(263 days)
The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities. 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 provides high flow gases with simultaneous oxygen delivery to spontaneously breathing patients with or without bypassed upper airways in hospitals and sub-acute facilities.
The Airvo 3 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 is not intended to provide total ventilatory requirements and is not for use during field transport.
The F&P Airvo 3 is a high-flow device comprised of heated humidifier with integrated flow source, intended to treat spontaneously breathing patients, pediatrics and adults, who would benefit from receiving high flow, warmed and humidified entrained air and oxygen (if required).
The F&P Airvo 3 can be reprocessed for use on multiple patient interfaces, heated breathing tube, and water chambers are disposable and are for single patient use only, however, the internal outlet elbow is high-level-disinfected for multi-patient use.
The F&P Airvo 3 is comprised of two main connected functional units: the blower and the humidifier.
The blower is a motorized fan assembly that provides air flow. The flow is adjustable, where a separate source of oxygen independently controlled can be input and mixed with the entrained air. The blower assembly output connects directly to a humidification chamber at the front of the device.
The second functional unit of the F&P Airvo 3 is a heated passover humidifier. The water is contained in a humidification chamber positioned on a heater plate at the front of the unit. The gas is warmed and humidified in the chamber to the dew point set temperature, transported through the heated breathing tube and delivered to the patient through the selected interface.
The provided text pertains to the FDA 510(k) clearance of the F&P Airvo 3 device, a high flow humidified oxygen delivery device. It outlines the regulatory process and demonstrates substantial equivalence to predicate devices, focusing on non-clinical performance data and adherence to recognized standards.
However, the document does not contain information regarding:
- Specific acceptance criteria values and reported device performance in a table for each performance test.
- Sample sizes used for test sets, their data provenance (country, retrospective/prospective).
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- The specific type of ground truth used (e.g., pathology, outcomes data), if applicable to this type of device.
- Sample size for training sets.
- How ground truth for the training set was established.
The document primarily focuses on non-clinical (bench) testing and adherence to recognized standards to demonstrate substantial equivalence, rather than clinical study results with human participants or AI performance metrics.
Therefore, I can provide the available information from the document, but many of your requested points cannot be answered based on the input.
Available Information from the Document:
1. A table of acceptance criteria and the reported device performance
The document states that comparative performance testing was performed to demonstrate substantial equivalence and to meet the Special Controls requirements of 21 CFR 868.5454. It lists the categories of performance testing but does not provide a table with specific quantitative acceptance criteria or detailed reported device performance values for each.
| Test Category | Basis for Evaluation | Specific Acceptance Criteria & Reported Performance |
|---|---|---|
| Blending accuracy | Demonstrates substantial equivalence and meets 21 CFR 868.5454 Special Controls requirements. | Not specified in the document. |
| Flow rate accuracy | Demonstrates substantial equivalence and meets 21 CFR 868.5454 Special Controls requirements. | Not specified in the document. |
| Continuous use thermal stability | Demonstrates substantial equivalence and meets 21 CFR 868.5454 Special Controls requirements. | Not specified in the document. |
| Humidification output | Demonstrates substantial equivalence and meets 21 CFR 868.5454 Special Controls requirements. | Not specified in the document. |
| Biocompatibility | ISO 10993-1, ISO 18562-1 (recognized by FDA). | "demonstrates an appropriate biocompatibility profile for the device." (No specific criteria/values provided.) |
| Electrical Safety | ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012 | "The system complies with... demonstrated the appropriate electrical safety profile for the device." (No specific criteria/values provided.) |
| EMC | IEC 60601-1-2:2014, AIM Standard 7351731 Rev. 2.00 2017-02-23 | "The system complies with... demonstrated the appropriate electromagnetic compatibility profile for the device." (No specific criteria/values provided.) |
| Alarms | ANSI AAMI IEC 60601-1-8:2006 and A1:2012 | Testing performed, implies compliance. (No specific criteria/values provided.) |
| Software | FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." | "Software verification, validation and hazard analysis was conducted, and documentation was provided as recommended." (No specific criteria/values provided.) |
| Cleaning/Reprocessing | AAMI TIR30:2011 | Outlet Elbow classified as semi-critical, subject to cleaning and high-level disinfection. (No specific criteria/values for cleaning effectiveness provided.) |
| SpO2 Sensing (New Feature) | Internal testing by F&P | "F&P has conducted testing that demonstrates that the SpO2 and pulse rate values calculated by the pulse oximetry system are not corrupted during communication to the Airvo 3 and are displayed accurately on the user interface." (No specific criteria/values provided.) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The performance data summarized relates to non-clinical (bench) tests rather than human clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document. The device is a medical equipment (high flow humidified oxygen delivery device), not an imaging or diagnostic AI device that typically relies on expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. The F&P Airvo 3 is a medical device, not an AI-assisted diagnostic or interpretation tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. This is not an AI algorithm but a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly stated in detail. For physical performance tests (like blending accuracy, flow rate accuracy, thermal stability, humidification output), the "ground truth" would implicitly be defined by the measurement standards and calibrated reference equipment used during bench testing. For biocompatibility, it's adherence to ISO standards; for electrical safety, adherence to IEC/ANSI AAMI standards.
