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Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

The LungPoint Software is a device that guides a bronchoscope and commercially available endoscopic tools to a prespecified target in or adjacent to the bronchial tree by providing a path, which is displayed on a 3D reconstruction of a CT scan. The Software allows visualization of the interior of the bronchial tree; placement of catheters in the bronchial tree; visualization of a prespecified target in lung tissue; and placement of markers into soft lung tissue to guide radiosurgery and thoracic surgery. The FlexNeedle is an aspiration needle. When used together with the LungPoint Software, the needle can be guided to a prespecified targeted area within the respiratory organs. The software is installed on an off-the-shelf PC computer system, and is intended to be used with commercially-available flexible bronchoscopes with CT scans that are saved in DICOM format.

Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

LungPoint Procedure Planning, a software only device. As with the predicate, it provides the physician with 3D reconstruction of the patient's lungs, derived from the CT images and thus provides a more realistic view of the lungs. The physician can use the 3D virtual animation and associated images to view and explore pre-selected targets in the lung tissue before conducting a procedure. Like the predicate, the software allows for printing the procedure plan as a map, which consists of a bifurcation-by-bifurcation description of the route to the selected target. The LungPoint Procedure Planning software is installed on an off-the-shelf PC computer, and is intended to be used in conjunction with commercially-available CT scan images that are saved in DICOM format.

Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

This premarket notification covers Broncus' LungPoint VBN System. The VBN System is a software only device, providing a navigation system to help the bronchoscopist plan and proceed to a predefined target site (also referred to as region of interest (ROI) in the tracheobronchial tree. Specifically, the VBN system provides guidance to targets preselected by the bronchoscopist in lung tissue. In doing so, the VBN can provide guidance to lymph nodes to enable tissue sampling. It can also facilitate the return to an exact location in the lungs that had previously been treated for assessment of or continued therapy, or enable marker placement.

The Yield Tissue Sampler is indicated for use in aspiration in carinal, paratracheal and hilar lesions of the bronchial tree where biopsy forceps cannot obtain a submucosal sample.

This premarket notification covers Broncus' Yield Tissue Sampler. The Yield Tissue Sampler is a transbronchial aspiration needle used for transbronchial retrieval of tissue samples. It is compatible with flexible 2-mm working channel bronchoscopes and is available in two sizes, 18 and 21 gauge.

The Yield Mini Doppler Probe with Broncus® Monitor is intended for use through a bronchoscope to detect blood flow behind airway walls in the tracheobronchial tree.

This premarket notification covers Broncus' Yield Mini Doppler System, which comprises the Yield Mini Doppler Probe and Broncus Monitor. The Mini Doppler System will enable the bronchoscopist to identify vessel-free areas prior to performing transbronchial procedures such as needle aspiration or biopsy.

Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

This premarket notification covers Broncus' LungPoint VBN System. The VBN System is a software only device, providing a navigation system to help the bronchoscopist plan and proceed to a predefined target site in the tracheobronchial tree. Specifically, the VBN system provides global quidance to targets preselected by the bronchoscopist in peripheral airways. In doing so, the VBN can provide local guidance to lymph nodes to enable tissue sampling. It can also facilitate the return to an exact location in the lungs that had previously been treated for assessment of or continued therapy. The VBN software is installed on an off-the-shelf PC computer system, and is intended to be used with commercially-available flexible bronchoscopes with HRCT scans that are saved in DICOM format.

The Exhale Probe is intended for blood-flow detection and electrosurgery procedures (i.e. coagulation/cauterization, hemostasis, etc.) in the upper airways and tracheobronchial tree through a bronchoscope.

The Exhale Probe is a multi-function catheter that provides: (1) Doppler audio output in the presence of pulmonary vessel blood-flow; and (2) radiofrequency (RF) energy to a target site within the upper airway or tracheobronchial tree. The probe is inserted into through the 2 mm working channel of a standard bronchoscope and connects to the Exhale Doppler Processing Unit and a standard, commercially available, electrocautery radiofrequency generator.

The Broncus™ Coagulation Electrode System is intended for coagulation or hemostasis in the tracheobronchial tree.

The Broncus Coagulation Electrode System consists of a catheter, a RF generator, and a commercially available patient return electrode. The RF generator produces RF power in a monopolar mode. The catheter delivers RF energy to the desired target site and relays temperature and other feedback to the RF generator. The patient return electrode is used to complete the return path for the electrical current.