FDA
FDA approval will be necessary in order to bring the device into the market. The prototype belongs to the Class I Device category and is not intended for life-sustaining or life-supporting purposes, nor is it used to prevent significant impairment of human health. Moreover, device use does not pose any significant risks of injury or illness. However, the splint cannot qualify for prior filed exemptions as it differs significantly from the products already filed for and available in the market. This splint features a unique combination of materials along with a size adjustment sliding mechanism that distinguishes it from the existing products on the market, despite the fact that some comparisons can be drawn between different arm splints due to their similar functionality and design. The premarket 510(k) notification is likely to be the route taken for this device, as there are many predicate devices available for this product, and a thorough MAUDE search was conducted to gain insights into the past experience of manufacturers and users of similar devices and devise solutions to possible issues related to the production and utilization of the device.
IP
The device’s intellectual property lies in its distinctive combination of components and mechanisms. A patent search was conducted to identify any existing patents that may impede the device’s patent process, but no such patents that are substantially similar to the device were found. Although similar mechanisms may have been employed in other products or fields, the length-adjusting mechanism integrated into the splint, as well as the unique combination of materials, are specific to this device and distinct from those currently available on the market. Precautions to safeguard the device’s intellectual property will be taken once it has been tested on more subjects, including pediatric patients, and the final size adjustments have been made.