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The Fluent Pro Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation liquid flowing into and out of the uterus while providing drive, control and suction for hysteroscopic morcellators.

The Fluent Pro Fluid Management System is a hysteroscopic fluid management system and drive console for hysteroscopic morcellators. The Fluent Pro Fluid Management System consists of a console and single-use procedure kit. The single-use procedure kit consists of sterile inflow (In-FloPak) and outflow (Out-FloPak) tube sets, and a non-sterile waste bag. The FloPaks and waste bag connect for use in hysteroscopic procedures. The console includes motors that control fluid inflow and outflow for hysteroscopic insufflation, as well as a pressure sensor monitoring system and graphical user interface. In addition, the console includes a connection for MyoSure Tissue Removal Devices and a pneumatic foot pedal to perform tissue removal procedures. The Fluent Pro Fluid Management System is compatible with currently marketed MyoSure Tissue Removal Devices.

The Monarch® Platform, Urology and its accessories are intended to access and visualize anatomical locations within the urinary tract and interior of adolescents and adults, aged 12 and up, for diagnostic and therapeutic procedures with transurethral access or transurethral access in conjunction with percutaneous access. The Monarch® Platform, Urology, the Ureteroscope, and endourology accessories are indicated to provide endoscopic visualization and access of organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) with transurethral access or transurethral access in conjunction with percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

The Monarch® Platform, Urology ("Proposed Device") is a capital equipment platform that enables electro-mechanical articulation and precise control of a flexible ureteroscope and/or a flexible suction catheter for visualization and access to the urinary tract for diagnostic and therapeutic procedures. The ureteroscope and suction catheter move only under continuous and direct physician control, via the Monarch Controller. The proposed device consists of Monarch® Tower, Monarch® Cart, Monarch® Fluidics Pump, Monarch® Software, Monarch® Controller, Monarch® Ureteroscope and endourology instruments and accessories needed to perform Monarch Urology diagnostic and therapeutic procedures. The device as well as its instruments and accessories are used together during urological diaenostic and therapeutic procedures and are bundled in this 510(k) submission so they can be addressed during one review. The summary descriptions of each component are outlined below. Monarch® Tower: The Monarch® Tower (Tower) contains the primary procedural display interface for the physician that is provided by a touchscreen monitor for physician viewing and computers running the Monarch software. The monitor has a touchscreen and allows for user input during setup and intra-operative use. The tower has integrated electromagnetic (EM) tracking and video signal processing components. In addition, the tower provides connectivity for the endoscope camera as well as the fluidics pump. Monarch® Cart: The Monarch® Cart (Cart) contains a touchscreen, three robotic arms and electronic systems required to power and operate the robotic arms. The Cart touchscreens accepts user input and shows instructions for arm deployment and cart functions. The robotic arms possess multiple degrees of freedom. The cart transmits the physician directed movement to the Ureteroscope and other instruments during a procedure. Monarch® Fluidics Pump: The Monarch® Fluidics Pump (Fluidics Pump) controls the irrigation and suction during a procedure. The Fluidics Pump is connected to the Monarch Tower via an umbilical cable allowing electrical and data communication. The Fluidics Pump provides the physician with the ability to control irrigation and suction levels during a procedure. The Urology Irrigation Cartridge and Suction Set are irrigation and suction tubing provided as sterile accessories to connect the Fluidics Pump to the Ureteroscope and Instruments during ureteroscopy or PCNL procedures. Monarch® Software: The Monarch® Software provides the user with the ability to safely drive the Monarch® Ureteroscope and Monarch® Mini-PCNL suction catheter around the kidney and within the calyces of interest as well as provides optional navigation guidance to the user to insert the needle to the target during Monarch® PCNL procedure. It receives user input from the Monarch® Controller, computes the appropriate robotic motion to coordinate the movement of the robotic arms and endoscopic devices loaded onto the Cart. It provides a graphical user interface where the endoscopic camera view is shown in real time and displays important system status information. Monarch® Controller: The Monarch® Controller) is a handheld device that serves as the user interface that allows the physician to control the system during a procedure. An Umbilical cord connects the Controller to the Tower. Monarch® Ureteroscope: The Monarch® Ureteroscope (Ureteroscope) is comprised of an endoscope that provides vision, illumination, and a working channel to the distal tip of the device. The Ureteroscope can be navigated by the user within the bladder, urinary tract, and kidney. It contains a working channel to accommodate compatible commercially available working channel instruments. The Ureteroscope can be articulated 2-directions (along a single plane) when manually driven or can be articulated 4-directions (along two planes) when mounted to the electromechanical arms under command by the physician using the endoscopic controller. The shaft of the ureteroscope can also be rolled 155° in either direction to reorient the camera and working channel. The Ureteroscope is packaged within the Monarch® Ureteroscopy Kit. The Monarch® Ureteroscopy Kit also includes Ureteroscope Valve, Ureteroscope Driver and Laser Driver (accessories for Ureteroscopy procedure). Procedural specific instruments and accessories for the proposed device are outlined below, these devices are single-use devices and sterilized via EO. - Monarch® Mini-PCNL Suction Catheter: The Monarch® Mini-PCNL Suction Catheter ● (Suction Catheter) is part of the Monarch® Mini-PCNL Kit. The Suction Catheter is a flexible device that is inserted into the kidney via antegrade tract under direct visualization from the ureteroscope. It has a center lumen which allows for the suction of stone debris and can articulate in 4 directions. The suction catheter is manipulated by one robotic arm under the control of a physician who is concurrently controlling the Ureteroscope. - Dilation Set: The Dilation Set is part of the Monarch® Mini-PCNL Kit. The Dilation Set ● includes: - 8Fr dilator - 10Fr catheter - Percutaneous Sheath Dilator ● - Percutaneous Sheath: The Percutaneous Sheath is part of the Monarch® Mini-PCNL Kit. The Percutaneous Sheath consists of an inner metal sheath with a threaded connection and a metal outer sheath. It is designed to establish percutaneous access and designed to allow simultaneous irrigation and suction of fluid to support removal of kidney stones. The outer sheath has a molded hub with an angled luer connection for irrigation and an insertion depth marking on the distal end.