8. The sample size for the training set
This information is not provided in the document. This device does not appear to involve machine learning or AI models with "training sets" in the conventional sense.
9. How the ground truth for the training set was established
This information is not provided in the document. As noted above, this type of device does not typically have "training sets" or "ground truth" established in this manner.
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Image /page/0/Picture/0 description: The image shows 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" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
January 27, 2023
Fisher & Paykel Healthcare Reena Daken Regulatory Affairs Manager 15 Maurice Paykel Place Auckland, 2013 New Zealand
Re: K221338
Trade/Device Name: F&P Airvo 3 Regulation Number: 21 CFR 868.5454 Regulation Name: High Flow Humidified Oxygen Delivery Device Regulatory Class: Class II Product Code: QAV, BTT Dated: December 28, 2022 Received: December 28, 2022
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 (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 located 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.
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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ethan L. Nyberg -S
for James Lee, Ph.D. Division Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, 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) K221338
Device Name F&P Airvo 3
Indications for Use (Describe)
The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities. 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 provides high flow gases with simultaneous oxygen delivery to spontaneously breathing patients with or without bypassed upper airways in hospitals and sub-acute facilities.
The Airvo 3 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 hypoxema in the hospital setting. The Airvo 3 is not intended to provide total ventilatory requirements and is not for use during field transport.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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5 510(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 |
| Regulatory Affairs Specialist | |
| Contact Person | Reena Daken |
| Regulatory Affairs Manager | |
| Telephone: +64 9 574 0100 | |
| Email: Reena.Daken@fphcare.co.nz | |
| Date Prepared | 27 January 2022 |
II. DEVICE
| Name of Device | F&P Airvo 3 |
|---|---|
| Common/Usual Name | High Flow Humidified Oxygen Delivery Device |
| Classification Name | High Flow/High Velocity Humidified Oxygen Delivery Device |
| Primary Regulatory Class | Class II (21 CFR §868.5454) |
| Primary Product Code | QAV |
| Secondary Regulatory Class | Class II (21 CFR §868.5450) |
| Secondary Product Code | BTT |
PREDICATE DEVICES III.
- Primary Predicate Device
| FDA Clearance Number | Device Name |
|---|---|
| DEN170001 | Precision Flow® HVNI |
- Secondary Predicate Device .
| FDA Clearance Number | Device Name |
|---|---|
| K131895 | AIRVO 2 Humidifier |
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DEVICE DESCRIPTION IV.
The F&P Airvo 3 is a high-flow device comprised of heated humidifier with integrated flow source, intended to treat spontaneously breathing patients, pediatrics and adults, who would benefit from receiving high flow, warmed and humidified entrained air and oxygen (if required).
The F&P Airvo 3 can be reprocessed for use on multiple patient interfaces, heated breathing tube, and water chambers are disposable and are for single patient use only, however, the internal outlet elbow is high-level-disinfected for multi-patient use.
The F&P Airvo 3 is comprised of two main connected functional units: the blower and the humidifier.
