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The intended use for Medela's Basic and Dominant Flex Suction Pumps is to provide a vacuum source for use in hospitals and clinics. Basic: The intended use of the Basic suction pump is the creation of a constant vacuum for use in hospitals and clinics. This vacuum can be used for general suction, to aspirate and remove: surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials and during specific procedures which may include, vacuum extraction, aspiration during flexible endoscopy, use with cardiac tissue stabilizers during off-pump coronary artery bypass and epicardial ablation probes. Dominant Flex: The intended use of the Dominant Flex suction pump is the creation of a constant vacuum for use in hospitals and clinics. This vacuum can be used for general suction, to aspirate and remove: surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials and during specific procedures which may include, vacuum extraction, aesthetic body contouring, aspiration during flexible endoscopy, use with cardiac tissue stabilizers during off-pump coronary artery bypass, and epicardial ablation probes.

The Medela" Basic and Dominant Flex are high vacuum and high flow, AC-powered suction pumps that can be used when large quantities of fluid must be suctioned quickly in the hospital, ambulatory surgery center, clinic, and doctors' practice. Their construction includes a piston and cylinder system which provides strong suction performance and quiet, dependable operation and a microcontroller which is used to control motor speed and the user interface. Additional advantages of the Medela" Basic and Dominant Flex are user friendliness and simple cleaning. Medela® Basic and Dominant Flex cover the 4 main functions of - . Powerful and high suction capacity - . Rapid vacuum build-up - Low vibrations and quiet - . Design; smooth surface and easy to use and clean The Medela" Basic provides a fixed airflow of 30 l/m and the Medela" Dominant Flex offers the innovative function of selectable airflow of 40, 50 or 60 l/m. All operating elements for nurses or doctors are located on the front side of both pumps. These include the vacuum gauge, vacuum regulator knob, operating elements and Safety Set. The Safety Set consists of a 0.25l jar, lid and float and prevents an overflow into the pump. The Medela" Basic and Dominant Flex suction pumps can be operated via capacitive sensors (called "CleanTouch") to turn the pumps on/off. Additionally the Dominant Flex has capacitive sensors for adjusting the flow between 40, 50 and 60 l/m. Both pumps have a knob for the vacuum regulator. The vacuum inside the tubing is displayed on the vacuum gauge. The Medela" Basic and Dominant Flex use three indicator lights to provide information to the user on the status of the pump. All operating elements for the biomedical technicians are located on the back side. This is where the appliance inlet for plugging in the power cord is located. Both pumps are available either as rack or portable version can be combined with the trolley to create a mobile version. A variety of reusable and disposable accessories are available for use with the Medela" Basic and Dominant Flex suction pumps or are intended to be marketed with these pumps.

The intended use for Medela's Basic and Dominant Flex Suction Pumps is to provide a vacuum source for use during surgery. The Basic Suction Pump is indicated for vacuum extraction, aspiration during flexible endoscopy, and aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system either during surgery or at the bedside. The Basic Pump can also be used to provide the vacuum required for use with cardiac tissue stabilizers used in off-pump coronary artery bypass and for use with epicardial ablation probes. The Dominant Flex Suction Pump is indicated for vacuum extraction, aesthetic body contouring, aspiration during flexible endoscopy, and aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system either during surgery or at the bedside. The Dominant Flex Pump can also be used to provide the vacuum required for use with cardiac tissue stabilizers used in off-pump coronary artery bypass and for use with epicardial ablation probes.

The Medela" Basic and Dominant Flex are high vacuum and high flow, AC-powered suction pumps that can be used when large quantities of fluid must be suctioned quickly in the hospital, ambulatory surgery center, clinic, and doctors' practice. Their construction includes a piston and cylinder system which provides strong suction performance and quiet, dependable operation and a microcontroller which is used to control motor speed and the user interface. Additional advantages of the Medela " Basic and Dominant Flex are user friendliness and simple cleaning. Medela" Basic and Dominant Flex cover the 4 main functions of - . Powerful and high suction capacity - . Rapid vacuum build-up - . Low vibrations and quiet - . Design; smooth surface and easy to use and clean The Medela" Basic provides a fixed airflow of 30 l/m and the Medela" Dominant Flex offers the innovative function of selectable airflow of 40, 50 or 60 l/m. All operating elements for nurses or doctors are located on the front side of both pumps. These include the vacuum gauge, vacuum regulator knob, operating elements and Safety Set. The Safety Set consists of a 0.25l jar, lid and float and prevents an overflow into the pump. The Medela" Basic and Dominant Flex suction pumps can be operated via capacitive sensors (called "CleanTouch") to turn the pumps on/off. Additionally the Dominant Flex has capacitive sensors for adjusting the flow between 40, 50 and 60 l/m. Both pumps have a knob for the vacuum regulator. The vacuum inside the tubing is displayed on the vacuum gauge. The Medela " Basic and Dominant Flex use three indicator lights to provide information to the user on the status of the pump. All operating elements for the biomedical technicians are located on the back side. This is where the appliance inlet for plugging in the power cord is located. Both pumps are available either as rack or portable version can be combined with the trolley to create a mobile version. A variety of reusable and disposable accessories are available for use with the Medela" Basic and Dominant Flex suction pumps or are intended to be marketed with these pumps.

The Basic and Dominant Flex Suction Pumps are indicated for vacuum extraction, aspiration during flexible endoscopy and aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system either during surgery or at the bedside.

The Medela Basic and Dominant Flex are high vacuum and high flow, AC-powered suction pumps that can be used when large quantities of fluid must be suctioned quickly in the hospital, ambulatory surgery center, clinic, and doctors' practice. Their construction includes a piston and cylinder system which provides strong suction performance and quiet, dependable operation and a microcontroller which is used to control motor speed and the user interface. Additional advantages of the Medela Basic and Dominant Flex are user friendliness and simple cleaning. Medela Basic and Dominant Flex cover the 4 main functions of - Powerful and high suction capacity . - Rapid vacuum build-up . - Low vibrations and quiet . - Design; smooth surface and easy to . use and clean The Medela Basic provides a fixed airflow of 30 l/m and the Medela "Dominant Flex offers the innovative function of selectable airflow of 40, 50 or 60 I/m. All operating elements for nurses or doctors are located on the front side of both pumps. These include the vacuum gauge, vacuum regulator knob, operating elements and Safety Set. The Safety Set consists of a 0.25l jar, lid and float and prevents an overflow into the pump. The Medela Basic and Dominant Flex suction pumps can be operated via capacitive sensors (called "CleanTouch") to turn the pumps on/off. Additionally the Dominant Flex has capacitive sensors for adjusting the flow between 40, 50 and 60 l/m. Both pumps have a knob for the vacuum regulator. The vacuum inside the tubing is displayed on the vacuum gauge. The Medela Basic and Dominant Flex use three indicator lights to provide information to the user on the status of the pump. All operating elements for the biomedical technicians are located on the back side. This is where the appliance inlet for plugging in the power cord is located. Both pumps are available either as rack or portable version can be combined with the trolley to create a mobile version. A variety of reusable and disposable accessories are available for use with the Medela ` Basic and Dominant Flex suction pumps or are intended to be marketed with these pumps.

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.