Well ryan your way of thinking may be right but as we know FDA classification is more of risk based.Ibased.I believe that the device name looks like it must be class 3 device because it is attached to heart but risk of using the device is lower then any class 3 device that are more likely to fail when used. Maybe this is why it has been classified among the class 2 devices.

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.

I believe the system is fine as is. During this weeks mini-sim i chose the bluetooth connected glucose meter and pump. Although there has not been a device like this on the market, you can think of this as a combination of two different devices, a glucose meter and insulin pump. Therefore, my initial instinct was to pick this as a class 2 device, however I was incorrect and learned that this would be a class 3 device. To my understanding of the mini-sim this would be because of the software that is involved in the bluetooth connected glucose meter and pump, and the possible issues that could arise because of this new software. Therefore, the classification of this device was a class 3. I believe rightfully so, because although there are similar devices on the market it is in the best interest of public health to test this device more thoroughly in order to prove utmost safety and efficacy.

Over a medical device's lifetime the amount of information regarding its safety and effectiveness will increase and can possibly reduce the risk associated with the device. If this happens there is a reclassification process that can be used to update the class of the device type based on current information. The type of the device being changed from class III to class II, for example, would allow devices of the same type created after that device to be also classified as class II if they are shown to be substantially equivalent. The fact that a device must be "substantially equivalent" protects against less safe devices being classified under the same type. The device stop gap is a type of LAA closure device and was classified as a class II, through the De Novo process, because the general and special controls for LAA Closure devices have shown reasonable assurance of safety and effectiveness for their intended use. Further, regulatory and quality controls will ideally prevent an unsafe product from being on the market.

I agree that this system is fine as it is. I do not believe that more classes need to be created. As stated before this system runs entirely on risk and safety of the product. In the mini-sim the LAA closure device was considered as a class II because it is a heavily used product and its regards to safety are well known. The original question asks, "what if the company made an LAA device a little differently than the previously created versions, should it still be in class II". I believe the answer to this would really depend on how different it was. If it was very different, than no, it will not remain as a class II device, and should instead be put into class III. The FDA does not need to create another type of classification for devices that have been developed before because many new devices use the previously created products to classify themselves. Making more classes would cause a lot of confusion, and does not seem very necessary.

I don't think there is a need for a separate classification for the device as the function of the device is known and such devices already exist in the market so it falls into class II classification of devices. If changes are made to the LAA closure device that in some way change the function of the device, if the function is unique to the device then there is a need for clinical trial and the device would come under class III category.

I do not think this is a problem as there have probably been hundreds of medical devices approved using predicate devices and which have probably benefited society due to the faster track of class 2 devices. just because it has a lower risk rating does not mean it is simply thrown into the market without proper justification of safety and efficacy. There are still protocols which need to be done to collect this data and has to be accepted by the FDA. This lower classification can mean the difference between whether a certain project gets shut down by a company because the class 3 route may be deemed too lengthy and costly to pursue. While an extremely small percentage of devices may abuse this system or slip through the cracks, I think the predicate device exemption does more good than harm.

I believe that the system is okay as is. I believe the ability to approve medical devices based on predicate devices speeds up the process of approving necessary devices for the population. This is a bit of a different example but for rare diseases know as orphan diseases, which only affects a small percentage of the population the FDA offers the ability to expedite the process because there might not be many treatments out there for these diseases. While I agree with your point that the difference between the proposed device and the predicate device might be significant, the FDA determines the risk. If they see that the risk is greater and creates a significant difference from the predicate device then they would classify as a class III.

In my opinion, I don't think it is necessary to have a separate classification for the device as the function of the device is already known in the market or FDA database. If the FDA finds the devices with more risks than normal it would lead them to classify differently. Therefore, I think it is based on the risk of the device that it can be classified among three class. Furthermore, the departments such as regulatory and quality controls will significantly review the device to prevent a hazardous product from releasing in the market.

The FDA classification system seems fine for the most part. There have been previous issues with the "predicate device" exemption when companies try to base this off something that was developed more than 15 years ago. Technology has improved so much in that time that it is hard to compare new products to such seemingly archaic products. But besides this, class II devices still need to provide sufficient clinical data to verify its safety and efficacy but helps it get to market faster without the barriers and stipulations of class III. While class III is certainly for high risk products, another key feature is that is a novel idea. This means something like it has never been done before so the risk profile is generally unclear. I think there are more benefits with comparing to predicate devices in terms of making it easier for devices to get approved than there are unsafe products slipping through using this loophole.