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The Pneupac paraPAC plus™ Model 300/310 Ventilators are gas-powered emergency and transport portable ventilators that are primarily intended for use in transport applications in vehicles including fixed and rotary winged aircraft. They are suitable for emergency use at the accident scene, intra and inter-hospital transport and within medical facilities including medical imaging systems to 3 Teslas. They should only be used under the constant supervision of trained healthcare professionals. The devices are intended to provide ventilatory support to adults, children and infants (above approx. 10kg). The devices also provide free flow oxygen therapy and CPAP therapy for spontaneously breathing patients.

The Pneupac® paraPAC plus™ Model 300/310 Ventilators are gas powered portable medical devices intended for the ventilation of adults, children and infants (above approximately 10kg (or 22lb)) during transportation and emergency situations. These models are the enhanced versions of the Pneupac® Parapac® P200D Medic (K020899) gas powered time cycled emergency and transport ventilator which is also one of the predicate devices. Similar to the Pneupac® Parapac P200D, the Pneupac® paraPAC plus™ Model 300/310 Ventilators depend solely on the pressure of the supply gas for their operation. This enables them to be suitable for use in transport applications in vehicles including fixed and rotary winged aircraft. As with the Pneupac® Parapac® P200D, these models also incorporate an integrated electronic pressure alarm unit to alert the user of certain significant changes (such as for high or low inflation pressure) that may occur in patient's ventilation. Loss of battery power for the alarm is signaled to the user, but will have no effect on the performance of the ventilator, nor affect the pneumatically operated alarms and the ventilators functioning. Calibrated frequency and tidal volume controls are color coded to indicate the recommended settings for adults, children and infants. A Positive End Expiratory Pressure (PEEP) control is provided to set PEEP between 0 and 20 cm H2O. It also has a Continuous Positive Airway Pressure (CPAP) control to provide CPAP therapy for spontaneously breathing patients which is also one of the features of the predicate device, the O Two Carevent Systems (K051469). This is achieved by connecting a Pneupac® paraPAC plus™ Disposable CPAP Circuit to the Pneupac® paraPAC plus™ Model 310 Ventilator. An air mix control in the Pneupac® paraPAC plus™ Model 300/310 Ventilators gives FiQ2 option of 0.50 or 1.0. This enables the device to provide a combination of air and oxygen. The Pneupac® paraPAC plus™ Model 300/310 Ventilators use currently available technology found in many legally marketed ventilators. Testing was performed to demonstrate that they are safe and would perform within the environment(s) for which they are to be marketed. The Pneupac® paraPAC plus™ Model 300 Ventilator consists of a control module with user manual, oxygen gas specific standard input hose and a standard disposable patient circuit. The Pneupac® paraPAC plus™ Model 310 Ventilator consists of a control module with user manual, oxygen gas specific standard input hose, standard disposable patient circuit, CPAP disposable patient circuit and hyperinflation bag (K970785). The Pneupac® paraPAC plus™ Disposable CPAP Circuit is an air entrainment device with an attached oxygen and pressure monitoring line for connection solely to the Pneupac® paraPAC plus™ 310 Model Ventilators. The Instructions for Use of the Pneupac® paraPAC plus™ Disposable CPAP Circuit state that it can only be used with the Pneupac® paraPAC plus™ Model 310 Ventilator. As the Pneupac® paraPAC plus™ Disposable CPAP circuit cannot be used without the Pneupac® paraPAC plus™ Model 310 Ventilator, the Pneupac® paraPAC plus™ Disposable CPAP circuit is considered as an integral part of the Pneupac® paraPAC plus™ Model 310 Ventilator for the purposes of this Premarket Notification. The disposable patient circuits provided with the Pneupac® paraPAC plus™ Model 300/310 Ventilators are specifically designed for use with the Pneupac® paraPAC plus™ Model 300/310 Ventilators and the Instructions for Use state that these are the only circuits to be used with the Pneupac® paraPAC plus™ Model 300/310 Ventilators. As the Pneupac® paraPAC plus™ Model 300/310 Ventilators cannot be used without the patient circuit, the patient circuit is considered an integral part of Pneupac® paraPAC plus™ Model 300/310 Ventilators for the purposes of this Premarket Notification.

