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The products are used to store medical devices before, during, and after sterilization. The products are intended to enable sterilization of the enclosed medical devices but are not intended to maintain sterility on their own; instead, they are used in conjunction with an FDA-approved sterilization wrap that is legally available on the market. The products have no medical indications. Sterilization cycle times are as follow: Exposure time: 3 min Temperature: 132 ℃ Drying time: 20 min The maximum validated load weight for all devices listed below is 4.5 kg (approx. 9.92 lbs). All measurements are in millimeter and are coded as follows [WidthxHeightxLength]. UNIVERSAL PERFORATED BASKET 1 (33001); 732x117x282) UNIVERSAL PERFORATED BASKET 2 (33002); (743x200x282) UNIVERSAL PERFORATED BASKET 3 (33003); (538x117x250) UNIVERSAL PERFORATED BASKET 4 (33004); (538x117x250) UNIVERSAL PERFORATED BASKET 5 (33005); (549x200x250) PERFORATED BASKET FOR SMALL PARTS (33006); (128x40x121) PERF. BASKET – KNEE ARTHROSC. BASIC SET (33007); (549x150x250) PERF. BASKET - KNEE ARTHROSC. ACL/PCL 1 (33008); (549x150x250) PERF. BASKET - KNEE ARTHROSC. ACL/PCL 2 (33009); (549x150x250) PERF. BASKET FOR KNEE ARTHROSC. PREP TAB (33010); (549x150x250) PERF. BASKET FOR VERTEBRIS LUMBAR (33011); (549x150x250) PERF. BASKET FOR SHOULDER ARTHROSCOPY (33012); (538x117x250) PERF. BASKET FOR VERTEBRIS FORAMINOTOMY (33013); (525x65x255) PERF. BASKET FOR VERTEBRIS STENOSIS (33015); (549x150x250) PERFORATED BASKET FOR CAMERA HEAD (38002); (448x73x200) PERFORATED BASKET, UPPER URINARY TRACT 1 (38003); (635x75x132) PERF. BASKET FOR CYSTOSCOPE/TELESCOPE (38004); (467x75x132) PERFORATED BASKET FOR DISCOSCOPE (38005); (467x75x132) PERFORATED BASKET FOR HYSTEROSCOPE 1 (38006); (467x75x132) PERF. BASKET FOR VIDEO MEDIASTINOSCOPE (38007); (256x85x250) PERFORATED BASKET FOR TELESCOPE (38008); (467x75x132) PERFORATED BASKET FOR HYSTEROSCOPE 2 (38009); (467x90x132) PERFORATED BASKET FOR STEREO TELESCOPE (38010); (477x139x196) PERFORATED BASKET FOR NEPHROSCOPE (38011); (467x75x172) PERFORATED BASKET FOR MORCESCOPE (38012); (467x75x172) PERFORATED BASKET FOR CYSTO-URETHROSCOPE (38013); (451x64x80) PERFORATED BASKET FOR 3D TELESCOPE (38014); (583x80x200) PERF. BASKET FOR STANDARD TELESCOPE 1 (38015); (297x54x59) PERF. BASKET FOR STANDARD TELESCOPE 2 (38016); (481x54x59) PERF. BASKET FOR STANDARD TELESCOPE 3 (38017); (619x54x59) PERFORATED BASKET FOR PAIN THERAPY (33014); (525x95x255)

The PERFORATED BASKETS all have the same basic configuration, a metal basket base and a basket lid, with optional product specific instrument carriers (for multiple levels) or adapters and an additional basket for small parts. The base part and the lid of the PERFORATED BASKET are connected by a locking mechanism, which assures a tight connection of both parts.

The product is used for generating high frequency electrical current for cutting and coagulating tissue electrosurgically.

The HF SURGERY GENERATOR 400KHZ is used for electrosurgical cutting and coagulation of living human tissue. For this purpose, electrical energy from the power supply network is transformed into high frequency current which allows this surgical property. The device offers a multitude of different profiled current forms which are optimized for the different surgical requirements. It is equipped for monopolar and bipolar cutting and coagulation in micro- and macrosurgical operations.

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 D Camera Controller 5522101 has been designed for high-definition video endoscopy and can be used for both, diagnostic and therapeutic interventions. The Camera Controller is used in conjunction with other video equipment and endoscopic accessories.

The D Camera Controller 5522101 has been designed for high-definition video endoscopy and can be used for both, diagnostic and therapeutic interventions. The Camera Controller is used in conjunction with other video equipment and endoscopic accessories. The subject device is used in combination with sensor endoscopes and a monitor for visualization. In this context, the D Camera Controller is the control unit, its primary performance characteristics are signal processing of the image data and image recording. No further light source is required for the intervention. The D Camera Controller supplies the distal LED of the endoscope with light. The electrical signals provided by the sensor endoscope are processed and adequately converted to render a visible image of the endoscopic scene on a connected display device for the user.

The products are used in invasive surgery or via natural orifices for diagnosis and therapy and serve to visualize the inside of the body. The products are used for interventions in different medical disciplines, such as surgery and laparoscopic interventions e.g. in urology and gynecology.

