(270 days)
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.
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.
The provided text is a 510(k) Summary for the F&P Airvo 3 NIV device. It focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to this document as it does not describe an AI/ML device or a study of its clinical performance against specific acceptance criteria for such an algorithm.
However, I can extract information related to performance testing from the "PERFORMANCE DATA VII." section, which includes "Bench / Performance Testing."
Here's an attempt to answer your request based on the provided document, noting the limitations due to the nature of the submission:
Acceptance Criteria and Study for F&P Airvo 3 NIV (K233643)
The F&P Airvo 3 NIV is a respiratory support device and not an AI/ML driven diagnostic or therapeutic device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical testing performed to establish substantial equivalence to predicate devices and ensure general safety and effectiveness in line with recognized medical device standards.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance testing conducted but does not explicitly state numerical acceptance criteria or reported device performance values in a table format. Instead, it states that the testing "demonstrated the appropriate electrical safety and electromagnetic compatibility profile for the device" and that "The testing demonstrated the appropriate biocompatibility profile for the device" and "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" as well as "Alarms testing was performed in accordance with ANSI AAMI IEC 60601-1-8:2006 and A1:2012." For reprocessing, "The acceptance criteria and endpoints used are based on the following standard: AAMI TIR30:2011". For comparative performance, it states "Comparative performance testing was performed to demonstrate substantial equivalence."
Given the information, a table with specific numerical acceptance criteria and performance values cannot be fully populated as requested for items like blending accuracy, flow rate accuracy, etc. The document implies compliance with relevant standards as the "acceptance criteria."
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied by standard compliance) | Reported Device Performance (Implied by positive statement) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 and ISO 18562-1 (FDA recognized standards). | "Testing of the Airvo 3 System demonstrates an appropriate biocompatibility profile for the device." |
| Electrical Safety, EMC, Alarms | Compliance with ANSI AAMI ES 60601-1, IEC 60601-1-2, AIM Standard 7351731, and ANSI AAMI IEC 60601-1-8. | "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 V&V | Compliance with FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Device Software Functions." | "Software verification, validation and hazard analysis was conducted, and documentation was provided as recommended by FDA's Guidance..." (implies successful completion). |
| Cleaning/Reprocessing | Compliance with AAMI TIR30:2011 ("A compendium of Processes, Materials, Test Methods, And Acceptance Criteria for Cleaning Reusable Medical Devices"). | "The acceptance criteria and endpoints used are based on the following standard: AAMI TIR30:2011..." (implies successful validation for semi-critical device reprocessing). |
| Bench/Performance Testing | Demonstration of "substantial equivalence" for parameters like blending accuracy, flow rate accuracy, continuous use thermal stability, pressure waveform analysis, humidification output. (Specific numerical criteria not provided). | "Comparative performance testing was performed to demonstrate substantial equivalence" (implies successful demonstration against predicate devices' performance characteristics). |
2. Sample size used for the test set and the data provenance:
- Not applicable for an AI/ML context. This device is hardware with embedded software, thus performance testing involves engineering verification and validation, not a test set of patient data for an algorithm. The testing described focuses on functional aspects of the device, not an algorithm's performance on a dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for an AI/ML context. Ground truth, in the sense of clinical expert assessment of data, is not mentioned in relation to the device's technical performance testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for an AI/ML context. This type of adjudication is relevant for resolving discrepancies in expert interpretations of clinical data, which is not described here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is not an AI-assisted tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not feature a standalone algorithm performing a diagnostic or therapeutic task.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For engineering and performance testing described (electrical safety, EMC, flow rate accuracy, etc.), the "ground truth" would be established physical and engineering principles, international standards, and measurements from calibrated reference instruments. It is not clinical "ground truth" as typically defined for AI/ML performance.
8. The sample size for the training set:
- Not applicable. There is no mention of an AI/ML training set. Software verification and validation refer to standard software engineering practices.
