(270 days)
No
The document does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies.
Yes
The device provides respiratory support and therapy for patients with respiratory insufficiency, delivering warmed and humidified gases and offering non-invasive ventilation modes like CPAP and Bi-Level S/T.
No
The device is described as a respiratory support device for delivering High Flow and NIV therapy, not for diagnosing conditions. While it has an integrated oxygen analyzer and visual display, this feature is for assuring the user of the air/oxygen mixture, not for diagnosing a patient's condition.
No
The device description clearly states it is a "respiratory support device" and mentions hardware components like a "single limb circuit kit" and testing related to "Electrical Safety, Electromagnetic Compatibility (EMC), and Alarms," indicating it is a physical device with integrated software, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as providing respiratory support (non-invasive ventilation and high flow therapy) to spontaneously breathing patients. It focuses on delivering warmed and humidified gases and providing pressure support. This is a therapeutic function, not a diagnostic one.
- Device Description: The description reinforces that it's a respiratory support device for delivering therapy.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
- Performance Studies: The performance studies focus on aspects like biocompatibility, electrical safety, software validation, cleaning, and bench/performance testing related to gas delivery and pressure, not diagnostic accuracy.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Airvo 3 NIV's function is to support breathing, which is a therapeutic intervention.
N/A
Intended Use / 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 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.
Product codes
MNT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
NIV mode: adult patients (66 lb/30 kg and above)
High Flow mode: infant, child, adolescent and adult patients
Intended User / Care Setting
Intended User: healthcare professionals, namely respiratory therapists, doctors and nurses
Care Setting: hospitals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility Testing
The biocompatibility evaluation for the Airvo 3 device was conducted in accordance with the International Standards ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," and "ISO 18562-1 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. Testing of the Airvo 3 System demonstrates an appropriate biocompatibility profile for the device.
Electrical Safety, Electromagnetic Compatibility (EMC), and Alarms
Electrical safety, thermal safety, mechanical safety, EMC and radiofrequency identification testing were conducted on the Airvo 3 system. The system complies with ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2:2014 and AIM Standard 7351731 Rev. 3.00 2017-02-23. The testing demonstrated the appropriate electrical safety and electromagnetic compatibility profile for the device. Alarms testing was performed in accordance with ANSI AAMI IEC 60601-1-8:2006 and A1:2012.
Software Verification and Validation Testing
Software verification, validation and hazard analysis was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Device Software Functions."
Cleaning/Reprocessing
As per the FDA Guidance: "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", the Outlet Elbow is classified as a semi-critical device and was therefore subject to cleaning followed by high-level disinfection. The acceptance criteria and endpoints used are based on the following standard:
- AAMI TIR30:2011 A compendium of Processes, Materials, Test Methods, And Acceptance Criteria for Cleaning Reusable Medical Devices
Bench / Performance Testing
Comparative performance testing was performed to demonstrate substantial equivalence, and included:
- Blending accuracy
- Flow rate accuracy
- Continuous use thermal stability
- Pressure waveform analysis
- Humidification output
Key Results: The conclusions drawn from the non-clinical tests demonstrate that the device is substantially equivalent to the legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K082660, K113640, K121623, K103167, K162553, K033008
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5895 Continuous ventilator.
(a)
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.(b)
Classification. Class II (performance standards).
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" stacked on top of each other.
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"
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.
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,
2
Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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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4
510(k) Summary
As required by 21 CFR 807.92
I. SUBMITTER
| Company Name and Address | Fisher & Paykel Healthcare Limited
15 Maurice Paykel Place
East Tamaki
Auckland 2013, New Zealand
Telephone: +64 9 574 0100 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Prepared and Submitted by | Hannah Matthews
Senior Regulatory Affairs Specialist |
| Contact Person | Reena Daken
Regulatory Affairs Manager
Telephone: +64 9 574 0100
Email:Reena.Daken@fphcare.co.nz |
| Date Prepared | 9 August 2024 |
II. DEVICE
| Name of Device | F&P Airvo 3 NIV
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 | |
| V8000 | Used to support claims of substantial | |
| equivalence with respect to User | ||
| Adjustable Pressure Support Settings | ||
| K113640 | STELLAR 150 | Used to support claims of substantial |
| equivalence with respect to User | ||
| Adjustable Pressure Support Settings | ||
| K121623 | BIPAP A 40 VENTILATORY | |
| SUPPORT SYSTEM | Used to support claims of substantial | |
| equivalence with respect to User | ||
| Adjustable Pressure Support Settings | ||
| K103167 | STELLAR 150 | Used to support claims of substantial |
| equivalence with respect to User | ||
| Adjustable Pressure Support Settings | ||
| K162553 | AirSpiral Heated Breathing Tube | Used to support claims of substantial |
| equivalence with respect to the AirSpiral | ||
| NIV Tube and Chamber Kit | ||
| K033008 | AIR SAFETY HEPA AND NON- | |
| HEPA FILTERS | Used to support claims of substantial | |
| equivalence with respect to the patient | ||
| 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
6
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.
