This article explains how to fix a 510k submission ecopy on a USB flash drive–including how to debug problems created by the most recent Microsoft Windows 10 Update.
The above picture is a USB flash drive with a replacement ecopy for a recent 510k submission I worked on. A couple of weeks ago, one of these little USB flash drives and the Microsoft Corporation conspired to create one of the most creative riddles I have ever solved in my entire life.
How do you delete a file you can see?
Not just any old hidden file, but a hidden system file called: “IndexerVolumeGuid.”
ecopy with System Volume Information Folder
IndexerVolumeGuid is a special system file that was on my brand new USB flash drive in the System Volume Information Folder. This file keeps an index of the files in the System Volume Information Folder. Your computer can use that index to recover accidentally deleted information. Normally this is a useful and desirable feature, but I purchased my brand new USB flash drive to send an ecopy 510k submission to the FDA Document Center. Unfortunately, the FDA Document Center can not accept system files. The problem was that I couldn’t see the files, because they are hidden.
How can you delete a file you can’t see?
I had a software problem, and the process used to fix software problems is called debugging.
Debugging Windows Software Updates
There is a specific position that you should be in when you are trying to debug a software problem. First, you need to be sitting down and hunched over your computer. Second you need to rest your forehead in your hand, sigh heavily and maybe even moan softly from time to time. Personally I prefer to curse the genius programmers at Microsoft and repeat my mantra of “I can’t believe this. It’s ridiculous.” You really know you are concentrating properly if the vein in your forehead is throbbing so much that other people can see it throbbing through your hand.
The most valuable tool for debugging software problems with Windows is Windows Help. It’s an on-line manual that has the answers to every conceivable question you can ask about Windows. The only time it’s really failed to be helpful is when I’m trying to connect to the internet. The “on-line” nature of Windows Help limits its usefulness in solving problems with internet connections for some reason.
Finding Hidden System Files
I typed into Windows Help, “Show hidden system files.” After a 10 minutes of reading I learned that the default setting for Windows Explorer is to hide system files, and bad things can happen if you unhide those files. I also learned that you can change the default setting by entering the Windows Control Panel, and then clicking on “Appearance and Personalization.” Finally, you click on “File Explorer Options,” click on “View” and then scroll through about 50 possible configuration options until you see the setting for “Hide Protected Operating System Files.” Then you deselect this option–despite the recommendation to keep these files hidden.
Finding the Control Panel
Next I typed into Windows Help, “How to find Windows Control Panel.” After another 10 minutes of reading I learned about a secret key stroke that pulls up a secret, black menu (Windows Key + “X” Key). On that menu is the Windows Control Panel. Of course there are about 20 different ways to reach the Windows Control Panel, but this secret key stroke is by far the coolest method.
I followed the instructions from Windows Help and finally I could see the hidden system folder, but I couldn’t delete it.
Next I tried formatting the USB drive. That worked, until I pulled the USB drive out and inserted it again. Windows has a cool new feature that automatically creates a hidden system folder on your USB drive–even if you don’t want one.
Disable Removable Drive Indexing
Windows Help again to the rescue. I learned that I needed to disable the removable drive indexing feature. In order to do that I needed to use Group Policy Editor, which I didn’t have. Windows Help told me that I could use the Windows Registry Editor or “regedit” program instead if I was unfortunate enough to be using something other than Windows XP. Next Windows Help instructed me to open a folder called Windows Search. Windows Search was a folder found 7-levels deep in the registry of the computer, but it seemed to be missing from my computer. Again, Windows Help instructed me on how to create a Windows Search Folder and add a file called “DisableRemovableDriveIndexing”. Then I only needed to change the settings from a “0” to a “1” and reboot my computer.
Finally, 2 hours later my USB drive no longer had a hidden system file on it and my computer would no longer create one automatically–until the next Windows update, which occurred a week later.
Last week I recorded a live webinar on “510k Lessons Learned.” If you are interested in specific guidance related to ecopy, you can also review the following FDA guidance documents:
- ecopy Guidance – FDA Guidance document revised 12/3/2015; ecopy Program for Medical Device Submissions
- ecopies Validation Module (a voluntary tool that verifies the format of an ecopy you have already developed on your local drive)