F&P Airvo 3 NIV (PT311US)
Device Facts
| Record ID | K233643 |
|---|---|
| Device Name | F&P Airvo 3 NIV (PT311US) |
| Applicant | Fisher & Paykel Healthcare, Ltd. |
| Product Code | MNT · Anesthesiology |
| Decision Date | Aug 9, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5895 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
When used in NIV mode: The Airvo 3 NIV provides non-invasive ventilator support for non-ventilator dependent, spontaneously breathing adult patients (66 lb/30 kg and above) with respiratory insufficiency. It is intended to be used in hospitals. It is not intended for life support. When used in High Flow mode: The Airvo 3 NIV is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals. It adds heat and moisture to the flow of air, or blended air/medical oxygen mixture, and assures the user of the air/oxygen mixture using an integrated oxygen analyzer and visual display. The flow may be from 2 to 70 L/min depending on the patient interface. The Airvo 3 NIV provides high flow gases with simultaneous oxygen delivery to spontaneously breathing patients with or without bypassed upper airways in hospitals. The Airvo 3 NIV provides high flow gases with simultaneous oxygen delivery through nasal cannula interfaces to augment the breathing of spontaneously breathing patients suffering from respiratory distress and/or hypoxemia in the hospital setting. The Airvo 3 NIV is not intended to provide total ventilatory requirements and is not intended for use during field transport. AirSpiral NIV tube and chamber kit (900PT573): For use with noninvasive ventilator support for non-ventilator dependent, spontaneously breathing adult patients (66 lbs./30 kg and above) with respiratory insufficiency. It is intended to be used in hospitals. It is not intended for life support.
Device Story
The F&P Airvo 3 NIV is a non-implantable, hospital-use respiratory support device operated by healthcare professionals (respiratory therapists, doctors, nurses). It functions as a continuous ventilator (NIV mode) or high-flow humidifier (High Flow mode). Inputs include wall-supplied oxygen (HPO) or low-pressure oxygen (LPO) and ambient air. A centrifugal blower with a low-inertia impeller, controlled by microprocessors using pressure and flow sensor feedback, delivers gas. In NIV mode, it provides CPAP, Bi-Level S/T, and Bi-Level PCV therapies. In High Flow mode, it delivers 2-70 L/min of warmed, humidified gas. The device features an integrated oxygen analyzer and visual display for FiO2 monitoring. It supports external pulse oximeter connectivity via USB. The output (pressurized or high-flow gas) is delivered via a single-limb AirSpiral NIV tube and chamber kit. Clinicians use the device to augment breathing in patients with respiratory insufficiency or distress. By providing non-invasive pressure support or high-flow oxygenation, the device aims to improve patient respiratory status without the need for invasive ventilation.
Clinical Evidence
No clinical data. Substantial equivalence is supported by bench testing, including blending accuracy, flow rate accuracy, continuous use thermal stability, pressure waveform analysis, and humidification output. Biocompatibility, electrical safety (ANSI AAMI ES 60601-1), EMC (IEC 60601-1-2), and alarm testing (ANSI AAMI IEC 60601-1-8) were performed.
Technological Characteristics
Centrifugal blower with low-inertia impeller; pressure and flow sensors; microprocessor-controlled. Modes: CPAP, Bi-Level S/T, Bi-Level PCV. High Flow: 2-70 L/min, 31-37 °C. Connectivity: USB for external SpO2. Power: 100-240 VAC, 50-60 Hz. Materials: AirSpiral tube (two-spiral wall, heated wire). Sterilization: Not provided sterile; semi-critical components (outlet elbow) validated for high-level disinfection per AAMI TIR30.
Indications for Use
Indicated for non-ventilator dependent, spontaneously breathing adult patients (≥30 kg) with respiratory insufficiency (NIV mode) and spontaneously breathing infant, child, adolescent, and adult patients requiring high flow warmed/humidified respiratory gases (High Flow mode) in hospital settings. Not for life support or field transport.
Regulatory Classification
Identification
A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
Predicate Devices
Reference Devices
- V60 VENTILATOR, MODEL V8000 (K082660)
- STELLAR 150 (K113640)
- BIPAP A 40 VENTILATORY SUPPORT SYSTEM (K121623)
- STELLAR 150 (K103167)
- AirSpiral Heated Breathing Tube (K162553)
- AIR SAFETY HEPA AND NON-HEPA FILTERS (K033008)
Submission Summary (Full Text)
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August 9, 2024
Fisher & Paykel Healthcare Ltd Reena Daken Regulatory Affairs Manager 15 Maurice Paykel Place, East Tamaki Auckland, 2013 New Zealand
Re: K233643
Trade/Device Name: F&P Airvo 3 NIV (PT311US) Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous ventilator Regulatory Class: Class II Product Code: MNT Dated: July 15, 2024 Received: July 15, 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"
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(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.
