To better judge the qualification of the Left-Atrial Appendage Closure Device, we should first recognize that classification is based entirely on risks. The risk for any devices ( medical or not) becomes less prominent as the use of the device becomes more common. This statement implies that we tend to learn and know more about an instrument by simply making use of the instrument itself. Based on this type of reasoning, I believe that if similar devices to ‘the Stop-Gap’ have been previously manufactured and have been extensively used in the medical arena, then the risks associated with these devices have been thoroughly and repeatedly evaluated. The people using these devices then have a pretty solid idea of what to expect as it pertains to risks. This conclusion then doesn’t really fit the definition of the class III device, since it requires the device to be completely novel and voided of any previously known risks.