Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

My company is developing an accessory to be used with a specific cleared medical device. This accessory will either replace an existing surgical procedure step (we provide one component and hospital must provide other component to complete this step) or be included as a second option for the surgical step. There are no changes to the main device. We plan to include the new accessory in the existing packaging for the cleared device and update the existing labeling accordingly. Although we haven't completed the initial risk assessment yet, I suspect the risk analysis will tell us the accessory is still class II. A few questions:

1) For the addition of the accessory to the cleared device, is a special 510(k) a reasonable pathway assuming the requirements are met?
2) With regards to a predicate device, do I need to include another predicate for the accessory in addition to the cleared device? or is it reasonable, if true, to substantiate this as a different technological characteristic that does not raise new questions of safety and effectiveness?
3) Is this considered an accessory if we decide to replace the current surgical step with this accessory? or only if we add this as an alternative way to complete the step?

Thank you!

Anon

Hello,

In regards to adding accessories to an existing device, it really depends on if the intended use and intended purpose changes.  To answer your questions:

1) Recommend going through the changes to a device for 510(k) submission guidance https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device. As just adding an accessory may have other impacts.  If indeed it is maybe making the process easier and less cumbersome, then the addition of an accessory might not need a new filing.
2) If you determined a new 510(k) application is needed, maybe a Special 510(k), then most likely could use your own device as the predicate.  Initial thoughts usually an accessory would not have a significant risk impact on the intended use.
3) Unfortunately without knowing the device, the surgical procedure, the intended purpose, this is a hard question to answer.  It can depend on many factors.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 22-Feb-2021 16:17
From: Anonymous Member
Subject: Addition of component/accessory to cleared device

This message was posted by a user wishing to remain anonymous

Hello,

My company is developing an accessory to be used with a specific cleared medical device. This accessory will either replace an existing surgical procedure step (we provide one component and hospital must provide other component to complete this step) or be included as a second option for the surgical step. There are no changes to the main device. We plan to include the new accessory in the existing packaging for the cleared device and update the existing labeling accordingly. Although we haven't completed the initial risk assessment yet, I suspect the risk analysis will tell us the accessory is still class II. A few questions:

1) For the addition of the accessory to the cleared device, is a special 510(k) a reasonable pathway assuming the requirements are met?
2) With regards to a predicate device, do I need to include another predicate for the accessory in addition to the cleared device? or is it reasonable, if true, to substantiate this as a different technological characteristic that does not raise new questions of safety and effectiveness?
3) Is this considered an accessory if we decide to replace the current surgical step with this accessory? or only if we add this as an alternative way to complete the step?

Thank you!

Anon