The blower is a motorized fan assembly that provides air flow. The flow is adjustable, where a separate source of oxygen independently controlled can be input and mixed with the entrained air. The blower assembly output connects directly to a humidification chamber at the front of the device.
The second functional unit of the F&P Airvo 3 is a heated passover humidifier. The water is contained in a humidification chamber positioned on a heater plate at the front of the unit. The gas is warmed and humidified in the chamber to the dew point set temperature, transported through the heated breathing tube and delivered to the patient through the selected interface.
V. INDICATIONS FOR USE
The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities. 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 provides high flow gases with simultaneous oxygen delivery to spontaneously breathing patients with or without bypassed upper airways in hospitals and sub-acute facilities.
The Airvo 3 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 is not intended to provide total ventilatory requirements and is not for use during field transport.
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES VI.
Table 1: Subject Device Comparison with the Primary Predicate Device
| Feature/Characteristicfor Comparison | Subject DeviceF&P Airvo 3 Base Model | Primary Predicate DevicePrecision Flow Hi-VNI (DEN170001) | Similarity of Subject Device toPrimary Predicate Device |
|---|---|---|---|
| Device Image | Image: F&P Airvo 3 Base Model | Image: Precision Flow Hi-VNI (DEN170001) | N/A |
| Classification | |||
| Legal manufacturer | Fisher & Paykel Healthcare Ltd | Vapotherm | N/A |
| Device Regulation | Class II, Regulation: 21 CFR §868.5454 | Class II, Regulation: 21 CFR §868.5454 | Identical |
| Product code | QAV | QAV | Identical |
| Classification name | High flow humidified oxygen deliverydevice | High flow humidified oxygen deliverydevice | Identical |
| Classification Panel | Anesthesiology | Anesthesiology | Identical |
| Intended Use/ Indications for Use | |||
| Feature/Characteristicfor Comparison | Subject DeviceF&P Airvo 3 Base Model | Primary Predicate DevicePrecision Flow Hi-VNI (DEN170001) | Similarity of Subject Device toPrimary Predicate Device |
| Indications for use | The Airvo 3 is intended to provide highflow warmed and humidified respiratorygases for administration to spontaneouslybreathing infant, child, adolescent andadult patients in hospitals and sub-acutefacilities. It adds heat and moisture to theflow of air, or blended air/medical oxygenmixture, and assures the user of theair/oxygen mixture using an integratedoxygen analyzer and visual display. Theflow may be from 2 to 70 L/min dependingon the patient interface. The Airvo 3provides high flow gases withsimultaneous oxygen delivery tospontaneously breathing patients with orwithout bypassed upper airways inhospitals and sub-acute facilities.The Airvo 3 provides high flow gases withsimultaneous oxygen delivery throughnasal cannula interfaces to augment thebreathing of spontaneously breathingpatients suffering from respiratory distressand/or hypoxemia in the hospital setting.The Airvo 3 is not intended to providetotal ventilatory requirements and is notfor use during field transport. | Precision Flow® Hi-VNI is intended foruse to add warm moisture to breathinggases from an external source foradministration to a neonate/infant,pediatric and adult patients in the hospitaland subacute institutions settings. It addsheat and moisture to a blended medical air/oxygen mixture and assures the integrityof the precise air/oxygen mixture via anintegral oxygen analyzer. The flow ratesmay be from 1 to 40 liters per minute vianasal cannula.Precision Flow® Hi-VNI provides highvelocity nasal insufflation (HVNI) withsimultaneous oxygen delivery to augmentbreathing of spontaneously breathingpatients suffering from respiratory distressand/or hypoxemia in the hospital setting.Precision Flow® Hi-VNI is not intendedto provide total ventilatory requirementsof the patient and not for use during fieldtransport. | EquivalentBoth the primary predicate and thesubject device have the same overallintended use, of delivering high flowbreathing gases (air/oxygenmixtures) with humidification forpatients who are suffering fromrespiratory distress and/orhypoxemia.The subject device indications for useis a combination of the indications foruse of the primary predicate and thesecondary predicate device, AIRVO2 Humidifier (K131895). |
