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The HyperSnap Surgical System is a real-time video camera system utilising computational hyperspectral imaging in the visible spectrum. The system is intended to be used intraoperatively to relay a standard RGB video feed used for visualisation alongside corresponding tissue oxygenation information presented as a corresponding two-dimensional real-time video feed. The system is intended for use as an adjunctive monitor of the haemoglobin oxygen saturation of blood (StO2) in the superficial tissue in the surgical field of view. The HyperSnap Surgical System may help identify patients at risk of tissue ischaemia. The system is indicated for use in all populations for open and minimally invasive general surgical applications utilising compatible surgical telescopes (exoscopes and rigid endoscopes). The prospective clinical value of measurements made with StO2 has not been demonstrated in disease states.

Hyperspectral imaging (HSI) is an optical imaging modality that carries information about tissue properties, facilitating objective tissue characterisation without the need for any exogenous contrast agent. HSI is non-invasive, non-contact, and does not make use of ionising radiation. The HSS is an HSI system that seamlessly integrates into surgical workflows to provide critical, but currently unavailable, tissue property information during surgery. The HSS provides for visualisation of real-time tissue oxygenation saturation (StO2) information alongside conventional red-green-blue (RGB) visualisation. Additionally, the mean StO2 value within a user-defined ROI is reported. Imaging is displayed at video rate ensuring instant surgeon feedback and intra-operative tissue assessment to facilitate surgical guidance and decision making. The HSS is an artificial intelligence (AI) / machine learning (ML) enabled device. Training data for the deep learning algorithm comprises high resolution medical imaging datasets which collectively offer representative spatial and spectral variation across the intended target tissues and surfaces. The core components of the HSS include, amongst others, a hyperspectral camera, the HyperSnap Camera, a computational workstation, the Camera Control Unit (CCU), the Camera Electrical Isolator and Camera Electrical Isolator Power Supply. The HyperSnap Camera is a lightweight surgical camera with a snapshot hyperspectral imaging sensor. Our surgical imaging technology exploits highly optimised algorithms and software to leverage snapshot HSI hardware for the extraction of advanced optical properties of observed tissues. The camera can be securely mounted but is easily manoeuvrable, allowing for controlled mobilisation and immobilisation of the imaging system by a single operator without the need for an assistant. The CCU runs the HyperSnap Software which implements a deep learning approach for super-resolution and reconstruction of acquired snapshot hyperspectral images.

### a. Processor EP-8000 - The EP-8000 is an endoscopic processor with an integrated light source that is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording. - This product can be used in combination with compatible medical endoscope, a monitor, a recorder and various peripherals. - It supplies air through the endoscope, for obtaining clear visualization and is used for endoscopic observation, diagnosis and treatment. - BLI (Blue Light Imaging), LCI (Linked Color Imaging), ACI (Amber-red Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examinations which can be used to supplement Fujifilm white light endoscopy. BLI, LCI, ACI and FICE are not intended to replace histopathological sampling as a means of diagnosis. ### b. Endoscope Model EG-860R This product is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

