Working on a 510(k) that is very similar to the predicate device

[robertjbeck]

I am working on a 510(k) that is very similar to the predicate device, which is an earlier version of the new device. one difference is that the original 510(k) had a contraindication (stating the device should not be used in patients with pacemakers). there is no data that supports this contraindication. the company is embarking on a clinical trial that includes patients with pacemakers, and FDA has ruled that this study is a non-significant risk study.

any suggestions about how to proceed with removing this contraindication in the new 510(k)?

 

[Ronen E]

Re: 510(k)

I am working on a 510(k) that is very similar to the predicate device, which is an earlier version of the new device. one difference is that the original 510(k) had a contraindication (stating the device should not be used in patients with pacemakers). there is no data that supports this contraindication. the company is embarking on a clinical trial that includes patients with pacemakers, and FDA has ruled that this study is a non-significant risk study.

any suggestions about how to proceed with removing this contraindication in the new 510(k)?

What's the basis for the NSR determination? Is there any clinical evidence available to support use in patients with pacemakers?

I'd say that the risk should be formally analysed and managed, and that clinical evidence should be compiled to support the risk estimates / evaluations. The highlights could be included in the 510(k) submission where you discuss the differences from the predicate, to support a decision that the devices are still equivalent although the contraindication is removed (i.e. the risk is not significantly increased).

Cheers,
Ronen.

 

[robertjbeck]

Re: 510(k)

The NSR came from a proposal for a trial that uses the device in patients with pacemakers. FDA responded with a determination that the "proposed clinical investigation is a non-significant risk device study .. therefore an IDE is not required for the study." pacemakers were not listed as an exclusion criterion in the study protocol. there is a section in the protocol that specifically states, "subjects with pacemakers or ICDs will be included into this study .." based on a previous study.

This previous study evaluated the system for electromagnetic interference in 100 patients, with no interference detected. I suppose this data could be included in the 510(k) if necessary, but apparently the study sponsor doesn't want to provide it except as a summary with not much more detail that the previous sentence.

I think your suggestion about using a risk-based approach sounds very good.

 

[Ronen E]

Re: 510(k)

The NSR came from a proposal for a trial that uses the device in patients with pacemakers. FDA responded with a determination that the "proposed clinical investigation is a non-significant risk device study .. therefore an IDE is not required for the study." pacemakers were not listed as an exclusion criterion in the study protocol. there is a section in the protocol that specifically states, "subjects with pacemakers or ICDs will be included into this study .." based on a previous study.

This previous study evaluated the system for electromagnetic interference in 100 patients, with no interference detected. I suppose this data could be included in the 510(k) if necessary, but apparently the study sponsor doesn't want to provide it except as a summary with not much more detail that the previous sentence.

I think your suggestion about using a risk-based approach sounds very good.

From the sound of it FDA didn't really look into the issue, and since the specific risk(?) wasn't highlighted, it could be plain oversight. So I wouldn't count on that.

Were there any subjects with pacemakers in the previous study (electromagnetic interference)?

 

[robertjbeck]

Re: 510(k)

Yes, there were. I don't have the details available but the protocol states, 'the [device] was placed on the skin directly over the implanted device in 100 subjects. in 208 successful uses, no EMI was detected.' I realize this is hardly complete data, for instance, the total number of uses is missing, but I think this is worth citing as data showing that risk with pacemaker patients is low.