9. How the ground truth for the training set was established:
- Not applicable. There is no mention of an AI/ML training set or its associated ground truth establishment.
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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"
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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 Limited15 Maurice Paykel PlaceEast TamakiAuckland 2013, New ZealandTelephone: +64 9 574 0100 |
|---|---|
| Prepared and Submitted by | Hannah MatthewsSenior Regulatory Affairs Specialist |
| Contact Person | Reena DakenRegulatory Affairs ManagerTelephone: +64 9 574 0100Email:Reena.Daken@fphcare.co.nz |
| Date Prepared | 9 August 2024 |
II. DEVICE
| Name of Device | F&P Airvo 3 NIVAirSpiral 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, MODELV8000 | Used to support claims of substantialequivalence with respect to UserAdjustable Pressure Support Settings |
| K113640 | STELLAR 150 | Used to support claims of substantialequivalence with respect to UserAdjustable Pressure Support Settings |
| K121623 | BIPAP A 40 VENTILATORYSUPPORT SYSTEM | Used to support claims of substantialequivalence with respect to UserAdjustable Pressure Support Settings |
| K103167 | STELLAR 150 | Used to support claims of substantialequivalence with respect to UserAdjustable Pressure Support Settings |
| K162553 | AirSpiral Heated Breathing Tube | Used to support claims of substantialequivalence with respect to the AirSpiralNIV Tube and Chamber Kit |
| K033008 | AIR SAFETY HEPA AND NON-HEPA FILTERS | Used to support claims of substantialequivalence with respect to the patientinspiratory 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,Continuous,MinimalVentilatory Support,Facility Use | Ventilator, Continuous, MinimalVentilatory 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-invasiveventilator support for non-ventilatordependent, spontaneously breathingadult patients (66 lb/30 kg and above)with respiratory insufficiency. It isintended to be used in hospitals. It is notintended for life support.When used in High Flow mode:The Airvo 3 NIV is intended to providehigh flow warmed and humidifiedrespiratory gases for administration tospontaneously breathing infant, child,adolescent and adult patients in hospitals.It adds heat and moisture to the flow ofair, or blended air/medical oxygenmixture, and assures the user of theair/oxygen mixture using an integratedoxygen analyzer and visual display. The | The Vivo 40 is an assist ventilatorintended to augment the breathing ofspontaneously breathing adult patients>66 lbs (>30 kg) suffering fromrespiratory failure, respiratoryinsufficiency, or obstructive sleep apnea.The Vivo 40 is not intended to providethe total ventilatory requirements of thepatient.The Vivo 40 is intended to be used forboth invasive and non-invasiveapplications.The Vivo 40 is intended to be operatedby qualified and trained personnel.The Vivo 40 is intended for use inclinical settings (e.g., hospitals, sleep | EquivalentUse of the subject device in high flowmode is equivalent to the secondarypredicate device, Airvo 3 (K221338).The subject device is not intended to beused 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/mindepending on the patient interface. TheAirvo 3 NIV provides high flow gaseswith simultaneous oxygen delivery tospontaneously breathing patients with orwithout bypassed upper airways inhospitals.The Airvo 3 NIV provides high flowgases with simultaneous oxygen deliverythrough nasal cannula interfaces toaugment the breathing of spontaneouslybreathing patients suffering fromrespiratory distress and/or hypoxemia inthe hospital setting. The Airvo 3 NIV isnot intended to provide total ventilatoryrequirements and is not intended for useduring field transport. | laboratories, sub-acute care institutions)and home environments.The Vivo 40 must always be prescribedby a licensed physician. | |||
| Operation and Safety Features | ||||
| Availability | Prescription Only | Prescription Only | Identical | |
