robert.beck
Involved In Discussions
Hi there,
first some background .. am familiar with the guidance doc on when to submit a new 510k, have read the 2010 510k working group report which discussses intended use vs. indication for use. here is my question:
the device has an approved 510k from 2007. at that time it was developed as an adjunct to another medical device which is now becoming obsolete. the company that makes this device makes many other similar models, and so do its competitors.
we've made a new version which works better and even considering all of the changes for this new version, a new 510k is not needed. so from a technology, risk, materials, patient population, warnings, etc. a new 510k is not needed.
The intended use is not changing at all. But I would like to change the indications for use by removing the reference to specific model and brand of the device, substituting the general category of device but otherwise keeping the indications for use identical. the only possible way this changes the patient population is that the target market is increased numerically but not changed in terms of any definition of what an appropriate patient is.
I know that following the guidance document's flowchart literally results in having to file a new 510k. however, I think this is a minor change. the guidance document also states that "any change in the indications for use that limits use to within the currently cleared indication may occur without the submission of a 510(k)." The section of the guidance document that elaborates on the flowchart has this relevant statement:
"A1 Does the change affect the indications for use? .. any change in the indications for use that limits use to within the currently cleared indication may occur without the submission of a 510(k) .. If the expansion is to a population with similar demographics, diagnosis, prognosis, comorbidity and potential for complications as the original, then a new 510(k) is not ordinarily expected.
is it reasonable to document this but not file a new 510k? What's your opinion?
first some background .. am familiar with the guidance doc on when to submit a new 510k, have read the 2010 510k working group report which discussses intended use vs. indication for use. here is my question:
the device has an approved 510k from 2007. at that time it was developed as an adjunct to another medical device which is now becoming obsolete. the company that makes this device makes many other similar models, and so do its competitors.
we've made a new version which works better and even considering all of the changes for this new version, a new 510k is not needed. so from a technology, risk, materials, patient population, warnings, etc. a new 510k is not needed.
The intended use is not changing at all. But I would like to change the indications for use by removing the reference to specific model and brand of the device, substituting the general category of device but otherwise keeping the indications for use identical. the only possible way this changes the patient population is that the target market is increased numerically but not changed in terms of any definition of what an appropriate patient is.
I know that following the guidance document's flowchart literally results in having to file a new 510k. however, I think this is a minor change. the guidance document also states that "any change in the indications for use that limits use to within the currently cleared indication may occur without the submission of a 510(k)." The section of the guidance document that elaborates on the flowchart has this relevant statement:
"A1 Does the change affect the indications for use? .. any change in the indications for use that limits use to within the currently cleared indication may occur without the submission of a 510(k) .. If the expansion is to a population with similar demographics, diagnosis, prognosis, comorbidity and potential for complications as the original, then a new 510(k) is not ordinarily expected.
is it reasonable to document this but not file a new 510k? What's your opinion?
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