(649 days)
No
The summary describes a heated humidifier flow source with a blower and humidifier, controlled by software for flow and temperature. There is no mention of AI, ML, or any features that would typically utilize these technologies, such as image analysis, predictive algorithms, or adaptive control based on patient data beyond basic flow and temperature settings. The performance studies focus on standard medical device testing and substantial equivalence to a predicate device, not AI/ML performance metrics.
Yes
The device is intended for the treatment of spontaneously breathing patients to provide high flow warmed and humidified respiratory gases, which clearly indicates a therapeutic purpose.
No
Explanation: The device description states its purpose is to provide high flow warmed and humidified respiratory gases for treatment, not for diagnosing medical conditions.
No
The device description clearly outlines hardware components such as a blower (motorized fan assembly), a humidifier (heated Passover humidifier with a heater plate and humidification chamber), and a heated breathing tube. While software controls the fan speed, the device is fundamentally a hardware-based system for delivering warmed and humidified respiratory gases.
Based on the provided information, the myAirvo 3 device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "treatment of spontaneously breathing patients... who would benefit from receiving high flow warmed and humidified respiratory gases." This describes a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a heated humidifier flow source that delivers warmed and humidified gases to the patient. This is consistent with a respiratory support device, not a device used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease based on the analysis of biological samples.
The myAirvo 3 is a respiratory therapy device designed to provide warmed and humidified air and oxygen to patients.
N/A
Intended Use / 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.
Product codes
BTT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
infant to adult
Intended User / Care Setting
Intended User Group: Patients and healthcare professionals
Environment of use: Homes and Long-Term Care Facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The F&P myAirvo 3 has been tested to the applicable requirements of the following standards:
- ISO 5367: 2014 Anaesthetic and respiratory equipment. Breathing sets and connectors
- ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
- IEC 62304:2015 Consolidated Version Medical device software - software lifecycle processes
- AIM Standard 7351731 Rev. 2.00 2017-02-23 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard
- IEC 62366-1:2015 + AMD:2020 Medical devices - Part 1: Application of usability engineering to medical devices
- ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within 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 vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- ISO 10993-18:2020 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
- ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
- ISO 18562-2: 2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
- ISO 18562-3: 2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - 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 ES60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment – Part 1-: General requirements for basic safety and essential performance - Collateral standard: Usability
- ANSI AAMI IEC 60601-1-8:2006 and A1:2012 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 60601-1-11:2015 (Second Edition) Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements, for medical electrical equipment and medical electrical systems used in the home healthcare environment
- ISO 80601-2-61:2017 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- ISO 80601-2-74:2017 Medical electrical equipment - Part 2-74: Particular requirements for basic safety 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 the medical device manufacturer for the processing of medical devices.
- IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, 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. Basic requirements: Atmospheric conditioning, compression, fixed displacement or random vibration, and shock vibration
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" 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"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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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4
510(k) Summary 1
As required by 21 CFR 807.92
I. SUBMITTER
| Company Name and Address | Fisher & Paykel Healthcare Limited
15 Maurice Paykel Place
East Tamaki
Auckland 2013, New Zealand
Telephone: +64 9 574 0100 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Prepared and Submitted by | Hannah Matthews
Senior Regulatory Affairs Specialist |
| Contact Person | Reena Daken
Regulatory Affairs Manager
Telephone: +64 9 574 0100
Email: Reena.Daken@fphcare.co.nz |
| Date Prepared | 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
5
| 510(k) Number | Device Name | Reason for Reference |
|---|---|---|
| K102465 | BiPAP Avaps | |
| Ventilatory Support | ||
| System | Used to support claims of substantial equivalence | |
| with respect to the following performance: | ||
| • Use of SpO2 sensing in a medical device. | ||
| K162553 | Nasal Cannula | |
| Infant | ||
| Nasal Cannula | ||
| Pediatric | Used to support claims of substantial equivalence | |
| with respect to the following performance: | ||
| • Use of pediatric patient interfaces with the | ||
| myAirvo 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.
6
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VII.
Table 1: Subject Device Comparison with Predicate Devices
| Feature/Characteristic
for Comparison | Subject Device
F&P myAirvo 3 | Predicate Device
myAIRVO 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/Characteristic
for Comparison | Subject Device
F&P myAirvo 3 | Predicate Device
myAIRVO 2 Humidifier (K131895) | Comment |
| 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. | The myAIRVO 2 is for the treatment of
spontaneously breathing patients 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 2 is for
patients in homes and long-term care
facilities. | 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 to
adult. | Spontaneously breathing patients | Equivalent
Despite the difference in
terminology, the patient populations
covered by the subject device are
identical to that of the predicate
device.
This has previously been discussed
in Q181564/S003
This difference does not raise any
new questions of safety and
effectiveness. |
| Intended User Group | Patients and healthcare professionals | Patients and healthcare professionals | Identical |
| Patient Consciousness | Spontaneously Breathing Patients | Spontaneously Breathing Patients | Identical |
| Feature/Characteristic
for Comparison | Subject Device
F&P myAirvo 3 | Predicate Device
myAIRVO 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 reprocessed
between patients | Multi-patient reusable when reprocessed
between patients | Identical |
| High Level Disinfection
Methods | High-Level Disinfection using
Disinfection Kit
Thermal Disinfection (with automated
washer-disinfector) | High-Level Disinfection using
Disinfection Kit | This difference does not raise new
questions of safety and effectiveness.
The High-Level Disinfection method
using the disinfection kit is identical
to the predicate device (myAIRVO 2
- K131895) except for addition of a
single rinsing step.