7
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, | |||
| Continuous, | ||||
| Minimal | ||||
| Ventilatory Support, | ||||
| Facility Use | Ventilator, Continuous, Minimal | |||
| Ventilatory Support, Facility Use | Identical | |||
| Classification Panel | Anesthesiology | Anesthesiology | Identical | |
| Intended Use / Indications for Use | ||||
| 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 | The Vivo 40 is an assist ventilator
intended to augment the breathing of
spontaneously breathing adult patients
66 lbs (>30 kg) suffering from
respiratory failure, respiratory
insufficiency, or obstructive sleep apnea.
The Vivo 40 is not intended to provide
the total ventilatory requirements of the
patient.
The Vivo 40 is intended to be used for
both invasive and non-invasive
applications.
The Vivo 40 is intended to be operated
by qualified and trained personnel.
The Vivo 40 is intended for use in
clinical settings (e.g., hospitals, sleep | Equivalent
Use of the subject device in high flow
mode is equivalent to the secondary
predicate device, Airvo 3 (K221338).
The subject device is not intended to be
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
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. | laboratories, sub-acute care institutions)
and home environments.
The Vivo 40 must always be prescribed
by a licensed physician. | | |
| Operation and Safety Features | | | | |
| Availability | Prescription Only | Prescription Only | Identical | |
| Patient Population | NIV mode - Adults > 30kg
NHF mode - Infant to Adult | NIV Mode - Adults > 30kg
NHF Mode - N/A | Equivalent
The patient population of the device
when used in NHF mode is Identical to
the secondary predicate device, F&P
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
Sleep Laboratories
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
centrifugal blower with a low inertia
impeller to control the pressure based on
the device setting as well as pressure and
flow sensor measurements. The Airvo 3
NIV has three modes of NIV therapy: Bi-
Level S/T, Bi-Level PCV and CPAP. | The Vivo 40 uses a centrifugal blower in
combination with an electronically
controlled valve to control the pressure
delivered to the patient based on device
settings and measurements from the
pressure and flow sensors.
The Breas Vivo 40 has three modes of
operation: PSV (more commonly known
as Bi-Level S/T), PCV, and CPAP. | Equivalent
The service life of the Airvo 3 NIV is
identical to the secondary predicate
device, Airvo 3 (K221338) | |
| Oxygen Input Sources | High-Pressure Oxygen (HPO) Inlet Port:
Via DISS inlet from wall supply 200-600
kPa (41- 87 psi)
When oxygen is delivered via the LPO
port, the fraction of inspired oxygen is
measured and displayed on the Airvo 3
NIV screen as FiO2 (fraction of inspired
oxygen).
And | Low-Pressure Oxygen with a flow that
does not exceed 15 l/min | Equivalent | |
| Feature/Characteristic for
Comparison | Subject Device
F&P Airvo 3 NIV | Primary Predicate Device
Breas Vivo 40 System (K090113) | Similarity of Subject Device to
Primary Predicate Device | |
| | Low-Pressure Oxygen (LPO) Inlet Port:
Via low-pressure connector (from
rotameter)
When oxygen is delivered via the HPO
port, the device controls the FiO2 to the
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)
pulse oximeter to USB port, displays
sensed SpO2 and pulse rate on user
interface | No SpO2 Sensing | The use of SpO2 Sensing with the subject
device is identical to the secondary
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
identical to the reference device, Airvo 3
(K221338) | |
| Temperature Range (High Flow) | 31 – 37 °C | No High Flow Mode | The high flow operation of the device is
identical to the reference device, Airvo 3
(K221338) | |
| Electrical System Characteristics | | | | |
| Supply Frequency | 50 – 60 Hz | 50 – 60 Hz | Identical | |
| Supply Voltage | 100 – 115 VAC
220-240 VAC | 100-240 VAC | Identical | |
| Pressure Support Technological Characteristics | | | | |
| Blower for creating pressure and
maintaining pressure | Yes | Yes | Identical | |
| Pressure and flow sensors for
measurement | Yes | Yes | Identical | |
| Feature/Characteristic for Comparison | Subject Device
F&P Airvo 3 NIV | Primary Predicate Device
