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The HOPKINS Telescopes when used with sheaths are intended to be used to permit viewing of the cervical and uterine cavity for the purpose of performing diagnostic and surgical procedures.

The HOPKINS Telescopes are rigid telescopes that utilize the rod lens technology. At the distal end of the telescope's shaft is the lens and the other end of the shaft is attached to the eyepiece. Throughout the central lumen of the HOPKINS Telescopes, optical glass rods are used to transmit and magnify the image received from the lens. The HOPKINS Telescopes are available with 0°, 12° and 30° direction of view, 2mm, 2.9mm, 4mm diameter and 26cm, 30cm, 36cm working lengths.

The HOPKINS Telescopes are intended to provide visualization during laparoscopy and general surgery in adults and pediatrics.

The HOPKINS Telescopes are rigid telescopes that utilize the rod lens technology. At the distal end of the telescope's shaft is the lens and the other end of the shaft is attached to the eyepiece. Throughout the central lumen of the HOPKINS Telescopes, optical glass rods are used to transmit and magnify the image received from the lens. The HOPKINS Telescopes are available with 0°, 25° and 45° direction of view, 5mm diameter and 29cm working lengths.

The KARL STORZ H1 camera head, in combination with an appropriately indicated camera control unit (CCU), light source, and monitor, and with an appropriately indicated endoscope, or microscope, is used for real-time visualization in diagnostic and surgical procedures.

The camera head consists of an anodized aluminum, stainless steel enclosure containing a CMOS (Complementary metal-oxide-semiconductor) NTSC image sensor that converts light into electrons, the transistors in each pixel then amplify and move the charge using the more traditional wires forming conventional output signals. The camera head is intended to be attached to the proximal end of the endoscopes and is connected via cable to the compatible CCU for power and operational functions. The camera head is designed to be compatible for use with all standard KARL STORZ Endoscopes, Fiberscopes and Microscope for endoscopic observation in general endoscopic procedures.

The HD Mediastinoscope is intended to aid the surgeon in viewing the mediastinum and facilitate the introduction and removal of surgical instruments during ENT endoscopic surgical procedures.

The HD Mediastinoscope is a reusable videoendoscope intended to be used in conjunction with the X-link module of the Image1 S Camera Control Unit. The HD Mediastinoscope is comprised of four main components: CMOS sensor at the distal end of the endoscope, an oval insertion portion (spatula), handle, and internal LED light source. The spatula can accommodate up to 2 x 5 mm instruments.

The Flexible HD Cysto-Urethroscope System is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of urinary tract including the urethra, bladder, ureters, and kidneys.

The Flexible HD Cysto-Urethroscope System (Part Number: 11272VH(U)-TL) is intended to be used with the IMAGE1 S CCU consisting of Connect / Connect II and X-Link modules (cleared in K201135). Identical to the predicates, the scope cannot be operated on its own because it produces image data output in the form of video signals which require external processing and display. When the scope is used with the compatible CCU, it becomes the Flexible HD Cysto-Urethroscope System, which can then be operated as intended and indicated. The Flexible HD Cysto-Urethroscope System consists of the following key components: 11272VH-TL / 11272VHU-TL – Cysto-Urethroscopes with positive (VH-TL) / contra-positive (VHU-TL) deflection control and permanent T-Luer affixed to working channel TC200US / TC201US / TC301US – Connect/Connect II/Link camera control unit (CCU) modules for image processing The subject device is a lower cost alternative to the primary predicate and incorporates the following differences. Housing Plug: Due to lack of clinical need, the subject device replaces the suction channel of the primary predicate device with a permanent stainless steel housing plug. Fixed LUER: The subject device uses a removable T-Luer whereas the primary predicate supported a removable T-Luer or Stopcock.

The HD Mediastinoscope is intended to aid the surgeon in viewing the mediastinum and facilitate the introduction and removal of surgical instruments during ENT endoscopic surgical procedures.

The components subject of this submission are: HD Mediastinoscope (Part Number: 10973HD), and the IMAGE1 S CCU. The CCU consists of the IMAGE1 S Connect Module (Model Number: TC200US) and IMAGE1 S X-Link (Model Number: TC301US).

