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The Affirm 800 is used in viewing intra-operative blood flow in the cerebral vascular area including, but not limited to, assessing cerebral vessel branch occlusion, as well as intraoperative blood flow and vessel patency in bypass surgical procedures in neurosurgery.

The Affirm 800 module is designed to work in conjunction with the Class I Digital Surgical Microscope (DSM) RE3. The Affirm 800 module, a Class II device, comprises hardware and software components that enable the Digital Surgical Microscope to emit excitation light in specific wavelengths to activate the fluorescence properties of Indocyanine Green (ICG). The fluorescence signal emitted by the patient represents the distribution of the infrared dye in the patient's blood vessels during surgery. The emitted light is then captured by the optics of the digital microscope, passed through filters to remove unwanted wavelengths of light, and finally detected by the image sensors. This detected signal is then projected on a 3D monitor, which is part of the microscope system, enabling the surgeon to view the magnified image. The integrated Affirm 800 fluorescence module is used to visualize infrared fluorescent areas in the surgical field and includes features to record and play back a video clip of the area of focus where fluorescent light is emitted. The module has been designed for excitation in the wavelength range from 740 nm to 800 nm and for fluorescence visualization in the wavelength range from 820 nm to 900 nm. The fluorescence feature generates an image in the infrared spectrum, which means it cannot be seen by the naked eye.

The Arthrex Synergy Vision Endoscopic Imaging System is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, urology, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery. The Arthrex Synergy Vision Endoscopic Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. Upon intravenous administration and use of ICG consistent with its approved label, the system enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the Arthrex Synergy Vision Endoscopic Imaging System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization. Upon interstitial administration and use of ICG consistent with its approved label, the Arthrex Synergy Vision Endoscopic Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. Upon administration and use of pafolacianine consistent with its approved label, the Arthrex Synergy Vision Endoscopic Imaging System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug. The Arthrex NanoNeedle Scope when used with the Synergy Vision Endoscopic Imaging System is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, urology, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery. For pediatric patients, the Arthrex NanoNeedle Scope is indicated for laparoscopy and orthopedic procedures.

The Arthrex Synergy Vision Endoscopic Imaging System includes a camera control unit (CCU) console, camera heads, endoscopes, and a laser light source. The system provides real-time visible light and near-infrared (NIR) illumination and imaging. The Arthrex Synergy Vision Endoscopic Imaging System uses an integrated LED light to provide visible light illumination and imaging of a surgical site. For NIR imaging, the system interacts with the laser light source to visualize the presence of a fluorescence contrast agent, indocyanine green (ICG) and pafolacianine. The contrast agent fluoresces when illuminated through the laparoscope with NIR excitation light from the laser light source and the fluorescent response is then imaged with the camera, processed, and displayed on a monitor.

QFR is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of coronary vessels in X-ray angiographic images, for use on individual patients with coronary artery disease. When the quantified results provided by QFR are used in a clinical setting on X-ray images of an individual patient. The results are only intended for use by the responsible clinicians.

QFR is delivered as a standalone software package which is installed and running on a server system in the server room of the cathlab or the hospital. The server offers all functionalities that are required to work with the quantitative measurement in X-ray Angiographic (XA) patient studies supported by the QFR device. QFR will be used by interventional cardiologists and researchers to obtain quantifications of lesions in coronary vessels. QFR has been developed as a web-based application to run in a web browser in the control room of the cathlab or in a hospital image review room. The import of images and the export of analysis results are via PACS. The QFR device calculates the QFR value based on an anatomical model which is the result of a 3D reconstruction using the 2D contours obtained from two angiographic projections with angles >=25 degrees apart. These projections are acquired through monoplane or biplane XA systems. The algorithm involves three key steps: (1) Vessel Selection, (2) Contours Detection, and (3) QFR Analysis: 1. Vessel Selection: Angiograms are pre-classified by a deep learning model, identifying main epicardial vessels such as RCA, LAD, and LCx. The user then chooses the segment for analysis, and the software automatically selects end-diastolic image frames. The end-diastolic frame is determined as the angiogram frame with the vessel lumen adequately filled with contrast in both image sequences. This selection is either based on the patient's electrocardiogram when available or performed by the software using a deep learning model. It is essential for the user to verify this selection before proceeding with the analysis. The chosen end-diastolic frame serves as the projection view for the subsequent 3D reconstruction of the vessel. 2. Contours Detection. First, the system runs another deep learning model for coronary vessel segmentation as input to identify anatomical corresponding points on both projections for automatic correction of the system distortions introduced by the isocenter offset and the respiration-induced heart motion. Second, begins the automatic detection of start and end positions of the vessel segment to be reconstructed on the projection views, and extract its contours and centerline. Third, the position of the start and end point must be confirmed by the user. 3. QFR Analysis: The QFR value is computed from the arterial and reference diameter function calculated from the 3D reconstruction based on the contours detected on the cross-sections of the vessel segment, and the patient-specific volumetric flow rate calculated from the automated TIMI frame count. The reference diameter and bifurcations are used to determine the flow distribution at coronary bifurcations and calculate the reference diameter function. The reconstructed 3D model is used to calculate the QFR value. A report is generated by QFR that shows patient information, image acquisition information (both obtained from the DICOM input), analysis results (vessel sizing and QFR value) and snapshot images showing the vessel boundaries.

