Material Change - New 10993 Testing and Submitting a New 510(k)

[temujin]

Hi,

We are considering substituting one material in our cardiac probes, and I am a little confused with regard to the text in Deciding When to Submit a 510(k) for a Change to an Existing Device

The question is if we need to submit a new 510(k) when new 10993-testing is necessary.

C2.2.1
(...)
A 510(k) may not be needed if the manufacturer has satisfactory results from the testing indicated by ISO 10993-1 in its files for the material in question or if such results are available to the manufacturer, e.g., are available in the open published literature or have been provided to the 510(k) holder by the material supplier.
(...)

If I understand the text right, if the material supplier can prove that the material has been tested with respect to the necessary 10993 standards we do not need to submit a new 510(k).

However, if we decide to run the tests ourselves (or through an extern test laboratory) we need to submit a new 510(k).

Which would mean that in order to avoid a new 510(k) we could simply carry out the new testing through the material supplier.?? This sounds strange to me....?

Any suggestions as to how I should interpret this ?

best regards
t.

[Steve McQuality]

Originally Posted by temujin

Hi,

C2.2.1
(...)
A 510(k) may not be needed if the manufacturer has satisfactory results from the testing indicated by ISO 10993-1 in its files for the material in question or if such results are available to the manufacturer, e.g., are available in the open published literature or have been provided to the 510(k) holder by the material supplier.
(...)

If I understand the text right, if the material supplier can prove that the material has been tested with respect to the necessary 10993 standards we do not need to submit a new 510(k).

However, if we decide to run the tests ourselves (or through an extern test laboratory) we need to submit a new 510(k).

Which would mean that in order to avoid a new 510(k) we could simply carry out the new testing through the material supplier.?? This sounds strange to me....?

Any suggestions as to how I should interpret this ?

best regards
t.

Hi t.

This is just my opinion from interpretting the C2.2.1 excerpt you've quoted, but I read this as either obtaining satisfactory results from ISO 10993-1 testing performed OR obtaining the information from your supplier. It seems to me that you are being provided the option.

However, if the results of the ISO 10993-1 are different from the original material then you must submit a new 510(k).

...just my opinion regarding MY interpretation of the standard you've quoted.

-Steve

[Gert Sorensen]

Originally Posted by temujin

C2.2.1
(...)
A 510(k) may not be needed if the manufacturer has satisfactory results from the testing indicated by ISO 10993-1 in its files for the material in question or if such results are available to the manufacturer, e.g., are available in the open published literature or have been provided to the 510(k) holder by the material supplier.
(...)

If I understand the text right, if the material supplier can prove that the material has been tested with respect to the necessary 10993 standards we do not need to submit a new 510(k).

However, if we decide to run the tests ourselves (or through an extern test laboratory) we need to submit a new 510(k).

Which would mean that in order to avoid a new 510(k) we could simply carry out the new testing through the material supplier.?? This sounds strange to me....?

The new 10993, has the intention of reducing testing on animals, and it seems that the FDA has accepted this to some extent. IMO what this means in this case is that if the new material has been tested (and approved) and you have access to these data, either from literature, supplier or laboratory etc, then you can use these data as the rationale for your substition, and you will not need a new 510K.

However, you will of course need to update your DMR to reflect the changes. You will also need to make sure that any testing done is actually sufficient. In 10993 the responsibility for choosing the correct testing lies solely with the manufacturer. So if your new material has not been previously tested with regards to, say intracutaneous reaction or long term use, then it is your responsibility to have it tested for this if this test applies to your product.

Additionally you will of course also need to test the material for its intended use in your device.

[Ajit Basrur]

There are different criteria applicaqble for the type of the device. For eg. - change in material in case of implant, "Manufacturers should submit a new 510(k) for a change in implant material where the material contacts tissue (including bone tissue) or body fluid. Examples of devices for which changes in material type would normally require a new 510(k) are total joints or their components. On the other hand, changes in materials of an implant that are not intended to contact body tissues or fluids are not likely to require a 510(k) submission. Examples of such changes in material type are changes in the interior materials of an implantable electric stimulator (e.g., a single chamber cardiac pacemaker) which are sealed from ingress of body fluids or tissues."

Sometimes change in materials may affect the performance standards in which case, the manufacturer has to decide whether a 510 (K0 is required.

Pl refer http://www.fda.gov/cdrh/ode/510kmod.html#page16

Thus IMO, you can not come out with a generic statement as mentioned in the OP.

[temujin]

Thanks to all so far,

I have used the Flow Charts in the FDA´s guidance document. The device is not an implant,but it will be in contact with body tissue/blood in vivo.

This takes me to section 2.2.1-" Considering that the material is likely to contact in vivo body tissues or fluids and the requirements of ISO 10993-1, is additional testing required"

I find it hard to interpret what they mean.
The material we introduce is new to us, so testing it according to the relevant 10993 standards is something we must do.

But even at this point, I´m not sure if we need to submit a new 510(k).

If I interpret the text I quoted in my first post to be such that as
<< We don´t need to submit a new 510(k) as long as we have the respective 10993 test reports - either from the supplier or made by us in an external laboratory >> Then why is this question even in FDA´s flowchart.

Wouldn´t just everybody arriving at this point just carry out the tests and document it without submitting a new 510(k) if this is a possiblility.

t.