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FDA 510K - Justifying Fatigue Test results - 3rd Party Component Failure

J

jtavares

#1
Hi,

I am needing some guidance on trying to justify one of our fatigue test results due to the fact it was the 3rd party component that failed and not our specimen. Is this possible, how would I do it? And would the FDA approve our device?
 
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Qara123

Involved In Discussions
#2
Hi jtavares,

Are you preparing a new 510(k) submission or is this a response to an FDA deficiency letter?

In any case, a risk analysis is vital to your justification. I suggesting listing all the ways the device could malfunction as a result of the faulty component and provide a rationale why each risk is acceptable.

Note: You probably need to provide more information in your post so that others can give you more advice. I understand the submission information is sensitive but it is really difficult to make suggestions based on what you have provided... Maybe a consultant with an NDA (non-disclosure agreement) would be your cup of tea.

Q
 
J

jtavares

#3
Thank you for the reply.

We are currently going through the fatigue testing portion to establish substantial equivalence for a 510K class 2 endosseous dental abutment. We are using a 3rd party implant body. We have had 2 successful run outs to 5 million cycles, which is required and 1 is currently still running, however 1 did fail at the same load. Based on the FDA criteria it states that we need to get 3 successful run outs to 5 million cycles. What we are looking for is how to write the substantial equivalence in order to justify that our system is marketable. The technicians at our testing lab have observerved cracking in the 3rd party component and I am needing some guidance to "How" we can justify the data in our favour in order to get an approval.
 

Qara123

Involved In Discussions
#4
Firstly, I must say I have no clue what is an endosseous dental abutment so I'm just shooting out ideas (yeah, the usual "don't kill me, i'm just the messenger" statement:)).

A quick search on FDA's website yields a guidance document for the device. Specifically, page 9 provides recommendations for fatigue testing at the endurance load. After re-reading your posts, I was a little confused. Can you clarify whether your situation is:


S1. The 3rd party component cracked, but your device is OK (in your 1st post). What is your concern since your device meets FDA's recommendations for fatigue testing?

OR

S2. The 3rd party component cracked and your device failed (in your 2nd post). However, you believe your device failure was a direct result of the cracked component and not a fatigue issue. If this is the case, why do you feel the need to submit data from the cracked component test? Doesn't the cracked component void the test?

OR

S3. Something else altogether, meaning "Q, you should quit your job and become a sci-fi writer, your imagination borders the realm of legendary".


Q
 
J

jtavares

#5
Sorry, definitely new to this. It was the 3rd party component that failed first and then due to the force ours snapped. We were told by the testing lab that ig we could find a way to justify the fact that our medical device is just as good as other predicate devices but it was the 3rd party component that was substandard then there was a possibility of being approved. I was just wondering if anyone else has had this issue and how to write a proper substantial equivalence justification.

Do Sci-Fi writers get paid well? It's a thought...
 

Qara123

Involved In Discussions
#6
Do Sci-Fi writers get paid well? It's a thought...
Only the good ones... :) Meanwhile, somewhere on planet Earth...


I guess the fatigue test is long and painful so you don't want to re-test your device. In lieu of more test data, I think the best bet would be some form of statistical analysis to demonstrate your device was doing fine before the component cracked and that it would have performed similarly to the other 2 devices that met the fatigue test requirements. Showing that the cracked component caused the failure may not go well with the FDA because it does not indicate that your device meets FDA's recommended test requirements, just that you had a bad part.

The FDA guidance document also suggests comparing your test results with the predicate device. If your test results are considerably better than the predicate device, be sure to point that out. Let your numbers to the talking.

While I am unfamiliar with your device, I believe the key ingredient is to provide FDA a good scientific rationale for them to approve your device (boy, it felt good to state the obvious!). You may wish to consider hiring a consultant (not me) familiar with your device to help you out. Good luck.


Q
 
M

MIREGMGR

#7
OT...

Do Sci-Fi writers get paid well? It's a thought...
Asimov's Science Fiction magazine is an established market for science fiction stories. We pay on acceptance, and beginners get 6.0 cents a word to 7,500 words, 5.0 cents a word for stories longer than 12,500 words, and $450 for stories between those lengths. We seldom buy stories longer than 15,000 words
So the answer is, no, they aren't paid well.
 
A

AmericanSwede

#8
Based on what you said
…but it was the 3rd party component that was substandard...
I'm sorry, but we're talking about a critical component in a medical device here. If there's one thing the FDA doesn't like, is a manufacturer putting the blame on "others" for their own products. Your company has presumably spent tons of hours designing, prototyping and testing this device - but your company has also selected who will supply you with this "critical component". Trying to think up a way to justify using a component that causes failures in your medical device is just asking for trouble, if not now, later down the road when it fails in people’s mouths. Risk analysis should never be used to get around safety issues, it should be used to find the risk areas and mitigate them.

This is an old post, and probably this product has already hit the shelves (or the dentist office). I hope that your company has found another critical component supplier that meets your minimum standards, until then I’ll keep away from getting any of my teeth replaced with implants.
 
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