As seen in the image above, the market for urology surgical instruments is predicted to continue to grow. Most importantly in 2019, the U.S. market is estimated at 3.16 billion (USD). Due to the rising market, more companies have developed their own iterations of urology surgical instruments. At the moment there is no market for attachable force sensors for ureteral access sheaths, but the market for these instruments is incredibly high. UroCare will focus on establishing partnerships with medical device companies in order to add our SafePassage3 as part of a ureteroscopy instrument package. Uro care also has the possibility of selling the device as individual sales for surgery centers.
In order to file a 510K, evidence must be provided to show that the medical device is equivalent to another U.S. marketed device. The evidence must show in the comparison of the devices that the intended use is the same, they contain the same technological characteristics, and its safe and effective. Our device will be a modified version of a current ureteroscope and its accessories, which according to the FDA is already a Class II medical device. Overall, due to the nature of our project and current classification a 510K filing will be needed to satisfy regulatory requirements before commercialization.