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510(k) Data Aggregation
(266 days)
The Saans System is intended to provide continuous positive airway pressure (CPAP) support to spontaneously breathing neonates and infants weighing up to 10 kg who require respiratory assistance, including those with conditions associated with prematurity such as Respiratory Distress Syndrome (RDS). The device is intended for use in hospital environments.
The Saans System is a medical device designed to deliver Continuous Positive Airway Pressure (CPAP) therapy. The Saans System consists of the Saans device and accessories that work together to deliver the required therapy to the patient. This submission covers the Saans Device. The Saans device takes ambient air and oxygen as input and provides the mixed gas as output. This gas mixture is supplied to the humidifier, the output of which is connected to the breathing circuit. The breathing circuit is connected to the patient interface and the Bubble CPAP Generator.
The key features and functionalities of the Saans System are:
Gas Source and Mixture: The system utilizes an oxygen source and ambient air to create the required gas mixture for therapy. This blending approach allows for oxygen delivery to the patient.
User Interface and Control: The system incorporates a user interface enabling users to adjust and monitor various therapy parameters. Users can set the desired flow rate and oxygen concentration (FiO2).
Pressure Regulation: A Bubble CPAP Generator is employed to achieve the desired pressure levels within the system. The generator provides a continuous positive pressure in the patient's airways.
Monitoring: The Saans System provides displays of parameters such as delivered flow, pressure, and FiO2. The pressure is measured at the end of the inspiratory limb, right before the patient interface.
Safety: The Saans System provides safety alarms like blockage, leakage and FiO2 alarms
Delivery Mechanism: Heated and humidified respiratory gas is delivered to the patient through an inspiratory breathing circuit (Inspiratory Limb) connected to a nasal interface (Patient Interface). An expiratory circuit (Expiratory Limb) completes the loop, connecting the nasal interface to the Bubble CPAP Generator for pressure regulation.
Humidification and Accessories: An external humidifier is used to provide humidified gas. The details for the breathing circuits, nasal interface, humidification chamber, and Bubble CPAP generator are all a part of the information provided to the user in the User Manual.
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(260 days)
Fisher & Paykel Healthcare OptiPAP Junior is for single-patient use and is intended to deliver noninvasive positive airway pressure (PAP) therapy to spontaneously breathing patients who require respiratory support.
OptiPAP Junior is designed for use in hospital environments where the patient is continually monitored and must be prescribed by a physician. It is intended for use by trained medical professionals on a pediatric subpopulation that includes neonates and infants from birth up to two years of age.
The F&P OptiPAP Junior is intended to deliver heated and humidified Positive Airway Pressure (PAP) therapy to neonates and infants requiring respiratory support.
The F&P OptiPAP Junior is a prescription-only device provided in a non-sterile state and intended to be used in a hospital environment and must be prescribed by a physician. The F&P OptiPAP Junior is for single- patient-use up to 14 days. The F&P OptiPAP Junior will be offered in multiple size variants.
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