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When to submit a 510(k) for a change to an exisiting medical device
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When to submit a 510(k) for a change to an exisiting medical device
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  Post Number #1  
Old 23rd February 2009, 11:35 PM
celia4237

 
 
Total Posts: 93
Question When to submit a 510(k) for a change to an exisiting medical device

I have some questions when i am reading the guidance document " deciding when to submit a 510(k) for a change to an exsiting device", especially the item B8.3, "Occasionally, however, either routine design validation activities produce unexpected results or otherwise prove to be inadequate to validate the design change.In such instances, questions of safety and effectiveness may be asociated with the design change, and the manufacturer may need to submit a new 510(k)".

Let's take the blood pressure monitor for example, if we made the change in software as well as the firmware, for example, the CPU is changed to achieve a quick response, or the PCB is changed to fit a new type of case housing, or a cheaper component replace the original one, that is, we fit the criteria of B8 of the guidance, the next step, we have to go to B8.1, B8.2, B8.3 of the flowchart for determination. Actually, i think we have to do the 60601-1 test and the 60601-1-2 test, the SP10 test, the software validation as the design validation. The question is, if the scheme of the design validation remains the same, and the results of the design change validation are as predicted, is a new 510(k) needed? Or document the efforts only is enough?

Is there anyone who can help me?

Thanks a lot

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  Post Number #2  
Old 24th February 2009, 01:05 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,265
Re: When to submit a 510(k) for a change to an exisiting medical device

You cite a lot of examples and the actions needed on each one may vary (for example, if you change your PCB you might need to retest to safety standards, but not necessarily because of a potential 510K change, but simply because you device configuration - ex., creepage and clearance distances - have changed).

Regarding the question - if the scheme of the design validation remains the same, and the results of the design change validation are as predicted, is a new 510(k) needed? Or document the efforts only is enough?

The scheme i understand this as the design validation process) is not the main concerne, the problem are the results. You can use the same design validation process and have results that show new issues of safety and effective.

So, if you "predicted" means a result which do not raise new issues, just the documentation would be ok.

One point to bear in mind as a tip is that, if your design validation process needs to be differente, this is generally because thereīs a new funcionality / part / etc. in the device design, and this means that the probabilities that a new 510 K is needed are higher (but still need to be investigated anyway:-))
Thank You to Marcelo Antunes for your informative Post and/or Attachment!
  Post Number #3  
Old 25th February 2009, 03:02 AM
celia4237

 
 
Total Posts: 93
Re: When to submit a 510(k) for a change to an exisiting medical device

Thanks Marcelo, your response really help me a lot, but i think i am still confused about the meaning of "shows new issue of safety and effectiveness."

Can you give me some more detailed example of modification whose result shows new issue of safety and effectiveness?

Thanks a lot.
  Post Number #4  
Old 25th February 2009, 04:09 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,265
Re: When to submit a 510(k) for a change to an exisiting medical device

Quote:
Can you give me some more detailed example of modification whose result shows new issue of safety and effectiveness?
I think youīre getting things wrong here. Modifications, and their design validations, MIGHT result in new issues of safety and effective, so, in a theoretical way, i cannot give examples.

This depends on the modification, on the validation, and, more importantly, on theway youīre conducting your regulatory scheme - it really depends on how you show the safety and effectiveness (S&E) of your device.

Letīs try a "big picture" example: take the information on this link - http://www.fda.gov/cdrh/pdf2/p020056b.pdf. Itīs a "SUMMARY OF SAFETY AND EFFECTIVENESS DATA" for a Silicone Gel-Filled Breast Implant. This contains the information that the manufacture defined as representing how he dealt with S&E of the device, and which concludes that the device is safe and effective. In a general way, any device modification that changes any of the information contained in this document MIGHT raise new issues of S&E. SOme modifications can have no impact, and some can have a big impact. Itīs up to you as the manufacturer to investigate this.

If you want a lower picture, practical scheme: every requirement of a device has to be verified and validated and the related risks, dealt with. If a new requirement introduces a new risk or modifies an older risk, this deals directly with the safety (and effectiveness in omst of the cases) of the device (if youīre using a risk management framework based on ISO 14971, for example, you already have to do all this iīm talking about).

Some practical examples: if youīre device is electrically powered, ons of the safety issues you have to deal with is electrical safety. One of the aspects of electrical safety is leakage current. If you declare that your electrical risk of leakage current is deatl with using a transformer with double insulation (itīs not this simple but letīs assume it is for exampling purposes), then it can be accepted by reg authorities. if you change your transformer supplier, you would have to validate again the transformer. The result might be that your new supplier cannot deliver a double insulation transformer, meaning you would need to look for and implement another solution for your leakage current electrical safety problem (in general you would need to put another insulation barrier somewhere). You can see by the line of thought why i said before that itīs difficult to give examples.

Hope this clarified things a little.
  Post Number #5  
Old 25th February 2009, 11:48 PM
celia4237

 
 
Total Posts: 93
Re: When to submit a 510(k) for a change to an exisiting medical device

Thank you Mr. Marcelo. You have explained the problem from 3 angles of view, and this really help me a lot.

For the practical problem you have mentioned that " if you change your transformer supplier, you would have to validate again the transformer. The result might be that your new supplier cannot deliver a double insulation transformer, meaning you would need to look for and implement another solution for your leakage current electrical safety problem (in general you would need to put another insulation barrier somewhere). " I think you mean that, if the result of the validation shows that the transformer can't acheive a double insulation, then the modification has BROUGHT THE NEW ISSUE OF SAFETY AND EFFECTIVENESS. And i have to submit a new 510(k)?

