F&P myAirvo 3
Device Facts
| Record ID | K222292 |
|---|---|
| Device Name | F&P myAirvo 3 |
| Applicant | Fisher & Paykel Healthcare |
| Product Code | BTT · Anesthesiology |
| Decision Date | May 8, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5450 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
The myAirvo 3 is for the treatment of spontaneously breathing patients, infant to adult, 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 myAirvo 3 is for patients in homes and long-term care facilities.
Device Story
F&P myAirvo 3 is a heated humidifier flow source for high-flow respiratory therapy; treats spontaneously breathing patients (infant to adult) in homes and long-term care facilities. Device comprises a motorized blower fan and a heated Passover humidifier; water in a chamber on a heater plate is warmed/humidified to a set dew point; gas is delivered via a heated breathing tube and patient interface. Clinicians or patients operate the device; flow rates (2-60 L/min) and oxygen fraction (21-100%) are controlled via software. New feature includes external pulse oximeter connectivity via USB to display SpO2 and pulse rate on the user interface. Output provides warmed, humidified air/oxygen to support respiratory function; visual/audible alarms alert users to system status. Benefits include improved patient comfort and respiratory support.
Clinical Evidence
Bench testing only. Performance validated against ISO 80601-2-74 (respiratory humidifying equipment) and ISO 80601-2-61 (pulse oximeter equipment). Biocompatibility, electrical safety, electromagnetic compatibility, usability, and software lifecycle processes verified per applicable standards (ISO 10993, IEC 60601 series, IEC 62304).
Technological Characteristics
Heated Passover humidifier with integrated motorized blower. Flow range 2-60 L/min; temperature range 31-37 °C. Connectivity: USB port for external pulse oximeter. Power: 100-115/220-240 VAC, 50-60 Hz. Dimensions: 180x295x170 mm. Reusable with high-level disinfection (disinfection kit or automated washer-disinfector). Software-controlled fan speed and alarm system.
Indications for Use
Indicated for spontaneously breathing patients, infant to adult, requiring high flow warmed and humidified respiratory gases, including those with bypassed upper airways. Flow range 2-60 L/min. For use in homes and long-term care facilities.
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
- myAIRVO 2 Humidifier (K131895)
Reference Devices
- BiPAP Avaps Ventilatory Support System (K102465)
- Nasal Cannula Infant Nasal Cannula Pediatric (K162553)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
May 9, 2024
Fisher & Paykel Healthcare Reena Daken Regulatory Affairs Manager 15 Maurice Paykel Place Auckland, 2013 New Zealand
Re: K222292
Trade/Device Name: F&P myAirvo 3 Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory gas humidifier Regulatory Class: Class II Product Code: BTT Dated: April 17, 2024 Received: April 17, 2024
Dear Reena Daken:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
{1}------------------------------------------------
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
{2}------------------------------------------------
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
# Indications for Use
510(k) Number (if known) K22292
Device Name F&P myAirvo3
Indications for Use (Describe)
The myAirvo 3 is for the treatment of spontaneously breathing patients, infant to adult, 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 myAirvo 3 is for patients in homes and long-term care facilities.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
# CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
## 510(k) Summary 1
As required by 21 CFR 807.92
#### I. SUBMITTER
| Company Name and Address | Fisher & Paykel Healthcare Limited<br>15 Maurice Paykel Place<br>East Tamaki<br>Auckland 2013, New Zealand<br>Telephone: +64 9 574 0100 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Prepared and Submitted by | Hannah Matthews<br>Senior Regulatory Affairs Specialist |
| Contact Person | Reena Daken<br>Regulatory Affairs Manager<br>Telephone: +64 9 574 0100<br>Email: Reena.Daken@fphcare.co.nz |
| Date Prepared | 17 April 2024 |
| II.<br>DEVICE | |
|---------------------|-----------------------------|
| Name of Device | F&P myAirvo 3 |
| Common/Usual Name | Respiratory Humidifier |
| Classification Name | Respiratory Gas Humidifier |
| Regulatory Class | Class II (21 CFR §868.5450) |
| Product Code | BTT |
## PREDICATE DEVICE III.
- . Predicate Device
| FDA Clearance Number | Device Name |
|----------------------|----------------------|
| K131895 | myAIRVO 2 Humidifier |
### REFERENCE DEVICES IV.
- . Reference Devices
{5}------------------------------------------------
| 510(k) Number | Device Name | Reason for Reference |
|---------------|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K102465 | BiPAP Avaps<br>Ventilatory Support<br>System | Used to support claims of substantial equivalence<br>with respect to the following performance:<br>• Use of SpO2 sensing in a medical device. |
| K162553 | Nasal Cannula<br>Infant<br>Nasal Cannula<br>Pediatric | Used to support claims of substantial equivalence<br>with respect to the following performance:<br>• Use of pediatric patient interfaces with the<br>myAirvo 3. |
#### DEVICE DESCRIPTION V.
The F&P myAirvo 3 device is a heated humidifier flow source. The subject device is intended to treat spontaneously breathing patients, pediatrics and adults, who would benefit from receiving high flow, warmed and humidified entrained air and oxygen (if required).