The Arthrex NanoScope System is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, and urology. The device is also intended to be used as an accessory for microscopic surgery. For pediatric patients, the Arthrex NanoScope System is indicated for use in laparoscopy and orthopedic procedures.

The Arthrex NanoScope System provides real-time visible light illumination and imaging. The system includes a non-sterile reusable camera control unit (CCU) console and sterile disposable camera handpieces. The system integrates high-definition camera technology, LED lighting, and an imaging management system into a single console with touchscreen interface.

CAAS Workstation features segmentation of cardiovascular structures, 3D reconstruction of vessel segments and catheter path based on multiple angiographic images, measurement and reporting tools to facilitate the following use: - Calculate the dimensions of cardiovascular structures; - Quantify stenosis in coronary vessels; - Determine C-arm position for optimal imaging of cardiovascular structures; - Quantify pressure drop in coronary vessels; - Enhance stent visualization and measure stent dimensions; CAAS Workstation is intended to be used by or under supervision of a cardiologist.

CAAS Workstation is an image post-processing software package for advanced visualization and ysis in the field of cardiology or radiology and offers functionality to view X-Ray angiographic images, to segment cardiovascular structures in these images, to analyze and quantify these cardiovascular structures and to present the results in different formats. CAAS Workstation is a client-server solution intended for usage in a network environment or standalone usage and runs on a PC with a Windows operating system. It can read DICOM X-ray images from a directory, or receive DICOM images from the X-ray or PACS system. CAAS Workstation is composed out of the following analysis workflows: StentEnhancer and vFFR for calculating dimensions of coronary vessels, quantification of stenosis and calculating the pressure drop and vFFR value based on two 2D X-Ray angiographic images. Semi-automatic contour detection forms the basis for the analyses. Results can be displayed on the screen, printed or saved in a variety of formats to hard disk, network, PACS system or CD. Results and clinical images with overlay can also be printed as a hardcopy and exported in various electronic formats. The functionality is independent of the type of vendor acquisition equipment.

Modus IR used with the Synaptive Surgical Exoscope is indicated for fluorescence imaging in conjunction with indocyanine green to aid in the visualization of vessels (micro- and macro-vasculature) and blood flow in the cerebrovasculature before, during, and after neurosurgery, plastic, and reconstructive surgeries.

Modus IR is an accessory of the Synaptive surgical exoscope. Modus IR provides surgical staff with a means to visualize vessels and blood flow during surgical procedures that may not be visible under white light conditions. When used with the appropriate imaging agent, light output at a specific wavelength excites the imaging agent, which emits light at a specific wavelength that is detected by the optical system, thereby allowing the user to differentiate the structure that the imaging agent has concentrated in. The imaging agent is not packaged or sold as part of Modus IR. It is the responsibility of the user to source and administer the applicable imaging agent according to the excitation and observation wavelengths of Modus IR. Modus IR is selectively enabled by authorized personnel using software configuration management.

Upon intravenous administration and use of an ICG (Indocyanine green for Injection) consistent with its approved label, the EXPLORER AIR® II is used in capturing fluorescent images for the visual assessment of blood flow and tissue perfusion, before, during, and after vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgeries. The EXPLORER AIR® II is indicated for use in adult and pediatric patients one month of age and older. Upon administration and use of pafolacianine consistent with its approved labeling, the EXPLORER AIR® II is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

EXPLORER AIR® II consists of an imaging system that contains two cameras (one (1) for fluorescence, one (1) for color images) suspended by an articulated arm attached to a trolley. A touch screen and secondary monitor are also mounted on the trolley. EXPLORER AIR® II enhances the surgeon's vision with use of near infrared fluorescence (NIR) imaging. The technology is based on the exposure of the tissue of interest to light after fluorescent dye such as indocyanine green (ICG) or pafolacianine has been administered to the patient. The EXPLORER AIR® II visualizes fluorescence excited by infrared light (740-760nm) and emitted in the band around 800nm. After image acquisition, the composite image (overlay of fluorescence and color images) is displayed along with the fluorescent and color images. The user can tag and compare images, play the recorded videos, and export the selected files. The EXPLORER AIR® II must be used with EXPLORER AIR® Sterile Drape for use under sterile conditions.

