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The KARL STORZ Cholangiography Set consists of manually operated reusable surgical devices intended for use by qualified surgeons in minimally invasive intraoperative cholangiography in adults and pediatric patients ≥ 13 years of age.

The KARL STORZ Cholangiography Set are manually operated reusable surgical devices consisting of: Cholangiography Fixation Clamp, Guide Tube for Cholangiocatheter, and BERCI Plastic Stylet. The KARL STORZ Cholangiography Set includes devices which are used to facilitate the execution of cholangiograms (x-ray pictures of the bile ducts) during endoscopic surgery.

The Cholangiography Fixation Clamp, Guide Tube for Cholangiocatheter, and BERCI Plastic Stylet work together to ensure accurate and clear cholangiography during minimally invasive procedures.

• The Cholangiography Fixation Clamp secures the catheter in place after insertion, preventing movement and ensuring proper positioning.
• The Guide Tube provides a smooth, controlled pathway for the catheter during insertion.
• The BERCI Plastic Stylet eliminates metal shadows by remaining in place when the metal trocar sheath is removed, preserving clear X-ray imaging of the biliary system.

The devices facilitate precise catheter placement, reduce interference in imaging, and maintain optimal procedure conditions for successful cholangiography.

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The Nuvis Wireless HD Camera System is indicated for use in diagnostic and operative endoscopic procedures, supplying visualization of an interior cavity of the body.

The Nuvis Wireless HD Camera System (or "System" or "Nuvis-2K") consists of two wireless reusable camera heads that can be paired to a wireless base station. When the camera head is attached to an arthroscope/light source (using a C-mount coupler) AND the wireless base station is attached to a clinic supplied video system, arthroscopic examinations can be viewed and pertinent data recorded. A tablet with NuvisCon Application (APP) can be connected to the wireless base station to enter patient and case data. The System can transmit uncompressed video content from the camera head to the wireless base station up to 5 meters (15 feet) away. Recorded video and snapped pictures are saved to an internal storage drive in the wireless base station.

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For telescope (27033AA)
The endoscopes when used with sheaths and obturators are intended to provide visualization of the operative site during minimal invasive urological endoscopic procedures in adults and pediatrics.

The Miniature Telescope for Urology (27033AA) is a semi-rigid telescope that utilizes fiber optic technology. The shaft of the endoscope consists of phynox or stainless steel. An optical fiber bundle runs through a central lumen in the shaft and transmits the image received at the distal end to the eyepiece. Other fibers illuminate the operative site by transmitting light. The Miniature Telescope for Urology (27033AA) is just an optic, without a working or irrigation channel. It is always used in combination (e.g. with sheath (or working element and sheath). Thus providing instruments access to the operative site.

The Miniature Telescope for Urology (27033AA) is available in the following:
Direction of View: 0°
Field of View: 72.5°
Diameter: 3.5Fr
Working Length: 21cm

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The VISERA ELITE III Surgical Imaging System is intended to provide real-time visible and near infrared fluorescence imaging.

Upon intravenous administration and use of ICG consistent with its approved label, VISERA ELITE III Surgical Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic 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 and common hepatic duct), using near infrared imaging.

Fluorescence imaging of biliary ducts with the VISERA ELITE III Surgical 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 VISERA ELITE III Surgical Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

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 subject devices of the OLYMPUS VISERA ELITE III Surgical Imaging System are identical to and unchanged from the VISERA ELITE III Surgical Imaging System (K242067):

• VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 (Model Number: OLYMPUS OTV-S700) – OLYMPUS OTV-S700 is 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.

  • OTV-S700 3D UPGRADE PACK (Model Number: OLYMPUS MAJ-2511) – A function activation portable memory key accessory that unlocks the 3D software function when connected with VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 to enable 3D observation mode.

• VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 (Model Number: OLYMPUS CLL-S700) – A LED light source that provides examination light to a video endoscope and a camera head.

• 4K Camera Head OLYMPUS CH-S700-XZ-EA (Model Number: 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.

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The device is intended to be used with endoscopic accessories such as a biopsy forceps and Electronic Endoscope Image Processor for endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney.

The Flexible Ureterorenoscope System consists of a sterile Flexible Ureterorenoscope and an Electronic Endoscope Image Processor with its accessories power adapter. The Flexible Ureterorenoscope is provided sterile (sterilized by EO) and is single use.

The Flexible Ureterorenoscope consists of a head section, bending section, insertion section, operating section, electrical connection section, and built-in LED light source. The Electronic Endoscope Image Processor is powered by the main line.

The Flexible Ureterorenoscope is an endoscope instrument and is intended to be used with the Electronic Endoscope Image Processor during endoscopic procedures. The handle section features several key components, including a control lever, a handle for manipulation, a button for capturing photos or video, and a Luer port for the insertion of accessories or irrigation to the working channel.

The insertion section houses a working channel and wiring to transmit the image signals to the image processor. The distal bending section of the insertion section contains a camera lens for real-time image capture, an LED light source for illumination, and a distal outlet for the working channel.

The Electronic Endoscope Image Processor is a video processor which is intended and designed for use during endoscopic procedures. It receives and processes image signals from the endoscope and outputs signals to an external medical monitor for display.

