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The electrosurgical generator, in conjunction with compatible devices and electrosurgical accessories, is intended for cutting and coagulation of soft tissue and for ligation of vessels. The electrosurgical generator utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments. The electrosurgical generator is intended to be used in the following medical fields: - · Open surgery - · Laparoscopic surgery, including single-site surgery - · Endoscopic surgery Only for use by a qualified physician in an adequate medical environment.

The subject device ESG-410 is a reusable, non-sterile electrosurgical generator that features different high frequency monopolar and bipolar cutting and coagulation modes with a maximum output power of 320 W, as well as capability to power the existing Olympus ultrasonic THUNDERBEAT and SONICBEAT devices via a redesigned HYBRID ULTRASONIC socket and four new modes using high frequency (RF bipolar output) energy and supporting ultrasonic energy. The maximum RF output power for the THUNDERBEAT mode is 110 W. The electrosurgical generator, in conjunction with compatible devices and electrosurgical accessories and ancillary equipment, is intended for cutting and coagulation of soft tissue in open surgery, laparoscopic surgery (including single-site surgery), endoscopic surgery and for ligation of vessels. The electrosurgical generator utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments. The front panel of the proposed ESG-410 features a touch screen GUI (graphical user interface) as well as the power switch (on/off), six output sockets and one neutral electrode socket. The touch screen GUI displays the current settings of the chosen output mode, the connection status of accessories and peripherals connected to the electrosurgical generator. Soft keys are integrated into the GUI to switch between the output sockets, to enter the menu in order to edit settings/procedures (e.g. create/ edit user-defined settings/ procedures), to edit preferences (e.g. select language, touch tone control, output volume, or brightness) and to show service options (e.g. software version identifier, for service and maintenance purposes) or to access user-defined settings and procedures.

HF cables for electrosurgical use in laparoscopic, and open surgery in combination with compatible active accessories and compatible electrosurgical generators

The HF-cables (see Table 2.1) subject to this submission are reusable, non-sterile devices, that connect electrosurgical generators as sender to compatible active accessories as receiver for electrosurgical use in laparoscopic, endoscopic, and open surgery. The devices are used as part of a system. The HF-cables are class II medical device accessories under the regulation number 878.4400 and the product code GEI - "Electrosurgical cutting and coagulation device and accessories". Regulation Medical Specialty: General & Plastic Surgery. There are monopolar as well as bipolar HF-cable models subject of this submission. All of the subject HF-cables are delivered non-sterile. They are reusable and fully autoclavable. Before first and each subsequent use the cables must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use. The HF-cables are available with different cable lengths and with different plugs for the working element/instrument as well as for the electrosurgical generator side. The different plugs allow different compatibilities in accordance with their respective labeling.

Transmission of light energy from the light source to an optical instrument. The light-guide cable is used to transmit light during endoscopic procedures or for other medical illumination application when the properties and operating instructions are complied with. The light-guide cable is designed for use with halogen, xenon or LED based light which are utilized in medical applications that involve endoscopes, medical instruments or microscopes.

The Olympus Light-Guide Cables that are subject to this submission are intended to transmit light from the light source to an optical instrument. For that purpose the Light-Guide Cable includes a bundle of optical fibers as transmission medium. The light guide adapters are intended for the mechanical connection of the Light-Guide Cables to light sources or to endoscopes. There are two variants of Light-Guide Cables which differ according to the shaft diameter of the connected endoscope. Cable WA03300A (2.8 mm, 3 m, CF type) can be combined with endoscopes, which have a diameter ≤ 4.1mm. Endoscopes with a diameter > 4.1mm are combined with WA03310A (4.25 mm, 3 m, CF type). Otherwise the Light-Guide Cables are identical.

Sheath with integrated stopcocks are used in conjunction with a hysteroscope to permit direct viewing of the cervical canal and the uterine cavity to perform diagnostic and surgical procedures.

The subject device is a reusable sheath (Part WA4777A) and stopcock (Part WA47778A), provided non-sterile and labeled for reprocessing via cleaning and steam sterilization. The sheath is a rigid instrument made from stainless steel. The sheath has a working length of 206.7 ± 0.15 mm. The sheath has a single lumen shaped to allow for both, insertion of one 3 mm hysteroscope as well as a 5 Fr instrument channel for the instrument and irrigation inflow. There are three ports, one for irrigation, one for instruments, and one for the hysteroscope. There is no outflow channel for the irrigation fluid; the irrigation fluid flows out between the sheath and the cervix channel. A hysteroscope can be inserted into the hysteroscope channel of the sheath from the proximal end to provide an endoscopic image during the procedure. The endoscopic image can be viewed using the ocular or by connecting a compatible camera head. Compatible surgical instruments can be inserted into the instrument channel of the sheath. The irrigation stopcock made from stainless steel and polyether ether ketone (PEEK) can be used to control the inflow of the irrigation fluid. The instrument stopcock controls the passage of the surgical instruments.