| Availability | Prescription use only(Part 21 CFR 801 Subpart D) | Prescription use only(Part 21 CFR 801 Subpart D) | Identical |
| Feature/Characteristicfor Comparison | Subject DeviceF&P Airvo 3 Base Model | Primary Predicate DevicePrecision Flow Hi-VNI (DEN170001) | Similarity of Subject Device toPrimary Predicate Device |
| Patient Population | Infant, child, adolescent, and adult | Neonate/infant, pediatric and adult | EquivalentThe subject device's patientpopulation is a subset of the primarypredicate devices patient population. |
| Intended User Group | Healthcare Professionals | Healthcare Professionals | Identical |
| Patient Consciousness | Spontaneously Breathing Patients | Spontaneously Breathing Patients | Identical |
| Environment of use | Hospital and subacute facilities | Hospital and subacute institutions settings | IdenticalSubacute facilities and subacuteinstitutions have identical definitionsand reflect an identical environmentto each other.Additionally, the user group andpatient population defined by theseenvironments of use are identical. |
| Reusability | Multi-patient reusable when reprocessedbetween patients | Multi-patient reusable when cleaned anddisinfected between patients. | Identical |
| Sterility | Device not provided sterile | Device not provided sterile | Identical |
| Life Supporting or LifeSustaining | No | No | Identical |
| Service Life | 5 years | 5 years | Identical |
| Physical Specifications | |||
| Feature/Characteristicfor Comparison | Subject DeviceF&P Airvo 3 Base Model | Primary Predicate DevicePrecision Flow Hi-VNI (DEN170001) | Similarity of Subject Device toPrimary Predicate Device |
| Device dimensions | 205 mm x 295 mm x 190 mm(8.0" x 11.7" x 6.6") | 203.2 mm x 292.1 mm x 177.8 mm(8" x 11.5" x 7")(W x H x D) | EquivalentThe subject device is larger than theprimary predicate device by 1.8 mmx 2.9 mm x 12.2 mm (W x H x D) |
| Device weight (deviceonly) | 4.45 kg (9.8 lb.) | 4.81 kg (10.6 lb.) without disposablepatient | EquivalentThe subject device is 0.36 kg lighterthan the primary predicate device. |
| Technology | |||
| Operating principle | Constant flow of warmed, humidified gasdelivery via blower and humidifier | Constant flow of warmed, humidified gasdelivery via blender and humidifier | The operating principle of the subjectdevice is identical to the secondarypredicate device (AIRVO 2 -K131895). |
| Oxygen input sources | High-Pressure Oxygen (HPO) Inlet Port:Via DISS inlet from wall supply 200-600kPa (41-87 psi)AndLow-Pressure Oxygen (LPO) Inlet Port:low-pressureconnectorVia(from | Via DISS inlet from wall supply only, 28-586 kPa (4-85 psi) | The oxygen input via low-pressureoxygen (LPO) port connector isavailable in the previously- clearedsecondary predicate device (AIRVO2 — K131895).The rated flow range of the Low-Pressure Oxygen Port is identicalbetween the Subject and secondary |
| rotameter) | predicate device. The oxygen sourceof the subject device is a subset of thesecondary predicate device. | ||
| High Pressure OxygenInlet (HPO Port) - RatedPressure Range | 280 kPa to 600 kPa(41 PSI to 87 PSI) | 28 kPa to 586 kPa(4 PSI to 85 PSI) | SimilarThe maximum rated pressure of thesubject device is approximately 2 %higher than the primary predicatedevice. |
| Feature/Characteristicfor Comparison | Subject DeviceF&P Airvo 3 Base Model | Primary Predicate DevicePrecision Flow Hi-VNI (DEN170001) | Similarity of Subject Device toPrimary Predicate Device |
| The minimum rated pressure of thesubject device is a subset of thepressure range of the primarypredicate device. | |||
| High Pressure OxygenInlet (HPO Port) –Source of High PressureOxygen | Medical Oxygen | Medical Oxygen | Identical |
| Humidity source | Heated humidification chamber. | Vapor Transfer Cartridge | The method of humidification used inthe Airvo 3 is identical to thesecondary predicate device, AIRVO2, cleared in K131895. |
| 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 | New FeatureF&P has conducted testing thatdemonstrates that the SpO2 and pulserate values calculated by the pulseoximetry system are not corruptedduring communication to the Airvo 3and are displayed accurately on theuser interface. |