The Electronic Endoscope Image Processor has integrated software to control the operation of the device and is a reusable device that does not require sterilization before use, as there is no direct/in-direct patient contact material. The image processor is intended to be cleaned and disinfected before use, the cleaning and disinfection method is validated and recommend in the User Manual.

The equipment is for use in a hospital or qualified medical institution. It is only to be used by skilled physicians trained in clinical endoscopic techniques and procedures.

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Kii Structural Balloon Access System is indicated for use in patients undergoing laparoscopic surgery requiring a path of entry and/or tissue retraction of the extraperitoneal space.

Applied Medical's Kii Structural Balloon Access System provides a path of entry and/or tissue retraction for laparoscopic procedures in the extraperitoneal space. The system is provided sterile.

The system is composed of four main components:

• An obturator that facilitates insertion of the system through an incision.
• A cannula with bolster and attached balloon, encased within a perforated sheath.
• A seal which maintains insufflation.
• An inflation bulb that is used to manually inflate and deflate the balloon.

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The GripTract-GI Endoscopic Tissue Manipulator (GripTract) Upper GI Model is an accessory intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment.

GripTract Upper GI Model is indicated for use in the upper gastrointestinal tract with any standard endoscope as follows:

The GripTract-GI™ Endoscopic Tissue Manipulator (GripTract) Upper GI Model GT-GS100 is a disposable, non-sterile accessory intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment.

The GripTract Handpiece attaches to the endoscope control body just below the working channel. The soft End Cap with two integrated Fingers for tissue manipulation is placed on the distal end of the endoscope. Two Control Knobs on the Handpiece each operate a corresponding Finger, permitting the User to rotate and extend/retract the Fingers for tissue manipulation and visualization independent of the endoscope's movement or the presence of other tools in the endoscope's working channel.

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Stellar Imaging System is intended to provide real-time visible and near-infrared imaging in minimally invasive procedures.

Upon intravenous administration and use of an ICG agent consistent with its approved label, Stellar Imaging System is used to perform fluorescence imaging visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts.

Upon interstitial administration and use of an ICG agent consistent with its approved label, the Stellar Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Stellar Imaging System comprises Image Processing Unit, Light Source, Camera Head, Laparoscope and relevant accessories. During surgical procedures, Stellar Imaging System is used to provide real-time 3D visible and fluorescence imaging in endoscopic surgery.

The Stellar Imaging System including the laparoscope is designed to work with an approved infrared dye (Indocyanine green (ICG). ICG may be excited at excitation at either 785 or 805 nm. The System provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye via the camera head. Fluorescence imaging with ICG permits the system to visualize blood flow and related tissue circulation, of lymphatic flow, etc.

The System allows the capture of normal (white) light image in parallel with the fluorescence image and displays both to the surgeon to provide a view of the anatomy. In addition, the System permits recording surgical procedures, storing them on removable storage devices, and replaying the procedures.

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The UV5000W Handle is to be used with UroViu Cannula Uro-G HD, Uro-G, Uro-V, Uro-N, and Hystero-V and is intended to be used to permit viewing of the urethra and bladder or cervical canal and uterine cavity for the purpose of performing diagnostics.

The UroViu Cannula Uro-G HD, Uro-G, Uro-V, Uro-N, and Hystero-V connect to the UV5000W Handle to become an endoscopic system that is intended to allow visualization of the urethra and bladder or cervical canal and uterine cavity for the purpose of performing diagnostics. This 510(k) discloses the modifications made to the UV5000 Handle (K250797) with the capability of transmitting the images captured wirelessly to an external monitor.

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The VereSee Optical Veres Needle and Endoscopic Camera is intended for:

• Percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic surgery

• Use as an endoscopic video camera to provide visible light imaging in a variety of endoscopic and laparoscopic diagnostic and surgical procedures

The VereSee Optical Veres Needle and Endoscopic Camera System consists of two components: 1) VereSee Optical Veres Needle and Endoscopic Camera, and 2) VereSee Camera Control Unit.

The VereSee Optical Veres Needle and Endoscopic Camera consists of a series of three concentric stainless steel cannulas with a handle and an umbilical cable to connect it to the VereSee Camera Control Unit. It is provided sterile, for single patient use. The three concentric stainless steel cannulas include: 1) an Outer Cannula (or Insufflation Cannula), 2) a Central Cannula (or Access Cannula) with a clear, pointed tip for penetration and visualization during body cavity entry, and 3) Inner Cannula (or Camera Cannula) with a CMOS camera surrounded by light fibers at its tip.

The VereSee Camera Control Unit connects the CMOS camera in the VereSee Optical Veres Needle and Endoscopic Camera to HDMI compatible monitors to provide an image for endoscopic procedures. The VereSee Camera Control Unit (CCU) includes an LED driver to power the LED. The CCU connects to the Optical Veres Needle and Endoscopic Camera via an umbilical cable. The CCU converts signals from the CMOS camera in the VereSee Optical Veres Needle and Endoscopic Camera to a format compatible with HDMI display input requirements.

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