We recently submitted a 510k for a new multiparameter monitor that has two indications for use (one a diagnostic and one a theragnostic). The first requires only the base functions and the second requires the base functions, plus an additional component. There is a strong predicate device for each use that also covers the technological characteristics.
Each indication would require review by a separate panel and though the two uses rely on the same monitoring function and seem to essentially follow Example 4 of the Guidance, Bundling Multiple Device or Multiple Indications in a Single Submission, the intake reviewer has requested that we instead submit two separate 510ks.
1) is the distinction being made because the two indications require review by two different panels?
If we submit two 510ks to the two separate panels simultaneously:
2) what is the experience of the group in the coordination, if any between the two panels.
3) will this hurt, help or complicate our review process timeline?
4)and the primary question: how and when do they later become combined or do we simply market the device using two 510ks? What if later we make even minor changes to the device, do we always have to submit two 510ks!?
If any one has experience with this type or similar submissions it would be great to hear from you.
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Sabina Bruehlmann
Calgary AB
Canada
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