S
Hi
USB Cable is an accessory to our data management software. This cable has undergone some mior changes and the change was documented under Letter to File. I am working on filing a 510k for a data management system which was previous cleared under another 510k. There are cumulative changes now and as a result of that I need to do this filing. In addition to some changes in the data management software (to show the software is compatible with the new Microsoft operating systems), the USB cable driver was update and got certified by Microsoft.
Questions:
1) My understanding is that I don't need to include USB Cables change documentation processed under the Letter to File because they were minor. If this is true, it is required to provide a summary of the letter to file to show history of change OR I just need to leave it out altogether.
2) For the USB driver update, do I need to include the full V&V documentation or just a summary of V&V work in the 510k?
Thanks
USB Cable is an accessory to our data management software. This cable has undergone some mior changes and the change was documented under Letter to File. I am working on filing a 510k for a data management system which was previous cleared under another 510k. There are cumulative changes now and as a result of that I need to do this filing. In addition to some changes in the data management software (to show the software is compatible with the new Microsoft operating systems), the USB cable driver was update and got certified by Microsoft.
Questions:
1) My understanding is that I don't need to include USB Cables change documentation processed under the Letter to File because they were minor. If this is true, it is required to provide a summary of the letter to file to show history of change OR I just need to leave it out altogether.
2) For the USB driver update, do I need to include the full V&V documentation or just a summary of V&V work in the 510k?
Thanks