The X-FLO Fluid Management System is intended to: · Warm and pump fluid, via intravenous (IV) bags or fluid bottles, to provide fluid distention and flushing of the uterus for gynecology procedures. The device can also measure fluid deficit of the surgical procedure. · Warm and pump fluid, via IV bags or fluid bottles, to provide fluid distention and flushing of the bladder and kidneys, or general distention and flushing, for urological procedures. The device can also measure fluid deficit of the surgical procedure. · Warm and pump fluid, via IV bags or fluid bottles, to provide fluid distention and flushing of the shoulder, knee, or other small joints for orthopedic procedures. The device can also measure fluid deficit of the surgical procedure.

The X-FLO Fluid Management System ("X-FLO") (P/N 01910), with an optional deficit module (P/N 01601) is intended for fluid distention, fluid warming, and fluid volume/deficit measurements, as well as external suction regulation pertaining to deficit measurements for diagnostic and/or operative endoscopic procedures within gynecology, urology, and orthopedic disciplines. The X-FLO utilizes a touchscreen user interface and performs fluid pressurization, warming, and volume/deficit monitoring functions. More specifically, the device employs a peristaltic pump to pressurize and deliver fluid to the surgical site for distending and continually flushing the surgical site for visualization purposes, utilizes infrared lamps to optionally warm the fluid to body temperature, and uses fluid bag weight to monitor fluid inflow. Regarding the optional deficit monitoring function, the device utilizes external suction to return fluid from the surgical site. The X-FLO monitors and adjusts the vacuum level to the operator selected setpoint by opening the suction line to atmosphere if necessary. Once the fluid is returned from the surgical site, the single-use deficit cartridge measures the fluid volume collected, prior to transfer to fluid collection equipment and/or the hospital's waste disposal system. The X-FLO is controlled via a Graphical User Interface (GUI), wherein the user is guided to select a surgical discipline and a procedure type. Once selected, the user can input the desired setpoint within the established minimum and maximum parameters for that procedure type. As set forth below, the X-FLO can operate in Pressure Control (the default control, or X-Control. Each control view has defaults and adjustment ranges for fluid pressure, flow, temperature, deficit alarm, and external suction regulation. In addition to adjusting the fluid pressure setpoint via the GUI, the user may optionally utilize a foot pedal included with the X-FLO to temporarily increase the fluid pressure. By pressing the foot pedal, the user initiates an increase in fluid pressure. The increase is user configurable but can never exceed the maximum allowable fluid pressure for the procedure. When the user desires to have the fluid pressure return to the setpoint, the foot pedal is released.

