(649 days)
The myAirvo 3 is for the treatment of spontaneously breathing patients, infant to adult, who would benefit from receiving high flow warmed and humidified respiratory gases. This includes patients who have had upper airways bypassed. The flow may be from 2 - 60 L/min depending on the patient interface. The myAirvo 3 is for patients in homes and long-term care facilities.
The F&P myAirvo 3 device is a heated humidifier flow source. The subject device is intended to treat spontaneously breathing patients, pediatrics and adults, who would benefit from receiving high flow, warmed and humidified entrained air and oxygen (if required).
The F&P myAirvo 3 is comprised of two main connected functional units: the blower and the humidifier.
The blower is a motorized fan assembly that provides air flow. The fan speed is directly related to the delivered flow and it is controlled by the software. The blower assembly output connects directly to a humidification chamber at the front of the device.
The second functional unit of the F&P myAirvo 3 device is a heated Passover humidifier. The water is contained in a humidification chamber positioned on a heater plate at the front of the unit. The gas is warmed and humidified in the chamber to the dew point set temperature, transported through the heated breathing tube and delivered to the patient through the selected interface.
This document is a 510(k) Summary for the F&P myAirvo 3, a respiratory humidifier. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it does not contain acceptance criteria or study data related to the performance of an AI/ML powered device. The provided text primarily focuses on comparative claims against a predicate device and adherence to various safety and performance standards relevant to a medical device's physical and functional specifications.
Therefore, I cannot extract information about acceptance criteria or a study proving an AI/ML device meets them from this document. The questions posed in the prompt (regarding AI/ML performance, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to the content provided, as it describes a traditional medical device (a respiratory humidifier) and not an AI/ML algorithm.
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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" in a stacked format.
May 9, 2024
Fisher & Paykel Healthcare Reena Daken Regulatory Affairs Manager 15 Maurice Paykel Place Auckland, 2013 New Zealand
Re: K222292
Trade/Device Name: F&P myAirvo 3 Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory gas humidifier Regulatory Class: Class II Product Code: BTT Dated: April 17, 2024 Received: April 17, 2024
Dear Reena Daken:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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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.
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
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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) K22292
Device Name F&P myAirvo3
Indications for Use (Describe)
The myAirvo 3 is for the treatment of spontaneously breathing patients, infant to adult, who would benefit from receiving high flow warmed and humidified respiratory gases. This includes patients who have had upper airways bypassed. The flow may be from 2 - 60 L/min depending on the patient interface. The myAirvo 3 is for patients in homes and long-term care facilities.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary 1
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 | 17 April 2024 |
| II.DEVICE | |
|---|---|
| Name of Device | F&P myAirvo 3 |
| Common/Usual Name | Respiratory Humidifier |
| Classification Name | Respiratory Gas Humidifier |
| Regulatory Class | Class II (21 CFR §868.5450) |
| Product Code | BTT |
PREDICATE DEVICE III.
- . Predicate Device
| FDA Clearance Number | Device Name |
|---|---|
| K131895 | myAIRVO 2 Humidifier |
REFERENCE DEVICES IV.
- . Reference Devices
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| 510(k) Number | Device Name | Reason for Reference |
|---|---|---|
| K102465 | BiPAP AvapsVentilatory SupportSystem | Used to support claims of substantial equivalencewith respect to the following performance:• Use of SpO2 sensing in a medical device. |
| K162553 | Nasal CannulaInfantNasal CannulaPediatric | Used to support claims of substantial equivalencewith respect to the following performance:• Use of pediatric patient interfaces with themyAirvo 3. |
DEVICE DESCRIPTION V.
The F&P myAirvo 3 device is a heated humidifier flow source. The subject device is intended to treat spontaneously breathing patients, pediatrics and adults, who would benefit from receiving high flow, warmed and humidified entrained air and oxygen (if required).
The F&P myAirvo 3 is comprised of two main connected functional units: the blower and the humidifier.
