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The AIRVO 2 and myAIRVO 2 humidifiers are for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases. This includes patients who have had upper airways bypassed. The flow may be from 2 - 60 L/min depending on the patient interface.

The AIRVO 2 is for patients in hospitals and long-term care facilities. The myAIRVO 2 is for patients in homes and long-term care facilities.

The AIRVO 2 Series Humidifier system is a heated humidifier with integrated flow source and a heated breathing tube to deliver conditioned respiratory gas flow to a patient. The AIRVO 2 Series comprises two similar devices; the AIRVO 2, is intended for use in hospitals and long term care facilities and myAIRVO 2, intended for home use and long term care facilities.

The AIRVO 2 Series Humidifier is comprised of two connected functional units. One is a motorised fan assembly that provides air flow. The fan speed is directly related to delivered flow, and is controlled by software with a flow sensor. The blower assembly output connects directly to a humidification chamber at the front of the device.

The second functional unit of the AIRVO 2 Series Humidifier is a heated passover humidifier. The water is contained in a humidification chamber positioned on a heater plate at the front of the unit. The chamber connects directly to the blower assembly via a port at the back of the chamber. Software monitors ambient temperature and flow to optimise humidity delivery to the patient and minimise condensation.

The device interfaces with the patient via a nasal cannula, tracheostomy interface, or face mask.

The AIRVO 2 Series Humidifier is reusable and by using the high level disinfection kit it can be used on multiple patients. The interfaces, tubes and water chambers are disposable and are for single patient use only. The device may be operated by nurses, respiratory therapists, doctors or patients.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the AIRVO 2 Series Humidifier does not explicitly list distinct "acceptance criteria" with numerical targets and corresponding "reported device performance" values in a table format regarding clinical effectiveness. Instead, it describes a process of non-clinical testing and benchmarking against predicate devices to establish substantial equivalence.

The document highlights the following characteristics as relevant for demonstrating substantial equivalence and performance:

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