The babyPAC 100 is a portable gas powered transport ventilator, suitable for use in an MRI environment up to 3 Testa, which features a battery powered integrated electronic pressure alarm unit. It is designed for use by qualified medical caregivers, paramedics and other trained personnel, for ambulance, hospital, emergency and transport ventilation of patients during respiratory distress or insufficiency. It can be used on neonates and infants up to a bodyweight of 44lb (20 kg).

The babyPAC ventilator consists of a control module with a disposable conventional Y patient circuit. The babyPAC ventilator is a pressure generator which depends solely on the pressure of the supply gas for its operation. The babyPAC 100 additionally incorporates an integrated electronic pressure alarm unit which becomes operational during Controlled Mandatory Ventilation. This unit provides a warning of significant changes which may occur in the patient's ventilation. Loss of battery power for the alarm is signaled to the user but will have no effect on the ventilation performance of the babyPAC ventilator, nor affect the mechanically operated alarms and performance on the babyPAC ventilator (K970158) already on the market. The babyPAC 100 portable ventilator is designed for use as an emergency and transport ventilator in ambulances and hospitals, and can be used in an MRI environment up to 3 Teslas. It is intended for transportation and for resuscitation of infants (above approx 11lb [5 kg]) and neonates up to 44 lb (20 kg). The control module of the babyPAC ventilator is rugged by virtue of its thick section structural foam plastic case and the controls for the gauge and internal pneumatics are recessed to minimise the possibilities of damage and inadvertent operation. The babyPAC 100 portable ventilator consists of a control module and the following items: 22mm disposable Polyethylene respirator hose/ 22mm OD female connector and Paediatric 'Y' piece connector The module weighs 8.25 lb (3.75 kilograms) The module control panel has the following features: - Adjustable Relief Pressure Control, range 12 to 80 cm H2O. - Inspiratory Time Control, range 0.25 to 2.0 seconds. - Expiratory Time Control, range 0.25 to 4.0 seconds - Inspiratory Pressure Control, range 12 to 70 cm H2O, with click action warning at and above 40 cm H2O. - PEEP/ CPAP Control, range 0 to 20 cm H2O with click action warning at and above 10 cm H2O. - IMV Control, range Expiratory time 2.5 to 40 seconds with CPAP Pressure level and oxygen concentration as selected. - Patient Inflation Pressure Manometer, range -10 to +100 cm H2O. - Variable Oxygen Concentration, range 45 (approx) to 100% with oxygen only as supply, 21 to 70 % with oxygen and air supplies - Supply Gas Failure Alarm indicators- One for air, the other for oxygen, these mechanically operated visual alarms give a warning that the supply gas has dropped to a pressure at which the ventilator will no longer be operating to specification (< 35 psi). With low pressure they show red, with adequate pressure they show white. Any visible red indicates that the supply should be changed. As the pressure falls the display will begin to oscillate from white to partial red as the supply pressure falls to the lower threshold level. The visual indication will be accompanied by an electronically generated medium priority (to EN 475: 1995) audible warning. - Electronic alarm bezel indicating - High Pressure/ Constant Positive Inflation Pressure Indicator Flashes Red LED with audible alarm at set relief pressure and with continuous positive pressure - Inflation Indicator Flashes Green LED every time inflation pressure rises through 10 cm H2O. - Low Pressure/ Disconnect Indicator Flashes Yellow LED with audible alarm if pressure does not rise through 10 cm H2O within eight seconds - Silence button silences audible alarm for 60 seconds. Flashes Orange LED to indicate to the operator that the audible alarm is silenced. - Single Gas Use Indicator Flashes a Green LED as a burst of 3 flashes every 30 seconds, whenever the ventilator is being used with only a single gas input (ie oxygen or air only). In the event that the single gas fails (ie. where the audible gas failure alarm has activated) the Low Pressure/ Disconnect Indicator will activate together with the audible alarm. - Low battery indicator Flashes Yellow LED with audible alarm.