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The Kiwi Complete Vacuum Delivery System (Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)) is indicated for use in the following conditions:

• Prolonged second stage of labor (arrest of descent) where fetopelvic relationships are adequate
• Presumed fetal jeopardy that is not considered to be severe
• Elective shortening of the second stage for selected maternal or fetal conditions

The subject device is a fetal vacuum extractor (Kiwi® Complete Vacuum Delivery System) that includes four different models: OmniCup® (VAC-DUAL M); OmniCup® with Traction Force Indicator (VAC-DUAL MT); OmniC Cup® for Cesarean Section (VAC-DUAL C); ProCup® (VAC-DUAL S). All models use the same pump assembly, which allows the user to generate vacuum by squeezing the handle repeatedly. The pump/handle assembly includes a vacuum gauge that is color-coded to indicate safe operating pressures for the device. Models M and MT differ only in the inclusion of a traction force indicator (MT). Model C differs from models M/MT in the cup design, which has a lower profile cup with finger grooves to facilitate use in cesarean sections, as well as a baffle instead of an inner filter. The model S design is suggested for use in vaginal births and includes a combined tube and cup portion that is flexible and fits over the fetal head.

For vaginal delivery, the device is operated by inserting the cup into the vagina and placing the cup at the flexion point on the fetal skull. The Omni-C is designed specifically for the confined abdominal space of C-section deliveries. It is designed with a slimmer cup profile, finger grooves and baffle filter on the inside. For cesarean delivery, the cup is inserted into the incision over the flexion point.

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