The Arthrex Synergy Vision Endoscopic Imaging System is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including but not limited to: orthopedic, spine, laparoscopic, urologic, sinuscopic, plastic surgical procedures, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery. The Arthrex Synergy Vision Endoscopic Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. Upon intravenous administration and use of ICG consistent with its approved label, the system enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the Arthrex Synergy Vision Endoscopic Imaging System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization. Upon interstitial administration and use of ICG consistent with its approved label, the Arthrex Synergy Vision Endoscopic Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

The Arthrex Synergy Vision Endoscopic Imaging System includes a non-sterile camera control unit (CCU) console, camera heads, a laser light source, and endoscope. The system integrates ultra-high-definition camera technology, light emitting diode (LED) lighting, and an image management system into a single console with a tablet interface. The system provides real-time visible and near-infrared light illumination and imaging. The Arthrex Synergy Vision Endoscopic Imaging System interacts with the laser light source to be able to provide near-infrared (NIR) imaging to visualize the presence of Indocyanine Green (ICG). The ICG fluoresces when illuminated through a laparoscope with NIR excitation light from the laser light source and the fluorescence response is then imaged with the camera, processed, and displayed on a monitor.

· INFRARED 800 with FLOW 800 Option is a surgical microscope accessory intended to be used with a compatible surgical microscope in viewing and visual assessment of intraoperative blood flow in cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency of very small perforating vessels. It also aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery. Likewise, INFRARED 800 with FLOW 800 Option used during fluorescence guided surgery aids in the visual assessment of intra-operative blood flow as well as vessel patency in bypass surgical procedures in neurosurgery, plastics and reconstructive procedures and coronary artery bypass graft surgery. · YELLOW 560 is a surgical microscope accessory intended to be used with a compatible surgical microscope in viewing and visual assessment of intraoperative blood flow in cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency of very small perforating vessels. It also aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery.

Fluorescence accessories (YELLOW 560 and INFRARED 800 with FLOW 800 option) are an accessory to surgical microscope and are intended for viewing and visual assessment of intra-operative blood flow as well as aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery. The functionality of these filters is derived from their ability to hight fluorescence emitted from tissue that has been treated with a fluorescence agent by applying appropriate wavelengths of light and utilizing selected filters. This helps a surgeon to visualize different structural body elements (such as vessels, tissue, blood flow, occlusions, aneurysms, etc.) during various intraoperative procedures. The fluorescence accessory can be activated by the user via the Graphical User Interface (GUI), foot control panel or the handgrips, for example. For these accessories to be used with a qualified surgical microscope, the critical components of the surgical microscope need to fulfill the clinically relevant parameters for the Indications for Use of YELLOW 560 and INFRARED 800 with FLOW 800 Option. The fluorescence accessories are embedded into the surgical microscope. The emission filter wheels are present within the head of the microscope. For filter installation into the surgical microscope, two emissions filters (one for each eyepiece) are placed into each of these filter wheel is present in front of the light source, which is installed along with the excitation filter

Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the SPY-PH System is used with SPY AGENT GREEN to perform intraoperative fluorescence angiography. The SPY-PHI System is indicated for use in adult and pediatric patients one month of age and older. The SPY-PHI System is indicated for fluorescence imaging of blood flow and tissue perfusion before, and after. vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgical procedures. Upon interstitial administration of SPY AGENT GREEN, the SPY-PHI System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. Upon intradermal administration of SPY AGENT GREEN, the SPY-PHI System is indicated for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults with breast cancer for which this procedure is a component of intraoperative management.

The SPY-PHI System is a real-time white-light and near-infrared illumination/ fluorescence imaging system used during open-field surgical procedures. Near-infrared illumination is used for fluorescence imaging using SPY AGENT® GREEN for the visual assessment of blood flow, tissue perfusion and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. It consists of the SPY Portable Handheld Imager/ imaging head with an integrated light guide and camera cable and the Video Processor/ Illuminator. Additionally, SPY-QP Fluorescence Assessment Software is provided as an optional upgrade to the SPY-PHI System that enables relative quantification of NIR fluorescence.