510(k) statement or 510(k) summary ?

#1
Hi All,

Can anyone tell me, why some medical devices have the detailed 510(k) summary in the 510(k) search database, but some only have the brief 510(k) statement?

Here are the examples:

1. K153283, VivoSight Dx Topical OCT System, only has the brief 510(k) statement in the database, but

2. K160878, OPTIS Metallic Stent Optimization E.4 SW, has the detailed 510(k) summary in the database,

even though these two devices have the same Regulation Number (892.1560).

Thanks.
 

bio_subbu

Forum Moderator
Moderator
#2
Hi All,

Can anyone tell me, why some medical devices have the detailed 510(k) summary in the 510(k) search database, but some only have the brief 510(k) statement?

Here are the examples:

1. K153283, VivoSight Dx Topical OCT System, only has the brief 510(k) statement in the database, but

2. K160878, OPTIS Metallic Stent Optimization E.4 SW, has the detailed 510(k) summary in the database,

even though these two devices have the same Regulation Number (892.1560).

Thanks.
It's a manufacturer choice to choose either to submit a 510(k) summary or a statement. If manufacturer submitted a 510(k) statement, the detailed 510(k) won't be available in the database, but its 510(k) owners responsibility to provide safety and effectiveness information supporting the FDA finding of substantial equivalence to ANY person within 30 days of a written request. you can contact the company directly, and you will get the redacted copies of 510(k) (with patient identifiers, trade secret and confidential information deleted).

See the link on Content of a 510(k), Content of a 510(k) and refer particularly Sec. 807.93 Content and format of a 510(k) statement, Or you can request 510k through the FDA FOIA (Freedom of Information Act).
 
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#3
Thank you bio_subbu!

I have read the "Content of a 510(k)" before, but I didn't notice that the company has to provide the information to "ANY" person.

I will try to ask for some 510(k) information.

Thanks again!
 
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