FUJIFILM Video Processor EP-8000 is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording. FUJIFILM Video Processor EP-8000 relays the image from an endoscope to a video monitor. The projection can be either analog or digital at the user's preference. The processor employs fiber bundles to transmit light from four LED lamps (Violet, Blue, Green, and Amber), with a total power of 79.2W lamps, to the body cavity. The EP-8000, like the VP-7000 and BL-7000, has additional image processing options called BLI, BLI-bright, and LCI that provide endoscopic assistance for white light imaging (WLI). There is also an additional image processing option called "ACI"(Amber-red Color Imaging). ACI is an image processing function that simultaneously emphasizes the brightness and color difference of red information in endoscopic images and serves as an adjunct to white light imaging (WLI). Compared to WLI mode, ACI relatively increases the ratio of amber red light and decreases the ratio of violet light. Relatively high-saturation red information such as blood-like red in the image signal digitized by the camera unit is enhanced by signal processing. The EP-8000 also has a Multi Observation option that allows endoscopic images to be displayed in the main screen area and sub-screen area by switching image processing options at every frame. This allows each image frame to be displayed in the main screen area and sub-screen area 1 with a different combination of image processing options applied [WLI+(LCI), LCI+(WLI), BLI+(WLI), WLI+(BLI)]. The device is AC operated at a power setting of 100-240V/50-60Hz/ 3.0-1.5A. The processor is housed in a steel-polycarbonate case measuring 395x210x515mm The insertion portion of the device has a mechanism (hereinafter "the bending portion") which bends the tip from right to left and up and down, and a flexible tube (hereinafter "the flexible portion") consists of the bending portion and operating portion with a knob which controls the bending portion. The forceps channel which runs through the operating portion to the tip is arranged inside the insertion portion for inserting the surgical instrument. The insertion portion of the endoscopes comes into contact with the mucosal membrane. The tip of the insertion portion is called the "Distal end" which contains the Imaging section, Distal cap, Objective lens, Air/water nozzle, Water jet nozzle, Instrument channel outlet, Objective lens, and Light guide. The bending portion is controlled by knobs on the control portion/operation section to angulate the distal end to certain angles. The Flexible portion refers to the long insertion area between the Bending portion and the Control portion (a part of Non-insertion portion). This portion contains light guides (glass fiber bundles), air/water channels, a forceps/suction channel, a CMOS image sensor, and cabling. The glass fiber bundles allow light to travel through the endoscope to illuminate the body cavity, thereby providing enough light to the CMOS image sensor to capture an image and display the image on a monitor. The forceps channel is used to introduce biopsy forceps and other endoscopic accessories, as well as providing suction. The control portion/operating section provides a grip to grasp the endoscopes and contains mechanical parts to operate the endoscopes. This section includes a Forceps inlet, which allows endoscope accessories to be introduced. The Scope connector connects the endoscopes to the light source and video processor, respectively.

The VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 is intended to process electronic signals transmitted from a video endoscope/camera head and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, light sources, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation. The VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 is intended to provide light to an endoscope/video endoscope in order to process electronic signals transmitted from them and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, video system centers, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation. The 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA is intended to be used with endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

The VISERA ELITE III Surgical Imaging System is intended to be used with ancillary equipment for endoscopic diagnosis, treatment, and observation and supports the function of high definition (HD) videoscopes and is Camera Head (CH) compatible. The following devices of the VISERA ELITE III Surgical Imaging System are the subject of this premarket notification submission: - **VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 (Model: OLYMPUS OTV-S700)** - A video system center that processes electronic signals transmitted from a video endoscope or a camera head and outputs the image signal to a monitor. - **VISERA ELITE III 3D Upgrade Pack (Model: MAJ-2511)** - A function activation portable memory key accessory that unlocks the 3D software function when connected with OTV-S700 to enable the observation of 3D mode. - **VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 (Model: OLYMPUS CLL-S700)** - A LED light source provides examination light to a video endoscope and a camera head. - **4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA (Model: OLYMPUS CH-S700-XZ-EA)** - A 4K Inline camera head is intended to be used with Olympus endoscopes, the video system center, and other ancillary equipment for the visualization of internal organs (endoscopic diagnosis), treatment and observation.

The Endoscopic Video Image Processor is used in conjunction with the Single-Use Video Flexible Cysto-Nephroscope (Models: RP-U-C01F, RP-U-C01FS) to process the images collected by the video endoscope and send them to the display, and provide power for the endoscope.

The Endoscopic Video Image Processor is a video processing system intended for use during endoscopic procedures. It receives and processes image signals from a compatible video endoscope and produces live video images during endoscopic procedures. Apart from the image processing functions, it also provides the power supply for the endoscope. The Endoscopic Video Image Processor is a reusable device. It does not require sterilization before use, as there is no direct/indirect patient contact. The device needs to be cleaned and disinfected before use. and the cleaning and disinfection method is outlined in the Instructions for Use.

