Two or more predicates suitable? 510K submission

[Shawna]

I am wondering whether we can use two or more predicates for our scope prodcut's 510K submission. We have a wireless scope product, of which the image is transferred to display by wifi. So we are planning to use one predicate for the scope hardware, another software predicate for our wireless transfer software, because we can't find single one product as predicate. 1. anyone know whether two or more predicates are appropriate. 2. in 510K database, the entry of 1980's or older doesn't have any summary or statement. The establishment associated seems not to be found. I think maybe the establishment doesn't exist anymore or changed its name or was purchased by other company. In this case, how can we know more information about the product and its establishment? I searched the product in Google but got no luck. I know we can contact FOIA but it takes too long. Thanks for any help

 

[Shawna]

I am wondering whether we can use two or more predicates for our scope prodcut's 510K submission. We have a wireless scope product, of which the image is transferred to display by wifi. So we are planning to use one predicate for the scope hardware, another software predicate for our wireless transfer software, because we can't find single one product as predicate. 1. anyone know whether two or more predicates are appropriate. 2. in 510K database, the entry of 1980's or older doesn't have any summary or statement. The establishment associated seems not to be found. I think maybe the establishment doesn't exist anymore or changed its name or was purchased by other company. In this case, how can we know more information about the product and its establishment? I searched the product in Google but got no luck. I know we can contact FOIA but it takes too long. Thanks for any help

 

[Ronen E]

See https://www.fda.gov/media/82395/download
Look at C. Predicate Device(s) on pp. 10-13

In general information related to devices cleared in the 1980s (or earlier) is harder to get. I recommend you build your submission around more contemporary devices (say, 1995 or later).

 

[Shawna]

Thank you, Ronen, for bringing the guidance document which is completely out of my mind .

 

[Shawna]

Ronen, it is so lucky that we have you here

 

[pziemlewicz]

If you decide to use multiple predicates, FDA will evaluate as part of Administrative Review. See questions C16 and C17 in the RTA checklist. I have been asked to clarify based on this section before.

Refuse to Accept Policy for 510(k)s - Guidance for Industry and FDA