| Performance Specifications | |||
| Flow range | Infants: 2 - 25 L/minChildren: 2 - 36 L/minAdolescents: 10 - 70 L/minAdults: 20 - 70 L/minThe achievable flow range depends on thepatient interface selected. | 1 – 40 L/min | Flow rates of up to 60 L/min areavailable in the secondary predicatedevice, AIRVO 2 (K131895). Theuse of flow rates above 60 L/min isalready common in the field usingstandalone air/oxygen blenders incombination with humidifiers. |
| Maximum O2 flowrate(Low Pressure Oxygen | 60 L/min | 60 L/min | Identical |
| Feature/Characteristicfor Comparison | Subject DeviceF&P Airvo 3 Base Model | Primary Predicate DevicePrecision Flow Hi-VNI (DEN170001) | Similarity of Subject Device toPrimary Predicate Device |
| Inlet Port) | |||
| Temperature range | 31 - 37 °C | 33 – 38 °C | The set temperature range of thesubject device is identical to that ofthe secondary predicate deviceAIRVO 2 (K131895). |
| Ambient operatingtemperature range | 18 – 28 °C | 18 - 30 °C | EquivalentThe subject device's ambientoperating temperature range is asubset of the primary predicatedevices ambient operatingtemperature range. |
| Alarms | |||
| Alarm method | Visual and audible alarm system.Mute button. | Visual and audible alarm system.Mute button. | Identical |
| Electrical System Characteristics | |||
| Supply Frequency | 50-60 Hz | 50/60 Hz | Identical |
| Supply Voltage | 100 - 115 VAC220-240 VAC | 100-240 VAC | Identical |
| Accessories | |||
| Patient interfaces | Nasal cannulaAndUnsealed tracheostomy connectorAndUnsealed mask adapter | Nasal cannula | Unsealed tracheostomy connectorand unsealed mask adapters areavailable for use with the secondarypredicate device, AIRVO 2(K131895). |
| Feature/Characteristicfor Comparison | Subject DeviceF&P Airvo 3 Base Model | Primary Predicate DevicePrecision Flow Hi-VNI (DEN170001) | Similarity of Subject Device toPrimary Predicate Device |
| Heated Breathing tube | Heated breathing tube: single-lumen,spiral heater wires | Heated breathing tube: triple-lumen,water filled | This tube construction has beencleared for use with the secondarypredicate device, AIRVO 2(K162553). |
| Duration of Use - HeatedBreathing Tube | 14 Days single patient use | 30 Days single patient use | EquivalentThe duration of use of the subjectdevice is shorter than that of theprimary predicate device. |
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PERFORMANCE DATA VII.
Summary of non-clinical tests
The F&P Airvo 3 has been tested to the applicable requirements of the following standards:
| Standards and DesignationNumber | Standards Title |
|---|---|
| ISO 5367: 2014 | Anaesthetic and respiratory equipment. Breathing sets and connectors |
| ASTM D4169-16 | Standard Practice for Performance Testing of Shipping Containers andSystems |
| IEC 62304:2015 ConsolidatedVersion | Medical device software - software lifecycle processes |
| AIM Standard 7351731 Rev. 2.002017-02-23 | Medical Electrical Equipment and System Electromagnetic ImmunityTest for Exposure to Radio Frequency Identification Readers – An AIMStandard |
| IEC 62366-1:2015 + AMD:2020 | Medical devices - Part 1: Application of usability engineering to medicaldevices |
| ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluation and testingwithin a risk management process |
| ISO 10993-3:2014 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity,carcinogenicity, and reproductive toxicity |
| ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in vitrocytotoxicity |
| ISO 10993-10:2010 | Biological evaluation of medical devices - Part 10: Tests for irritationand skin sensitization |
| ISO 10993-11:2017 | Biological evaluation of medical devices - Part 11: Tests for systemictoxicity |
| ISO 10993-18:2020 | Biological evaluation of medical devices - Part 18: Chemicalcharacterization of materials |
| ISO 18562-1:2017 | Biocompatibility evaluation of breathing gas pathways in healthcareapplications - Part 1: Evaluation and testing within a risk managementprocess |
| ISO 18562-2: 2017 | Biocompatibility evaluation of breathing gas pathways in healthcareapplications - Part 2: Tests for emissions of particulate matter |
| ISO 18562-3: 2017 | Biocompatibility evaluation of breathing gas pathways in healthcareapplications - Part 3: Tests for emissions of volatile organic compounds |
