Hello Lutz,
You might want to get some other expert advice specific to your situation because there are many different ways medical devices can be identified or provide traceability through article numbers, model numbers, part numbers, SKUs, etc. You can have different part numbers or model numbers existing within a Product Family which are all covered under the same 510(k). If you introduce a new part number or article number for a device outside the current range cleared under the 510(k), then need to review how this may impact the safety and/or efficacy (performance) of the device. When making line extensions, these are often accepted to complete a change order and no new 510(K) is required, but just keep in mind the aspect of safety and efficacy. If the line extension, new article number, is significantly different, then this may require something else like a new 510(k) submission.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 25-Sep-2022 12:44
From: Anne LeBlanc
Subject: 510 (k) new article number
Dear Lutz
It sounds like the thing has clearance as a device, but now you are thinking of making a family group of devices.
So one question would be why do they need this new device. Is it for a different patient population? Is it for a different procedure, or a different illness? That could lead you through the part of the flowchart about changed indications for use.
You'll probably need to check the part of the flowchart about changes in the labeling.
It may be true there are no new risks. You might review Appendix A examples 14-17 that talk about potential impact or non-impact of dimension changes, in case any considerations like those might be applicable.
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Anne LeBlanc
United States
Original Message:
Sent: 24-Sep-2022 14:34
From: Lutz Babilon
Subject: 510 (k) new article number
Dear Scott and Richard,
thanks for your reply. In fact i am talking about different model numbers (e.g. a new instrument (forceps), similar, but a bit longer)
Tests may be needed, but no new risks are expected.
iam curious about your opinion.
br
Lutz
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Lutz Babilon
Director QM/RA Black Forest Medical Group
Freiburg im Breisgau
Germany
Original Message:
Sent: 24-Sep-2022 04:30
From: Richard Vincins
Subject: 510 (k) new article number
Hi,
Yea agree, needs a bit more clarity on the question because not understanding what you mean by a new article number - maybe a model number?
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 23-Sep-2022 16:59
From: Scott Bishop
Subject: 510 (k) new article number
Lutz:
Perhaps you can expand on what you mean with 'article' number - is article number meant to convey part number or SKU? Perhaps you are referring to what some might call a line extension?
With some additional clarity, you might receive some valuable feedback.
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Scott Bishop
McKinney TX
United States
Original Message:
Sent: 23-Sep-2022 08:52
From: Lutz Babilon
Subject: 510 (k) new article number
Dear Community,
i have maybe a stupid question - but iam not sure.
What is your experience/knowledge about the follwing:
If you create a variant of an existing device, wich can be evaluated similar per FDA procedure ("Desciding When to submit a 510 (k) for a change to an existing device") but has another article number and is existing in paralell with the other article.
What is your opinion? I s a "device" nessecarily = article number?
thanks for your support
Lutz
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Lutz Babilon
Director QM/RA Black Forest Medical Group
Freiburg im Breisgau
Germany
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