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AVETA SYSTEM 2.0: USING BIPOLAR RF DEVICE: -Hysteroscopy: Aveta System 2.0 for Hysteroscopy: The Aveta System 2.0 is intended for intrauterine use by trained gynecologists to permit viewing of the cervical canal and the uterine cavity, provide liquid distension of the volume differential between the irrigation fluid flowing into and out of the uterus during diagnostic and surgical procedures to resect, remove and coagulate tissue such as submucous myomas, endometrial polyps, adhesions and retained products of conception using a bipolar resecting device. USING MECHANICAL RESECTING DEVICES: -Hysteroscopy: The Aveta System 2.0 is intended for intrauterine use by trained gynecologists to permit viewing of the cervical canal and the uterine cavity, provide liquid distension of 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. -Cystoscopy: The Aveta System 2.0 is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the system allows the user to perform various diagnostic and therapeutic procedures. AVETA DISPOSABLE HYSTEROSCOPE (Pearl/Opal/Coral): The Aveta Disposable Hysteroscope (Pearl/Opal/Coral) is intended to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. AVETA DISPOSABLE CYSTOSCOPE (Coral): The Aveta Disposable Cystoscope (Coral) is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the Cystoscope allows the user to perform various diagnostic and therapeutic procedures.

The Aveta System 2.0 is an integrated system which allows for visualization of the intended cavity for the purpose of performing diagnostic and operative procedures (hysteroscopy and cystoscopy). The Aveta System consists of the components listed in Table 1. The system includes a Controller 2.0 with integrated fluid management which incorporates a dual peristaltic pump design to control the continuous inflow and outflow of saline to provide fluid distention of the cavity. Controller 2.0 provides continuous monitoring of the cavity pressure to the set pressure. For hysteroscopy, it also monitors the volume differential between saline inflow and outflow from the uterus (fluid deficit). Controller 2.0 connects to a sterile, single use disposable Scope (available in various configurations, see below) that allows visualization of the cavity and displays the images obtained from the Scope on a standard monitor. The Controller 2.0 provides bipolar Radiofrequency (RF) energy to deliver to the Aveta Glo Disposable RF Device for CUT and COAG functions. For operative hysteroscopy procedures, the Aveta System also includes sterile, mechanical Disposable Resecting Device (available in various configurations, see below) powered by an integrated motor in the device handset. The resecting device (RF or mechanical) is inserted through the working channel of the sterile hysteroscope to resect the target tissue/pathology. For cystoscopy, when combined with accessory instruments the cystoscope is used for diagnostic and therapeutic procedures.

AVETA SYSTEM: Hysteroscopy: 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. Cystoscopy: The Aveta System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the system allows the user to perform various diagnostic and therapeutic procedures. AVETA DISPOSABLE HYSTEROSCOPE (Pearl/Opal/Coral): The Aveta Disposable Hysteroscope (Pearl/Opal/Coral) is intended to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. AVETA DISPOSABLE CYSTOSCOPE (Coral): The Aveta Disposable Cystoscope (Coral) is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the Cystoscope allows the user to perform various diagnostic and therapeutic procedures.

The Aveta System is an integrated system which allows for visualization of the intended cavity for the purpose of performing diagnostic and operative procedures (hysteroscopy and cystoscopy). The Aveta System consists of the components listed in Table 1. The system includes a Controller with integrated fluid management which incorporates a dual peristaltic pump design to control the continuous inflow and outflow of saline to provide fluid distention of the cavity. The Controller provides continuous monitoring of the cavity pressure to the set pressure. For hysteroscopy, it also monitors the volume differential between saline inflow from the uterus (fluid deficit). The Controller connects to a sterile, single use disposable Scope (available in various configurations, see below) that allows visualization of the cavity and displays the images obtained from the Scope on a standard monitor. For operative hysteroscopy procedures, the Aveta System includes sterile, mechanical Disposable Resecting Device (available in various configurations, see below) powered by an integrated motor in the device handset or by use of an external Resecting Handset (available in two configurations, as a disposable device or a reusable device). The resecting device is inserted through the working channel of the sterile hysteroscope to resect the target tissue/pathology. For cystoscopy, when combined with accessory instruments the cystoscope is used for diagnostic and therapeutic procedures.

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.

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 Aveta System is an integrated system which allows for visualization of the cervical canal and the uterine cavity for the purpose of performing diagnostic and operative hysteroscopic procedures. The system includes a Controller with integrated fluid management which incorporates a dual peristaltic pump design to control the continuous inflow and outflow of saline to provide fluid distention of the uterine cavity. The Controller provides continuous monitoring of the intrauterine pressure to the set pressure, as well as monitoring of the volume differential between saline inflow from the uterus. The Controller connects to a sterile, single use Disposable Hysteroscope via a Reusable Hysteroscope Handset that allows visualization of the cervical canal and the uterine cavity and displays the images obtained from the hysteroscope on a standard monitor. For operative procedures, the Aveta System includes a sterile, mechanical Disposable Resecting Device powered by a motorized, Reusable Resecting Handset which is inserted through the sterile hysteroscope working channel to resect and remove endometrial polyps, submucous myomas and retained products of conception under suction.