The F&P myAirvo 3 is comprised of two main connected functional units: the blower and the humidifier.
The blower is a motorized fan assembly that provides air flow. The fan speed is directly related to the delivered flow and it is controlled by the software. The blower assembly output connects directly to a humidification chamber at the front of the device.
The second functional unit of the F&P myAirvo 3 device 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 gas is warmed and humidified in the chamber to the dew point set temperature, transported through the heated breathing tube and delivered to the patient through the selected interface.
#### VI. INDICATIONS FOR USE
The myAirvo 3 is for the treatment of spontaneously breathing patients, infant to adult, 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 myAirvo 3 is for patients in homes and long-term care facilities.
{6}------------------------------------------------
## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VII.
Table 1: Subject Device Comparison with Predicate Devices
| Feature/Characteristic<br>for Comparison | Subject Device<br>F&P myAirvo 3 | Predicate Device<br>myAIRVO 2 Humidifier (K131895) | Comment |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Image | | | N/A |
| Classification | | | |
| Legal manufacturer | Fisher & Paykel Healthcare Ltd | Fisher & Paykel Healthcare Ltd | Identical |
| Device Regulation | Class II, Regulation: 21 CFR §868.5450 | Class II, Regulation: 21 CFR §868.5450 | Identical |
| Product code | BTT | BTT | Identical |
| Classification name | Respiratory gas humidifier | Respiratory gas humidifier | Identical |
| Classification Panel | Anesthesiology | Anesthesiology | Identical |
| Intended Use/ Indications for Use | | | |
| Feature/Characteristic<br>for Comparison | Subject Device<br>F&P myAirvo 3 | Predicate Device<br>myAIRVO 2 Humidifier (K131895) | Comment |
| Indications for use | The myAirvo 3 is for the treatment of<br>spontaneously breathing patients, infant<br>to adult, who would benefit from<br>receiving high flow warmed and<br>humidified respiratory gases. This<br>includes patients who have had upper<br>airways bypassed. The flow may be from<br>2 - 60 L/min depending on the patient<br>interface. The myAirvo 3 is for patients in<br>homes and long-term care facilities. | The myAIRVO 2 is for the treatment of<br>spontaneously breathing patients who<br>would benefit from receiving high flow<br>warmed and humidified respiratory gases.<br>This includes patients who have had<br>upper airways bypassed. The flow may be<br>from 2 - 60 L/min depending on the<br>patient interface. The myAIRVO 2 is for<br>patients in homes and long-term care<br>facilities. | Identical |
| Operation and Safety Features | | | |
| Availability | Prescription use only<br>(Part 21 CFR 801 Subpart D) | Prescription use only<br>(Part 21 CFR 801 Subpart D) | Identical |
| Patient Population | Spontaneously breathing patients, infant to<br>adult. | Spontaneously breathing patients | Equivalent<br><br>Despite the difference in<br>terminology, the patient populations<br>covered by the subject device are<br>identical to that of the predicate<br>device.<br><br>This has previously been discussed<br>in Q181564/S003<br><br>This difference does not raise any<br>new questions of safety and<br>effectiveness. |
| Intended User Group | Patients and healthcare professionals | Patients and healthcare professionals | Identical |
| Patient Consciousness | Spontaneously Breathing Patients | Spontaneously Breathing Patients | Identical |
| Feature/Characteristic<br>for Comparison | Subject Device<br>F&P myAirvo 3 | Predicate Device<br>myAIRVO 2 Humidifier (K131895) | Comment |
| Environment of use | Homes and Long-Term Care Facilities | Homes and Long-Term Care Facilities | Identical |
| Reusability | Multi-patient reusable when reprocessed<br>between patients | Multi-patient reusable when reprocessed<br>between patients | Identical |
| High Level Disinfection<br>Methods | High-Level Disinfection using<br>Disinfection Kit<br>Thermal Disinfection (with automated<br>washer-disinfector) | High-Level Disinfection using<br>Disinfection Kit | This difference does not raise new<br>questions of safety and effectiveness.<br>The High-Level Disinfection method<br>using the disinfection kit is identical<br>to the predicate device (myAIRVO 2<br>- K131895) except for addition of a<br>single rinsing step.<br>The High-Level Disinfection using<br>an automated Washer-Disinfector is<br>not available for the predicate<br>device, but testing has<br>been<br>completed to validate the efficacy. |
| Sterility | Device not provided sterile | Device not provided sterile | Identical |
| Life Supporting or Life<br>Sustaining | No | No | Identical |
| Service Life | 5 years | 5 years | Identical |
| Physical Specifications | | | |