The XR-MX/1000 system is a solid-state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimally invasive urological surgery). The system may be used for urological treatment, planning and diagnostic procedures, including but not limited to: Querying and retrieving patient information and/or image from other modalities- X-ray examinations of the urogenital area (e.g. cystoscopy, kidney, bladder, ureter, urethra) including KUB², IVP, reflux-cystogram, cystourethrogram, and micturition cystourethrogram combined with uroflow measurements.3 Endourological interventions (e.g. of the urethra, prostate, bladder, sphincter, ostium, kidney and ureter, catheter placement, penile implant placement, transurethral resection of prostate or bladder, alternative treatment of the BPH and brachytherapy).3 Percutaneous interventions (e.g. PCN nephrolithotomy, resection, percutaneous nephrostomy)2 Application of fistula (kidney/bladder)3 Simple procedures (e.g. urethra, testis, phimosis)3 Intracorporeal shock wave lithotripsy3 Uroflow/urodynamics3 Pediatric radiological and therapeutic applications3(ages 2 to 22 years)

The operating principle of the subject devices, XR-MX/1000, manufactured by STORZ MEDICAL, AG., is identical to the predicate device, Uroview FD, manufactured by Pausch Medical GMBH, cleared via K161019. Both the subject and predicate devices include the following major X-ray components: Basic unit (C-MX C-Arc) X-Ray generator (source) X-Ray tube and housing (column) Collimator (image receptor) Measuring chamber (image receptor) Detector (image receptor) Digital image station (image receptor) The basic unit of the subject devices is comprised of an arm that is shaped in the letter “C” which gives the component its name “C-arc". One end of the C-arc includes an x-ray source and the opposite end includes an image receptor; while the basic unit of the predicate device is comprised of a urological table. The x-ray source emits the focused x-ray energy which is then transmitted through the body and is finally captured by the receptor, providing an image of the desired anatomy. The basic unit in both the subject and predicate devices is able to move, allowing the user to position the X-ray image chain at various angles and distances with respect to the patient anatomy being imaged. Additionally, the subject and predicate devices both include a workstation, which includes a monitor suspension arm that allows dual monitors for image display (radiologic and/or endoscopic) and space that allows other devices (e.g. camera control unit, documentation unit, etc.)

The CO2mbi LED SCB is a combination of an LED light source, intended to provide illumination, and an insufflation/ irrigation pump, intended to insufflate CO2 or air as a distention media in the gastronitestional tract or water irrigation for lens cleaning when used in conjunction with flexible endoscopes for GI endoscopic procedures.

CO2mbi LED SCB is a portable and compact all-in-one LED Light source and insufflation unit that includes a touchscreen control display, an insufflation pump and internal LED light source, intended to be connected to a compatible GI Videoendoscope and CCU for illumination and insufflation purposes. It is also equipped with a water bottle and lid with tube to provide irrigation for lens cleaning.

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.

The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging. The KARL STORZ Endoscopic ICG 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, or at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the KARL STORZ Endoscopic ICG 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. Additionally, the KARL STORZ Endoscopic ICG System enables surgeon to perform minimally invasive cranial neurosurgery in adults and pediatrics and endonasal skull base surgery in adults and pediatrics > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging. The KARL STORZ VITOM II ICG System is intended for capturing fluorescent mages 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 VITOM II ICG System is intended to provide a magnified view of the surgical field in standard white light.

The KARL STORZ ICG Imaging System is used to provide real-time high-definition (HD) endoscopic or telescopic images of visible (VIS) and near-infrared (NIR) indocyanine green (ICG) dye fluorescence during minimally invasive, neuro- and endonasal skull base surgery as well as plastic, micro- and reconstructive surgical procedures in general and pediatric populations. The overall system includes a 4mm HOPKINS ICG/NIR Endoscope (0°, 30° or 45°) for use in neuro- and endonasal skull base surgery, a 5mm & 10mm HOPKINS ICG/NIR Endoscope (0° or 30°) for use in minimally invasive procedures and a VITOM II ICG/NIR Telescope for use in plastic, micro- and reconstructive surgical procedures for VIS and NIR illumination and imaging, a light source with foot switch for emission of VIS and NIR illumination, a color video camera head capable of capturing both VIS and NIR imaging, and a KARL STORZ ICG Kit. Additional accessories used with the KARL STORZ ICG Imaging System include two standards fiber-optic light cables for transmission of VIS and NIR light and the Image1 S Camera Control Unit (CCU). The KARL STORZ ICG Imaging System can be used with any medical grade HD monitor with a DVI-D or 3G-SDI input.