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The Hysteroscopy System is indicated for rapid transcervical aspiration of the uterine cavity during the first trimester of pregnancy. It has an additional feature of visualization.

The Hysteroscopy System is designed to visualize the uterus and to facilitate physicians in the procedure of vacuum aspiration of the uterine cavity during the first trimester of pregnancy. Components of the Hysteroscopy System include an EOsterilized single-use cannula and reusable image processing unit. The Hysteroscopy System is available in five sizes that differ in length and width. Each cannula includes an internal channel to draw vacuum or negative pressure up to 500 mmHg. The optical system, which includes a CMOS image sensor, lens, and 40 mW LED, is located at the distal end of the cannula. A lens cover shields the electronics from bodily fluids. The Hysteroscopy System has two connectors: one is an electrical/data connection and the second connection is for vacuum. The cannula is not indicated for use with any other accessories. The patient-contacting materials are medical grade stainless steel, polycarbonate, medical glue, and medical nylon.

For rapid transcervical aspiration of the uterine cavity.

The Berkeley VC-10 Vacuum Curettage System uses aspiration to remove uterine contents through the cervix. The system includes the vacuum pump, collection containers, connection tubing, and patient contacting vacurettes. The vacuum pump is electrically powered and generates suction through vacuum pressure. The vacuum pump console is not provided sterile and is a multi-use device. The patient contacting vacurettes of the VC-10 system are provided as sterile, single use disposable devices. Similar to the predicate device VC-10, the modified Berkeley VC-10 includes a high capacity. double diaphragm pump and motor, enclosed in a stainless steel cabinet. Collection canisters sit on top of the cabinet, and a large vacuum gauge and vacuum control knob are easily accessed on the top of the cabinet. A vacurette (available in various shapes and sizes) is attached to a collection set (includes a plastic swivel handle with a slip ring to control the vacuum and PVC tubing) and is attached to the patient port of the first collection container. Two accessories, which can be used to collect tissue, include a tissue trap, which is connected to the collection tubing and the collection container, or a gauze sack, which is placed inside the collection container. The modified VC-10 offers the same foot actuator pedal for vacuum supply.

For transcervical aspiration of the uterine cavity.

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The Disposable Endoscopic Cannula is indicated for rapid transcervical aspiration of the first trimester of pregnancy. It has an additional feature of visualization.

The Disposable Endoscopic Cannula is a sterile, single patient use device composed of transparent cover, suction orifice, dual-function cannula, handle, suction port, connection port, and data cable. The patient contacting components of this device are transparent cover, suction orifice and dual function cannula that are manufactured with polycarbonate. The transparent cover contains a LED light source and CMOS camera at the distal end for visualization of the cervical canal and uterine cavity. This device has two channels, one for transcervical aspiration of the uterine cavity and the other for transmitting the image signal through a cable connected to the Endoscopic Workstation. The images captured by the camera are transmitted to the endoscopic workstation through the cable for display. When the embryo tissues are located, the operator sucks out the embryo tissues through the suction orifice connected to a vacuum source. The Disposable Endoscopic Cannula is provided with five sizes based on outer cannula diameter: 5mm (RL1205 model), 6mm (RL1206 model), 7mm (RL1207 model), 8mm (RL1208 model), and 9mm (RL1209 model) (outer diameter). All models have a length of 170mm.

For uterine aspiration/uterine evacuation in obstetric and gynecological patients. Indications for use are rapid transcervical aspiration of the uterine cavity during the first trimester of pregnancy.

The Rigid Cannulae are injection molded plastic devices approximately 190mm in length, made from a styrenic copolymer manufactured in sizes 6mm. 7mm. 8mm. 9mm. 10mm, 11mm, and 12mm (outer diameter), straight and curved.

For rapid transcervical aspiration of the uterine cavity.

The Berkeley® VC-10 Vacuum Curettage System and Accessories has been tested and compared to similar devices, and is substantially equivalent to the predicates in characteristics described and the parameters tested.