Breas Vivo 40 System (K090113) | Similarity of Subject Device to
Primary Predicate Device | |
| Microprocessors for control of pressure, user interface and other tasks. | Yes | Yes | Identical | |
| Powered via mains power (100 to 240V). | Yes | Yes | Identical | |
| Breathing tube to connect NIV interface to device. | Yes | Yes | Identical | |
| Pressure Regulating Valve | The Airvo 3 NIV blower is designed such that a pressure regulating valve is not required. | The Breas device uses a blower in combination with a pressure regulating valve to control pressure | Equivalent | |
| Non-Invasive Therapy Modes | | | | |
| PCV (Pressure Control Ventilation) | Yes | Yes | Identical | |
| CPAP | Yes | Yes | Identical | |
| Bi-Level S/T | Yes | Yes
Although Bi-Level S/T therapy is well understood there is no consistent naming convention for Bi-Level S/T therapy. As a result, Breas has labelled their implementation of Bi-Level S/T therapy as PSV (Pressure Support Ventilation) | Identical | |
| High Flow Therapy | Yes | No | The high flow operation of the device is identical to the secondary predicate device, Airvo 3 (K221338) | |
| User Adjustable Pressure Support Settings | | | | |
| IPAP Range | 4 – 30 cmH2O | 4 – 40 cmH2O | Equivalent | |
| Feature/Characteristic for
Comparison | Subject Device
F&P Airvo 3 NIV | Primary Predicate Device
Breas Vivo 40 System (K090113) | Similarity of Subject Device to
Primary Predicate Device | |
| EPAP Range | 4-25 cmH2O | 2 - 20 cmH2O | Equivalent | |
| CPAP Range | 4-25 cmH2O | 4 - 20 cmH2O | Equivalent | |
| Alarms | | | | |
| Alarm Method | Visual and audible alarm | Visual and audible alarm | Identical | |
8
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10
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1.1 900PT573 – AirSpiral NIV Tube and Chamber Kit
The table below provides a side-by-side comparison of the subject and reference device, AirSpiral Heated Breathing Tube.
Table 2: Subject Device Comparison with Reference Device, AirSpiral Heated Breathing Tube
| Feature/Characteristic for
Comparison | Subject Device
AirSpiral NIV Tube and Chamber Kit | Reference Device
AirSpiral Heated Breathing Tube (K162553) | Similarity of Subject Device to
Reference Device |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Heated Breathing Tube for NIV Therapy | | | |
| Indications for Use | 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. | Heated breathing tube for delivery of
humidified respiratory gases.
For use with AIRVO and AIRVO 2
Series humidifiers in hospitals and long-
term care facilities.
For use at flows from 2 to 60 L min-1
depending on the patient interface. | Equivalent |
| Principle of Operation | Used as part of the Airvo 3 NIV system,
the single limb AirSpiral NIV heated
breathing tube provides a conduit for
humidified heated respiratory gases that
connects the humidifier to the patient
interface. | Used as part of the Airvo or Airvo 2
Series humidifier system, the single limb
AirSpiral heated breathing tube provides
a conduit for humidified heated
respiratory gases that connects the
humidifier to the patient interface. | Identical |
| | The heater wires maintain the gas
temperature for delivery and are
controlled by the humidifier.
The tubing provides insulation from the
ambient air. | The heater wires maintain the gas
temperature for delivery and are
controlled by the humidifier.
The tubing provides insulation from the
ambient air. | |
| Inspiratory Limb | Tubing
18.25 mm diameter, 1.8 m heated tube to
transport humidified gas between the
Unit End and Patient End.
Two-spiral wall tubing design: | Tubing
13.1 mm diameter, 1.8 m heated tube to
transport humidified gas between the
Unit End and Patient End.
Two-spiral wall tubing design: | Equivalent |
| Feature/Characteristic for
Comparison | Subject Device
AirSpiral NIV Tube and Chamber
Kit | Reference Device
AirSpiral Heated Breathing Tube
(K162553) | Similarity of Subject Device to
Reference Device |
| | Insulating spiral made of Spiral-wound bubble tubing Heated spiral encapsulating heater wire The resistance to flow of the inspiratory
limb is between 2.72 and 4.72 cmH2O at
60 l/min. | Insulating spiral made of Spiral-wound bubble tubing Heated spiral encapsulating heater wire The resistance to flow of the inspiratory
limb is