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Predicate Device Information for 510(k) Submission


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In putting together a 510(k) submission for electrosurgical device, I'd like to get a copy of the predicate's submission. I'm familiar with how to request via Freedom of Information Act, but would prefer not to wait 18 months for the information needed. FOIServices doesn't have the submission in their inventory. Does anyone have another, quicker way to obtain?

Specifically, I'm interested in the waveform diagram information as defined by the following: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery. "For each mode, you should provide a graphical display of the output waveform at the rated load, identifying the associated mode, amplitude, frequency, duty cycle, load used, and crest factor." I'm assuming that this info wouldn't be redacted because it is part of labeling, but would also appreciate if someone can confirm.
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I would never assume that anything has not been redacted.

You could ask the companies who have cleared 510(k)s with these diagrams for a copy of theirs. Since these companies would presumably be your competitors, you wouldn't think they'd be inclined to share, but it happens.

You could also ask healthcare providers who purchase these devices if they would share a copy of the labeling with you...if you can identify healthcare providers and if they aren't too chummy with your competition and they aren't too litigation averse to just say no to doing anything they don't have to do.

I would contact every companies by all means available...snail mail, email, phone. I would contact both RA and Marketing and quote applicable FDA regulations. (I think they are supposed to share, but I can't remember for sure and not going to look it up.) You might find a surgeon to contact them on your behalf, hopefully to be confused with a potential customer.

After two weeks of trying to know avail, I would contact FDA. You can try DICE, but I prefer to contact the head of the reviewing branch for the product of interest. I would briefly summary my efforts (including determining that FOI services doesn't have this) and then politely ask for their suggestion of how you might proceed. They might blow you off by suggesting you file an FOI request. They might recommend you file an FOI request so they can help you (and might or might not tell you that this is the plan). They might recommend an alternative approach. They might recommend a pre-sub to discuss the situation. Or they might just send you a copy of one of these diagrams for cleared device.

I am assuming it is the information in the diagram, not the diagram itself, that is of interest to you. You can also buy one or more of the other 510(k) devices and find out this information by testing...I would think. I don't know anything about this technology, but usually this is possible. Companies are understandably loathe to spend the money, so if you are going to spend it, you probably want to confirm first that you can in fact take this approach.

If there is an applicable standard that all such device are likely to meet, you can probably use it instead of the data on the predicate device, Others here can tell you more about this approach than I can.

Ronen E

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You can also buy one or more of the other 510(k) devices and find out this information by testing...
Maybe testing won't even be required because the device might come with the diagram as part of its labeling.
Mind you, the manufacturer might not agree to sell to you (a competitor) directly, so maybe suggest to a potential user that they "buy" it for their own use with your funding, under condition that you get full access to the device and all the labeling it comes with (a written agreement seems essential after initial verbal agreement, to ensure everyone is on the same page).


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We do have a predicate device, purchased from a third-party seller. Unfortunately it did not come with full label information. Comparative bench testing is already complete.

The biggest question on waveform diagram is what range they plotted, and how many points were shown. Ideally we'd use exactly the same to demonstrate equivalence.
it did not come with full label information
If this device was cleared by FDA and the diagram is part of the labeling, then its omission is probably a strong violation of the FC&C Act.* In that case, you can first contact the third-party seller and point out that the full labeling was not required by FDA. If they have it, they will probably cough it up. Unfortunately, you might have purchased a knock-off, in which case it might not even have the full labeling. Also....just because you don't have enough stuff keeping you awake nights already....any data you collect using it might not be valid. :cry: The next step would be to contact the manufacturer and tell them you purchased their device from [Third Party] and are concerned you didn't receive complete labeling. Who knows, this might turn out to be very helpful for them to know, and they might reward you with a copy of their diagram. As I said, it happens.

An oft-used slogan in RA is "it depends." There is always a chance the 510(k) applicant was able to make a compelling case to FDA that the diagram wasn't needed, maybe not at all, maybe just not in the labeling. (Would users know what to make of it?) In that case, you would either need to make a similarly compelling case, or you get the full 510(k), which might or might not include the diagram, and, if included, might or might not be redacted, sigh.

Also, at some point, you probably want to ask yourself whether it is worth it to you to wait 18 months for a 510(k) that might not have the information you need, or more in your interests to hire a consultant to deal with them for you. Depending on your situation, that might be the best way to go from a business perspective. Or not. One reason companies hire RA consultants is their experience in dealing with these issues, especially directly with FDA. Another reason is because they can deal with them without anyone else involved knowing their identity.

If you should decide to hire someone, I hope you will come back to Elsmar for more info on this option. There are consultants and there are consultants.

I can't speak for Ronen E, but I hope you will keep us informed as to what you try, what works, what doesn't, if you just decide to wait it out. Very helpful for us when it comes to advising the next person in this situation. It's not uncommon, and I don't think anyone has found a magic bullet.
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