(89 days)
Intended to provide CPAP for use in hospitals to treat newborns and infants less than 5kg body weight with RDS or which are recovering from RDS (Respiratory Distress Syndrome). May or may not include humidification capabilities.
The Guardian Neonate CPAP / Humidification systems is non-invasive respiratory support device for neonatal patients
The provided text describes the "Guardian Neonatal CPAP / Humidification System" and confirms its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets those criteria, nor does it include details typically found in performance studies for medical devices like sample sizes, ground truth establishment, or expert involvement.
The document is a "Summary of Safety and Effectiveness" (510(k) summary) and an FDA clearance letter. These documents primarily focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting raw performance data or detailed study results against specific acceptance criteria. The "Measured Data" section lists ranges for various parameters but doesn't present them as acceptance criteria or performance results from a study.
Therefore, I cannot fulfill the request as the necessary information is not present in the provided text. I can only report on what is explicitly stated.
§ 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).