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The VS3-Iridium System is intended to provide real-time visible and near infrared fluorescence imaging in both open and minimally invasive procedures. Upon intravenous administration and use of an ICG consistent with its approved labeling, the VS3-Iridium System is used to perform fluorescence imaging visualization of vessels, blood flow and tissue perfusion before during and after general minimally invasive surgical procedures and plastic, micro-, reconstructive surgeries. Upon interstitial administration and use of ICG consistent with its approved labeling, the Endoscope configuration of the VS3-Iridium 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 labeling, the VS3-Iridium 785 nm System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

The VS3-Iridium System is an advanced stereoscopic visualization system made up of a combination of hardware and software to provide high definition visible and near infrared (IR) fluorescent imaging. The visualization system can incorporate an endoscope for minimally invasive surgical procedures and a microscope positioned above the patient during open surgical procedures. The VS3-Iridium System including the endoscope and the microscope is designed to work with an approved infrared dye (Indocyanine green (ICG) or pafolacianine sodium injection or pafolacianine). ICG may be excited at excitation at either 785 or 805 nm, and pafolacianine is excited only by the 785 nm wavelength. The principle of operation is the same for both infrared dyes. That is, the VS3-Iridium System provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye using an IR camera, enabling qualitative and quantitative measurement of the IR intensity. Near IR fluorescence imaging with ICG permits the system to visualize blood flow and related tissue circulation, of lymphatic flow. The VS3-Iridium System allows the capture of normal (white) light image in parallel with the fluorescence IR image and displays both to the surgeon to provide a view of the anatomy. In addition, the VS3-Iridium System permits recording surgical procedures, storing them on removable storage devices, and replaying the procedures.

The VS3 Iridium System is intended for viewing anatomical structures during invasive surgery and for viewing fluorescent images for the visual assessment of blood flow and lymphatic flow. The unit is indicated for viewing internal surgical sites during general surgical procedures. It provides an adjunctive method for the evaluation of tissue perfusion and related tissue transfer circulation in tissue and free flaps used in general, plastic, micro-and reconstructive surgical procedures. It also enables the identification of functional lymphatic vessel, and/or lymph nodes. The VS3 Iridium System is also intended to visualize tissues that have taken up the pafolacianine during procedures that are consistent with the approved labeling of that dye. Upon intravenous administration and use of an ICG consistent with its approved labeling, the Iridium Module of the VS3-IR System is used to perform intraoperative fluorescence angiography. Upon interstitial administration and use of ICG consistent with its approved labeling, the Endoscope configuration of the VS3-IR 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 in accordance with its approved labeling, the VS3-IR 785 nm System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

The VS3 Iridium System is an advanced stereoscopic visualization system made up of a combination of hardware and software to provide high definition visible and near infrared (IR) fluorescent imaging. The visualization system can incorporate an endoscope for minimally invasive surgical procedures and a microscope positioned above the patient during open surgical procedures. The VS3 Iridium System including the endoscope and the microscope is designed to work with an approved infrared dye (Indocyanine green (ICG) or pafolacianine sodium injection or pafolacianine). ICG may be excited at excitation at either 785 or 805 nm, and pafolacianine is excited only by the 785 nm wavelength. The principle of operation is the same for both infrared dyes. That is, the VS3 Iridium System provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye using an IR camera, enabling qualitative and quantitative measurement of the IR intensity. Near IR fluorescence imaging with ICG permits the system to visualize blood flow and related tissue circulation, of lymphatic flow. The VS3 Iridium System allows the capture of normal (white) light image in parallel with the fluorescence IR image and displays both to the surgeon to provide a view of the anatomy. In addition, the VS3 Iridium System permits recording surgical procedures, storing them on removable storage devices, and replaying the procedures. This Traditional 510(k) premarket notification is to expand the indication for use statement to include the additional cleared infrared dye, pafolacianine sodium injection, for use with infrared imaging.

Intended to facilitate passage of a laparoscope through the anus allowing visual examination of the rectum and distal portions of the colon. Use of device is limited to non-sterile procedures where non-sterile laparoscopes are used.

Not Found

The system is intended for viewing internal surgical sites during general surgical procedures, visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and large joint arthroscopic procedures.

The VS3 ETV endoscope is the same endoscope as the predicate VS3 with the addition of 3 working channels. The endoscope is designed and manufactured the same way. The endoscope is a rigid metal shaft that uses a proximal sensor module which is mounted onto a camera block on the proximal side of the endoscope (the handle). The endoscope uses stereoscopic images which are transmitted from the visual field at the distal end of the scope through an optical transmission (for left and right channels). The endoscope camera sensor module picks up the left and right images of the scene inside the body and delivers them to the external display. The endoscope incorporates fiber optic threads that transfer the light from the illumination unit to the surgical scene. The VS3 ETV endoscope contains 3 working channels. The endoscope utilizes the same principle of operation, software, system architecture, camera and visual viewing technologies, illumination sources, display monitors, carts, CCU and couplers as the predicate VS3.

