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510(k) Data Aggregation
(121 days)
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:
| Feature | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (AIRVO 2 Series Humidifier) |
|---|---|---|
| Flow Range | Comparable to predicate MR850 ( < 60 L/min) and AIRVO Series (5 - 50 L/min) | 2 - 60 L/min (Wider range than AIRVO Series predicate, encompassing MR850 predicate) |
| Oxygen Input | Comparable to predicate AIRVO Series (< 30 L/min) | < 60 L/min (Increased capacity to allow higher oxygen fraction settings) |
| Treatment Conditions | Delivery of high flow warmed and humidified respiratory gases | Delivers high flow warmed and humidified respiratory gases to spontaneously breathing patients (including those with bypassed upper airways). |
| Temperature Settings | Comparable to predicate AIRVO Series (31 °C, 34 °C, 37 °C) | 31 °C, 34 °C, 37 °C |
| Alarm Conditions | Functionality for Temperature, Flow, and Oxygen Fraction | Audible and visual alarms for Temperature, Flow, and Oxygen Fraction. |
| Safety (Mechanical, Electrical, Thermal, EMC) | Compliance with standards like IEC 60601-1, IEC 60601-1-2 | Undergone non-clinical testing and risk management covering mechanical, electrical and thermal safety, environmental conditions, electromagnetic compatibility. The device complies with the standards for medical electrical equipment. |
| Biocompatibility | Compliance with standards like ISO 10993 series | Patient contacting parts have been evaluated and tested for biocompatibility; complies with biocompatibility requirements. |
| Functional Verification | Verification of flow and temperature delivery, oxygen fraction measurement, alarm conditions | Software and hardware bench tested for flow and temperature delivery, oxygen fraction measurement and accuracy, alarm conditions, over stated flow and temperature ranges, in normal use and single fault situations. System performance tested with humidifier, water chamber, and breathing tube with patient interfaces. |
| Environmental Conditions | (Implicitly by ISO standards compliance) | Undergone non-clinical testing for environmental conditions. |
| Software/Hardware Control | Safe and effective control with feedback sensors and hardware backups | Software control using feedback sensors with hardware back-ups; bench tested for normal use and single fault situations. |
| Intended Use | Covers specified patient populations and settings | For spontaneously breathing patients benefiting from high flow warmed and humidified respiratory gases. AIRVO 2 for hospitals/long-term care; myAIRVO 2 for homes/long-term care. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not describe a test set with a specific sample size of patients or patient data. The evaluation is based on non-clinical bench testing of the device's functional and safety aspects. Therefore, there is no "data provenance" in terms of country of origin or retrospective/prospective clinical data for the performance evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. As the testing was non-clinical bench testing, no human experts were used to establish a "ground truth" for patient-related outcomes or conditions. The "ground truth" for the device's technical specifications and safety was established by engineering and regulatory standards (e.g., ISO, IEC) and internal testing protocols.
4. Adjudication Method for the Test Set
Not applicable. There was no test set involving human assessment or interpretation that would require an adjudication method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a respiratory humidifier, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant in this context.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of an algorithm without human intervention. Since the AIRVO 2 is a physical medical device (a humidifier) and not an AI algorithm, the concept of "standalone performance" in this AI-centric sense is not applicable. The device's performance is inherently "standalone" in that it performs its function (humidification, flow delivery) without a human-in-the-loop determining its output based on interpretation. However, a human operates and monitors it.
The "standalone" performance that was evaluated involved the device's ability to maintain specified flow ranges, temperature settings, oxygen fraction measurements, and alarm functions through bench testing of its integrated components and software.
7. The Type of Ground Truth Used
The "ground truth" for the device's evaluation was primarily based on:
- Engineering specifications and design requirements: The device was designed to meet certain flow rates, temperatures, and safety parameters.
- International Standards: Compliance with recognized standards like ISO 8185 (respiratory tract humidifiers), IEC 60601-1 (medical electrical equipment safety), IEC 60601-1-2 (EMC), and ISO 10993 series (biocompatibility). These standards define objective criteria and test methods.
- Predicate Device Performance: The performance of the predicate devices (AIRVO Series Humidifier and MR850 Humidifier) served as a benchmark for demonstrating substantial equivalence, particularly for flow range and general operating principles.
8. The Sample Size for the Training Set
Not applicable. As a physical medical device, the AIRVO 2 Series Humidifier does not utilize machine learning or AI that would require a "training set" of data in the conventional sense. Its "training" is in its design, engineering, and manufacturing to meet specified parameters.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for an AI algorithm. The "ground truth" for the device's design and manufacturing (which could be analogized to establishment of its foundational "knowledge") was established through:
- Expert engineering design.
- Adherence to regulatory requirements and international standards for medical devices.
- Internal quality control processes and risk management.
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