Digitally signed by John S. John S. Bender -S Bender -S 15:10:16-04'00'
for Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia,
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Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K233643
Device Name F&P Airvo 3 NIV (PT311US)
Indications for Use (Describe) F&P Airvo 3 NIV (PT311US)
When used in NIV mode:
The Airvo 3 NV provides non-invasive ventilator support for non-ventilator dependent, spontaneously breathing adult patients (66 lb/30 kg and above) with respiratory insufficiency. It is intended to be used in hospitals. It is not intended for life support.
### When used in High Flow mode:
The Airvo 3 NIV is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals. It adds heat and moisture to the flow of air, or blended air/medical oxygen mixture, and assures the user of the air/oxygen mixture using an integrated oxygen analyzer and visual display. The flow may be from 2 to 70 L/min depending on the patient interface. The Airvo 3 NVV provides high flow gases with simultaneous oxygen delivery to spontaneously breathing patients with or without bypassed upper airways in hospitals.
The Airvo 3 NIV provides high flow gases with simultaneous oxygen delivery through nasal cannula interfaces to augment the breathing of spontaneously breathing patients suffering from respiratory distress and/or hypoxemia in the hospital setting. The Airvo 3 NIV is not intended to provide total ventilatory requirements and is not intended for use during field transport.
AirSpiral NIV tube and chamber kit (900PT573):
For use with noninvasive ventilator support for non-ventilator dependent, spontaneously breathing adult patients (66 lbs./30 kg and above) with respiratory insufficiency. It is intended to be used in hospitals. It is not intended for life support.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary
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 | 9 August 2024 |
II. DEVICE
| Name of Device | F&P Airvo 3 NIV<br>AirSpiral NIV tube and chamber kit | |
|---------------------|-------------------------------------------------------------------|--|
| Common/Usual Name | ventilator, continuous, minimal ventilatory support, facility use | |
| Classification Name | Continuous Ventilator | |
| Regulatory Class | Class II (21 CFR §868.5895) | |
| Product Code | MNT | |
### PREDICATE DEVICES III.
- Primary Predicate Device
| FDA Clearance Number | Device Name |
|----------------------|----------------------|
| K090113 | Breas Vivo 40 System |
- Secondary Predicate Device .
| FDA Clearance Number | Device Name |
|----------------------|-------------|
| K221338 | F&P Airvo 3 |
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| FDA Clearance Number | Device Name | Reason for Reference |
|----------------------|------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| K082660 | V60 VENTILATOR, MODEL<br>V8000 | Used to support claims of substantial<br>equivalence with respect to User<br>Adjustable Pressure Support Settings |
| K113640 | STELLAR 150 | Used to support claims of substantial<br>equivalence with respect to User<br>Adjustable Pressure Support Settings |
| K121623 | BIPAP A 40 VENTILATORY<br>SUPPORT SYSTEM | Used to support claims of substantial<br>equivalence with respect to User<br>Adjustable Pressure Support Settings |
| K103167 | STELLAR 150 | Used to support claims of substantial<br>equivalence with respect to User<br>Adjustable Pressure Support Settings |
| K162553 | AirSpiral Heated Breathing Tube | Used to support claims of substantial<br>equivalence with respect to the AirSpiral<br>NIV Tube and Chamber Kit |
| K033008 | AIR SAFETY HEPA AND NON-<br>HEPA FILTERS | Used to support claims of substantial<br>equivalence with respect to the patient<br>inspiratory filter |
- Reference Devices
### DEVICE DESCRIPTION IV.
The subject device, F&P Airvo 3 NIV is a respiratory support device for the delivery of High Flow and NIV (Non-Invasive Ventilation) therapy intended to treat spontaneously breathing patients who would benefit from receiving High Flow or respiratory pressure support. The Airvo 3 NIV is NOT to be used for life-supporting or life-sustaining purposes.
The Airvo 3 NIV is a non-implantable, prescription-only device, provided in a non-sterile state, and intended to be used by healthcare professionals, namely respiratory therapists, doctors and nurses in hospitals. When used in High Flow mode, the Airvo 3 NIV delivers gas at flow rates of between 2-70 L/min. The Airvo 3 NIV also has three non-invasive ventilation therapy modes: CPAP, Bi-Level S/T and Bi-Level PCV.
