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The Cellvizio® 100 series system with Confocal Miniprobes™ is a confocal laser system with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells, vessels and their organization or architecture. The Cellvizio® 100 Series System F400 is indicated for in vascular areas, including microvasculature and capillaries. Upon intravenous administration and use of an ICG consistent with its approved labeling, the Cellvizio® 100 Series System F800 is used to perform fluorescence angiography. Upon interstitial administration and use of ICG consistent with its approved labeling, the Cellvizio® 100 Series System F800 is used to perform 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 Cellvizio® 100 Series System F800 is used to perform fluorescence imaging of tissues that have taken up the drug. The GastroFlex™ (UHD, UHD-C) and ColoFlex™ (UHD, UHD-C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscopic accessories. The AlveoFlex™ (-. -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e. respiratory systems, accessed by an endoscope or endoscopic accessories. The CholangioFlex™ (-, -C) Confocal Miniprobes™ are intended to allow imaging of the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories. The AQ-Flex™ 19 (-, -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscopic accessories (e.g. aspiration needles used during procedures including but not limited to EUS-FNA, EBUS-TBNA and TBNA). The CystoFlex™ (F. F-C. and UHD, UHD-C) and UroFlex™ B (-, -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories. The CelioFlex™ (UHD 5, UHD 5-C) Confocal Miniprobes™ are intended to provide visualization of body cavities, organs, and canals during endoscopic surgical procedures, including robot-assisted procedures. The CranioFlex™ (-, -C) Confocal Miniprobes™ are indication within the central nervous system during cranial diagnostic and therapeutic procedures such as turnor biopsy and resection.

Confocal Miniprobes™ are used with Cellvizio® 100 series (F800) system, which is a confocal imaging system with fiber optic probes which allows visualization of internal microstructure of tissues and blood flow including, but not limited to, the identification of cells, vessels and their orqanization or architecture, during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures. To achieve this function, the Cellvizio® 100 series system F800 with its Confocal Miniprobes™ has been designed: - . To excite fluorescent components within the human tissue with the laser light emitted by the Cellvizio® at 785nm. - To receive fluorescence signal emitted from tissue microstructures within the spectral detection . bandwidth of the Cellvizio® 800-905 nm. ICG absorbs light in the near-infrared (NIR) region within a range of 780 nm to 805 nm with a peak absorption of 805 nm and emits fluorescence within a range of 810 nm to 850 nm with a peak emission of 820 nm (cf. ICG labeling). Therefore, the Cellvizio® 100 series system F800 can excite ICG circulating in the vascular and lymphatic systems and image signal emitted by ICG in these two systems. Pafolacianine absorbs light in the near-infrared (NIR) region within a range of 760 nm to 785 nm with a peak absorption of 776 nm and emits fluorescence within a range of 790 nm to 815 nm with a peak emission of 796 nm (cf. Pafolacianine Sodium labeling). Therefore, the Cellvizio® 100 series F800 model can: - A excite ICG in the vascular system or the Ivmphatic system and image signal emitted by ICG in the vascular system or the lymphatic system after ICG has been administered to the patient according to its approved labeling. - A excite pafolacianine or tissues that have taken up pafolacianine and image signal emitted by pafolacianine or tissues that have taken up pafolacianine after pafolacianine has been administered to the patient according to its approved labeling.

The Cellvizio® I.V.E. system with Confocal Miniprobes™ is a confocal laser system with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells and vessels and their organization or architecture. The Cellvizio® I.V.E. system is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries. The GastroFlex™ N and ColoFlex™ N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories. The AlveoFlex™ N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories. The CholangioFlex™ N Confocal Miniprobes™ are intended to allow imaging of the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories. The AQ-Flex™ 19 N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscopic accessories (e.g. aspiration needles used during procedures including but not limited to EUS-FNA, EBUS-TBNA and TBNA). The CystoFlex™F N, CystoFlex™ R N and UroFlex™ N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories. The CelioFlex™ 5 N Confocal Miniprobes™ are intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.

