Hi. Our company is developing a dental laser and seeking 510k approval. We have used a third party reviewer and 510k submission was sent 2 weeks ago. Last week, we received a response with some deficiencies which are not in line with 510k guidance document and making the proper response somewhat difficult. We have in the past developed and submitted 510k for the exact same product without any challenges. The new 510k combines features of past cleared 510k devices and are substantially equivalent to our product .
We submitted 510k with 1 primary and 2 secondary predicate devices. In their response to us fda is ignoring both secondary predicates and we must prof substantial equivalence with the primary alone. The fda guidance document on the preparation of 510k's clearly states that multiple predicates can be used when combining features of multiple devices into 1 device. Our product combines features of primary and secondary predicates.
The fda is asking us to prove substantial equivalency with the primary predicate alone which we don't believe to be an issue. What triggered us to reach assistance is the fact that fda is also asking for animal study to prove substantial equivalency. It is important to disclose that primary predicate have submitted animal study in their submission.
We would like to have a conference call if possible, explain more in detail about our product submission, product and share with you the 510k deficiency report in order to seek guidance on how to proper respond back to them.+13 Other Responses