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The InstaTrak 3500 Plus System (K983529, originally cleared under the product name InstaTrak 3000) is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, visible on medical images such as CT, MR, or X-ray.

The InstaTrak system with Multiple Dataset Navigation provides the same capability as the existing system, with the additional functionality of utilizing two sets of medical images instead of one. By providing information from multiple datasets, the user can locate and visualize anatomical structures using different imaging modalities. The InstaTrak 3500 Plus System allows the user to view the medical images of the patient's anatomy in response to the mouse or the tracked surgical instrument. Alignment of the patient and medical images is accomplished through the registration process. In all types of surgery the goal is the same, to display to the surgeon based on the medical images, where the position of a tracked surgical tool is with regard to the patient's anatomy. With the additional capability of multiple dataset navigation, the surgeon can now view the position of the tracked instrument using two sets of medical images instead of one. The Multiple Dataset Navigation will provide the user with the ability to co-reqister (fuse) images from multiple datasets such as CT and MR. Using the existing InstaTrak 3500 Plus System software, the user will register one of the datasets, referred to as the Reference Dataset, to the patient. Navigation is then possible on the fused images, with secondary (registered) dataset(s) acting as a visualization enhancement for both surgical planning and intra-operative quidance. The sensors and instruments used for navigation are identical to those utilized by the existing InstaTrak system. Navigation will be disabled until the datasets have been successfully co-registered. Patient registration is the process by which the coordinate systems of the medical images and the pointing instrument are aligned. This is performed on the primary (reference) dataset. Both the method of registration on the primary (reference) dataset and the resulting accuracy are identical to that described in K983529. The current system provides displays for a single set of medical images. The Multiple Dataset Navigation option will provide displays for multiple sets of medical images. The addition of the Multiple Dataset Navigation operating mode does not change any of the major components of the InstaTrak System. There are no new receivers, transmitters, or instrument attachment configurations associated with this operational mode. Addition of the Multiple Dataset Navigation mode is a software change only.