| ISO 15223-1:2016 | Medical devices - Symbols to be used with medical device labels,labelling and information to be supplied - Part 1: General Requirements |
| ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012 | Medical electrical equipment - Part 1: General requirements for basicsafety and essential performance |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basicsafety and essential performance – Collateral Standard: Electromagneticdisturbances - Requirements and tests |
| IEC 60601-1-6 Edition 3.1 2013-10 | Medical electrical equipment - Part 1-: General requirements for basicsafety and essential performance – Collateral standard: Usability |
| ANSI AAMI IEC 60601-1-8:2006and A1:2012 | Medical electrical equipment - Part 1-8: General requirements for basicsafety and essential performance - Collateral Standard: Generalrequirements, tests and guidance for alarm systems in medical electricalequipment and medical electrical systems |
| ISO 80601-2-61:2017 | Medical electrical equipment - Part 2-61: Particular requirements forbasic safety and essential performance of pulse oximeter equipment |
| ISO 80601-2-74:2017 | Medical electrical equipment - Part 2-74: Particular requirements forbasic safety and essential performance of respiratory humidifyingequipment |
| ISO 80369-1:2018 | Small-bore connectors for liquids and gases in healthcare applications -Part 1: General Requirements |
| ISO 17664: 2017 | Processing of health care products - Information to be provided by themedical device manufacturer for the processing of medical devices. |
| IEC 62133-2:2017 | Secondary cells and batteries containing alkaline or other non-acidelectrolytes - Safety requirements for portable sealed secondary lithiumcells, and for batteries made from them, for use in portable applications -Part 2: Lithium systems |
| ISTA 2A | Procedure 2A: Packaged-Products weighing 150 lb (68 kg) or less. Basicrequirements: Atmospheric conditioning, compression, fixeddisplacement or random vibration, and shock vibration |
| AAMI TIR30:2011 | A Compendium of Processes, Materials, Test Methods, And AcceptanceCriteria For Cleaning Reusable Medical Devices |
| AAMI TIR12:2010 | Designing, testing, and labeling reusable medical devices forreprocessing in healthcare facilities |
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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. 2.00 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 Software Contained in Medical Devices."
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:
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- 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 to meet the Special Controls requirements of 21 CFR 868.5454 High flow humidified oxygen delivery device, and included:
- Blending accuracy
- . Flow rate accuracy
- Continuous use thermal stability
- Humidification output
VIII. CONCLUSIONS
The F&P Airvo 3 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.
§ 868.5454 High flow humidified oxygen delivery device.
(a)
Identification. A high flow humidified oxygen delivery device is a prescription device that delivers high flow oxygen with humidification for patients who are suffering from respiratory distress and/or hypoxemia.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, including the following:
(i) Alarm testing must be performed;
(ii) Continuous use thermal stability testing must be performed;
(iii) Humidity output testing must be performed; and
(iv) Blender performance testing must evaluate fraction of inspired oxygen (
Fi O2 ) blending accuracy.(3) Performance data must validate cleaning instructions for any reusable components of the device.
(4) Electrical safety, thermal safety, mechanical safety, electromagnetic compatibility, and radiofrequency identification testing must be performed.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Labeling must include:
(i) A description of available
Fi O2 ranges for different flowrates and inlet gas pressures;(ii) Instructions for applicable flowrates for all intended populations;
(iii) A warning that patients on high flow oxygen are acute and require appropriate monitoring, to include pulse oximetry;
(iv) A warning regarding the risk of condensation at low set temperatures and certain flows; and
(v) A description of all alarms and their functions.