Endomat Select is intended to: · provide the infusion of the sterile irrigant solutions into the ureter and upper urinary tract, as well as to suction off the irrigation fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic urological procedures · provide the infusion of the sterile irrigant solutions into the uterus, as well as to suction off the irrigation fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic hysteroscopic procedures · provide the infusion of the sterile irrigant solutions into organs and operating diagnostic and operative procedures in laparoscopic and open general surgery · provide sustained liquid irrigation of joint or intra-articular spaces during all phases of arthroscopic surgery · provide the infusion of the sterile irrigant solutions in order to enable the Lens Cleaning during endoscopically assisted Functional Endoscopic Sinus Surgery and endoscopically assisted transnasal pituitary gland surgery

The Endomat Select is a multi-functional, pressure-controlled, combined irrigation and suction pump. It can be used for irrigation and, where appropriate dilation, during Hysteroscopic (HYS), Arthroscopic (ART), Urological (URO) and General Surgical or Laparoscopic (SURG) interventions. The device can be used for suction during Urological (URO) and Hysteroscopic (IBS) interventions. In addition, the device can function in an oscillatory mode (ENT/Neuro) providing a fluid means to maintain lens clarity during use in Transnasal procedures. The device has a modern LCD display with touch screen user interface. The tubing sets are encoded so that they can be identified by the device, which selects the appropriate operating modes based on the tubing set connected. The device can also be connected to other Karl Storz devices using the proprietary Storz Control Bus (SCB) [K994348]. The device protects the patient from overpressure via software means. The software-controlled pressure measurement system can stop the actuator (roller pump) should the pressure rise beyond the pre-determined limit and will immediately reverse the pump roller direction to depressurize the fluid system if required. Additionally, the device has high pressure alarms to alert the operating room staff of a high-pressure situation. The device also requires positive action from the user to increase pressures above 100mmHg; the user is prompted to confirm their choice on the user interface. The accessories for this device are provided separately. All of the accessories for use with this device are already marketed in the U.S. and are either Class I, Class II 510(k) exempt or Class II previously cleared devices. The generic tubing sets for use with this device are single use, sterile Class I accessories.

The Aveta Disposable Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

The Aveta Disposable Hysteroscope is used by physicians in an office or operating room setting. The subject device includes the Aveta Disposable Hysteroscope and Aveta Controller. Like the Aveta Disposable Hysteroscope cleared under K190372, the modified Aveta Disposable Hysteroscope includes a camera and LED light. The Aveta Disposable Hysteroscope is connected to the Aveta Controller to provide the camera and light functions and to process and store the image obtained from the Aveta Disposable Hysteroscope. For fluid management, the Aveta Disposable Hysteroscope can be used with gravity fed pressurized saline bag or the fluid management system cleared under K190372. For therapeutic procedures, the Aveta Disposable Hysteroscope is used with the cleared Aveta Disposable Resecting Device (K190372). The only functional buttons on the Aveta Disposable Hysteroscope handle are the image capture and the image transfer buttons. For the modified device, when other buttons on the handle are pressed, the Aveta Controller does not take any action. Other than minor change to the Aveta Controller software to disable fluid management related buttons on the Aveta Disposable Hysteroscope, there is no change to the components of the cleared Aveta System (K190372).

The Aveta System is intended for intrauterine use by trained gynecologists to permit viewing of the cervical canal and the uterine cavity, provide liquid distension of the uterus and monitor the volume differential between the irrigation fluid flowing into and out of the uterus during diagnostic and surgical procedures to resect and remove tissue such as submucous myomas, endometrial polyps and retained products of conception.

The modified Aveta System is used by physicians in an office or operating room setting. The Aveta Controller acts as the hub of the system. For diagnostic procedures, the Aveta Fluid Management Accessory, the Aveta Handswitch, the Aveta Scale, the Waste Management Bags, saline bags and an external monitor are all connected to the Aveta Controller. The inflow and outflow of the fluid management accessory are connected to the corresponding ports of a compatible hysteroscope. For therapeutic procedures, the Aveta Reusable Resecting Handset or the Aveta Disposable Resecting Handset are connected to the Aveta Controller for powering the Aveta Disposable Resecting Device.

Endomat Select is intended to: • provide the infusion of the sterile irrigant solutions into the ureter and upper urinary tract, as well as to suction off the irrigations fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic urological procedures • provide liquid distention of the uterus for diagnostic and operative hysteroscopy • provide the infusion of the sterile irrigant solutions into organs and operating fields during diagnostic and operative procedures in laparoscopic and open general surgery • provide sustained liquid irrigation and distention of joint or intra-articular spaces during all phases of arthroscopic surgery • provide the infusion of the sterile irrigant solutions in order to enable the Lens Cleaning during endoscopically assisted Functional Endoscopic Sinus Surgery and endoscopically assisted transnasal pituitary gland surgery

