Traditional or Special 510(k)

#1
Hello everyone,

One question for you guys, if you can help me.

My company produces medical robots for surgeon interventions (class II), and for workflows use external software for planning of interventions. it consist of HW and FW and use external software for planning, for both two workflows.

Now, my team developed software for planning (with added one workflow more - third).
Question is, to submit this design change as a special 510k or traditional?

Intended use remains same (with modification that device can use either external software for planning, or new developed internal software). For nowin indications for use is stated that use external software for planning. In general device architecture was added internal software, and software development documentations is completed. Also, added one more workflow with navigation.

Is it enough, on question from FDA guidance: Is there well established method to evaluate the change? to be answer yes, because we have internal validation and verification procedures and methods, and also, software is developed according to 62304 FDA recognized standard?

Verification procedure for new version with internal software have new methods and tests applicable to new software, old version of procedure didn`t have.

Btw, for software will be used medical PC, already pre-approved (safety testing etc.)

Device is already EMC tested, and we buy EMC tested medical PC. is that enough, or we should test whole system again according to 60601-1 and 60601-1-2?

Thanks in advance.
 
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#2
Could you please clarify the following statement?
My company produces medical robots for surgeon interventions (class II), and for workflows use external software for planning of interventions. it consist of HW and FW and use external software for planning, for both two workflows.
What do you mean by "Surgeon interventions"? Do you mean this robot is used for assisting surgeons during surgery? Also, What does planning of intervention mean? Is your system executing 3rd party code on your medical device? Does this mean your FW has built-in safeguards?
 
#3
Could you please clarify the following statement?

What do you mean by "Surgeon interventions"? Do you mean this robot is used for assisting surgeons during surgery?
Yes, just assisting. Surgeon moves a robot with joystick into desired position, then manually with his hands do intervention. Robot is basically needle holder and precise positioning tool.

Also, What does planning of intervention mean?
Surgeons take X-ray or CT images on they own machines, independently from robot. And based on needle position and target point he make a plan how to access to target point (angulation, distance...) and centers the needle accurately via robot. Then take image again to verify proper position. That planning is done by their software, without robot. Now we have an internal software solution.

Is your system executing 3rd party code on your medical device? Does this mean your FW has built-in safeguards?
No, 3rd party code is external software. Not integrated in our robot at all. Now we develop software which is intended to be installed on medial touchscreen PC, so we would not have need to use external software for planning.

Hope I answered to your questions correctly.
 
#5
What do you mean by planning? I don't understand what planning is needed for your device.
Planning is making a plan how to perform intervention on patient body. That includes:
- Patient registration
- Insert patient images from X-ray/CT
- Calculation of distance necessary to reach target point into body (depth)
- Calculation of number and size of tools (needle or something else)
- Estimation of appropriate trajectory into body
That is done with 2D images or visualization into 3D, where is presented target points on an organ versus needle trajectory. That is what software is supposed to do basically.

After planning stage is done, surgeon verifies that position is good, and then performs intervention.
 

mihzago

Trusted Information Resource
#6
Who currently owns the design for the external planning software and the original clearance? Is it your or another company? If it's another company, then you cannot submit Special.
If it's yours, and if the new/modified software has essentially the same functionality, and does not introduce new calculations or a different approach to planning then I think you may be OK with Special.
Did you collect any clinical data to validate the new workflow? If yes, then FDA will kick it into Traditional.

If you're unsure and want to be conservative, then submit traditional; or, you can submit Special and worst thing that happens is FDA will convert it to Traditional.
 
#7
Who currently owns the design for the external planning software and the original clearance? Is it your or another company? If it's another company, then you cannot submit Special.
Another companies. Software for planning up to now is fully external product, not our. I thought maybe if we add in Device architecture one SW part for planning, like a new feature, that would be enough for a special 510k.

If it's yours, and if the new/modified software has essentially the same functionality, and does not introduce new calculations or a different approach to planning then I think you may be OK with Special.
Complete solution is new designed: User interface, application, functions, calculations, modeling, database, etc.

Did you collect any clinical data to validate the new workflow? If yes, then FDA will kick it into Traditional.
We did some usability testing, together with verification and validation testing, according to design procedure. No clinical trials were conducted up to now.

If you're unsure and want to be conservative, then submit traditional; or, you can submit Special and worst thing that happens is FDA will convert it to Traditional.
If can not go with special 510(k) plan B. is to submit traditional: use current device for predicate and one reference for new workflow (new feature). In that case, I am not sure:
- do I need to repeat all safety and EMC testing (predicate have all test reports)? That is my biggest concern and reason why I would try how to go with special 510k.
- How really works utilizing of reference device? If ref. device is different, but have feature I need (new workflow I made on my software), how I can justify (with comparing to reference device) that differences in technology do not raise questions regarding safety and effectiveness?
- And, is it tricky if differences between reference device and new (subject device) are significant, also we have same intended use and similar a lot of technical features?

Thanks a lot!
 

mihzago

Trusted Information Resource
#8
For some reason I read that your company's robotic system is class III.
You could try submitting a Special to modify your current device, it may work. You could also try using other company's software as a reference device, but it may get tricky in a Special.
The problem with Special is that the more complex the new functionality and the more significant the differences, the more data you have to provide in the submission to support equivalence. FDA in the last several years has narrowed quite a bit the scope of what can be reviewed in a Special submission.
 
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