The blower is a motorized fan assembly that provides air flow. The fan speed is directly related to the delivered flow and it is controlled by the software. The blower assembly output connects directly to a humidification chamber at the front of the device.
The second functional unit of the F&P myAirvo 3 device is a heated Passover humidifier. The water is contained in a humidification chamber positioned on a heater plate at the front of the unit. The gas is warmed and humidified in the chamber to the dew point set temperature, transported through the heated breathing tube and delivered to the patient through the selected interface.
VI. INDICATIONS FOR USE
The myAirvo 3 is for the treatment of spontaneously breathing patients, infant to adult, who would benefit from receiving high flow warmed and humidified respiratory gases. This includes patients who have had upper airways bypassed. The flow may be from 2 - 60 L/min depending on the patient interface. The myAirvo 3 is for patients in homes and long-term care facilities.
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VII.
Table 1: Subject Device Comparison with Predicate Devices
| Feature/Characteristicfor Comparison | Subject DeviceF&P myAirvo 3 | Predicate DevicemyAIRVO 2 Humidifier (K131895) | Comment |
|---|---|---|---|
| Device Image | N/A | ||
| Classification | |||
| Legal manufacturer | Fisher & Paykel Healthcare Ltd | Fisher & Paykel Healthcare Ltd | Identical |
| Device Regulation | Class II, Regulation: 21 CFR §868.5450 | Class II, Regulation: 21 CFR §868.5450 | Identical |
| Product code | BTT | BTT | Identical |
| Classification name | Respiratory gas humidifier | Respiratory gas humidifier | Identical |
| Classification Panel | Anesthesiology | Anesthesiology | Identical |
| Intended Use/ Indications for Use | |||
| Feature/Characteristicfor Comparison | Subject DeviceF&P myAirvo 3 | Predicate DevicemyAIRVO 2 Humidifier (K131895) | Comment |
| Indications for use | The myAirvo 3 is for the treatment ofspontaneously breathing patients, infantto adult, who would benefit fromreceiving high flow warmed andhumidified respiratory gases. Thisincludes patients who have had upperairways bypassed. The flow may be from2 - 60 L/min depending on the patientinterface. The myAirvo 3 is for patients inhomes and long-term care facilities. | The myAIRVO 2 is for the treatment ofspontaneously breathing patients whowould benefit from receiving high flowwarmed and humidified respiratory gases.This includes patients who have hadupper airways bypassed. The flow may befrom 2 - 60 L/min depending on thepatient interface. The myAIRVO 2 is forpatients in homes and long-term carefacilities. | Identical |
| Operation and Safety Features | |||
| Availability | Prescription use only(Part 21 CFR 801 Subpart D) | Prescription use only(Part 21 CFR 801 Subpart D) | Identical |
| Patient Population | Spontaneously breathing patients, infant toadult. | Spontaneously breathing patients | EquivalentDespite the difference interminology, the patient populationscovered by the subject device areidentical to that of the predicatedevice.This has previously been discussedin Q181564/S003This difference does not raise anynew questions of safety andeffectiveness. |
| Intended User Group | Patients and healthcare professionals | Patients and healthcare professionals | Identical |
| Patient Consciousness | Spontaneously Breathing Patients | Spontaneously Breathing Patients | Identical |
| Feature/Characteristicfor Comparison | Subject DeviceF&P myAirvo 3 | Predicate DevicemyAIRVO 2 Humidifier (K131895) | Comment |
| Environment of use | Homes and Long-Term Care Facilities | Homes and Long-Term Care Facilities | Identical |
| Reusability | Multi-patient reusable when reprocessedbetween patients | Multi-patient reusable when reprocessedbetween patients | Identical |
| High Level DisinfectionMethods | High-Level Disinfection usingDisinfection KitThermal Disinfection (with automatedwasher-disinfector) | High-Level Disinfection usingDisinfection Kit | This difference does not raise newquestions of safety and effectiveness.The High-Level Disinfection methodusing the disinfection kit is identicalto the predicate device (myAIRVO 2- K131895) except for addition of asingle rinsing step.The High-Level Disinfection usingan automated Washer-Disinfector isnot available for the predicatedevice, but testing hasbeencompleted to validate the efficacy. |