The Flexible Video-Choledo-Cysto-Ureteroscope System is indicated for endoscopic examination in the urinary tract and can be used percutaneously to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures. The Flexible Video-Choledo-Cysto-Ureteroscope System is also indicated for the examination of bile ducts surgically, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.

Imaging Processor System (Including Light Source) is composed of lighting system, image processing board. The lighting system provides the light source for the endoscope probe at the back end. The image processing board receives electronic signals from the front-end camera module and processes them, and finally transmits them to the display through the video interface. Flexible Video-Choledo-Cysto-Ureteroscope is a kind of medical electronic optical instrument, also known as optical camera, which can enter into the human bladder, ureter, biliary and pancreatic duct for observation and diagnosis. The operator delivers the optical camera system to the site of diagnosis and treatment by means of a mechanical part with a flexible insertion tube and a system of bends. The product is equipped with tiny size digital imaging parts -- photoelectric sensors "CMOS", on which the objects in human cavity will be transferred though lens optical system, and converts light signals into electrical signals. The electrical signal will be transferred to Imaging Processor System (Including Light Source) and display images on it's monitor output for doctor observation and diagnosis.

The VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500, when used with endoscopes, video endoscopes, camera heads, monitors and other ancillary equipment for endoscopic surgery, is intended to receive and process electronic signals transmitted from a video endoscope/camera head and output image signal to monitor.

The OLYMPUS OTV-S500 is a "universal platform" which offers compatibility with various endoscopes for different medical specialties and enables operation to meet the clinical needs in the fields of urology and gynecology. The Subject device is intended to be used in conjunction with ancillary equipment for endoscopic diagnosis, treatment and observation. The OLYMPUS OTV-S500 consists of electrical circuit boards, electrical units (cooling fan, unit power supply, and control panel), harnesses between circuit boards, and optical components (lens and optical filter). A microprocessor is built into the OLYMPUS OTV-S500 which controls processing of observation images, user interface (front panel switch, indicator LEDs, warning buzzer etc.) and menu. These functions are implemented in the embedded software. Scopes including flexible videoscopes or fiberscopes and rigid videoscopes with camera heads and light source are directly connected to the Subject system. When connected, the endoscope (fiberscopes and rigid videoscope without camera head) acquires and displays images directly to the user or output onto a monitor when using a flexible endoscope or scope and camera head. The Subject devices submitted for clearance include one (1) major component: the Video System Center (OLYMPUS OTV-S500); and two (2) auxiliary components: Foot Holder (MAJ-2552) for the OLYMPUS OTV-S500 that are shipped with the Video System Center, and an optional HDMI cable (MAJ-2551).

EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500: The EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500 is intended to be used with Olympus ancillary equipment for endoscopic diagnosis, treatment, and video observation. This product is designed to process electronic signals transmitted from Olympus video endoscopes, output images to monitors, provide illumination to the endoscope, supply air through the endoscope while inside the body and control/monitor ancillary equipment. NBI (Narrow Band Imaging), RDI (Red Dichromatic Imaging), TXI (TeXture and color enhancement Imaging), and BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast) are adjunctive tools for endoscopic examination which can be used to supplement Olympus white light imaging. NBI, RDI, TXI and BAI-MAC are not intended to replace histopathological sampling as a means of diagnosis. The CV-1500 Video System Center is compatible with scopes within the EVIS 190 and 1100 families. COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL & CF-HQ1100DI: The COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I is intended to be used with an Olympus video system center, endoscope position detecting unit, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The COLONOVIDEOSCOPE CF-HQ1100DL &CF-HQ1100DI (product codes may be combined into a shorter code: CF-HQ1100DL/I) is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100: The GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 is intended to be used with an Olympus video system center, Light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The GASTROINTESTINAL VIDEOSCOPE GIF-1100 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).

