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The LungPoint® ATV Planning and Navigation Software for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools and cathere in the pulmonary tract to a location in the or lung tissue, and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not for pediatric use. When under fluoroscopy guidance, the software enables users to segment previously acquired 3D CT datasets and register these 3D segmented data sets with live fluoroscopy X-ray images of the same anatomy in order to support cathereldevice navigation. The 3D segmented data set can be displayed with a color map annotation received from an external source. The LungPoint tools (necdle, balloon dilator, and sheath) are used with a bronchoscope, navigated by the LungPoint Software.

The LungPoint Software is a software device, providing navigation guidance to help the physician plan and proceed to a predefined target site in the bronchial tree and surrounding soft lung tissue by providing a path, which is displayed on a 3D reconstruction of a CT scan. The LungPoint Software provides guidance to targets in the lung preselected by the physician. In doing so, the software provides guidance to lymph nodes or lesions to enable tissue sampling. It can also facilitate the return to the location that had previously been treated for assessment or continued therapy, or to enable marker placement in soft lung tissue. The software system consists of multiple modules that closely interact with each other to perform the overall product's functions. Each module is designed to perform a specific function such as airway tree segmentation, centerline calculation, etc and relies on outputs of other module(s) to perform its function. All modules share the same data structure defined in the Modules Interface section that is shared as binary and text files. The software consists of two key programs: Planning and Procedure. The procedure program contains two separate procedural options, depending on the complexity and location of the lesion in the lung: (a) Virtual Bronchoscopic Navigation (VBN) and (b) Navigation with fluoroscopic guidance.

The LungPoint Tools are endoscopic tools intended to be used with LungPoint Software guided bronchoscopes. The LungPoint Sheath is intended to be used as a working channel through which endoscopic tools may be introduced to targeted tissue. The LungPoint Dilation Balloon is intended to dilate tissue of the bronchial tree and may be inserted through the LungPoint Sheath or directly through the working channel of the bronchoscope. Not for pediatric use.

The LungPoint Tools are endoscopic tools used during bronchoscopy procedures. The LungPoint Sheath is designed to be used with a bronchoscope to provide a working channel through which endoscopic tools, such as needles, dilation balloons, or other endoscopic devices may be introduced to the targeted lung tissue within the respiratory organs. The LungPoint Dilation Balloon is used to dilate tissue of the bronchial tree and may be inserted through the sheath or directly through the working channel of the bronchoscope. The bronchoscope is advanced to a predefined target following guidance of the LungPoint Software (previously cleared under 510(k) #K 12051 to guide endoscopic tools or catheters in the lungs or to enable marker placement in soft lung tissue). The materials used in the LungPoint Tools are commonly used medical grade materials and include platinum iridium markers.