Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear All,

I am struggling with the topic compatible acessories for 510k submission of parent device.

I couldn't find an explicit requirement in FDA guidances whether all compatible accessories up to patient interface have to be mentioned for each claimed function in 510k submission for a parent device. I do not mean those accessories which are part of the submission, but those who are manufactured and cleared (or will be cleared) by anouther manufacturer.
Could you advise, if there are any FDA recommendations/guidance to this topic?
 
The only one I found - guidance "Format for Traditional and Abbreviated 510(k)s " chapter (10) Device Description FDA recommends: "We also recommend that you identify all models, as well as all accessories included in the submission."
And what about accessories and compatible products, which are not "included in my submission" and will be cleared by other manufacturers thorough a different 510k/excemption. 

For example: A ventilator can not be operated without breathing circuits, masks, cannulas, tracheostomy tube etc. My company doesnt supply all elements from the chain. Should I mention in the list of accessories all accessories for each functional claim (incl optional sensors, cannule, holders etc. starting from my device back to the patient interface). 
Is there a guidance that regulates that?

Thank you very much in advance!!

Hello Anon,

The reference you cited is probably the best explanation of inclusion of accessories of compatible devices in a 510(k) submission.  Often in my experience, the Device Description does describe what accessories are used with the parent or main device, which may be simple accessories to assist the user or may be more complicated to actually make the main medical device function, e.g. leads or connectors.  Without knowing the specific device or accessories you are speaking about, it might be a bit difficult to provide substantial information beyond ensuring any accessories or compatible devices are disclosed in the Device Description section.  Then depending on the accessory there may be other areas of the 510(k) submission where information needs to be provided such as Shelf Life (if like a gel-electrode), Labelling if a separate Instructions for Use (IFU) exists for the accessory(ies), or Bench Performance Testing.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 16-Nov-2022 10:45
From: Anonymous Member
Subject: Compatible accessories in 510k submission

This message was posted by a user wishing to remain anonymous

Dear All,

I am struggling with the topic compatible acessories for 510k submission of parent device.

I couldn't find an explicit requirement in FDA guidances whether all compatible accessories up to patient interface have to be mentioned for each claimed function in 510k submission for a parent device. I do not mean those accessories which are part of the submission, but those who are manufactured and cleared (or will be cleared) by anouther manufacturer.
Could you advise, if there are any FDA recommendations/guidance to this topic?

The only one I found - guidance "Format for Traditional and Abbreviated 510(k)s " chapter (10) Device Description FDA recommends: "We also recommend that you identify all models, as well as all accessories included in the submission."
And what about accessories and compatible products, which are not "included in my submission" and will be cleared by other manufacturers thorough a different 510k/excemption.

For example: A ventilator can not be operated without breathing circuits, masks, cannulas, tracheostomy tube etc. My company doesnt supply all elements from the chain. Should I mention in the list of accessories all accessories for each functional claim (incl optional sensors, cannule, holders etc. starting from my device back to the patient interface).
Is there a guidance that regulates that?

Thank you very much in advance!!