The AirSpiral NIV Tube and Chamber Kit is a single limb circuit kit designed for use with the Airvo 3 NIV device, for non- ventilator dependent, spontaneously breathing adult patients with respiratory insufficiency.
#### V. INDICATIONS FOR USE
F&P Airvo 3 NIV (PT311US)
# When used in NIV mode:
The Airvo 3 NIV provides non-invasive ventilator support for non-ventilator dependent, spontaneously breathing adult patients (66 lb/30 kg and above) with respiratory insufficiency. It is intended to be used in hospitals. It is not intended for life support.
# When used in High Flow mode:
The Airvo 3 NIV is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals. It adds heat and moisture to the flow of air, or blended air/medical oxygen mixture, and assures the user
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of the air/oxygen mixture using an integrated oxygen analyzer and visual display. The flow may be from 2 to 70 L/min depending on the patient interface. The Airvo 3 NIV provides high flow gases with simultaneous oxygen delivery to spontaneously breathing patients with or without bypassed upper airways in hospitals.
The Airvo 3 NIV provides high flow gases with simultaneous oxygen delivery through nasal cannula interfaces to augment the breathing of spontaneously breathing patients suffering from respiratory distress and/or hypoxemia in the hospital setting. The Airvo 3 NIV is not intended to provide total ventilatory requirements and is not intended for use during field transport.
# AirSpiral NIV tube and chamber kit (900PT573)
For use with noninvasive ventilator support for non-ventilator dependent, spontaneously breathing adult patients (66 lbs./30 kg and above) with respiratory insufficiency. It is intended to be used in hospitals. It is not intended for life support.
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### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES VI.
Table 1: Subject Device Comparison with Primary Predicate Device
| Feature/Characteristic for | Subject Device | Primary Predicate Device | Similarity of Subject Device to | |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Comparison | F&P Airvo 3 NIV | Breas Vivo 40 System (K090113) | Primary Predicate Device | |
| Classification | | | | |
| Legal Manufacturer | Fisher & Paykel Healthcare Ltd. | Breas Medical AB | N/A | |
| Device Regulation | Class II, Regulation: 21 CFR §868.5895 | Class II, Regulation: 21 CFR §868.5895 | Identical | |
| Product Code | MNT | MNT | Identical | |
| Classification Name | Ventilator,<br>Continuous,<br>Minimal<br>Ventilatory Support,<br>Facility Use | Ventilator, Continuous, Minimal<br>Ventilatory Support, Facility Use | Identical | |
| Classification Panel | Anesthesiology | Anesthesiology | Identical | |
| Intended Use / Indications for Use | | | | |
| Indications for Use | When used in NIV mode:<br>The Airvo 3 NIV provides non-invasive<br>ventilator support for non-ventilator<br>dependent, spontaneously breathing<br>adult patients (66 lb/30 kg and above)<br>with respiratory insufficiency. It is<br>intended to be used in hospitals. It is not<br>intended for life support.<br><br>When used in High Flow mode:<br>The Airvo 3 NIV is intended to provide<br>high flow warmed and humidified<br>respiratory gases for administration to<br>spontaneously breathing infant, child,<br>adolescent and adult patients in hospitals.<br>It adds heat and moisture to the flow of<br>air, or blended air/medical oxygen<br>mixture, and assures the user of the<br>air/oxygen mixture using an integrated<br>oxygen analyzer and visual display. The | The Vivo 40 is an assist ventilator<br>intended to augment the breathing of<br>spontaneously breathing adult patients<br>>66 lbs (>30 kg) suffering from<br>respiratory failure, respiratory<br>insufficiency, or obstructive sleep apnea.<br><br>The Vivo 40 is not intended to provide<br>the total ventilatory requirements of the<br>patient.<br><br>The Vivo 40 is intended to be used for<br>both invasive and non-invasive<br>applications.<br><br>The Vivo 40 is intended to be operated<br>by qualified and trained personnel.<br><br>The Vivo 40 is intended for use in<br>clinical settings (e.g., hospitals, sleep | Equivalent<br><br>Use of the subject device in high flow<br>mode is equivalent to the secondary<br>predicate device, Airvo 3 (K221338).<br>The subject device is not intended to be<br>used in Sub-Acute Care facilities. | |
| Feature/Characteristic for | Subject Device | Primary Predicate Device | Similarity of Subject Device to | |
