(456 days)
OmniNeb™: This device is to be used under medical supervision in hospitals, nursing homes, extended care facilities and outpatient clinics. The OmniNeb™ INebulizer is a low flow continuous nebulizer to be used to deliver aerosolized medications for up to four hours via direct patient interface on spontaneous breathing patients. Patient population: Asthma, Pneumonia. COPD. or any other conditions in which sympathomimetic ammines, parasympathetic ammines, Steroids, or other appropriate medications would be aerosolized. The Omni-Neb™ requires 45-55 psig source gas of Oxygen or Air.
OmniMax™: This device is to be used under medical supervision in hospitals. The OmniMax™ Nebulizer is to be used to deliver aerosolized medications in conjunction with Heliox therapy to sponfaneous breathing patients. Patient population: Asthma, Pneumonia, COPD, or any other condition in which sympathomimetic ammines, parasympathetic ammines, Steroids, or other appropriate medications would be aerosolized, and adjunctive Heliox would be beneficial. The Omni-Max® requires 45-55 psig of Oxygen source gas. 10 liters/minute of 80/20 Heliox is added via auxiliary gas port.
Nebulizer (Direct Patient Interface)
I apologize, but this document is a 510(k) clearance letter from the FDA for nebulizer devices (Omni-Neb and Omni-Max). It does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document primarily focuses on the substantial equivalence determination for these nebulizers.
Therefore, I cannot provide the requested information based on the content of this document.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).