The PANOVIEW Ultra telescopes (common name: telescopes) are rigid endoscopes which are used in invasive surgery or via natural orifices for diagnosis and therapy and serve to visualize the inside of the body. The products are used for interventions in different medical disciplines, such as surgery and laparoscopic interventions e.g. in urology and gynecology. The submitted devices can be grouped by working length (WL) and direction of view. The PANOVIEW Ultra telescopes (common name: telescopes) are rigid endoscopes with a fixed eyepiece, integrated light guide, optical system, cold light connector, with screw-on adapter for fiber light cables and with color coding ring for direction of view. The telescopes are constructed of a cladding tube, which is surrounded by a rigid sheath, a fixed eyepiece and an eyecup at the proximal end. Within the cladding tube, images are transferred via a rod lens system to the fixed eyepiece. Illumination is provided via light guide bundles connected to a light source. Visualization can directly be performed via the fixed eyepiece (direct visualization method) or alternatively via a monitor and user interface (indirect visualization method). For the second option, a camera must be attached to the fixed eyepiece and must be connected to a monitor.

Sensor-Ureterorenoscopes are used within the scope of therapeutic interventions. The products are active, sterile and for single-use. They are used for visualizing body cavities via natural passages and for the insertion of auxiliary instruments through the working channel as well as the supply of irrigation fluid. The Sensor-Ureterorenoscope is used in Urology for examination, diagnostics and/or therapy of the upper urinary tract. ADAPTER FOR CONTROLLER 5525 The products are used for operating a sensor endoscope in conjunction with an ENDOCAM Logic 5525 Camera Controller, for the mechanical connection to the sensor endoscope as well as for controlling the signals generated.

The Sensor-Ureterorenoscope features a semi-rigid instrument sheath and a flexible and actively deflectable tip. It is equipped with two separate working channels for applications with laser fibers and/or flexible auxiliary instruments. The two working channels have different diameters, allowing the insertion of the laser fiber via working channel (2) and a stone-extraction basket or flexible auxiliary instruments via working channel (1) Irrigation is effected via working channel (1) and is connected via the luer connector marked in blue on the housing. A third channel integrated in the instrument sheath allows the return flow via distal holes on the instrument head. The drain is effected via the lower luer connector marked in gray. The flexible deflectable tip can be controlled in both directions (upward and downward) +/-300° via the control wheel on the handle. Thanks to the high torsional stiffness of the semi-rigid instrument sheath the sheath movements are transmitted directly in radial and axial directions. The working channel (2) permits the insertion of laser fibers up to a diameter of 272 µm. For visualization the Sensor-Ureterorenoscope is connected to an endoscopy camera controller. The Sensor-Ureterorenoscope is sterile and for single-use. The ADAPTER FOR CONTROLLER 5525 is an accessory to the RIWO D-URS, which serves as an interface to connect the RIWO D-URS to an ENDOCAM Logic 5525 Camera Controller (not part of this submission).

ENDOCAM Logic 5525 Camera Controller: LOGIC HD CAMERA CONTROLLER / LOGIC 4K CAMERA CONTROLLER: The Logic HD Camera Controller and the Logic 4K Camera Controller have been designed for high-definition video endoscopy and can be used for both diagnostic and therapeutic interventions. The Camera Controllers are used in conjunction with other video equipment and endoscopic accessories. LOGIC HD LITE CAMERA CONTROLLER: The Logic HD lite Camera Controller has been designed for high-definition video endoscopy and can be used for both diagnostic and therapeutic interventions. The Camera Controller is used in conjunction with other video equipment and endoscopic accessories.

The ENDOCAM Logic 5525 Camera Controller describes all Richard Wolf ENDOCAM Logic Camera Controllers, by name LOGIC 4K CAMERA CONTROLLER, LOGIC HD CAMERA CONTROLLER and LOGIC HD Lite CAMERA CONTROLLER. The main purpose of the ENDOCAM Logic 5525 Camera Controller is identifying the applied part(s) and configuring the data stream, managing the interaction and providing an access point for the user. The ENDOCAM Logic 5525 Camera Controller contains software which is classified as a minor Level of Concern. The main features of the software are configuration of the image processing, archiving and providing different views and a user interface to the user. The ENDOCAM Logic 5525 Camera Controller is not intended to contact the patient directly or indirectly. The ENDOCAM Logic 5525 Camera Controller is delivered non-sterile. The devices are reusable and do require cleaning and reprocessing during their use-life, i.e. users are required to clean and disinfect the device before every application and before returning for repairs. Methods of cleaning and reprocessing are detailed in the Instruction for Use.

