T
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.
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.
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.
(...)
(...)
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.
