Search Results

The Fisher & Paykel Healthcare RT041 Hospital Full Face Mask Non Vented is a patient interface for use as an accessory to a respiratory therapy device, i.e. ventilator that has adequate alarms and safety systems for ventilator failure, providing noninvasive positive pressure respiratory therapy. The mask is for single patient use with spontaneously breathing adult (> 30 kg) patients with respiratory insufficiency or respiratory failure who are suitable for noninvasive pressure support ventilation in hospital/institutional environments only.

The purpose of the RT041 is to interface between a conventional mechanical ventilator (CBK) and the patient, delivering pressurized gasses to the nares and/or mouth of the patient. The mask interfaces with the patient's facial contours ensuring a good seal is achieved to deliver the pressurized gasses with minimal unintentional leakage. Some unintentional gas leak around the face is inevitable, however leak is minimized by a number of design features. The contoured shaping of the mask base and a soft, pliable facial seal improve closeness of fit to the skin. The headgear keeps the mask tight against the face and its soft, elastic fabric improves comfort. The glider and swivel elbow reduce pull from the tubing on the head moves. Pressure monitoring may be achieved by connecting a line to the pressure port on the mask.

I'm sorry, but the provided text does not contain the specific information required to answer your request regarding acceptance criteria and a study proving device performance. The document is a 510(k) summary for a medical device (face mask) focusing on its substantial equivalence to predicate devices, and it does not detail specific acceptance criteria or the results of a performance study in the format you've requested.

The document discusses:

• Description and Intended Use: What the RT041 mask is and how it's meant to be used.
• Technological Characteristics Comparison: How it compares to predicate devices (RT040 and PerformaTrak SE).
• Non-clinical Tests: A statement that "Comparative performance testing of the RT041 with the predicate masks RT040 & PerformaTrak SE show that the relevant features of each predicate are substantially equivalent." However, it does not provide details of these tests, including acceptance criteria, sample sizes, ground truth establishment, or specific performance metrics.
• Conclusion: That the device is substantially equivalent to predicate masks.
• FDA Clearance Letter: Confirming the 510(k) clearance based on substantial equivalence.

Therefore, I cannot populate the table or provide the detailed information about a study proving the device meets acceptance criteria as the necessary data is not present in the provided text.

Ask a specific question about this device