| 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 | |||
| Device Dimensions | 180 mm x 295 mm x 170 mm (7.0" x 11.7"x 6.6") | 175 mm x 295 mm x 170 mm x (6.9" x11.6" x 6.7") | EquivalentThe subject device is 5mm widerthan the predicate device.This difference does not raise any |
| Feature/Characteristicfor Comparison | Subject DeviceF&P myAirvo 3 | Predicate DevicemyAIRVO 2 Humidifier (K131895) | Comment |
| new questions of safety oreffectiveness | |||
| Technology | |||
| Operating principle | Heated humidifier with integrated flowsource for delivering constant flow ofwarmed and humidified respiratory gaseswhen connected to a breathing circuit andpatient interface. | Heated humidifier with integrated flowsource for delivering constant flow ofwarmed and humidified respiratory gaseswhen connected to a breathing circuit andpatient interface. | Identical |
| Humidity source | Heated humidification chamber. | Heated humidification chamber. | Identical |
| 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 testingthatdemonstrates that the SpO2 and pulserate values calculated by the Noninpulse oximetry system are notcorrupted during communication to themyAirvo 3 and aredisplayedaccurately on the user interface. |
| Performance Specifications | |||
| Flow range | 2 - 60 L/min delivered | 10 - 60 L/min delivered (Default)2 - 25 L/min delivered (Junior mode) | EquivalentDespite the difference interminology, the flow rangescovered by the subject device areidentical to that of the predicatedevice.This difference does not raise anynew questions of safety andeffectiveness. |
| MaximumOxygen | 15 L/min | 15 L/min | Identical |
| Feature/Characteristicfor Comparison | Subject DeviceF&P myAirvo 3 | Predicate DevicemyAIRVO 2 Humidifier (K131895) | Comment |
| Flowrate | |||
| Oxygen Fraction Range | 21-100% | 21-100% | Identical |
| Temperature range | 31 - 37 °C | 31 - 37 °C | Identical |
| Operating Conditions | |||
| Ambient operatingtemperature range | 18 – 28 °C | 18 – 28 °C | Identical |
| 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 - 115 VAC220 – 240 VAC | Identical |
| Accessories | |||
| Patient interfaces | Nasal InterfaceAndTracheostomy InterfaceAndVented Mask | Nasal InterfaceAndTracheostomy InterfaceAndVented Mask | Identical |
| Heated Breathing Tube | Heated breathing tube: single-lumen,spiral heater wires | Heated breathing tube: single-lumen,spiral heater wires | Identical |
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PERFORMANCE DATA VIII.
Summary of non-clinical tests
The F&P myAirvo 3 has been tested to the applicable requirements of the following standards:
| Standards and 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 Immunity Testfor 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 irritation andskin 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, labellingand information to be supplied – Part 1: General Requirements |
| ANSI AAMI ES60601-1:2005/(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 |
| IEC 60601-1-11:2015 (SecondEdition) | Medical electrical equipment - Part 1-11: General requirements for basicsafety and essential performance - Collateral Standard: Requirements, formedical electrical equipment and medical electrical systems used in thehome healthcare environment |
| ISO 80601-2-61:2017 | Medical electrical equipment - Part 2-61: Particular requirements for basicsafety and essential performance of pulse oximeter equipment |
| ISO 80601-2-74:2017 | Medical electrical equipment - Part 2-74: Particular requirements for basicsafety and essential performance of respiratory humidifying equipment |
| ISO 80369-1:2018 | Small-bore connectors for liquids and gases in healthcare applications -Part 1: General Requirements |
| ISO 17664-1: 2021 | 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 |
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IX. CONCLUSIONS
The F&P myAirvo 3 is substantially equivalent to the predicate 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 device.
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).