| Comparison | F&P Airvo 3 NIV | Breas Vivo 40 System (K090113) | Primary Predicate Device | |
| | flow may be from 2 to 70 L/min<br>depending on the patient interface. The<br>Airvo 3 NIV provides high flow gases<br>with simultaneous oxygen delivery to<br>spontaneously breathing patients with or<br>without bypassed upper airways in<br>hospitals.<br><br>The Airvo 3 NIV provides high flow<br>gases with simultaneous oxygen delivery<br>through nasal cannula interfaces to<br>augment the breathing of spontaneously<br>breathing patients suffering from<br>respiratory distress and/or hypoxemia in<br>the hospital setting. The Airvo 3 NIV is<br>not intended to provide total ventilatory<br>requirements and is not intended for use<br>during field transport. | laboratories, sub-acute care institutions)<br>and home environments.<br>The Vivo 40 must always be prescribed<br>by a licensed physician. | | |
| Operation and Safety Features | | | | |
| Availability | Prescription Only | Prescription Only | Identical | |
| Patient Population | NIV mode - Adults > 30kg<br>NHF mode - Infant to Adult | NIV Mode - Adults > 30kg<br>NHF Mode - N/A | Equivalent<br>The patient population of the device<br>when used in NHF mode is Identical to<br>the secondary predicate device, F&P<br>Airvo 3 (K221338). | |
| Intended User Group | Healthcare Professionals | Qualified and trained personnel | Equivalent | |
| Patient Consciousness | Spontaneously Breathing Patients | Spontaneously Breathing Patients | Identical | |
| Environment of Use | Hospital | Hospital<br>Sleep Laboratories<br>Sub-acute Care Settings | Equivalent | |
| Feature/Characteristic for | Comparison | Subject Device | Primary Predicate Device | Similarity of Subject Device to |
| | F&P Airvo 3 NIV | Breas Vivo 40 System (K090113) | Home | Primary Predicate Device |
| Sterility | Not provided sterile | Not provided sterile | Identical | |
| Life Supporting or Life Sustaining | No | No | Identical | |
| Service Life | 5 years | Not Specified | Equivalent | |
| Technology | | | | |
| Operating Principle | The Airvo 3 NIV design makes uses a<br>centrifugal blower with a low inertia<br>impeller to control the pressure based on<br>the device setting as well as pressure and<br>flow sensor measurements. The Airvo 3<br>NIV has three modes of NIV therapy: Bi-<br>Level S/T, Bi-Level PCV and CPAP. | The Vivo 40 uses a centrifugal blower in<br>combination with an electronically<br>controlled valve to control the pressure<br>delivered to the patient based on device<br>settings and measurements from the<br>pressure and flow sensors.<br>The Breas Vivo 40 has three modes of<br>operation: PSV (more commonly known<br>as Bi-Level S/T), PCV, and CPAP. | Equivalent<br>The service life of the Airvo 3 NIV is<br>identical to the secondary predicate<br>device, Airvo 3 (K221338) | |
| Oxygen Input Sources | High-Pressure Oxygen (HPO) Inlet Port:<br>Via DISS inlet from wall supply 200-600<br>kPa (41- 87 psi)<br>When oxygen is delivered via the LPO<br>port, the fraction of inspired oxygen is<br>measured and displayed on the Airvo 3<br>NIV screen as FiO2 (fraction of inspired<br>oxygen).<br>And | Low-Pressure Oxygen with a flow that<br>does not exceed 15 l/min | Equivalent | |
| Feature/Characteristic for<br>Comparison | Subject Device<br>F&P Airvo 3 NIV | Primary Predicate Device<br>Breas Vivo 40 System (K090113) | Similarity of Subject Device to<br>Primary Predicate Device | |
| | Low-Pressure Oxygen (LPO) Inlet Port:<br>Via low-pressure connector (from<br>rotameter)<br><br>When oxygen is delivered via the HPO<br>port, the device controls the FiO2 to the<br>user set value. | | | |
| Humidity Source | Heated Humidification Chamber | Optional use of an external humidifier | Equivalent | |
| 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 | The use of SpO2 Sensing with the subject<br>device is identical to the secondary<br>predicate device, Airvo 3 (K221338). | |
| Performance Specifications | | | | |
| Flow Range (High Flow) | 2 – 70 L/min | No High Flow Mode | The high flow operation of the device is<br>identical to the reference device, Airvo 3<br>(K221338) | |
| Temperature Range (High Flow) | 31 – 37 °C | No High Flow Mode | The high flow operation of the device is<br>identical to the reference device, Airvo 3<br>(K221338) | |
| Electrical System Characteristics | | | | |
| Supply Frequency | 50 – 60 Hz | 50 – 60 Hz | Identical | |
| Supply Voltage | 100 – 115 VAC<br>220-240 VAC | 100-240 VAC | Identical | |
| Pressure Support Technological Characteristics |…
