead to performing the same tests (the 3 basic tests). The only difference is that the FDA might additionally require for the second that you also do the acute systemic toxicity test. If FDA clearance is relevant to you and you already know the correct ProCode (3-letter FDA classification code), and that code has a device-type-specific guidance document (or another Special Control), the specific biocompatibility testing requirements might be spelled out in that document.

This FDA guidance might be relevant but it's quite old so I would caution.

In the above I've assumed that you don't market your syringes pre-filled.

Cheers,
Ronen.

 

Thanks Ronen, your explanation is very in depth, I am astonished. We dont market syringes pre-filled. I am very much inclined to go for the 1st option surface device, but I would go through some other documents as well, including one you have provided.

Have a great day ahead.

Nash

 

Hi, All:
In relation to a final product with multiple components comprising the "applied part," and the FDA Guidance on biocompatibility, the applied parts for our external device are in contact with intact skin for much less than 24 hours. FDA's Guidance Attachment A notes three types of putative biologic effects: "cytotoxicity," "sensitization," and "irritation or intracutaneous reactivity." The very high likelihood is that all the applied parts are biocompatible, given they are in wide use for other consumer products which have intact skin contact during use.

The questions we have relate to which tests if any we should use to demonstrate biocompatibility of the final product.

1. Is it a correct reading of FDA's guidance that animal tests and in vitro cellular tests may not be necessary if other information adequately address biocompatibility safety?
2. If so, then what type of non-animal/non-biologic studies might be suitable?
3. Is one approach to assess leachable chemicals from each part that is an applied part in the final product?
4. If so, then which ISO methods would be needed to chemically characterize leachable chemicals?
5. For these ISO methods in item #5, what are the ISO acceptance criteria (i.e., limits") for these tests.
6. If the leachable chemicals approach seems less than adequate, then what do you suggest for assessing biologic effects relating to: "cytotoxicity," "sensitization," and "irritation or intracutaneous reactivity" of our applied parts, which include: (a) a high quality widely-used copolyester thermoplastic elastomer; (b) silicone rubber; (c) a closed cell cross-linked ethylene copolymer foam.
Thanks
RWS