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.

Device Description

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.

AI/ML Overview

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.

Summary

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Airvo 2 Series Humidifier

510(k) Notification

510(k) Summary 5

Healthc Stewart Building 15 Maurice Paykel Place, East Tamaki P O Box 14 348, Panmure Auckland, New Zealand Telephone: +64 9 574 0100
Facsimile: +64 9 574 0158 Website: www.fphcare.com

Kr31895

Date prepared	21 June 2013
Submitter	Fisher & Paykel Healthcare15 Maurice Paykel PlaceEast TamakiAucklandNew ZealandTel: +64 9 574 0100Fax +64 9 574 0158	OCT 2 4 2013
Contact person	Brett WhistonRegulatory Affairs
Trade orproprietary name	AIRVO 2 Series Humidifier
Common name	Respiratory Humidifier
Classification name	Humidifier, Respiratory Gas, (Direct Patient Interface)(21. CFR § 868.5450, product code BTT)
Predicate device	K121975, AIRVO Series Humidifier, Fisher & Paykel Healthcare LtdK073706, MR850 Humidifier, Fisher & Paykel Healthcare Ltd

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Device description 5.1

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

5.2 Intended use

The AIRVO 2 and mvAIRVO 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.

5.3 Substantial equivalence

The following information presents summary technological features in the determination of substantial equivalence comparison of the proposed Airvo 2 Series Humidifier to the identified predicate devices.

Comparison to MR850 predicate 5.3.1

The MR850 is used as a predicate for flow range. The flow range of the AIRVO 2 Series Humidifier is within the flow range of the predicate MR850 humidifier.

Feature	Proposed deviceAIRVO 2 Series Humidifier	Predicate deviceMR850 Humidifier
Flow range	2 - 60 L/min	< 60 L/min

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5.3.2

The Airvo 2 Series Humidifier is a modification of the Airvo Series Humidifier and is the main comparison of features.

Feature	Proposed deviceAIRVO 2 Series Humidifier	Predicate deviceAIRVO Series Humidifier
Design	Integrated blower and humidifier withchamber and heated breathing tube.	Integrated blower and humidifier withchamber and heated breathing tube.
Energy Source	Electrical from mains supply to powerblower and heating.	Electrical from mains supply to powerblower and heating.
Materials	Moulded plastics and metal heater plate	Moulded plastics and metal heater plate
Temperature setting	31 °C, 34 °C, 37 °C	31 °C, 34 °C, 37 °C
Operating principle	Delivery of entrained, humidified Air/O2at constant flow to the patient	Delivery of entrained, humidified Air/O2at constant flow to the patient
Patient Interfaces	Nasal cannula, tracheostomy directconnection, face mask.	Nasal cannula, tracheostomy directconnection, face mask.
Alarms	Audible and visual for Temperature, Flowand Oxygen Fraction.	Audible and visual for Temperature, Flowand Oxygen Fraction.
User interface	User set point adjustment via menusystem on color display for temperatureand flow.	User set point adjustment via menusystem on color display for temperatureand flow.
Display	LED display for Temperature, Flow,Oxygen Fraction.	LED display for Temperature, Flow,Oxygen Fraction.
Control	Software control using feedback sensorswith hardware back ups	Software control using feedback sensorswith hardware back ups

Summary of same technological characteristics. o
. Summary of different technological characteristics.

Feature	Proposed deviceAIRVO 2 Series Humidifier	Predicate deviceAIRVO Series Humidifier
Flow range	2 - 60 L/min	5 - 50 L/min
Oxygen Input	< 60 L/min	< 30 L/min
Transport mode	Limits power to flow only	None

A wider flow range has been created to deliver flow from 2 L/min to accommodate more patients with differing inspiratory demand. The AIRVO 2 Series Humidifier has also increased oxygen input up to 60 L/min to allow oxygen fraction to be set higher above 30 L/min than is possible in the predicate. The transport mode allows battery power to last longer by disabling heating to keep flow operating during transportation of the patient. The indications for use differ only by the flow range to the predicate.

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Non clinical performance data 5.4

5.4.1 Summary of non clinical tests

Assessment of non clinical performance data is used in the determination of substantial equivalence. The AIRVO 2 Series Humidifier has undergone non-clinical testing and risk management that covers mechanical, electrical and thermal safety, environmental conditions, electromagnetic compatibility, functional verification and performance.

Software and hardware is bench tested for the flow and temperature delivery, oxygen fraction measurement and accuracy, alarm conditions, over the stated flow and temperature ranges, in normal use and single fault situations. The testing examines the humidifier, water chamber, and breathing tube with patient interfaces, to test system performance. Patient contacting parts have been evaluated and tested for biocompatibility.

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5.4.2 Standards applied

ISO 8185: 2007	Respiratory tract humidifiers for medical use - Particular requirements forrespiratory humidification systems
IEC 60601-1:1988	Medical Electrical Equipment, Part 1: General Requirements for Safety +A1:1991+A2:1995
IEC 60601-1-2:2007	General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - Requirements andtests
ISO 10993-1:2009	Biological evaluation of medical devices -- Part 1: Evaluation and testingwithin a risk management process
ISO 10993-3:2003	Tests for genotoxicity, carcinogenicity, and reproductive toxicity
ISO 10993-5:2009	Tests for in vitro cytotoxicity
ISO 10993-6:2007	Tests for local effects after implantation
ISO 10993-10:2010	Tests for irritation and skin sensitization

The device complies with the following applicable product standards:

ર.5 Conclusions on performance data

Testing carried out on the AIRVO 2 Series Humidifiers indicates that they meet design and performance functional requirements. The device complies with the standards for medical electrical equipment and respiratory humidifiers for safety and performance, and biocompatibility requirements.

The results obtained demonstrate that the AIRVO 2 Series Humidifier is substantially equivalent to the predicate AIRVO Series Humidifier, and has a similar operational flow range as the predicate MR850 Humidifier. It can be concluded that the AIRVO 2 Series Humidifier is substantially equivalent to the predicate AIRVO Series Humidifier and MR850 Humidifier.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine. The caduceus in the logo is depicted as a staff with a snake winding around it, and a pair of wings at the top.

October 24, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Fisher & Paykel Healthcare Limited Mr. Brett Whiston Regulatory Affairs Specialist 15 Maurice Paykel Place, East Tamaki P O Box 14 348, Panmure AUCKLAND, NEW ZEALAND 2013

Re: K131895

Trade Device Name: AIRVO 2 Series Humidifier Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: September 25, 2013 Received: September 26, 2013

Dear Mr. Whiston:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register,

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Mr. Whiston

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/6/Picture/8 description: The image shows a signature and some text. The text includes the name "Tejashri Purohit Sheth, M.D." and the title "Clinical Deputy Director". There is also the acronym "DAGRID" present. Finally, the word "FOR" is at the bottom right.

Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement 4

510(k) Number (if known)

AIRVO 2 Series Humidifier Device Name

Indications for Use:

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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

K131895

signed by Anya C. Harry -S U.S. Government, qu=HHS, Anva C. I *People cnoArva C Harry -S 2013 10:24 11:03:19 -04'00

Page 1 of 1

Regulation Number and Section

§ 868.5450 Respiratory gas humidifier.

(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).