This video system center is intended to be used with Olympus ancillary equipment for endoscopic diagnosis, treatment, and video observation. This product is designed to process electronic signals transmitted from Olympus video endoscopes, output images to monitors, provide illumination to the endoscope, supply air through the endoscope while inside the body and control/monitor ancillary equipment. NBI (Narrow Band Imaging), RDI (Red Dichromatic Imaging), TXI (TeXture and color enhancement Imaging), and BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast) are adjunctive tools for endoscopic examination which can be used to supplement Olympus white light imaging. NBI, RDI, TXI and BAI-MAC are not intended to replace histopathological sampling as a means of diagnosis. RDI (Red Dichromatic Imaging) observation: RDI is optical-digital observation using red dichromatic narrow band light and green illumination light to enhance visibility of bleeding points in the endoscopic image due to the difference in light absorption. TXI (TeXture and color enhancement Imaging): TXI emphasizes tonal changes, patterns, and image outlines. It also corrects the brightness of dark areas. BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast): BAI-MAC maintains the brightness of the bright part of the endoscopic image and corrects the brightness of the dark part of the endoscopic image. EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500: This video system center is indicated to process electronic signals transmitted from Olympus video endoscopes, output images to monitors, and be used with Olympus ancillary equipment for endoscopic diagnosis, treatment, and video observation. This product also functions as a pump to supply air through the endoscope, a light source to the endoscope, and a controller/monitor of ancillary equipment. COLONOSCOPE OLYMPUS CF-HQ1100DL &CF-HQ1100DIGASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100: The endoscope receives the illumination light from light guide connector connected to the video system center (CV-1500: part of this submission). The illumination light is transferred to the distal end through the optical fiber bundle inside of the endoscope and illuminates the inside of the patient body through the illumination lens at the distal end. The endoscope receives the reflected light from the inner lumen of a patient by objective lens at the distal end. The built-in CCD at the distal end converts the light to the electrical signal, and the signal is sent to the video system center via the electrical cable and the video connector of the endoscope. The endoscope transfers the image signal and displays the observation image on the screen. The endoscope consists of three parts: the control section, the insertion section, and the connector section. The basic principle including user interface and operation for the procedure of the endoscope is identical to that of the predicate device.

Upon intravenous administration of TRADENAME (ICG drug product), System green is used with TRADENAME (ICG drug product) to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when indicated, during intraoperative cholangiography. System green is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. System green enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment 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 System green 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 of TRADENAME (ICG drug product), System green is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes

System green combines the camera head, the rigid endoscope, the light source including light cables and a foot switch and the camera controller. The camera head is connected via a standard camera cable while the connection between the camera controller and light source is possible via a LAN (Ethernet) connection cable. This is the precondition for the video in fluorescence mode. The camera head is further connected to the rigid endoscope via a snap-on locking mechanism. The rigid endoscope is further coupled via the fiber light source, which can also be connected to an optional foot switch. System green allows for fluorescence imaging by exciting indocyanine green (ICG), a dye (FDA approved drug, not included in this submission) that is applied intravenously or interstitially in the body. Fluorescence imaging and white light imaging is possible with the same system setup at the same time. The NIR images can only be displayed as overlay pictures with the NIR information added to the white light image. The white light image can also be displayed on its own.

The TELE PACK + is an all-in-one Imaging System, which comprises a light source for illumination, Camera Control Unit (CCU) for use with compatible camera heads or video endoscopes for image processing, as well as a monitor for image display, intended for the visualization of endoscopic and microscopic procedures.

The Telepack + is a portable and compact all-in-one imaging system that includes a 18.5 inch screen display, a camera control unit and internal LED light source, that is intended to be connected to a compatible device (camera head or videoendoscope) for the purpose of visualization and documentation of endoscopic and microscopic procedures as well as stroboscopy. The Telepack + includes a LED illumination light source to illuminate the intended area and a 18.5 inch monitor for display. It also allows the users to redefine the functions that take place when a button is pressed. The Telepack + is a non-patient contacting and require only wipe down as needed.