| Patient Population | NIV mode - Adults > 30kgNHF mode - Infant to Adult | NIV Mode - Adults > 30kgNHF Mode - N/A | EquivalentThe patient population of the devicewhen used in NHF mode is Identical tothe secondary predicate device, F&PAirvo 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 | HospitalSleep LaboratoriesSub-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 acentrifugal blower with a low inertiaimpeller to control the pressure based onthe device setting as well as pressure andflow sensor measurements. The Airvo 3NIV has three modes of NIV therapy: Bi-Level S/T, Bi-Level PCV and CPAP. | The Vivo 40 uses a centrifugal blower incombination with an electronicallycontrolled valve to control the pressuredelivered to the patient based on devicesettings and measurements from thepressure and flow sensors.The Breas Vivo 40 has three modes ofoperation: PSV (more commonly knownas Bi-Level S/T), PCV, and CPAP. | EquivalentThe service life of the Airvo 3 NIV isidentical to the secondary predicatedevice, Airvo 3 (K221338) | |
| Oxygen Input Sources | High-Pressure Oxygen (HPO) Inlet Port:Via DISS inlet from wall supply 200-600kPa (41- 87 psi)When oxygen is delivered via the LPOport, the fraction of inspired oxygen ismeasured and displayed on the Airvo 3NIV screen as FiO2 (fraction of inspiredoxygen).And | Low-Pressure Oxygen with a flow thatdoes not exceed 15 l/min | Equivalent | |
| Feature/Characteristic forComparison | Subject DeviceF&P Airvo 3 NIV | Primary Predicate DeviceBreas Vivo 40 System (K090113) | Similarity of Subject Device toPrimary Predicate Device | |
| Low-Pressure Oxygen (LPO) Inlet Port:Via low-pressure connector (fromrotameter)When oxygen is delivered via the HPOport, the device controls the FiO2 to theuser 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, displayssensed SpO2 and pulse rate on userinterface | No SpO2 Sensing | The use of SpO2 Sensing with the subjectdevice is identical to the secondarypredicate 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 isidentical 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 isidentical to the reference device, Airvo 3(K221338) | |
| Electrical System Characteristics | ||||
| Supply Frequency | 50 – 60 Hz | 50 – 60 Hz | Identical | |
| Supply Voltage | 100 – 115 VAC220-240 VAC | 100-240 VAC | Identical | |
| Pressure Support Technological Characteristics | ||||
| Blower for creating pressure andmaintaining pressure | Yes | Yes | Identical | |
| Pressure and flow sensors formeasurement | Yes | Yes | Identical | |
| Feature/Characteristic for Comparison | Subject DeviceF&P Airvo 3 NIV | Primary Predicate DeviceBreas Vivo 40 System (K090113) | Similarity of Subject Device toPrimary 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 | YesAlthough 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 forComparison | Subject DeviceF&P Airvo 3 NIV | Primary Predicate DeviceBreas Vivo 40 System (K090113) | Similarity of Subject Device toPrimary 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 |
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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 forComparison | Subject DeviceAirSpiral NIV Tube and Chamber Kit | Reference DeviceAirSpiral Heated Breathing Tube (K162553) | Similarity of Subject Device toReference Device |
|---|---|---|---|
| Heated Breathing Tube for NIV Therapy | |||
| Indications for Use | For use with noninvasive ventilatorsupport for non-ventilator dependent,spontaneously breathing adult patients(66 lbs./30 kg and above) withrespiratory insufficiency. It is intendedto be used in hospitals. It is not intendedfor life support. | Heated breathing tube for delivery ofhumidified respiratory gases.For use with AIRVO and AIRVO 2Series humidifiers in hospitals and long-term care facilities.For use at flows from 2 to 60 L min-1depending on the patient interface. | Equivalent |
| Principle of Operation | Used as part of the Airvo 3 NIV system,the single limb AirSpiral NIV heatedbreathing tube provides a conduit forhumidified heated respiratory gases thatconnects the humidifier to the patientinterface. | Used as part of the Airvo or Airvo 2Series humidifier system, the single limbAirSpiral heated breathing tube providesa conduit for humidified heatedrespiratory gases that connects thehumidifier to the patient interface. | Identical |
