I find this discussion very interesting, because it involves an area in which I have limited experience and knowledge. However, that's never stopped me before. :)
I've never been under the impression that head-to-head testing was required to support a claim of substantial equivalence. Certainly this is the most unambiguous approach, but the requirement is for the two devices to have the same "technological characteristics," which I think can be (which is not to say whether FDA does or does not) interpreted pretty broadly. I think other approaches are often used, including the use of standards and historical data. I have wondered if the perception that head-to-head testing is required might stem from the fact that many 510(k)s claim SE to another device manufactured by the same company, in which case, of course you do head-to-head testing, and eventually the perception develops that head-to-head testing is how it is done?
I must say, I don't know about a pre-sub. I'm also under the impression that pre-subs are not routinely requested for 510(k)s., but maybe my impression has become outdated since the release of the guidance...and while there is still no fee for a pre-sub.
I thought pre-subs were usually requested for 510(k)s only if there was some special concern or complexity about the 510(k) and the demonstration of SE. Of course, there is a special concern in this case, which is that you can't do head-to-head testing because your predicate is not available, because it was never marketed. I concur with Mark's wisdom that it would probably be best not to point out to FDA that your predicate was never marketed. If the only reason for the pre-sub is to try to confirm that head-to-head testing isn't necessary, then it seems to me it could be a short hop to the reason you want to leverage standards instead of doing head-to-head testing.
If you think you can put together a good 510(k) leveraging standards, I might be more inclined to just do that. What's the worst that can happen? That's not a trick question, because the answer to this question is in large part a business question, and can only be answered with a knowledge of your company and how this device fits into its business goals. Assuming it's not a one-device start-up, where the entire company lives or dies on timely clearance of this one device, the worst might not be very bad at all. But that's something only you can determine, in consultation with your management.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 18-Dec-2017 00:29
From: Tina O'Brien
Subject: When the perfect predicate was never commercialized
So, here's a new one for me...
I have a new device that requires a 510(k) - there's only 1 other device (cleared in 2009) that has the exact same intended use within the ProCode. However, that device was evidently never commercialized and the company no longer exists, so we can't purchase it to conduct head-to-head testing for SE. Additionally, the sponsor submitted a 510(k) Statement in lieu of a 510(k) Summary, I was able to track down the person on the clearance letter and send a request for information, but have received neither acknowledgement nor response. I've also submitted a FOIA request for the device's original submission, but nothing received to-date - and no guarantee that the info I need won't be redacted.
As I suspect this is not an isolated incident, I'm hopeful that someone on RegEx has been through a similar situation and can share their experience.
Can I leverage standards related to this type of device (and assume that this predicate would meet the current standard)? Am I up a creek and need to identify a Plan B? Realistically, I could probably use a different predicate, but that means so much extra work to demonstrate that the differences don't raise new S&E questions = time and money I don't have. The predicate I'm targeting is exactly what I need, so I'm hopeful for a creative workaround.
Looking forward to hearing about actual experiences,
Tina
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Tina O'Brien RAC, MS
Director of Regulatory Affairs
Aroa Biosurgery
Auckland
New Zealand
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