Submit a 510(k) with a Predicate cleared but not Listed

Berni

Starting to get Involved
#1
We have received the 510(k) clearance letter. We also have prepared the submission of the new version of the cleared device, a new 510(k) which uses our cleared device as substantially equivalent. The new device includes wireless communication and some other changes but similar intended use.
This is the device we want to bring to the US market. Our idea is to submit the new 510(k) saving the costs of the registration and listing. Do you think this is possible? I haven't found anything that makes me think that we can't do it.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
21 CFR 807.92 (3) indicates that a device which has been found to be substantially equivalent through the 510(k) premarket notification process can serve as the legally marketed device to which a new device may be compared for a determination regarding substantial equivalence.
 

Sullen-gent

Starting to get Involved
#3
Would it matter if that device had not been used in clinical practice in the US? Is it still suitable as a predicate without any clinical use data?
 

mihzago

Quite Involved in Discussions
#4
There is no requirement to sell or use a device in the market after a clearance. Some companies dissolve soon after a clearance, and some use a step-wise approach to getting a clearance (start with basic claims and expand in subsequent submissions).

There's also no requirement to list a device after receiving a clearance if you do not plan to market the device.
 

Sullen-gent

Starting to get Involved
#5
21 CFR 807.92 (3) indicates that a device which has been found to be substantially equivalent through the 510(k) premarket notification process can serve as the legally marketed device to which a new device may be compared for a determination regarding substantial equivalence.
Would it matter if that device had not been used in clinical practice in the US? Is it still suitable as a predicate without any clinical use data?
 

mihzago

Quite Involved in Discussions
#6
It would not matter.
Other than recalls and MDRs, the FDA has no good way of knowing how a cleared device is used in clinical practice or if it's even used.
So yes, even if a cleared device has not been used in clinical practice, it is still a suitable predicate.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#8
Would it matter if that device had not been used in clinical practice in the US? Is it still suitable as a predicate without any clinical use data?
510k submissions don’t necessarily require clinical data. The base concept is that it’s enough to show identity in intended use and technological equivalence to demonstrate substantial equivalence.
 

Berni

Starting to get Involved
#9
Thanks a lot for your answers. It's weird they don't request some kind of clinical data or device usage for a predicate statement but in my case, is a good point. We want to reach the market with the new device which substantially improves the predicate in usability.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#10
It's weird they don't request some kind of clinical data or device usage for a predicate statement
510k's are only intended for low and moderate risk devices (classes I & II). The requirements are commensurate with the risk. Where the risk is higher (class III) clinical data is certainly required. I think it all makes sense.

We want to reach the market with the new device which substantially improves the predicate in usability.
(emphasis added)
You need to be careful - you need to ensure that:
(a) you don't deviate form the predicate's intended use (Remember: Intended use is the one implied from everything, not necessarily what one conveniently writes in their statement); and
(b) any technological differences don't raise new questions regarding safety & effectiveness.
 

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