The 3D Endoscope Module of the VS3-IR System is intended for viewing internal surgical sites during general surgical procedures, for use in visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures. The MMS configuration of the Iridium Module of the VS3-IR System is intended for capturing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic. micro- and reconstructive surgical procedures. The Endoscope configuration of the Iridium Module of the VS3-IR System is intended to provide real-time endoscopic visible and near infrared fluorescence imaging. Iridium Endoscope enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infrared imaging during minimally invasive surgery.

The VS3-IR System is made up of the following components: - VS3 3D Endoscope (K123467, K141002, K131434) - VS3-IR-MMS & ICG Kit (K150018) - VS3-IR-Endoscope & ICG Kit (not yet assigned). The VS3 3D endoscopes (cleared in K123467, K131434, and K141002) are based on the proximal camera concept with a stereoscopic camera block on the proximal side of the endoscope (the handle). The stereoscopic images are transmitted from the visual field at the distal tip of the endoscope to the proximal camera block through an optical transmission system to PC workstations or external display monitors for enhanced viewing or capturing. VS3 includes reusable endoscopes which are cleaned and sterilized using the same methods and are indicated for the same lifecycle. In addition to traditional endoscopic procedures, VS3-IR system includes support for Infrared (IR) Fluorescence visualization (hereafter referred to as Iridium utilizes the VS3 system with scopes that support IR fluorescence visualization. VS3 Iridium Miniature Microscope (VS3-IR-MMS) which was cleared in K150018 is positioned 20cm to 45cm above the patient during an open procedure. The proposed Iridium Endoscopes (VS3-R-Endoscope) is used during laparoscopic minimally invasive procedures. VS3 Iridium MMS and Endoscopes are designed to work with an approved IR fluorescence dve (Indocvanine Green or ICG), which has excitation at 805nm and emission band between 825nm and 850nm. VS3 Iridium (VS3-IR) provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye using an IR camera. Both the Iridium MMS and Iridium Endoscope utilize the left channel of the VS3 imaging system (camera and image processor) for IR fluorescence imaging and the right channel for visible light imaging. This structure allows fluorescence imaging to use the same acquisition and processing pathways as the approved 3D endoscopes (cleared in K123467, K131434, and K141002).

The Endoscope Module of the VS3-IR-MMS System is intended for viewing internal surgical sites during general surgical procedures, for use in visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures. The Iridium Module of the VS3-IR-MMS System is intended for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.

The VS3-IR-MMS System consists of the cleared base system and the Iridium Module that is the subject of this submission. The currently marketed VS3 system with endoscope functionality was cleared under the following product codes: GCJ (General Surgery Endoscope), GWG (Neurological Endoscope), and HRX (Orthopedic Arthroscope). The cleared base system consists of the following components and accessories: High Definition 3D Endoscope, High Definition 3D Camera with 3 control buttons and a focus adjustment knob, 2D Coupler, CCU, Light Source, and Display Monitor. The VS3-IR-MMS System that is the subject of this submission contains the previously cleared components of the cleared base system listed above, as well as a High Definition IR Fluorescence Scope (MMS), a Laser Light Source (LLS), associated software and VS, Iridium IR Fluorescence Kit. The new Iridium Module, which uses the newly added High Definition IR Fluorescence Scope (MMS) and a Laser Light Source (LLS), as well as the cleared High Definition 3D Camera, Camera Control Unit (CCU), and Display Monitor, is used to generate florescence excitation illumination for external use in capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.

The VS3-OT system is intended for viewing internal surgical sites during general surgical procedures, visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures.

The VS3 Stereoscopic High Definition Vision System, Model VS3-OT consists of the following components: - Endoscope - Light source - Camera Control Unit (CCU) - Camera - Display monitors - 2D Endoscope coupler The VS3 Stereoscopic High Definition ("3DHD") Vision System, Model VS3-0T is based on the proximal HD camera concept with a stereoscopic camera block located on the proximal side of the endoscope (the handle). This allows high resolution capture of the 3D video stream. The stereoscopic images are transmitted from the visual field at the distal tip of the endoscope to the proximal camera block containing the HD sensor module. The VS3 Stereoscopic High Definition Vision System. Model VS3-OT allows for separation of the camera module with image sensor module and electronics from the endoscope shaft housing optical relay components and light fibers. The VS3 Stereoscopic High Definition Vision System, Model VS3-OT also includes 2D coupler capability that allows the VS3 Stereoscopic High Definition Vision System, Model VS3-OT to be used with FDA-cleared, third party 2D scopes at user sites to display monocular video.