The instrument tray is intended to be used to enclose and protect one Olympus semi-rigid ureteroscope, models WA2UR11A, WA2UR12A, WA2UR14A, WA2UR21A, WA2UR22A, WA2UR22A, WA2UR23A WA2UR31A, and WA2UR32A (K200369), and accessories during sterilization in a prevacuum steam sterilizer using the following parameters or cycles: Prevacuum steam sterilization | - Exposure time at a temperature of 132 °C (269.6 °F:) | | |--------------------------------------------------------|--------| | Wrapped instruments | 4 min. | | Unwrapped non-porous instruments | 3 min. | - Exposure time at a temperature of 135 °C (275 °F:) Wrapped instruments .......................................................................................................................................................... Unwrapped non-porous instruments ................ 3 min. - Drying time.........................................................................................................................30 min. After steam sterilization, let the instrument tray cool down at room temperature. - Cool-down time...............................................................................................................................30 min. The instrument tray is also intended for the enclosure of Olympus semi-rigid ureteroscopes and accessories during transport and storage within the reprocessing cycle. The instrument tray is not compatible with flexible ureteroscopes. The instrument tray is to be used in conjunction with a FDA cleared sterilization wrap. Maintenance of sterility depends on the sterilization wrap. Worst case load: The instrument tray containing a ureteroscope, attachments, light-guide cable adapters, sealing caps and stopcocks must not exceed a weight of 3300 grams (7.27 lb) altogether.

The instrument tray, for semi-rigid ureteroscope is specifically designed for enclosure of Olympus ureteroscopes and accessories during sterilization and storage of Olympus ureteroscopes and accessories after sterilization, as well as enclosure during transport within the reprocessing cycle. A loaded instrument tray cannot be used for automated cleaning of the contained devices. The Olympus instrument tray is autoclavable and delivered in non-sterile condition to the customer. It is reusable and has to be reprocessed before first and each subsequent use according to defined reprocessing methods in the Instructions for Use.

Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications: Cutting, ablation, resection, vaporization and coagulation with HF current. Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications. The general indications include transcervical resection, vaporization, cutting and coagulation of tissue in the uterus in conductive irrigation fluid as part of a resectoscope system. Specific indications: transcervical diagnosis and treatment (resection, vaporization, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis), lysis of intrauterine septa, endometrial ablation.

The Olympus Resection Electrodes with HF cable that are subject to this submission are for application in saline. Depending on the characteristics of electrical current, which is provided by the electrosurgical generator, electrosurgery can be used for coagulation, vaporization and cutting. The subject HF-Resection Electrodes consist of an active tip, PTFE color code identification, an insulator between the electrode and electrode tube, a guiding tube, telescope clip and arm (shaft). The accompanying HF cables consist of two lantern plugs on the instrument side and one generator plug on the generator side. The design and dimensions of the electrodes vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops, bands, rollers, needles or buttons. The electrodes have a shaft diameter of 24 Fr, range in length from 261.8-336.7mm, and range in tip angle from 12° - 30° tips. The design of the HF cable plugs fits Olympus electrosurgical generators with Universal Socket. All subject Resection Electrodes are single-use electrodes and are delivered sterile. All subject Resection Electrodes are provided with a single-use, sterile cable to connect the electrode to the generator.

The ESG-400 is an electrosurgical generator intended for tissue cutting and coagulation in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment. The POWERSEAL Sealer and Divider is a bipolar electrosurgical device intended for use in laparoscopic/minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. POWERSEAL devices can be used on vessels (arteries and veins, pulmonary arteries, pulmonary veins) up to and including 7 mm, lymphatics, and tissue bundles. POWERSEAL devices are indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, sleeve gastrectomy, hysterectomy, oophorectomy. The POWERSEAL Sealer and Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the POWERSEAL devices for these procedures.