Confocal Miniprobes™ are used with Cellyizio® I.V.E. system. which is a confocal imaging system with fiber optic probes which allows visualization of internal microstructure of tissues and blood flow including, but not limited to, the identification of cells, vessels and their organization or architecture, during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures. Fluorescein Sodium is used as a fluorescence contrast agent to allow imaging of microvasculature and visualization of blood flow in vascular areas, including microvasculature and capillaries. Fluorescein Sodium can be used as a contrast agent with Cellvizio® I.V.E. system with Confocal Miniprobes™ without change of formulation, mode of action, approved dose or route of administration: it is delivered independent of Cellyizio® I.V.E. system in accordance with Fluorescein Sodium instruction for use.

The Cellvizio® I.V.E. with Confocal Miniprobes™ is a confocal laser system with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells and vessels and their organization or architecture. The GastroFlex™ N and ColoFlex™ N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts. i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories. The AlveoFlex™N Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories. The CholangioFlex™ N Confocal Miniprobe™ is intended to allow imaging of the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories. The AQ-Flex™ 19 N Confocal Miniprobe™ is intended to allow imaging of anatomical tracts. i.e.; gastrointestinal and respiratory tracts, accessed by an endoscopic accessories (e.g. aspiration needles used during procedures including EUS-FNA, EBUS-TBNA and TBNA). The CystoFlex™ F N, CystoFlex™ R N and Uroflex™ N Confocal Miniprobes™ are intended to allow imaging of anatomical tracts. i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories. The CelioFlex™ 5 N Confocal Miniprobe™ is intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.

The subject device Cellvizio® I.V.E. system with Confocal Miniprobes™ is a confocal laser imaging system that can be used with a variety of Confocal Miniprobe™ (fiber optic probes) to allow real-time imaging of the internal microstructure of tissues by direct contact with the tip of the Confocal Miniprobe™ during existing medical procedures, such as endoscopy or endoscopic or open surgical procedures. The technology provides the physician with additional information in the form of real-time images during these open or minimally invasive procedures. The Cellvizio® I.V.E. system with Confocal Miniprobes™ represents a refinement of the currently cleared and marketed predicate device, the Cellvizio® 100 Series System with Confocal Miniprobes™ (K172844). Design modifications and refinements include: - 1. Improving the integration of the system in endoscopy, interventional, or surgical operating suites by reducing the global footprint of the system. - 2. lmproving the user interface and ease-of-use of the system by replacing the keyboard and the trackball of the Cellvizio® 100 series with a touchscreen for review and interaction with the software and the addition of a separate remote (external) display screen for live imaging. This configuration allows better positioning of the physician's line of site during procedures. - 3. Simplifying the connection of the Miniprobes to the system. This improvement has no impact on other parts of the Confocal Miniprobe design, in particular the sheathed fiber and that are the patientcontacting parts are unchanged. - 4. The addition of "autofocus," allowing automatic positioning of the laser focal point for optimal optical injection from the Optical Scanning Unit into the fibers.

Cellvizio® 100 Series System with Confocal Miniprobes™ is a confocal laser system with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells, vessels and their organization or architecture. The Cellvizio® 100 Series System F400-v2 is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries. The GastroFlex™ UHD and ColoFlex™ UHD Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories. The AlveoFlex™ Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e. respiratory systems, accessed by an endoscope or endoscopic accessories. The CholangioFlex™ series of Confocal Miniprobe™ is intended to allow imaging of the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories. The AQ-Flex™ 19 Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscope, or endoscopic accessories (e.g. aspiration needles used during procedures including EUS-FNA, EBUS-TBNA and TBNA needles). The CystoFlex™ (F, UHD-R) and UroFlex™ B of Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories. The CelioFlex™ UHD 5 of Confocal Miniprobe™ is intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures. The CranioFlex™ Confocal Miniprobe™ is indicated to provide visualization within central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection.

Confocal Miniprobes™ are used with Cellvizio® 100 Series System (F400-v2), which is a confocal imaging system with fiber optic probes which allows visualization of internal microstructure of tissues and blood flow including, but not limited to, the identification of cells, vessels and their organization or architecture, during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures and during neurosurgical procedures. Fluorescein Sodium is used as a fluorescence contrast agent to allow imaging of microvasculature and visualization of blood flow. Fluorescein Sodium can be used as a contrast agent with Cellvizio® 100 Series system with Confocal Miniprobes™ without change of formulation, mode of action, approved dose or route of administration; it is delivered independent of Cellvizio® 100 Series system in accordance with Fluorescein Sodium instruction for use.

