S
Silvertabb
We have a cleared device. This device besides doing its primary function of measuring certain chemical in human bodily fluid also has some firmware which when plugged into PC allows data transfer, display, and report printing. We are adding additional features to the firmware side. Instead of updating the firmware on the device, we are planning on making the software available on CD and internet for download.
I believe at a minimum we will need to file a Special 510 and use the cleared device containing version 1.0 of the new, supposedly 2.0, software as a Predicate device.
The cleared predicate device is a Class II device and the Intended Use statement does not talk about the firmware for data management activities, but this is covered in the 510k V&V documents for this device. The justification for the predicate choice is based on the the firmware 1.0 and the new 2.0 software. I just thought I ask this question because Intended Use and Fundamental Technology besides other characteristics are important in substantial equivalence determination.
Is the predicate choice acceptable?
I believe at a minimum we will need to file a Special 510 and use the cleared device containing version 1.0 of the new, supposedly 2.0, software as a Predicate device.
The cleared predicate device is a Class II device and the Intended Use statement does not talk about the firmware for data management activities, but this is covered in the 510k V&V documents for this device. The justification for the predicate choice is based on the the firmware 1.0 and the new 2.0 software. I just thought I ask this question because Intended Use and Fundamental Technology besides other characteristics are important in substantial equivalence determination.
Is the predicate choice acceptable?
