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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 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.

The device is intended for the use of physicians and other professionals authorized to take sample cells from the cervix of the uterus, transfer them to a fluid suspension (or smear them on a slide, in the case of a traditional PAP test) for further preparation of cytological slides. CYTOPREP® was designed for use in conjunction with Liquid Based Cytology procedures. However, recent tests at the University of Munich. Germany, have proven it equally effective as a sampling device for the traditional PAP smear test. The device is used to sample the cervix of patients for the purpose of obtaining ecto-cervical, endo-cervical and T-zone sample cells. These sample cells are used for the "PAP" test. While the product is designed to be used in conjunction with liquid based cytology procedure (monolayer method), it can also be used in conjunction with the traditional "PAP" test procedure.

CYTOPRED® consists of two parts, the handle and the head. The handle is 214mm in length, cylindrical and on one end it carries the name of the product. On the other end , there are two recesses (female) to accommodate the bottom part of the head. These two recesses, along with a special edge (male) on the bottom of the head. secure the head. When the physician has inserted the head in the endocervical canal and is turning the handle to obtain sample cells, the head turns (follows the physician's manipulations) and there is no slippage. Tests made (see XI Performance for attached laboratory report), prove that it will be impossible for a bristle to break and remain in the patient's cervix and almost impossible for the head to accidentally separate from the handle and remain in the cervix. The head consists of: The "male" edge on the bottom that is secured in the handle recess (female), stabilizing the head on the handle; The base, upon which sit lengthy bristles on both sides of the center brush. The center brush end sits upon the base of the head and its center stem extends beyond the lengthy bristles. On its center stem, perpendicular to the lengthy bristles, sit bristles which extend from the base of the head to the end of the center stem.