There probably is not enough detail to comment as Loganathan mentions, though quick swag off the top would probably find Special 510(k) submission a viable pathway. There are specific reasons when a Special 510(k) can be used, i.e. your own device, no change to indications for use, no change to fundamental technology or operation. If this component to facilitate entry does not change the fundamental operation, then it might be able to file a Special 510(k). Definitely read the guidance document and information on FDA's website about Special 510(k). The biggest difference with a Special is you only submit the "new" testing showing the device safety and effectiveness has not been impacted by the change to device. However, I might lean toward Traditional because you already mention 'undergone multiple changes' that is the device is quite different from what was originally submitted this may lend itself also to a Traditional submission.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 22-Jul-2019 12:42
From: Loganathan Kumarasamy, MS RAC
Subject: Special vs Traditional 510(k)
Hello,
Unfortunately the above information seems limited for us to comment on whether it would quality or not. When you say it has undergone multiple changes, are there changes with the design, intended use or materials used?
I would suggest to run the changes with the flow chart provided by FDA. Please see below the link where FDA has provided the guideline to determine when ti would qualify for special 510(k).
https://www.fda.gov/media/99812/download
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Loganathan Kumarasamy, MS RAC
Senior Consultant
Waukegan IL
United States
Original Message:
Sent: 22-Jul-2019 00:01
From: Anonymous Member
Subject: Special vs Traditional 510(k)
This message was posted by a user wishing to remain anonymous
Hi,
We have a surgically invasive device (transient contact) Class II , 510(k) cleared , which has undergone multiple changes and we have done a LTF for the same including material changes . There's a another change proposed of inclusion of a component to facilitate the device entry . Although going by the primary product , its a class I , because of the intended use and its use with a Class II accessory , the device class is at a Class II.
Is there any chance that this device modification (including the former) can be cleared through a special 510(k).
According to me , it requires a traditional , however the project find this approach very attractive and are pushing for it. What are the reasons that I can put forth that this would not qualify for a Special ?
Thanks,