510(K) submission - Is it necessary if we changed from nylon to polyester suture?

C

Cinti

#1
Hi,

We are one of the leading manufacturers of ophthalmic eye care products. We are manufacturing surgical suture needles in four types of suture materials like Nylon, Silk, Polyester and Polypropylene. We have 510(K) approval for our Nylon and Silk sutures.

Recently we have gone through the guidelines “Deciding when to submit a 510(K) for a change to an existing device”, published on January 10, 1997. From material change and labeling change flow chart (Flow chart A and Flow chart B), we understood that we can submit documentation for the material change in an existing 510(K).

Is it possible to submit documents for getting 510(K) approval for Polyester suture other than filing new 510(K)? There is no change in our manufacturing and QA processes except material of suture (ie) instead of Nylon suture, we are attaching polyester suture in the needle. The only change in the labeling is the model number. Instructions like adverse reactions, warnings, precautions etc., in IFU are remain same. We are still manufacturing Nylon suture. This is for your kind information.

I will be very grateful if any one can advice me for submitting documents.
 
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sreenu927

Quite Involved in Discussions
#2
Re: 510(K) submission

Hi Cinti:

I don't think that you can submit for a supplementary 510(k) submission, although the intended use is the same for a material changed device/product, for ur case here.

From my view, as the material changing, which is a biomaterial, involves biocompatibility studies(toxicology studies for the material), which requires submission of new 510(k).

Regards
Sreenu
 

Michael Malis

Quite Involved in Discussions
#3
Re: 510(K) submission

Hi Cinti:

I don't think that you can submit for a supplementary 510(k) submission, although the intended use is the same for a material changed device/product, for ur case here.

From my view, as the material changing, which is a biomaterial, involves biocompatibility studies(toxicology studies for the material), which requires submission of new 510(k).

Regards
Sreenu
:agree:Absolutly - you need a new 510(k)
Material changed and Enginnering testing with ISO 10993 must prove that it new product is working the same way. Also you need to do Risk Analysis per ISI 14971...
 
M

MIREGMGR

#4
If you make the suture material itself, and if the polyester suture material is not already qualified as a freestanding device or is not made from an already qualified biomaterial formulation and grade, then yes, a new 510(k).

If on the other hand the substitution is one already-freestanding-qualified material for another similarly qualified material, or a material siilarly manufactured from an already qualified biomaterial formulation and grade for another similarly qualified formulation and grade, then a Special should be possible.
 

Michael Malis

Quite Involved in Discussions
#5
If on the other hand the substitution is one already-freestanding-qualified material for another similarly qualified material, or a material siilarly manufactured from an already qualified biomaterial formulation and grade for another similarly qualified formulation and grade, then a Special should be possible.
:yes: Agree with part 1.

:nope: Not part 2 - Both Materials can be qualified, however these 2 materials in question from mechanical properties* and processing stand point are not the same and therefore, will require Traditional 510(k)...
*Nylon to polyester have different mechanical properties and shrink factor and can't be 1 for 1 substitute for the same intended use.
 
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