| The heater wires maintain the gastemperature for delivery and arecontrolled by the humidifier.The tubing provides insulation from theambient air. | The heater wires maintain the gastemperature for delivery and arecontrolled by the humidifier.The tubing provides insulation from theambient air. | ||
| Inspiratory Limb | Tubing18.25 mm diameter, 1.8 m heated tube totransport humidified gas between theUnit End and Patient End.Two-spiral wall tubing design: | Tubing13.1 mm diameter, 1.8 m heated tube totransport humidified gas between theUnit End and Patient End.Two-spiral wall tubing design: | Equivalent |
| Feature/Characteristic forComparison | Subject DeviceAirSpiral NIV Tube and ChamberKit | Reference DeviceAirSpiral Heated Breathing Tube(K162553) | Similarity of Subject Device toReference Device |
| Insulating spiral made of Spiral-wound bubble tubing Heated spiral encapsulating heater wire The resistance to flow of the inspiratorylimb is between 2.72 and 4.72 cmH2O at60 l/min. | Insulating spiral made of Spiral-wound bubble tubing Heated spiral encapsulating heater wire The resistance to flow of the inspiratorylimb is < 6 cmH2O at 60 l/min. | ||
| Heater wireConsists of filament conductorPosition in tube: Double helix woundmoulded into bead of tube wall.Filament insulation: Filament is mouldedinto the bead. The bead provides theinsulation. | Heater wireConsists of filament conductorPosition in tube: Double helix woundmoulded into bead of tube wall.Filament insulation: Filament is mouldedinto the bead. The bead provides theinsulation. | ||
| Unit End ConnectorAssembled connector for connectionwith Airvo 3 NIV device; with retentionclips and boot providing a secureconnection. | Unit End ConnectorAssembled connector for connectionwith the Airvo device; with a locking,Sliding Collar providing a secureconnection. | ||
| Patient End ConnectorAssembled connector for connectionwith a Patient Inspiratory Filter designedwith Fisher & Paykel secure connectionfeatures. | Patient End ConnectorAssembled connector for connectionwith a Patient Interface designed withFisher & Paykel secure connectionfeatures. | ||
| Feature/Characteristic forComparison | Subject DeviceAirSpiral NIV Tube and ChamberKit | Reference DeviceAirSpiral Heated Breathing Tube(K162553) | Similarity of Subject Device toReference Device |
| An integrated temperature sensor at thepatient end eliminates the need forexternal probes, cables or adaptors | |||
| Tubing Clip | Yes | Yes | Identical |
| Humidification Chamber | 900PT290ESource of water vapor for humidifyingrespiratory gases | 900PT290ESource of water vapor for humidifyingrespiratory gases | Identical |
| Exhalation Port | Yes | No | Exhalation Port is an optional accessoryfor NIV applications. |
| Patient Inspiratory Filter | Yes | No | Patient Inspiratory Filter is an optionalaccessory for NIV applications. |
| Heater wire Resistance | 33.5 Ω | 22.0 Ω | Equivalent |
| Useful Life | 14 days | 14 days | Identical |
| Shelf Life | 3 Years | 5 Years | Equivalent |
| Therapy Mode Operation | NIV Therapy | High Flow | The reference device, AirSpiral HeatedBreathing Tube, is not cleared for NIVTherapy. The larger diameter tube resultsin a lower resistance to flow for deliveryof NIV therapy. |
| For use with F&P non-vented masks withanti-asphyxiation valve | Nasal Cannulaor | ||
| Intended Patient Interface | orF&P vented masks with anti-asphyxiation valve. | Tracheostomy InterfaceorFace Masks | Equivalent |
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PERFORMANCE DATA VII.
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 ●
VIII. CONCLUSIONS
The F&P Airvo 3 NIV is substantially equivalent to the predicate devices based on patient population, intended uses, comparison of the technological characteristics and performance. In addition, the conclusions drawn from the non-clinical tests demonstrate that the device is substantially equivalent to the legally marketed predicate devices.
§ 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).