The Endomat Select is a multi-functional, pressure- controlled, combined irrigation and suction pump. It can be used for irrigation and, where appropriate dilation, during Hysteroscopic (HYS), Arthroscopic (ART), Urological (URO) and General Surgical or Laparoscopic (SURG) interventions. The device can be used for suction during Urological (URO) interventions. In addition the device can function in an oscillatory mode (ENT/Neuro) providing a fluid means to maintain lens clarity during use in Transnasal procedures. The device has a modern LCD display with touch screen user interface. The tubing sets are encoded so that they can be identified by the device, which selects the appropriate operating modes based on the tubing set connected. The device can also be connected to other Karl Storz devices using the proprietary Storz Control Bus (SCB) [K994348]. The device protects the patient from overpressure via software means. The software controlled pressure measurement system can stop the actuator (roller pump) should the pressure rise beyond the pre-determined limit and will immediately reverse the pump roller direction to depressurize the fluid system if required. Additionally the device has high pressure alarms to alert the operating room staff of a high pressure situation. The device also requires positive action from the user to increase pressures above 100mmHg; the user is prompted to confirm their choice on the user interface.

The Fluent Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus while providing drive, control and suction for hysteroscopic morcellators.

The Fluent Fluid Management System is a hysteroscopic fluid management system and drive console for hysteroscopic morcellators. The Fluent Fluid Management System consists of a console and single-use procedure kit. The single use procedure kit consists of a sterile Inflow Tube Set (In-FloPak) and Outflow Tube Set (Out-FloPak) with a nonsterile Waste Bag. The two FloPaks and Waste Bag connect to the Console for performing hysteroscopic procedures. The console includes motors that control inflow and outflow of fluid for hysteroscopic insufflation, as well as a pressure sensor monitoring system and graphical user interface touchscreen. In addition, the console includes a connection for MyoSure Tissue Removal Devices and a pneumatic foot pedal to perform tissue removal procedures. The Fluent Fluid Management System is compatible with currently marketed MyoSure Tissue Removal Devices. The primary functions of the subject device are fluid distension, fluid deficit tracking, and morcellator drive control. The subject device includes a deficit alert feature as well as an overpressure protection mechanism.

The GYN-Pump PH304 is a combined suction and irrigation pump for use in hysteroscopic and laparoscopic interventions. During diagnostic and operative hysteroscopy, the GYN-Pump PH304 is intended to provide liquid distension of the uterus and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. During diagnostic and therapeutic laparoscopic procedures, the GYN-Pump PH304 is intended to irrigate fluid into and remove fluid from the abdominal cavity.

The GYN-Pump PH304 is a microprocessor controlled single roller pump that functions according to the peristaltic principle. It transports sterile irrigation fluid to distend the uterus and provides fluid deficit monitoring during operative hysteroscopy. It is also used to irrigate the abdominal cavity during laparoscopy and provides fluid aspiration. The pump consists of the following main components: a power supply, a power switch, a touch display, a connection for the suction function, a roller wheel, a pump head and a casing. The proposed pump is designed to be used with the Fluid Monitoring Unit PS304 in order to assist with fluid deficit monitoring. The Fluid Monitoring Unit PS304 is a component of the GYN-Pump PH304 and together they are a medical electrical system. The pump must be used with the following tube sets: Standard Irrigation Tube Set (also referred to as "ST261"), Suction Tube Set (one connection, "I"-shape; also referred to as "ST287"), Suction Tube Set (two connections, "Y"-shape; also referred to as "ST282"), Vacuum Tube Set (also referred to as "ST291").

The Aquilex® Fluid Control System AQL-100S is intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopy and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.

The Aquilex® Fluid Control System AQL-100S is a modified version of the primary predicate device, Aquilex Fluid Control System H112 (K112642). The proposed device is a microprocessor-controlled device that consists of the following two main components: (1) an irrigation pump unit including suction pumps (AQL-110P) and (2) and fluid monitoring unit (AQL-100CBS) that are to be placed on a roller stand. The irrigation pump unit (AQL-110P) of the Aquilex® Fluid Control System AQL-100S is a microprocessor-controlled device that functions according to the peristaltic principle and consists of the following components: (1) a casing. (2) a power switch, (3) a power supply, (4) mains cable, (5) a roller wheel, (6) a pump head, (7) suction pumps, (8) various setting keys and (9) display elements. The irrigation pump unit (AQL-110P) is to be used with specially designed single use irrigation and outflow tube sets that are delivered sterile (AQL-110 and AQL-111). In addition, the suction pumps of the irrigation pump unit are to be used with specially designed non-sterile vacuum tube sets (AQL-114). The fluid monitoring unit (AQL-100CBS) consists of the following main components: (1) two scale units, (2), a bag holder, (4) a bag deflector, (5) a container holder, and (6) a roller wheel base. The irrigation pump unit of the proposed device is only operational in conjunction with the fluid monitoring unit.