Here are some additional avenues I have utilized in the past:
1. Assuming that you know the pro-code for the device, do a through search through either FDA's TPLC listing to see all submissions or other creative sites such as How long will it take for my 510(k) to be cleared by the FDA? This can be used to guestimate (yes that's a word!) total clearance times and also sift out recent devices that were cleared using the same pro-code.
2. Use above data to review the 510k summary. Recent 510k summaries often contain a detailed substantial equivalence (or predicate analysis) for the cleared device. This gives good clues about key features/aspects that the reviewers are looking for. If you see a few recent clearance, you will quickly see a pattern in the list of features that are expected for this comparison. If you are lucky, you will also get clues about mandatory standards that must be satisfied.
3. If you are exploring devices used in hospital environment, never forget the power of YouTube. Lot of doctors like to show off their techniques and have extensive video feeds illustrating of certain techniques and they will include use of specific devices.
4. As pointed before, if some of your friendly customers or KOLs have competing products in their practice, you might be given access to see them using the system. This is well worth the time and effort. Do this task with a technical lead from your company or a product lead. This way, you can take note of things you dont understand and clarify them with the product manager who might have domain knowledge in this area. This way, you dont have to interrupt the clinician while they are using the system. If you can lucky, you could video tape some of this to review laer. This will give you invaluable know-how that will come in handy during interactive review periods and/or AI response time. It goes without saying, watch out for pitfalls such as accidentally capturing PHI in your data!
Thought it is quite frustrating, this is by far the most exciting part about piecing a 510k together. All the best.
Thas
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Thas Yuwaraj
Original Message:
Sent: 23-Sep-2016 11:28
From: Gretchen Upton
Subject: 510K substantial equivalence
I'd check clinicaltrials.gov to determine if they had an associated trial. If the trial is ongoing, perhaps you could obtain a copy of the Investigator's Brochure or protocol from recruiting site (that would be a bit tricky). I'd also search on Pub Med... see if they published a retrospective on the device prior to implementation.
Good luck!
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Gretchen Upton RAC
San Antonio TX
United States
Original Message:
Sent: 22-Sep-2016 09:33
From: Noemi Olivo
Subject: 510K substantial equivalence
I'm having a similar issue: Our device is a potential competitors to the predicate device we have chosen for our 510(k) submission and are not too keen on asking for their package insert since they require that we "sign-in"...any ideas on where else we may look? We need the package insert for information on the instructions for use and the product specs. Thanks!!
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Noemi Olivo
Milford CT
United States
Original Message:
Sent: 21-Sep-2016 13:40
From: Kathryn Howland
Subject: 510K substantial equivalence
I would first to go the company website of the predicate device. It is amazing what can be found there. Navigate through everything -- news letters, media updates, labeling, device descriptions, etc. Then, I would go to FDA website and see what I can find. As Gretchen wrote, you can find a lot of information there. I would also look at submissions of other companies who used the same device for their predicate device. Did the company of the device you wish to use as a predicate device submit a PMA or a 510(k). If they submitted a 510(k), look at what they used as a predicate device. By looking at the submissions of other companies who used the device in question as a predicate; and, also looking at the submission of the device you want to use as a predicate and finding what they used as the predicate, you can find a lot of information!
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Kathryn Howland RAC
Regulatory Affairs Specialist
Penngrove CA
United States
Original Message:
Sent: 21-Sep-2016 09:27
From: Alexandra Beumer Sassi
Subject: 510K substantial equivalence
How to proceed when you need to compare the new device to a predicate device for establishing substantial equivalency, but you can't obtain the predicate device since it is a prescription product only? Are there alternatives to that?
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Alexandra Beumer Sassi
alexandra.beumersassi@cardinalhealth.com
United States
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