The site is a little misleading, saying "Several of these devices even led to patient injuries including bleeding, organ puncture, and even cobalt poisoning." The majority of documentation in the 510k process is to mitigate harms to the patient. The catch phrase they use is "safety and efficacy". FDA doesn't really care if your device works as well / better / etc. The market will decide that. FDA cares that you don't injure people more than necessary / more than the predicate device does. (If that sounds strange, consider say a biopsy needle.)
The reason 510k is so popular is that introducing a completley new device is incredibly costly typically requriing a PMA (premarket authorization) requiring clinical trial data. If I'm making a new ultrasound machine I don't need to show that ultrasound works -- that's known. I need to show it works as well as one expectes an ultrasound to work, without danger to the patient. Same as if I'm releasing an updated version, re-trialing that doesn't make sense.
Honestly a lot of the documentation requirements are absurd -- you'd think "why would anyone do something so badly we need to document that we didn't do that"... but sadly most rules exist becuase of corners that were cut in the past...
The reason 510k is so popular is that introducing a completley new device is incredibly costly typically requriing a PMA (premarket authorization) requiring clinical trial data. If I'm making a new ultrasound machine I don't need to show that ultrasound works -- that's known. I need to show it works as well as one expectes an ultrasound to work, without danger to the patient. Same as if I'm releasing an updated version, re-trialing that doesn't make sense.
Honestly a lot of the documentation requirements are absurd -- you'd think "why would anyone do something so badly we need to document that we didn't do that"... but sadly most rules exist becuase of corners that were cut in the past...