Class 2 Medical Device Use Life Testing

N

NickV

Need some assistance on use life testing for a class 2 med device. Going for 510k clearance to extend a motor device from 15 uses to 1 year use life. Right now we have actual test/use life to demonstrate with 95/90 confidence 15 uses. We want to extend this to 1 year. We developed an automated test fixture that simulates use. The test scenario originally done was based off worst case we made up because we don't have any actual use data. So we said 3 procedures a day, 5 days a week, 50 weeks a year. With the correct confidence intervals this came out to 3 motors running 780 cycles with zero failures. Well we had 2 fail at the 155-160 cycle mark which works out to a little over 2 months using this method. The question was raised is 15 uses a week way to aggressive. Right now we have a limited launch with ~10 doctors using the device and the most any is doing is 3 a week, but it is a limited launch, and advertising/etc hasn't started. Project people want to repeat the testing for 1 year basically saying 3 a week instead of 15 a week. I'm trying to figure out if this is valid, or based of the current data we know is skewed low, how much of a safety factor to put in to ensure we test accurately for a 1 year use life.

I don't like the fact that we established baseline worst case 1 year use life, then basically taking the data and lowering our definition of a year just to meet our marketing goals. There is some validity to 15 uses a week 52 weeks a year is by far worst case and not realistic, but how do we figure this out?

Any standards? Suggestions?
 
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