DEVICE: Pre-Sure (G18910)

Device Description: End Users of the PRE-SURE device receive digital and/or physical patient anatomical models from Lazarus 3D. The physical models are intended for adjunctive use along with other diagnostic tools and expert clinical judgement for diagnosis, patient management, and/or treatment selection of genitourinary applications. Digital models may be viewed by End Users using any program cleared for their intended use. The PRE-SURE patient modeling system is a method for the creation of patient models. This system will be used exclusively by Lazarus 3D, with some physician input and feedback, to produce models for End Users. Importantly, and unlike other 3D modeling systems, in the PRE-SURE process the design and production of patient models is performed by Lazarus 3D and not by the End User or a third party. The internal process within Lazarus 3D used for creating PRE-SURE patient models includes use of an FDA cleared stand-alone software package. As a part of the PRE-SURE production process, this software is intended for internal use within Lazarus 3D to create digital anatomical models from patient radiological data that can be used by End Users for a variety of uses such as training, education, and pre-operative surgical planning. The patient specific digital anatomical models may be further used as an input to a 3D printing-based production process performed by Lazarus 3D to create physical patient models. Each individual patient’s model can be created rapidly from the patient’s radiological data using Lazarus 3D’s patented rapid prototyping technology. The resulting physical models of patient anatomy are primarily composed of silicone materials that can be cut, can be sutured, and in some cases can even bleed.