The High-Level Disinfection using
an automated Washer-Disinfector is
not available for the predicate
device, but testing has
been
completed to validate the efficacy. |
| Sterility | Device not provided sterile | Device not provided sterile | Identical |
| Life Supporting or Life
Sustaining | 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" x
11.6" x 6.7") | Equivalent
The subject device is 5mm wider
than the predicate device.
This difference does not raise any |
| Feature/Characteristic
for Comparison | Subject Device
F&P myAirvo 3 | Predicate Device
myAIRVO 2 Humidifier (K131895) | Comment |
| | | | new questions of safety or
effectiveness |
| Technology | | | |
| Operating principle | Heated humidifier with integrated flow
source for delivering constant flow of
warmed and humidified respiratory gases
when connected to a breathing circuit and
patient interface. | Heated humidifier with integrated flow
source for delivering constant flow of
warmed and humidified respiratory gases
when connected to a breathing circuit and
patient 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, displays
sensed SpO2 and pulse rate on user
interface | No SpO2 Sensing | New Feature
F&P has conducted testing
that
demonstrates that the SpO2 and pulse
rate values calculated by the Nonin
pulse oximetry system are not
corrupted during communication to the
myAirvo 3 and are
displayed
accurately 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) | Equivalent
Despite the difference in
terminology, the flow ranges
covered by the subject device are
identical to that of the predicate
device.
This difference does not raise any
new questions of safety and
effectiveness. |
| Maximum
Oxygen | 15 L/min | 15 L/min | Identical |
| Feature/Characteristic
for Comparison | Subject Device
F&P myAirvo 3 | Predicate Device
myAIRVO 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 operating
temperature 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 VAC
220 – 240 VAC | 100 - 115 VAC
220 – 240 VAC | Identical |
| Accessories | | | |
| Patient interfaces | Nasal Interface
And
Tracheostomy Interface
And
Vented Mask | Nasal Interface
And
Tracheostomy Interface
And
Vented Mask | Identical |
| Heated Breathing Tube | Heated breathing tube: single-lumen,
spiral heater wires | Heated breathing tube: single-lumen,
spiral heater wires | Identical |
7
8
9
10
11
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 Designation
| Number | Standards Title |
|---|---|
| ISO 5367: 2014 | Anaesthetic and respiratory equipment. Breathing sets and connectors |
| ASTM D4169-16 | Standard Practice for Performance Testing of Shipping Containers and |
| Systems | |
| IEC 62304:2015 Consolidated | |
| Version | Medical device software - software lifecycle processes |
| AIM Standard 7351731 Rev. 2.00 | |
| 2017-02-23 | Medical Electrical Equipment and System Electromagnetic Immunity Test |
| for Exposure to Radio Frequency Identification Readers - An AIM | |
| Standard | |
| IEC 62366-1:2015 + AMD:2020 | Medical devices - Part 1: Application of usability engineering to medical |
| devices | |
| ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluation and testing |
| within 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 vitro |
| cytotoxicity | |
| ISO 10993-10:2010 | Biological evaluation of medical devices - Part 10: Tests for irritation and |
| skin sensitization | |
| ISO 10993-11:2017 | Biological evaluation of medical devices - Part 11: Tests for systemic |
| toxicity | |
| ISO 10993-18:2020 | Biological evaluation of medical devices - Part 18: Chemical |
| characterization of materials | |
| ISO 18562-1:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare |
| applications - Part 1: Evaluation and testing within a risk management | |
| process | |
| ISO 18562-2: 2017 | Biocompatibility evaluation of breathing gas pathways in healthcare |
| applications - Part 2: Tests for emissions of particulate matter | |
| ISO 18562-3: 2017 | Biocompatibility evaluation of breathing gas pathways in healthcare |
| applications - 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 ES60601- | |
| 1:2005/(R)2012 and A1:2012 | Medical electrical equipment - Part 1: General requirements for basic |
| safety and essential performance | |
| IEC 60601-1-2:2014 | Medical electrical equipment – Part 1-2: General requirements for basic |
| safety and essential performance - Collateral Standard: Electromagnetic | |
| disturbances - Requirements and tests | |
| IEC 60601-1-6 Edition 3.1 2013-10 | Medical electrical equipment – Part 1-: General requirements for basic |
| safety and essential performance - Collateral standard: Usability | |
| ANSI AAMI IEC 60601-1-8:2006 | |
| and A1:2012 | Medical electrical equipment - Part 1-8: General requirements for basic |
| safety and essential performance - Collateral Standard: General | |
| requirements, tests and guidance for alarm systems in medical electrical | |
| equipment and medical electrical systems | |
| IEC 60601-1-11:2015 (Second | |
| Edition) | Medical electrical equipment - Part 1-11: General requirements for basic |
| safety and essential performance - Collateral Standard: Requirements, for | |
| medical electrical equipment and medical electrical systems used in the | |
| home healthcare environment | |
| ISO 80601-2-61:2017 | Medical electrical equipment - Part 2-61: Particular requirements for basic |
| safety and essential performance of pulse oximeter equipment | |
| ISO 80601-2-74:2017 | Medical electrical equipment - Part 2-74: Particular requirements for basic |
| safety 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 the |
| medical device manufacturer for the processing of medical devices. | |
| IEC 62133-2:2017 | Secondary cells and batteries containing alkaline or other non-acid |
| electrolytes - Safety requirements for portable sealed secondary lithium | |
| cells, 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. Basic |
| requirements: Atmospheric conditioning, compression, fixed | |
| displacement or random vibration, and shock vibration |
12
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.