(128 days)
The NeoPAP System is intended to provide continuous positive airway pressure (CPAP) for use in hospitals to treat newborns and infants, weighing less than 5 kg, with RDS or who are recovering from RDS. (Respiratory Distress Syndrome).
The Children's Medical Ventures LLC NeoPAP System provides nasal CPAP (continuous positive airway pressure) as a non-invasive method of breathing support for infants and newborns with compromised respiratory systems who weigh less than 5 kg.
The NeoPAP System provides CPAP therapy delivered to patient through a nasal cannula or mask. The system has a feature called Baby-Trak which actively regulates pressure at all times by monitoring pressure at patient's nose and adjusting flow from oxygen and air gas supplies using proportional solenoids. The Baby-Trak feature eliminates the need for a closely-fitted patient interface that can damage fragile tissues.
In addition to CPAP mode, the NeoPAP System offers a constant flow mode where the device delivers a fixed flow of humidified air/oxygen mixture through the nasal prongs or mask. There is also a resuscitation mode where the device delivers a fixed flow of unhumidified air/oxygen through the resuscitation port for use with a resuscitation or hyperinflation bag. The percentage of oxygen can be adjusted while in any mode by using a rotary knob on the user interface.
The NeoPAP System alarms when pressure levels or oxygen concentration are above or below alarm limits. The system also detects occlusion, disconnect, and other alarm conditions. The system displays a real-time bar graph that indicates delivered pressure.
The provided document describes the NeoPAP System, a medical device for providing continuous positive airway pressure (CPAP) to newborns and infants. It focuses on demonstrating substantial equivalence to a predicate device (Guardian Neonate CPAP / Humidification System, K040862) after modifications.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that "All tests that were created for the modified NeoPAP System had passing results with acceptance criteria successfully met, which demonstrates the safety & effectiveness of the system." However, the specific quantitative acceptance criteria and detailed performance results for each test are not explicitly listed in the provided text. The document primarily focuses on what was tested and the conclusion that criteria were met, rather than presenting the criteria and performance data in a tabular format.
A general summary of some "performance aspects" that are implied to meet criteria through comparison to the predicate device would be:
| Feature/Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Unchanged from predicate (K040862): provide CPAP for newborns/infants |
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).