Cellvizio® 100 Series Systems with Confocal Miniprobes™ are confocal laser systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues, including, but not limited to, the identification of cells and their organization or architecture. The AQ-Flex™ 19 Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscope, or endoscopic accessories (e.g. aspiration needles used during procedures including EUS-FNA, EBUS-TBNA and TBNA needles).

AQ-Flex™ 19 Confocal Miniprobes™ is used with Cellvizio® 100 Series system to provide imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscope, or endoscopic accessories. It is designed to be used during transbronchial needle aspiration (TBNA), endoscopic ultrasound transbronchial needle aspiration (EBUS-TBNA) and endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) procedures. There are no changes in design, materials, or function between the subject AQ-Flex™ 19 device and the cleared AQ-Flex™ 19 Confocal Miniprobe™ (K123676, K150831, and K172844), except for the length of the AQ-Flex 19 which has been reduced from 4 to 3 meters (AQ-Flex™ 19 Confocal Miniprobe™ has previously been cleared with a length of 4 meters). A locking accessory already available in the package of the predicate device is used as an aid to secure placement inside the needle used during EUS-FNA procedures and can also be used during TBNA, and EBUS-TBNA procedures.

The Cellvizio® 100 Series systems with Confocal Miniprobes™are confocal laser systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells and vessels and their organization or architecture. The CranioFlex™ (-,-C) Confocal Miniprobes™ are indicated to provide visualization within central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection.

The Cellvizio® 100 Series systems with Confocal Miniprobes™ are confocal laser systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues. Confocal Miniprobes™ are intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures and during neurosurgical procedures. CranioFlex™ (-,-C) Confocal Miniprobes™ are used with Cellvizio® 100 Series systems to provide imaging of the brain through contact of their distal tip with the tissue. They are designed to be used and manually handled during neurosurgical procedures.

The Cellvizio® 100 Series systems (400 and/or 800) with Confocal Miniprobes™ are confocal laser systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells and vessels and their organization or architecture. The GastroFlex™ (UHD, UHD-C) and ColoFlex™ (UHD, UHD-C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories. The AlveoFlex™ (-, -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories. The CholangioFlex™ (or GastroFlex™ M) series of Confocal Miniprobes™ are intended to allow imaging of the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscopic accessories. The AQ-Flex™ 19 Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., gastrointestinal tracts, accessed by an endoscope or endoscopic accessories, including through EUS-FNA needles. The CystoFlex™ (F, UHD R, UHD R-C) and Uroflex™ B of Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories. The CelioFlex™ (UHD 5, UHD 5-C) of Confocal Miniprobes™ are intended to provide visualization of body cavities. organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.

The Cellvizio® 100 Series systems with Confocal Miniprobes™ are a confocal laser systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues. Confocal Miniprobes™ are intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures. Materials, design and intended use of the aforementioned Cellvizio® 100 Series confocal laser imaging systems and their Confocal Miniprobes™ remain exactly the same as what were previously cleared in K111047, K122042, K123676, K133466, K150831, K151593, K160416 and K171345 respectively.

Cellvizio® 100 Series Systems with Confocal Miniprobes™ are confocal laser systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues. CelioFlex™ UHD Confocal Miniprobes™ are intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic and laparoscopic surgical procedures, including robotic-assisted procedures.

