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The pNeuton mini is intended to provide ventilatory support for critically ill patients who require the following general types of ventilatory support: - Positive pressure ventilation delivered invasively (via an ET Tube) or non-invasively (via a mask or nasal prongs) - CMV and IMV mode of ventilation with or without PEEP / CPAP - Provide oxygen or a mixture of medical air and oxygen

The pNeuton mini ventilator is a small, lightweight transport ventilator designed for use on patients from neonate to pediatric in size (400 gram to 25 kg). It is a time cycled, flow limited ventilator providing Continuous Mechanical Ventilation (CMV) or Intermittent Mandatory Ventilation (IMV). In these modes of ventilation, an adjustable inspiratory time, expiratory time and pressure is delivered to the patient. The patient is allowed to breath spontaneously between the mandatory breaths with little added work of breathing. A built-in PEEP / CPAP system can be set to provide expiratory positive pressure. The delivered oxygen is adjustable from 21 to 100 percent. The pNeuton mini ventilator is a pure pneumatic ventilator. Electrical power is not used. The ventilator operates from oxygen and medical grade air input pressures from 40 to 70 psi. The various control systems that manage the time controls, PEEP / CPAP, and safety systems / pneumatic alarms is powered with pure oxygen to maintain stability and accuracy. There are no electronic controls or software in this device. The device provides ventilation and CPAP support for the care of individuals who require respiratory assistance. The device is a restricted medical device for use by qualified medical personnel under the direction of a physician. The device may be used in prehospital environments, inter and intra-hospital patient transport, air and ground transport, and all areas of the hospital including the MRI (NOT for use in the presence of flammable anesthetics). The mini ventilator has been specifically designed for ruggedness and ease of use. The pNeuton mini ventilator uses accessories during normal operation. The primary accessory is a patient tubing circuit to attach the device to the patient. The patient circuit is a single-use disposable device. The patient circuit uses the same major component (expiratory valve) included with the predicate pNeuton Ventilator K043085 with smaller diameter hoses.

To provide CPAP to spontaneously breathing patients in the hospital, prehospital (EMS) and sub-acute / alternate site facility environments via Face Mask or endo-tracheal tube.

The device provides CPAP support for the care of spontaneously breathing individuals who require oxygen assistance. The device is a restricted medical device for use by qualified medical personnel under the direction of a physician. The device may be used in pre-hospital environments, inter and intra-hospital patient transport, air and ground transport, and all areas of the hospital (NOT for use in the presence of flammable anesthetics or in the MRI). MACS has been specifically designed for ruggedness and ease of use. The MACS CPAP device uses accessories during normal operation. The primary accessory is a patient tubing circuit and positive airway pressure face mask to attach the device to the patient. The patient circuit and face mask are single-use disposables. The patient circuit is the same circuit included with the previously cleared Pneuton Ventilator K024344 and K043085.

The device is intended for continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified medical personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients, 23 kg (50 lbs.) and greater who require the following general types of ventilatory support: - positive pressure ventilation delivered invasively (via an ET Tube) or non-invasively (via a mask) - CMV and IMV modes of ventilation - with or without PEEP / CPAP - with oxygen or a mixture of air and oxygen The ventilator is suitable for use in: - Pre-hospital transport applications including accident scene, emergency rescue vehicles - Hospital ICU and transport applications including emergency, radiology, surgery, recovery and MRI departments - Air transport via helicopter or fixed wing

Pneuton (pronounced "new-ton") is a small, lightweight transport ventilator designed for use on patients from pediatric to adult in size (23 kg and higher). It is a time cvcled, flow limited ventilator providing Continuous Mechanical Ventilation (CMV) or Intermittent Mandatory Ventilation (IMV). In these modes of ventilation, an adjustable respiratory rate and tidal volume are delivered to the patient. The patient is allowed to breath spontaneously between the mandatory breaths with little added work of breathing. A built-in PEEP / CPAP system can be set to provide expiratory positive pressure. The delivered oxygen is adjustable at 65 or 100 percent. Pneuton is a pneumatic ventilator. Electrical power is not required for patient ventilation. The pneumatic system operates at input pressures from 41 to over 66 psi. Various control systems manage the tidal volume and rate control, PEEP / CPAP, and safety systems / pneumatic alarms. This premarket submission makes the following changes to the Pneuton Ventilator: - adds a patient disconnect alarm system to the ventilator. The alarm includes audible and visual indication of patient disconnect - changes the minimum respiratory rate from 2 to 3 breaths per minute - changes to the minimum peak inspiratory pressure from 10 to 15 cm H₂O - increases the MRI compatibility to 3 tesla The ventilator will be marketed as a finished component, both with and without the changes identified above. The Pneuton Ventilator model A includes the changes; model S is the original device without the changes. The Pneuton Ventilator uses accessories for normal operation which are included with this submission. The primary accessory is a patient tubing circuit to attach the ventilator to the patient. The patient circuit is the same circuit included with the previously cleared Pneuton Ventilator K024344. Additional external accessories will be sold with the device including a remote alarm adapter, travel case, pole stand, mounting brackets, oxygen hose and oxygen tanks.

The device is intended for continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified medical personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients, 23 kg (50 lbs.) and greater who require the following general types of ventilatory support: - positive pressure ventilation delivered invasively (via an ET Tube) or non-invasively (via a mask) - CMV and IMV modes of ventilation - with or without PEEP / CPAP - with oxygen or a mixture of air and oxygen The ventilator is suitable for use in: - Pre-hospital transport applications including accident scene, emergency rescue vehicles - Hospital ICU and transport applications including emergency, radiology, surgery, recovery and MRI departments - Air transport via helicopter or fixed wing

Pneuton (pronounced "new-ton") is a small, lightweight transport ventilator designed for use on patients from pediatric to adult in size (10 kg and higher). It is a time cycled, flow limited ventilator providing Continuous Mechanical Ventilation (CMV) or Intermittent Mandatory Ventilation (IMV). In these modes of ventilation, an adjustable respiratory rate and tidal volume are delivered to the patient. The patient is allowed to breath spontaneously between the mandatory breaths with little added work of breathing. A built-in PEEP / CPAP system can be set to provide expiratory positive pressure. The delivered oxygen is adjustable at 65 or 100 percent. Pneuton is a pneumatic ventilator. Electrical power is not required for patient ventilation. The pneumatic system operates at input pressures from 41 to over 66 psi. Various control systems manage the tidal volume and rate control, PEEP / CPAP, and safety svstems / pneumatic alarms. The Pneuton Ventilator uses accessories for normal operation which are included with this submission. The primary accessory is a patient tubing circuit to attach the ventilator to the patient. The patient circuit is a class 1 device, currently exempt from premarket notification. The patient circuit is a disposable device, not to be sterilized or disinfected (see section 12 of this submission). Additional accessories will be sold with the device including travel case, pole stand and mounting brackets.