New 510(k) for new specs?

[dr1vn]

So I have an imaging device that is already cleared by the FDA. During our initial 510(k) we reported a field of view to be a certain value. Since that submission, we have made some improvements in our testing equipment and we can confirm that the value is much greater. I went through FDA's flowchart and I think this is just "Documentation" as there was no change to design. But, would you consider this a change to the effectiveness of the device? If so, Figure 1 says this is a new 510(k). But sine we have not changed the design of the device I don't think the flowchart comes into play at all and so we're still at "documentation".

Is my thinking correct?

 

[Nichole F]

If you are changing your claims beyond that which is cleared by your 510(k) you absolutely need a new 510(k). I really can't say if you need a traditional or special, but the flowchart sounds very much relevant if you are expanding your clams beyond that which is already cleared.

 

[EmiliaBedelia]

Agreed with the above... Improving the performance of the device is impacting effectiveness. Keep in mind that "intended use" and labeling cover more than just the IFU...you cannot read this flowchart looking only at form/fit/function, you need to consider the actual use of the device.

I think you do need consider this a change in the design and do a risk based assessment on how the change could impact the risk profile of the device. Whether the change necessitates a 510k depends on what that specification actually means, whether it is a clinically relevant value that impacts how the device would be used, and how it changes the risk level of the device.

For example, a common change is extending the shelf life of the device with new testing. This doesn't usually require a new 510k because there's no change in design, no change in test methods, no change in how the user will actually use the device, and no change to the risk.
However, if the change in the claimed specification could result in the device being used for new/different/broader uses, that could impact the risk and you need to consider that accordingly.

 

[Ed Panek]

Without knowing how field of view impacts performance (I assume its better) FDA will want to be notified of a product performance change. FDA needs to stay in rhythm with industry so they can raise the bar with new performance values or controls. If your change makes the device 10% more "life saving" FDA can update their criteria for evaluating new submissions (510(k))

This is our Table B for product improvements

FLOWCHART B – TECHNOLOGY, ENGINEERING, PERFORMANCE CHANGES?​
B1​	Is the device an IVD? Yes – See Chart D / No – See Question B2​	N/A​
B2​	Is it a control mechanism, operating principle, or energy type change? Yes – New 510K / No – See Question B3​	N/A​	​
B3​	Is it a change in sterilization, cleaning, or disinfection? Yes – See Question B3.1 / No – See Question B4​	N/A​	​
B3.1​	Is it a change to a Cat. B or novel method, does it lower the SAL, or is it a change to how the device is provided? Yes – New 510k / No – See Question B3.2​	N/A​	​
B3.2​	Could the change significantly affect performance/ biocompatibility? Yes – New 510k / No – Documentation​	N/A​	​
B4​	Is there a change in packaging or expiration dating? Yes – See Question B4.1 / No – See Question B5​	N/A​	​
B4.1​	Is the same method or protocol, described in previous 510(k), used to support change? Yes – Documentation / No – new 510k​	N/A​	​
B5​	Is it any other change in design (e.g., dimensions, performance specifications, wireless communications, components or accessories, patient/user interface)? Yes – See Question B5.1 / No – Documentation​	N/A​
B5.1​	Does the change significantly affect the use of the device? Yes – new 510k / No – See Question B5.2​	N/A​	​
B5.2​	Does a risk assessment identify any new or significantly modified risks? Yes – new 510k / No – See Question B5.3​	N/A​	​
B5.3​	Is clinical data necessary? Yes – new 510k / No – See Question B5.4​	N/A​	​
B5.4​	Any unexpected issues from V&V activities? Yes – new 510k / No – Documentation​	N/A​	​

However, even with this template, there may be digging or reporting you need to uncover. For a major change, prepare to update a lot of the DHF to reflect current performance.