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As the Select IUI® (predicate device), TheCurve™ (new device) is a single use, sterile, disposable, flexible catheter designed to be used for intrauterine artificial insemination.

TheCurve, such as the Select IUI, comprises a long clear polyethylene tube that is tightly surrounded on three quarters of its proximal length by an outer, clear polypropylene sheath. This leaves 4.5 cm of the inner polyethylene tube exposed at the distal end of the device. The proximal inner tube and outer sheath circumferences are molded directly onto the distal end of a luer lock hub so that only the lumen of the inner tube can provide a channel for flow. This design results in a single-channel catheter with two segments each having different degrees of flexibility. The extreme distal tip of TheCurve™ is open as compared to the extreme distal tip of the Select IUI® which is closed and has two side openings. Both TheCurve and Select IUI have six (6) coloured graduation markings placed at 5, 6, 7, 8, 9, and 10 cm distance from the extreme distal tip of the catheter. The distal portion of TheCurve is curved while the distal portion of the Select IUI is straight.

Biopsy to obtain a sample for histologic evaluation of the endometrium (uterine mucosal lining) or sample extraction of the uterine menstrual content for: - Evaluation of infertility conditions, menstrual disorders, postmenopausal bleeding, abnormal cytology suggesting endometrial origin, hormonal replacement therapy (HRT); - Detection of endometrial carcinoma (Please note: The most reliable method for the detection of endometrial carcinoma is dilation of the cervix and uterine curettage performed under general anesthesia); - Evaluation of luteal defect (Evaluation of luteal defect is visually determined histologically from endometrial tissue obtained only during the secretory [progestational] phase of the menstrual cycle); - Endometrial dating; - Microscopic examination; - and, this device is useful for patients presenting a narrow cervix or cervical canal and in postmenopausal women whose cervix might be narrower However, because of its smaller with any of the indications listed above. diameter, it should be recognized that the amount (quantity) of sample obtained with this device will be reduced.

The SelectCells Mini, like the Pipelle, comprises a long clear, flexible, polypropylene sheath and a rod made of acetal copolymer onto which a piston is molded. The sheath of the SelectCells Mini is a one part tube whose distal half has a smaller diameter than its proximal half. The sheath of the Pipelle is a one part tube with the same diameter throughout. The device opening, by which the specimen is to be aspirated, is located at 2.5 mm distance (3 mm for Pipelle®) from the extreme distal tip of the sheath. The extreme distal end of the sheath is rounded and closed. A piston is molded on the rod at almost its half length point (piston located at the distal end of the rod for Pipelle). This rod can be moved forward and backward within the proximal half length of the sheath lumen. The piston and rod are prevented from being totally withdrawn from the sheath during manipulation by the tapered proximal lumen end of the sheath (for Pipelle, by an identation in the sheath located at its proximal end). The new device has an ergonomic 2.5 cm long finger grip which is molded onto the rod that protrudes the proximal end of the sheath. The Pipelle has a cylindrical 2.4 cm long knob which is glued to the rod that protrudes the proximal end of the sheath. This finger grip (Knob, for Pipelle) is used to move the rod within the sheath. The SelectCells™Mini bears seven (7) coloured graduation marks with figures that are placed at 4. 5. 6. 7. 8. 9. and 10 cm distance from the extreme distal tip of the sheath. The predicate device bears four (4) coloured graduation marks with figures and three (3) marks in the form of a line that are placed at 4, 5, 6, 7, 8, 9 and 10 cm distance from the extreme distal tip of the sheath. The new and predicate devices bear an arrow on their sheaths indicating the location of the device opening. The graduation marks on the sheath serve as a guide for insertion depth of the device into the uterine cavity.