| Device Dimensions | 180 mm x 295 mm x 170 mm (7.0" x 11.7"<br>x 6.6") | 175 mm x 295 mm x 170 mm x (6.9" x<br>11.6" x 6.7") | Equivalent<br>The subject device is 5mm wider<br>than the predicate device.<br>This difference does not raise any |
| Feature/Characteristic<br>for Comparison | Subject Device<br>F&P myAirvo 3 | Predicate Device<br>myAIRVO 2 Humidifier (K131895) | Comment |
| | | | new questions of safety or<br>effectiveness |
| Technology | | | |
| Operating principle | Heated humidifier with integrated flow<br>source for delivering constant flow of<br>warmed and humidified respiratory gases<br>when connected to a breathing circuit and<br>patient interface. | Heated humidifier with integrated flow<br>source for delivering constant flow of<br>warmed and humidified respiratory gases<br>when connected to a breathing circuit and<br>patient interface. | Identical |
| Humidity source | Heated humidification chamber. | Heated humidification chamber. | Identical |
| SpO2 Sensing | Ability to connect an external (non F&P)<br>pulse oximeter to USB port, displays<br>sensed SpO2 and pulse rate on user<br>interface | No SpO2 Sensing | New Feature<br>F&P has conducted testing<br>that<br>demonstrates that the SpO2 and pulse<br>rate values calculated by the Nonin<br>pulse oximetry system are not<br>corrupted during communication to the<br>myAirvo 3 and are<br>displayed<br>accurately on the user interface. |
| Performance Specifications | | | |
| Flow range | 2 - 60 L/min delivered | 10 - 60 L/min delivered (Default)<br>2 - 25 L/min delivered (Junior mode) | Equivalent<br>Despite the difference in<br>terminology, the flow ranges<br>covered by the subject device are<br>identical to that of the predicate<br>device.<br>This difference does not raise any<br>new questions of safety and<br>effectiveness. |
| Maximum<br>Oxygen | 15 L/min | 15 L/min | Identical |
| Feature/Characteristic<br>for Comparison | Subject Device<br>F&P myAirvo 3 | Predicate Device<br>myAIRVO 2 Humidifier (K131895) | Comment |
| Flowrate | | | |
| Oxygen Fraction Range | 21-100% | 21-100% | Identical |
| Temperature range | 31 - 37 °C | 31 - 37 °C | Identical |
| Operating Conditions | | | |
| Ambient operating<br>temperature range | 18 – 28 °C | 18 – 28 °C | Identical |
| Alarms | | | |
| Alarm method | Visual and audible alarm system.<br>Mute button. | Visual and audible alarm system.<br>Mute button. | Identical |
| Electrical System Characteristics | | | |
| Supply Frequency | 50-60 Hz | 50-60 Hz | Identical |
| Supply Voltage | 100 - 115 VAC<br>220 – 240 VAC | 100 - 115 VAC<br>220 – 240 VAC | Identical |
| Accessories | | | |
| Patient interfaces | Nasal Interface<br>And<br>Tracheostomy Interface<br>And<br>Vented Mask | Nasal Interface<br>And<br>Tracheostomy Interface<br>And<br>Vented Mask | Identical |
| Heated Breathing Tube | Heated breathing tube: single-lumen,<br>spiral heater wires | Heated breathing tube: single-lumen,<br>spiral heater wires | Identical |
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
### PERFORMANCE DATA VIII.
# Summary of non-clinical tests
The F&P myAirvo 3 has been tested to the applicable requirements of the following standards:
| Standards and Designation<br>Number | Standards Title |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 5367: 2014 | Anaesthetic and respiratory equipment. Breathing sets and connectors |
| ASTM D4169-16 | Standard Practice for Performance Testing of Shipping Containers and<br>Systems |
| IEC 62304:2015 Consolidated<br>Version | Medical device software - software lifecycle processes |
| AIM Standard 7351731 Rev. 2.00<br>2017-02-23 | Medical Electrical Equipment and System Electromagnetic Immunity Test<br>for Exposure to Radio Frequency Identification Readers - An AIM<br>Standard |
| IEC 62366-1:2015 + AMD:2020 | Medical devices - Part 1: Application of usability engineering to medical<br>devices |
| ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluation and testing<br>within a risk management process |
| ISO 10993-3:2014 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity,<br>carcinogenicity, and reproductive toxicity |
| ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in vitro<br>cytotoxicity |
| ISO 10993-10:2010 | Biological evaluation of medical devices - Part 10: Tests for irritation and<br>skin sensitization |
| ISO 10993-11:2017 | Biological evaluation of medical devices - Part 11: Tests for systemic<br>toxicity |
| ISO 10993-18:2020 | Biological evaluation of medical devices - Part 18: Chemical<br>characterization of materials |
| ISO 18562-1:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare<br>applications - Part 1: Evaluation and testing within a risk management<br>process |
| ISO 18562-2: 2017 | Biocompatibility evaluation of breathing gas pathways in healthcare<br>applications - Part 2: Tests for emissions of particulate matter |
| ISO 18562-3: 2017 | Biocompatibility evaluation of breathing gas pathways in healthcare<br>applications -…