Am i right?

Waiting for your direction!
  Post Number #6  
Old 26th February 2009, 01:00 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,265
Re: When to submit a 510(k) for a change to an exisiting medical device

Quote:
I think you mean that, if the result of the validation shows that the transformer can't acheive a double insulation, then the modification has BROUGHT THE NEW ISSUE OF SAFETY AND EFFECTIVENESS. And i have to submit a new 510(k)?

As always, it depends :-). There are a lot of problems with this example, but letīs try to use it anyway.

Thereīs at least two answers, depending on some factors.

The first, quick one is: yes, thereīs a new issue of safety and effectivess because it introduces additional risks and then you would need to submit a new 510 (k).

Second option, a more elaborate one: although thereīs a new change, in fact the results of the validation using the new risk control mechanisms could be the same and then there would be no new issue of S&E.

OK, letīs delve some step further in this line of thought. If the transformer cannot achieve double insulation, you would need to make a design change to include an insulation in another place. Letīs say that you put an additional insulation barrier in the form of a capacitor between the patient and the transformer . So, your new way of dealing with the leakage current electrical safety hazard is now transformer + insulator capacitor (the original one, submitted to the reg agency, was just the transformer). This clearly means that itīs SEEMS a new issue of safety, because it can pose some additional risks (again, thatīs not that simple, could be effectiveness also, because a capacitor raises other issues, but letīs presume itīs simpler than that).

If you take a look at the flowchart of the fda guidance....this situation would be, in the main flowchart, a technology or performance change, and you would need to look at flowchart B. There you would discover another problem with the example. It does not fit clearlythe options in flowchart B. This situation is a change in a risk control measure, and it would seem to fit the the "change in control mechanism'..the problem is that control mechanism, as defined in the guidance, is the control to the output of the device, not risk control measures. The best guess on this would be to fit this change, weird as it may seem, in the"change in peformance specification" (this still does not fit right, because it differs from the definitions of performance on the guide. But, if you classify this as a control mechanism change , as i said in the first option, you would need almost surely a new 510 (k), and this in my opinion would not always be the case).

So, if we presume that this change is a "performance specification change" and we make the validation (for example, using the same electricals afety standard we have already used for testing), our predicted result would be that the results would be the same as if using only the transformer (and in practice, they will be in the way we are presuming the situation). So following B.5, in B.8.1 it would not affect IFU, in B.8.2 more clinical data would not be necessary, and in this particular case (with all the restrictions we are applying to the example) there woould not be a new issue of safety and effectiveness. So you would only need a documentation (there might be a need to update some documents, including your "SUMMARY OF SAFETY AND EFFECTIVENESS DATA") change.

Wow, i think i will stop here. This explanation is a little confusing, but thatīs because, as i told you before, it depends on a lot of things. I hope this has clarified things a little more that it confused :-)
  Post Number #7  
Old 26th February 2009, 04:08 AM
celia4237

 
 
Total Posts: 93
Re: When to submit a 510(k) for a change to an exisiting medical device

Thank you for your quick response. And it really clarifies a lot of things.

But it seems that the same modification can bring 2 different way of solution, a new 510(k) or not.

It is sure that FDA give the manufacturer the right to decide submitting a new 510(k) or not, but only 1 guidance document is provided for the manufacturers to refer to. So i think it is hard for the manufacturers to make a determination and the manufacturer will face more risk.

What do you think?

Thanks again.
  Post Number #8  
Old 28th February 2009, 03:34 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,265
Re: When to submit a 510(k) for a change to an exisiting medical device

Well, youīre correct in your statement.

To tell you the truth, the way i see regulatory affairs nowadays is something like "the field of of studying regulatory process / requirements, making decisions and how to meet them in a way as to minimize regulatory and other outside-of-company-control risks". In this way there will ALWAYS be risk on the decisions.

If you noted in my explanations, yes, there seems that the same modification can bring two different solutions. The point here is, what is the knowledge of the company and what level os risk it wants to take.

In the fisrt, straightforward example (thereīs a new issue of safety and effectivess because it introduces additional risks and then you would need to submit a new 510 (k)) - either the company does not know the whole process and nuances i mentioned in the second example (it happens a lot, mind you, because the second example is extremelly technical and companies sometimes do not have people with that kind and depth of experience) or the company does not wich to take any risk, simply going for the more obvious decision (make a new 510 (k)). Note that this decision, as in the second example, has a lot of financial, technical, temporal and other implications. So you would make this decision and them perform the rest of your actions based on that decision (including validation).

The second example, as i said, has a lot of problems. The main problem is that i had to assume a lot of things to finish the trail of the example, and a lot of them are not true. The main point is that, when you change then insutaion to a capacitor, i assumed that there were not be other safety issues, when in fact a lot more safety issues arise (for example, EMC). So, in fact, the second example, if done correctly, would in the end generally also need and 510 (k)....so in this way the outcome would be the same. You CAN do as i explained, just presuming a lot of things...but in this case the risk of it being questioned arises.

Resuming: thereīs no "correct answer", as it depends on the case, on the manufacturer, on the financial, temporal, technical, decision components, and level of risk the company allows itself to assume.

Iīm sorry if i cannot give you the "right" answer tou seek.

keep in mind that you cannot forget that all this is related to the safety of the device..... in both my examples, the "level of safety" will be more or less the same, what will change is the "path" yoy chose to get to them.
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