The Flexible Sensor-Ureterorenoscopes BOA Vision EF and Flexible Sensor-Ureterorenoscopes COBRA Vision EF are used for visualizing body cavities and organs via natural and surgically created passages. These products are exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately instructed persons. For examination, diagnostics and/or therapy in conjunction with endoscopic accessories. The product is used in the following disciplines: Urology: - Urogenital tract - Nephroscopy

The Flexible Sensor-Ureterorenoscope BOA VISION EF (short name: BOA) and Flexible Sensor-Ureterorenoscopes COBRA VISION EF (short name: COBRA) are flexible video endoscopes used for visualizing body cavities and organs via natural and surgically created passages. The Flexible Sensor-Ureterorenoscopes compromise a handle and a flexible shaft connected to the handle with an active controlled deflection section at the endoscope tip. The video image of the Flexible Sensor-Ureterorenoscopes is produced by a CMOS imaging sensor located at the tip of the insertion shaft together with the objective lens. The imaging sensor with the electronics in the handle generates a signal that is transferred to the designated camera controller ENDOCAM Flex HD (cleared with K161204), which processes the signals to display them on a monitor (not part of this submission). The Flexible Sensor-Ureterorenoscopes use integrated LED lights for illumination. The Flexible Sensor-Ureterorenoscopes provide a working channel with 1.2 mm diameter and a working length of 680 mm length. A Luer sealing cap may be used to seal the provided Luer connectors if not used. The Flexible Sensor-Ureterorenoscope COBRA VISION EF has a second separate channel with 0.8 mm diameter for laser fibers or continuous irrigation. The laser fiber channel is equipped with a laser adjustment unit for housing, clamping and aligning the laser fiber, which support to move the clamped laser fiber sensitively by turning an adjustment ring for contacting the stone. Parts of the Flexible Sensor-Ureterorenoscopes have direct patient contact. When used as intended, the duration of tissue contact is limited (up to 24 hours). The used raw material with direct or indirect patient consist of Stainless steel, optical glass, Polyurethane, Perfluoroalkoxy (PFA) and adhesives (epoxy).

LOGIC 4K CAMERA CONTROLLER: The ENDOCAM® Logic 4K Camera System 5525 has been designed for high-definition video endoscopy and can be used for both diagnostic and therapeutic interventions. The ENDOCAM® Logic 4K Camera System 5525 is used in conjunction with other video equipment and endoscopic accessories. LOGIC 4K CAMERA HEAD: Logic 4K Camera Head 85525942 is used for applications in conjunction with the Logic 4K Camera Controller 5525301 for diagnostic and therapeutic interventions. This product is exclusively intended for use by specialized medical personnel and may only be used by adequately qualified and trained medical doctors.

Richard Wolf's ENDOCAM® Logic 4K Camera System 5525 consists of the Logic 4K Camera Controller and Logic 4K Camera Head. The Logic 4K Camera System has been designed for highdefinition video endoscopy and is used in conjunction with other video equipment and endoscopic accessories. The Logic 4K Camera Controller is the control center of the system, its primary performance characteristics are signal processing of the image data and image recording. The Logic 4K Camera Controller is equipped with various outputs (e.g. HDMI 4K and HDMI HD) and can process a 2K / HD or 4K resolution. The Logic 4K Camera Controller device parameters are controlled and set via the touchscreen, access to all control elements / parameters is possible in OSD via the PC keyboard the handheld remote control or via core.nova. The Logic 4K Camera Controller housing is made of of powder-coated stainless steel measuring 300mm x 120mm x 416mm; the front foil consists of Polyester AUTOPEX. The Logic 4K Camera Head is used in conjunction with the Logic 4K Camera Controller, its primary performance characteristic is to receive and transfer an optical image from a variety of endoscopes (rigid, semi-rigid, and flexible endoscopes). The Logic 4K Camera Head housing is made of stainless steel measuring approximately 40mm x 47mm x 102mm. The camera head cable is securely attached and is 3.0m in length. The LOGIC 4K Camera Controller and LOGIC 4K Camera Head are not intended to contact the patient directly or indirectly. The LOGIC 4K Camera Controller and Logic 4K Camera Head are delivered non-sterile. The devices are reusable and do require processing during their use-life. Users are required to process the device for initial use and after each use. Methods of cleaning, disinfection, and sterilization are detailed in the Instruction for Use.

The RF instruments are used for tissue and vessel coagulation (hemostasis) by means of radio-frequency current. The products are intended for use in endoscopically performed or supported surgery intended are: - * Endoscopic procedures - * Orthopedic coagulation - * Neurosurgical coagulation The products are exclusively intended for use by specialized medical personnel and may only be used by adequately qualified and trained medical personnel.

The TipControl RF (Radio Frequency) Instruments, bipo are disposable single-use, sterile packaged electrosurgical devices, used for tissue and vessel coagulation (hemostasis) by means of radio-frequency current. The products are intended for use in endoscopic performed or supported surgeries. The types of surgery intended are: Endoscopic procedures, orthopedic coagulation, and neurosurgical coagulation. These products are exclusively intended for use by specialized medical personnel and may only be used by adequately qualified and trained medical personnel. The TipControl RF Instrument, bipo consists of a handle, a sheath tube, the TipControl RF electrode and a connection cable with an US 2-PIN device connector. The just mentioned components comprise a complete unit for disposable use and cannot be dismantled. They are currently available in a working length of 280 mm or 350 mm. The TipControl RF Instruments, bipo are designed to be used in conjunction with the electrosurgical bipolar radiofrequency generators Surgitron and Surgi-Max Plus up to 4 MHz and endoscopic accessories. The RF generator provides power and delivers electrical current to the distal tips of the RF instruments.