The subject device ESG-400 is a reusable, non-sterile electrosurgical generator that features different mono- and bipolar cutting and coagulation modes. The maximum output power is 320 W. The front panel features a touch screen GUI that displays current settings, connection status, and allows access to menus for editing settings, procedures, and preferences. Compatible accessories include previously cleared footswitches. The POWERSEAL 5mm laparoscopic curved jaw sealer divider is an electrosurgical bipolar device with an integral extending cutting blade. It features a pistol grip handle and will be provided in shaft lengths of 23, 37, and 44 cm. The POWERSEAL devices are sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with Olympus electrosurgical generators to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics. The jaws are designed to seal vessels, and grasp and dissect tissue during open and minimally invasive general surgical procedures using high frequency (HF) energy. A hand actuated mechanism opens and closes the jaws. A second control initiates bipolar energy delivery for sealing. A separate control activates a blade for tissue division.

ESG-410: The electrosurgical generator, in conjunction with electrosurgical accessories and ancillary equipment, is intended for cutting and coagulation of tissue in the following medical fields: - Open surgery - Laparoscopic surgery - Endoscopic surgery Only for use by a qualified physician in an adequate medical environment. PK Cutting Forceps (CF-PK0533): The PK Cutting Forceps are indicated for electrosurgical coagulation, mechanical cutting, and grasping of tissue during the performance of laparoscopic and open general surgical procedures.

ESG-410 Generator: The subject device ESG-410 is a reusable, non-sterile electrosurgical generator that features different mono- and bipolar cutting and coagulation modes. The maximum output power is 320 W. The front panel of the proposed ESG-410 features a touch screen GUI (graphical user interface) that displays the connection status of accessories and peripherals connected to the electrosurgical generator. Soft keys are integrated into the GUI to switch between the output sockets, to enter the Menu in order to edit settings/ procedures (e.g. create/ edit user-defined settings/ procedures), to edit preferences (e.g. select language, touch tone control, output volume, or brightness) and to show service options (e.g. software version identifier, for service and maintenance purposes) or to assess user-defined settings and procedures. PK Cutting Forceps: The PK Cutting Forceps are a bipolar electrosurgical device that may be utilized in laparoscopic and open general surgery to grasp, coagulate, transect, dissect and retract tissue. The PK Cutting Forceps were cleared via K142759. They are currently intended to be used only with the existing ESG-400 generator per the Indications for Use statement. This submission will demonstrate compatibility with the new ESG-410 generator, and the Indications for Use statement will remove a specific generator model and the compatible generators will be reflected in the labeling. Minor modifications, which did not affect safety and effectiveness, were assessed via internal documentation since the original clearance and will be identified within the submission.

The Olympus ureteroscopes can be utilized for endoscopic observation and therapy in the ureters, urethra, and urinary bladder. Semi-rigid optical instrument for the visualization of the following diagnostic and therapeutic procedures: - Transurethral inspection of the ureters and renal pelvis for diagnosis - Transurethral insertion of catheters, guide wires, cannulas, forceps, electrodes, baskets, lithotripsy probes and laser fibres into the ureter - Transurethral treatment and removal of tissue, catheters, guide wires, debris and stones from urethra, urinary bladder and ureters - Transurethral treatment and removal of tissue and stones from the ureters and renal pelvis. The products are not intended for treatment of infants. For children (>2 years) and adults, refer to the particular constitution and anatomy of the patient.

The OES Elite Ureteroscopes are inserted directly through the natural orifice urethra and are used to visualize a wide range of therapeutic procedures or to support diagnosis. The OES Elite Ureteroscopes are reusable semi-rigid endoscopes, which consist of an image relay system inside the main body and an outer tube that guides an image fiber bundle to transmit the endoscopic image. For therapeutic procedures, the device is used in combination with surgical instruments which can be introduced through the instrument channels. The OES Elite Ureteroscopes and accessories are delivered in non-sterile condition. They are reusable and fully reprocessable. Before first and each subsequent use the device must be inspected and reprocessed according to defined and validated reprocessing methods in the instructions for use. The OES Elite Ureteroscopes are available in different working lengths, ocular directions, image sizes, directions of views and with one or two instrument channels.

This instrument has been designed to be used with a video system center, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.

The ENDOEYE HD II - High Definition Digital Video Laparoscope is a rigid video telescope used for endoscopic diagnosis, treatment, video observation and surgery within the thoracic and abdominal cavities including female reproductive organs. For laparoscopic applications, the video telescope is inserted via a trocar into the patient. The ENDOEYE HD II is used with a video system center, light source and monitor to achieve its intended function. In addition, the ENDOEYE HD II can be inserted in compatible instrument trays for reprocessing. The ENDOEYE HD II can provide an image with either white light or narrow band imaging and WA50040A and WA50042A include a heater function at the distal tip to reduce fogging of the lens.