In the FDA Guidance Doc "Deciding When to Submit a 510(k) for a Change to an Existing Device" (Jan 10, 1997), multiple references are made to the term "performance specifications". However, nowhere do they define "performance specifications". We manufacture a device with thousands of specifications, e.g. dimensional, material, electrical, etc. We consider these specifications to be just that - specifications - as opposed to "performance specifications". My question: in this (FDA) context, does the term "performance specifications" refer to component performance specifications or finished device performance specifications? If only the latter, we have very few finished device specifications but *many* component performance specifications.

Hi,

It is my understanding that FDA is referring to the performance of your finished device,not of every component in your device.

When you are getting the 510(k) clearance in the first place you doso by demonstrating substantial equivalence to a predicate device, with respect to safety, effectivenessand performans etc.

from the fda site (http://www.fda.gov/CDRH/DEVADVICE/314.html):

A claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.

You can still demonstrate substantial equivalence to a predicate device even though your device has a e.g. capacitor with a better performance than any predicate device.

I assume this goes for changes to an existing device as well.

But this is just my opinion...

regards
t.

FDA is referring to the performance of your finished device,not of every component in your device.

I agree!

I disagree. FDA also calls for performance specifications in materials used to manufacture medical devices. For example, the plastics used to make catheters would have a specification for flexibility, among other things. Suture materials would have performance specification for strength, and the finished product would also be expected to go through its own types of testing because the manufacturing processes can affect the materials' inherent properties.

FDA references ASTM's performance specification for surgical mask materials: ASTM F2100-07. See it here at ATSM's web site (http://www.astm.org/cgi-bin/SoftCart.exe/DATABASE.CART/REDLINE_PAGES/F2100.htm?E+mystore).

The "Performance Specifications" refer to the device performance and not for the component. These specifications are usually spelt at the device design phase.

The term "malfunction" is usually defined for these performance specifications where, “Malfunction” refers to the failure of a device to meet one of its performance specifications or to otherwise perform as intended.

Performance specifications also include all claims made in the labeling for the device.

In my first pass through the FDA guidance document, I missed the definition of "Performance Specification":

"The performance characteristics of a device as listed in device labeling or in finished product release specifications."

This pretty much clears if up for me.

Now, with respect to Jennifer's point:

"FDA also calls for performance specifications in materials used to manufacture medical devices. For example, the plastics used to make catheters would have a specification for flexibility, among other things. Suture materials would have performance specification for strength, and the finished product would also be expected to go through its own types of testing because the manufacturing processes can affect the materials' inherent properties."

FDA does not call for any performance specifications. The device manufaturer/designer does that. As required ASTMs may be used to show conformance to a standard, but that is not an FDA call - only an option (that may indeed be the best option!) Component specifications that might impact a finished device characteristic are only an issue, again, if that characteristic is "listed in device labeling or in finished product release specifications".

Our device has *many* performance charateristics - the vast majority of which are not called out in either the labeling or the "finished product release specifications". They ARE called out, however, in many in-process inspection/testing requirements which provides us the assurance we need.