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The Medela® Single Use Silc Cup is intended to be used to facilitate the delivery of the fetus during childbirth. The device enables traction to be applied to the fetal head (in the birth canal) by means of a suction cup attached to the scalp. It is larmedd by an external vacuum source and indicated for using during vaginal or cesarean delivery. The Indications for use are - Fetal distress in the second stage - Maternal delay in the second stage - Maternal conditions requiring a short second stage

The Medela® Single Use Silc Cup is a sterile, disposable device made of an elastomer and available in one size, 60mm inner diameter. The instrument is elastomer and consists of a handle and a suction cup to be used with an external vacuum pump and tubing. The cup has a smooth external surface with a small longitudinal ridge, which makes it possible to observe any rotation. The inside of the cup is lined with mance it possible to objections enable the air between the cup and the child's Small projoctions: The projections that the cup sucks firmly against the child's head. The soft suction cup deforms, thereby ensuring optimal adhesion and minimizing trauma to the fetal scalp.

The VacuLink is intended for obstetric use in the measurement and recording of data related to vacuum-assisted delivery (such as vacuum, number and duration of pulls and number of pop-offs) on the strip chart.

The VacuLink is a small, battery powered single-use vacuum measuring device. It is connected in parallel to the vacuum chamber of commercial handheld vacuum assisted delivery systems (i.e. Mityvac & Kiwi PalmPump). As a redundant gauge to the vacuum gauges on those devices, it electronically measures the vacuum applied to the fetal head during a vacuum assisted delivery. It connects to the vacuum port of the maternal/fetal monitor (i.e. HP, Corometrics and Spacelabs) via electrical cable. The vacuum value is numerically displayed in centimeters of mercury (cm Hg). The vacuum value is also recorded from the uterine activity channel of the maternal/fetal monitor and it is permanently stored in the hospital database. The information may also be displayed on a video monitor as well. The VacuLink incorporates a light sequence of red, yellow, and green. When the VacuLink is first connected to the maternal/fetal monitor, all three lights will flash in sequence as a quick test of the internal components. At the successful completion of the test, the green LED illuminates until the VacuLink is disconnected from the maternal/fetal monitor. A flashing yellow LED illuminates when the battery voltage is low and the VacuLink should be replaced. If a VacuLink that has been used previously and is reconnected, the red LED illuminates indicating the VacuLink is no longer operational.

The Silicone Vacuum Cup is to assist a clinician in delivery of an infant during childbirth.

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Prism Enterprises, Inc.'s Mityvac® Merlin™ is intended to be utilized to assist a clinician in the delivery of an infant during childbirth. This device is indicated for use during vaginal delivery and Cesarean sections.

The Mityvac® Merlin™ System is a modification of the cleared Mityvac® MityOne™ System with M-Style® or MitySoft® Bell Cups (K011532). The primary difference between the Mityvac® Merlin™ System and the MityOne™ System is that the Merlin™ System utilizes a CO2 canister to create the energy for vacuum, while the MityOne™ uses a builtin hand driven pump as the energy source.

INDICATIONS FOR USE: - 1. Non-reassuring fetal status. - Failure of the fetus to deliver spontaneously following an appropriately 2. managed second stage. - Maternal need to avoid voluntary expulsive effort. 3. - 4. Inadequate maternal expulsive effort. - Selective shortening of the second stage when the fetal head is at the outlet 5. as defined by ACOG technical bulletin # 196 Aug. 1994.

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Use for fetal vacuum delivery assistance in conditions of: 1) dystocia, 2) uterine inertia, 3) maternal exhaustion (ineffective voluntary effort), or 4) maternal or fetal distress. Standard vacuum extraction Use for fetal vacuum extraction in conditions of 1) prolonged second stage of labor (arrest of descent) where fetopelvic relationships are adequate, 2) presumed fetal jeopardy which is not considered to be severe, or 3) elective shortening of the second stage for selected maternal or fetal conditions. Trial of vacuum extraction Vacuum delivery should be regarded as a "trial" 1) if there is arrest of descent in the second stage and fetopelvic relationships are considered to be boderline, or 2) in a mid-pelvic extraction when position and station are known. Vacuum extraction should be abandoned and birth completed by cesarean section 1) if no descent (progress) of the head occurs after 2 tractions. 2) if delivery is not achieved or imminent after 4 tractions, or 3) if the vacuum cup detaches ("pops-off") twice.

The Kiwi Complete Vacuum Delivery Systems are fetal vacuum extractors having a cup to attach to the fetal head, a handle with which to apply withdrawal force, and a vacuum pump built into the handle of the cup/handle combination. This palm pump includes a method for easily generating a vacuum by pumping the handle with the palm. A vacuum indicator and a vacuum relief valve are also integral to the palm pump. Two styles of cups are available; one of soft silicone (VFE-6000S) and the other of the Malmstrom design (VFE-6000M).

The Ameda Disposable Vacuum Assist Cup with Fluid Retention Trap is a sterile, single use, device intended to be connected to an externally powered fetal vacuum extractor to aid in vaginal or Cesarean delivery of term or near term infants. The Fluid Retention Trap is intended to collect fluids aspirated during the delivery procedure. Indications For Use: - Delay in second stage with the fetal head stationed at the outlet; on the pelvic floor; or in the . mid-pelvis. - Delay in the second stage associated with borderline cephalopelvic disproportion . - Fetal distress . - Shortening of second stage labor for fetal or maternal benefit . - Prolapse of the umbilical cord when the cervix is fully dilated ●

The purpose of this premarket notification is to add a fluid retention trap option to the current Ameda Disposable Vacuum Assist Cup in order to collect fluids that may be aspirated during the delivery procedure. The fluid retention trap consists of a housing segment that is constructed of high impact polystyrene and a polyurethane foam filter. The fluid retention trap, when used, is connected to the tubing of the device between the vacuum cup and the vacuum pump.

To facilitate delivery of a fetus during vaginal deliver

Prism's Mityvac and Gesco's Vac-U-Nate consist primarily of the following components: (1) a suction cup and shaft; and (2) handle and valve assemblies. Each device's cup and shaft have a positioning reference printed on them and the shaft has three molded ridges on it. Both devices have the same components. These components are composed of the same materials and processed in the same manner.

The Indications For Use for this vacuum device in childbirth are the following: Uterine inertia Maternal Exhaustion - ineffective voluntary effort Vertex Presentation Engagement of the Head Optional: A. Maternal distress B. Fetal distress

The new product is an improved vacuum extractor cup. The improvement is found in the location of the vacuum tubing attachment point, vacuum release valve and an adaptor for electric vacuum pumps.