My company submitted a 510k( our first) application for a class II titanium pin. We are undergoing the second round of questions which include sterilization validation. First they tell us we need more sterilization instructions now they want them validated (we copied them from a similar device). My question is three-part:
1: does the validation prove the sterilization pouch will do it's job and the device is sterile prove the product will hold up to sterilization or does a lab check for organisms?
2. Just because we validate the sterilization process that does not mean the end user will follow them or even use the same materials we used for the validation, so what good does it do?
3. What does one do to start the sterilization validation process?
Actually the FDA said we don't have to have the validation done for the 510k but we need to state we will do it. Any feedback is welcome as I don't know what to do next.
Thanks,
MED

I guess it's a bit late in the day is why nobody has replied yet. I'll toss the first grenade...

Two words: professional help! Find a (reputable) contract sterilization company and they can do the sterilization validation. I can offer a couple of companies that we've dealt with that I would consider reputable, if you need. They can tell you all the required validation activities (life testing, ect.).

All you can do is validate that the product is sterile when you deliver to the customer. Note that this includes delivery (shipping)! The packaging has to stand up to the rigors of shipping to ensure the product is sterile when the customer receives it. You might need something in the IFU describing proper storage conditions and how to use it properly. Again, some professional help is probably warranted here, too.

Hope that helps.

Hi,

Is the device supplied sterile, or "only" sterilized by the customer?


regards
t.

Yodon has given great advise. In addition, you could refer this article from Device Link - Validating Radiation Sterilization in a Global Marketplace (http://www.devicelink.com/mddi/archive/99/02/007.html)

Also this article from FDA, Premarket Notification 510(k) Submissions for Medical Sterilization Packaging Systems (http://www.fda.gov/cdrh/ode/guidance/1388.pdf) could be of additional interest to you.

Sorry, I forgot to mention we sell this non-sterile. We do offer a sterilization cassette made just for the pin and accessories and a sterilization pouch made by another medical company.
That is why I question this, we can spend the money for a lab only to have the customer do whatever they want.
MED

Here is my oponio for your reference:

When we submit 510(k) for a device which is provided non-sterile but need to be sterilized prior to use, cleaning and sterilization instructions are presented in the manual. This provided method shall be validated and a warning ' If the user sterilize the device with parameters other than we provide, they shall be validated per appropriate standards prior to sterilization'.

And it is mentioned that you provide a pouch along with your product, then I think the validation is necessary to evaluate the peneration performance of the pouch.

Hope this can help you.

Hello Med:
Maybe it is too late for your questions.
Due to more and more clinical incident happened because of the re-usable device, more standards are required to follow to reduce the risk, e.g. the impovement of usablity, and more clear IFU.
you can refer to:
EN ISO 17664:2004
Sterilization of medical devices - information to be provided by the manufacturer for processing of resterilization medical devices
ISO 62366:2007. Medical devices -- Application of usability engineering to medical devices

Best regards,
Fan

Thanks for the input but the project was completed using ISO 17665, part 1. The FDA did not recognize it at the time so we had to show it was equivelant to the outdated standard they wanted us to us. I think I read they now accept this standard.
Medic

i) Is yours device is strile before packed? or ii) it is to be sterilized by end user?

regardless of above case you need to do sterilization validation.

For example if you are doing Gamma sterilization with 25 Kgy dose then you need to do sterilization validation using ISO 11371.Validation here meaning is that 25 Kgy is sufficient to kill the all micro-organizm.You have to follow above ISO standard closely.You need to submit the validation report to FDA.

if you want the end user (surgeon) should do the sterilization prior to use then also you need to suggest sterilization methods ( eg gamma,plasma,steam ,electron beam etc) and also provide the validation report to FDA.

Is it clear now?

ith kind regards

Sanjay Lingot