AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER

K131895 · Fisher & Paykel Healthcare, Ltd. · BTT · Oct 24, 2013 · Anesthesiology

Device Facts

• Record ID: K131895
• Device Name: AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER
• Applicant: Fisher & Paykel Healthcare, Ltd.
• Product Code: BTT · Anesthesiology
• Decision Date: Oct 24, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

AIRVO 2 Series Humidifier delivers conditioned respiratory gas to spontaneously breathing patients; system comprises motorized fan assembly and heated passover humidifier. Device inputs include ambient temperature and flow data; software monitors these parameters to optimize humidity delivery and minimize condensation. Output is warmed, humidified air/O2 flow (2–60 L/min) delivered via nasal cannula, tracheostomy interface, or face mask. Operated by nurses, respiratory therapists, doctors, or patients in hospitals, long-term care facilities, or homes. Features include audible/visual alarms for temperature, flow, and oxygen fraction; transport mode disables heating to extend battery life. Healthcare providers use device to support respiratory function; output helps maintain airway hydration and patient comfort. Device is reusable with high-level disinfection; patient interfaces are single-use.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including mechanical, electrical, and thermal safety, electromagnetic compatibility, and functional performance verification. Testing confirmed accuracy of flow, temperature, and oxygen fraction delivery, as well as alarm functionality under normal and single-fault conditions. Biocompatibility of patient-contacting parts was evaluated per ISO 10993 standards.

Technological Characteristics

Heated passover humidifier with integrated blower. Materials: molded plastics, metal heater plate. Energy: mains electrical. Flow range: 2-60 L/min. Temperature settings: 31°C, 34°C, 37°C. Software-controlled feedback sensors with hardware backups. Connectivity: standalone. Sterilization: reusable device (high-level disinfection kit), single-use patient interfaces. Standards: ISO 8185, IEC 60601-1, IEC 60601-1-2, ISO 10993 series.

Indications for Use

Indicated for spontaneously breathing patients requiring high-flow warmed/humidified respiratory gases, including those with bypassed upper airways. Suitable for use in hospitals, long-term care facilities, and home settings.

Regulatory Classification

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.

Predicate Devices

• AIRVO Series Humidifier (K121975)
• MR850 Humidifier (K073706)

Submission Summary (Full Text)

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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: [phone]
Facsimile: [phone] Website: www.fphcare.com

Kr31895

| Date prepared | 21 June 2013 | |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Submitter | Fisher & Paykel Healthcare<br>15 Maurice Paykel Place<br>East Tamaki<br>Auckland<br>New Zealand<br>Tel: [phone]<br>Fax [phone] | OCT 2 4 2013 |
| Contact person | Brett Whiston<br>Regulatory Affairs | |
| Trade or<br>proprietary name | AIRVO 2 Series Humidifier | |
| Common name | Respiratory Humidifier | |
| Classification name | Humidifier, Respiratory Gas, (Direct Patient Interface)<br>(21. CFR § 868.5450, product code BTT) | |
| Predicate device | K121975, AIRVO Series Humidifier, Fisher & Paykel Healthcare Ltd<br>K073706, MR850 Humidifier, Fisher & Paykel Healthcare Ltd | |

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# Device description 5.1

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.

### 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 device<br>AIRVO 2 Series Humidifier | Predicate device<br>MR850 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 device<br>AIRVO 2 Series Humidifier | Predicate device<br>AIRVO Series Humidifier |
|---------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Design | Integrated blower and humidifier with<br>chamber and heated breathing tube. | Integrated blower and humidifier with<br>chamber and heated breathing tube. |
| Energy Source | Electrical from mains supply to power<br>blower and heating. | Electrical from mains supply to power<br>blower 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/O2<br>at constant flow to the patient | Delivery of entrained, humidified Air/O2<br>at constant flow to the patient |
| Patient Interfaces | Nasal cannula, tracheostomy direct<br>connection, face mask. | Nasal cannula, tracheostomy direct<br>connection, face mask. |
| Alarms | Audible and visual for Temperature, Flow<br>and Oxygen Fraction. | Audible and visual for Temperature, Flow<br>and Oxygen Fraction. |
| User interface | User set point adjustment via menu<br>system on color display for temperature<br>and flow. | User set point adjustment via menu<br>system on color display for temperature<br>and flow. |
| Display | LED display for Temperature, Flow,<br>Oxygen Fraction. | LED display for Temperature, Flow,<br>Oxygen Fraction. |
| Control | Software control using feedback sensors<br>with hardware back ups | Software control using feedback sensors<br>with hardware back ups |

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

| Feature | Proposed device<br>AIRVO 2 Series Humidifier | Predicate device<br>AIRVO 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 for<br>respiratory humidification systems |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1:1988 | Medical Electrical Equipment, Part 1: General Requirements for Safety +<br>A1:1991+A2:1995 |
| IEC 60601-1-2:2007 | General requirements for basic safety and essential performance -<br>Collateral standard: Electromagnetic compatibility - Requirements and<br>tests |
| ISO 10993-1:2009 | Biological evaluation of medical devices -- Part 1: Evaluation and testing<br>within 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 [phone] or [phone] 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 [phone] or [phone] 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 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.

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

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