CelioFlex™ UHD Confocal Miniprobes™ are used with Cellvizio® 100 Series systems to provide imaging of the internal microstructure of body cavities, organs, and canals through contact of their distal tip with the tissues. They are designed for use during laparoscopic surgical procedures, including robot-assisted procedures. CelioFlex™ UHD Confocal Miniprobes™ have a "grabule" (previously cleared in K151593 and K160416) on their distal tip. The "grabule" has been designed as a grip for laparoscopic grasping accessories, facilitating user control of the miniprobe distal tip during conventional laparoscopic procedures while preventing potential wear to the Miniprobe tip that repeated handling by forceps might cause. The diameter of the "grabule" is fitted for insertion of CelioFlex™ UHD Confocal Miniprobes™ through trocars with diameter larger or equal to 5 mm. CelioFlex™ UHD Confocal Miniprobes are also compatible with laparoscopy robot-assisted procedures. Robotic arm graspers can be used to manipulate CelioFlex™ UHD Confocal Miniprobes. During robotic-asisted procedures, CelioFlex™ UHD Confocal Miniprobes™ are inserted through a pre-installed trocar. When the CelioFlex™ UHD distal end appears on the monitor. the surgeon uses the robotic accessory to grasp the distal part of the Confocal Miniprobe™ or "grabule", with the laparoscopic grasper to position the Confocal Miniprobe-TM facing the tissue to be imaged.

Cellvizio® 100 Series Systems with Confocal Miniprobes™ are systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues. CelioFlex™ UHD 5-C Confocal Miniprobe is intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures. CystoFlex™ UHD R-C Confocal Miniprobe can be used within anatomical tracts, i.e., urinary, including, but not limited to urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.

Cellvizio® 100 Series systems with Confocal Miniprobes™ are confocal laser systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues. Confocal Miniprobes are intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures. Both CystoFlex UHD R-C and CelioFlex™ UHD 5-C have an achromatic UHD optical distal head that provide high resolution imaging for 488 to 785nm laser emission. A "-C" suffix has been added to the commercial name of these Confocal Miniprobes compared to the predicate devices when used with a Cellvizio 100 Series (800) which has been previously cleared as Cellvizio 100 Series with F700-v2 system (K133466).

The Cellvizio 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic probes that is intended to allow imaging of the internal microstructure of tissues in anatomical tracts, i.e., gastrointestinal or respiratory, accessed by an endoscope or endloscopic accessories. The GastroFlex M series of Confocal Miniprobes are intended to allow imaging of the internal microstructure of tissues in the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endloscopic accessories. The Cellvizio 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic probes that is intended to allow imaging of the internal microstructure of tissues in anatomical tracts, i.e., gastrointestinal. The AQ-Flex 19 member of the GastroFlex M series of Confocal Miniprobes can be used within anatomical tracts, i.e., gastrointestinal, accessed by an endoscope or endoscopic accessories, including through EUS-FNA needles. The Cellvizio® 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues. The Uroflex™B and CystoFlex™F Confocal Miniprobes can be used within anatomical tracts, i.e. Urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscopic accessories. The Cellvizio® 100 Series System with Confocal Miniprobes™ is a confocal laser system with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues. The CystoFlex UHD R Confocal Miniprobe can be used within anatomical tracts, i.e., urinary, including, but not limited to urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.

AlveoFlex™. ColoFlex™ UHD, GastroFlex™ UHD, CholangioFlex™, AQ-Flex™. UroFlex™ B and CystoFlex™ UHD R are Confocal Miniprobes which are compatible with specific high level disinfection and low temperature sterilization methods as described in the reprocessing instructions. Materials, design and intended use of the aforementioned Confocal Miniprobes remain exactly the same as what were previously cleared in K111047. K122042. K123676. K132389 and K141358 respectively. Low temperature sterilization methods will be added to the reprocessing instructions. Compatibility and efficacy of these methods with Confocal Miniprobes have been validated. The extent of validation testing relevant to this submission is provided below - 1. Validation of an additional low temperature sterilization system (STERRAD 100NX EXPRESS) on AQ-Flex™ 19 (K123673), UroFlex™ B (K132389) and CystoFlex™ UHD R (K141358). - 2. Validation of compatibility with low temperature sterilization systems (STERRAD 100S, and 100NX (EXPRESS)) with CholangioFlex™ (K122042), GastroFlex™ UHD, ColoFlex™ UHD and AlveoFlex™ (K111047). Verification and validation testing confirm that GastroFlex™ UHD, ColoFlex™ UHD, AlveoFlex™ and CholangioFlex™ Confocal Miniprobes™ can be reprocessed safely using STERRAD® sterilization systems 100S and 100NX (EXPRESS) according to reprocessing instructions.