(263 days)
K131895 (AIRVO 2 Humidifier)
No
The summary describes a high-flow respiratory device with standard components like a blower, humidifier, and oxygen analyzer. There is no mention of AI, ML, or any features that would suggest the use of such technologies for analysis, control, or prediction. The performance studies focus on standard medical device testing (electrical safety, biocompatibility, software validation, bench testing) and do not indicate any AI/ML-specific evaluations.
Yes.
The device administers warmed and humidified respiratory gases to patients to augment their breathing, particularly for those suffering from respiratory distress and/or hypoxemia, which directly addresses a health condition.
No
This device is a therapeutic device that provides high-flow warmed and humidified respiratory gases to spontaneously breathing patients. It is not designed to diagnose medical conditions.
No
The device description clearly outlines hardware components like a blower (motorized fan assembly), a heated humidifier, a heater plate, and a breathing tube. The performance studies also include testing related to electrical safety, EMC, and cleaning/reprocessing of hardware components.
Based on the provided information, the Airvo 3 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the Airvo 3 is for providing warmed and humidified respiratory gases to spontaneously breathing patients. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details a system for generating and delivering respiratory gases, including a blower and a humidifier. This aligns with a respiratory support device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The Airvo 3 is a medical device used for respiratory support, specifically high-flow therapy.
N/A
Intended Use / 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 hypoxema in the hospital setting. The Airvo 3 is not intended to provide total ventilatory requirements and is not for use during field transport.
Product codes
QAV, BTT
Device Description
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.
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, child, adolescent and adult
Intended User / Care Setting
Hospitals and sub-acute facilities.
Healthcare Professionals
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
Summary of non-clinical tests:
The F&P Airvo 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 ES 60601-1:2005/(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
- 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: 2017 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
- AAMI TIR30:2011 A Compendium of Processes, Materials, Test Methods, And Acceptance Criteria For Cleaning Reusable Medical Devices
- AAMI TIR12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in healthcare facilities
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:
The Outlet Elbow is classified as a semi-critical device and was subject to cleaning followed by high-level disinfection. The acceptance criteria and endpoints used are based on 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
Key results: 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. The conclusions drawn from the non-clinical tests demonstrate that the device is substantially equivalent to the legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
DEN170001 (Precision Flow® HVNI)
Reference Device(s)
K131895 (AIRVO 2 Humidifier)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
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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3
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 |
4
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.
5
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES VI.
Table 1: Subject Device Comparison with the Primary Predicate Device
| Feature/Characteristic
for Comparison | Subject Device
F&P Airvo 3 Base Model | Primary Predicate Device
Precision Flow Hi-VNI (DEN170001) | Similarity of Subject Device to
Primary 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 delivery
device | High flow humidified oxygen delivery
device | Identical |
| Classification Panel | Anesthesiology | Anesthesiology | Identical |
| Intended Use/ Indications for Use | | | |
| Feature/Characteristic
for Comparison | Subject Device
F&P Airvo 3 Base Model | Primary Predicate Device
Precision Flow Hi-VNI (DEN170001) | Similarity of Subject Device to
Primary Predicate Device |
| 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. | Precision Flow® Hi-VNI is intended for
use to add warm moisture to breathing
gases from an external source for
administration to a neonate/infant,
pediatric and adult patients in the hospital
and subacute institutions settings. It adds
heat and moisture to a blended medical air/
oxygen mixture and assures the integrity
of the precise air/oxygen mixture via an
integral oxygen analyzer. The flow rates
may be from 1 to 40 liters per minute via
nasal cannula.
Precision Flow® Hi-VNI provides high
velocity nasal insufflation (HVNI) with
simultaneous oxygen delivery to augment
breathing of spontaneously breathing
patients suffering from respiratory distress
and/or hypoxemia in the hospital setting.
Precision Flow® Hi-VNI is not intended
to provide total ventilatory requirements
of the patient and not for use during field
transport. | Equivalent
Both the primary predicate and the
subject device have the same overall
intended use, of delivering high flow
breathing gases (air/oxygen
mixtures) with humidification for
patients who are suffering from
respiratory distress and/or
hypoxemia.
The subject device indications for use
is a combination of the indications for
use of the primary predicate and the
secondary predicate device, AIRVO
2 Humidifier (K131895). |
| Availability | Prescription use only
(Part 21 CFR 801 Subpart D) | Prescription use only
(Part 21 CFR 801 Subpart D) | Identical |
| Feature/Characteristic
for Comparison | Subject Device
F&P Airvo 3 Base Model | Primary Predicate Device
Precision Flow Hi-VNI (DEN170001) | Similarity of Subject Device to
Primary Predicate Device |
| Patient Population | Infant, child, adolescent, and adult | Neonate/infant, pediatric and adult | Equivalent
The subject device's patient
population is a subset of the primary
predicate 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 | Identical
Subacute facilities and subacute
institutions have identical definitions
and reflect an identical environment
to each other.
Additionally, the user group and
patient population defined by these
environments of use are identical. |
| Reusability | Multi-patient reusable when reprocessed
between patients | Multi-patient reusable when cleaned and
disinfected between patients. | Identical |
| 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 | | | |
| Feature/Characteristic
for Comparison | Subject Device
F&P Airvo 3 Base Model | Primary Predicate Device
Precision Flow Hi-VNI (DEN170001) | Similarity of Subject Device to
Primary 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) | Equivalent
The subject device is larger than the
primary predicate device by 1.8 mm
x 2.9 mm x 12.2 mm (W x H x D) |
| Device weight (device
only) | 4.45 kg (9.8 lb.) | 4.81 kg (10.6 lb.) without disposable
patient | Equivalent
The subject device is 0.36 kg lighter
than the primary predicate device. |
| Technology | | | |
| Operating principle | Constant flow of warmed, humidified gas
delivery via blower and humidifier | Constant flow of warmed, humidified gas
delivery via blender and humidifier | The operating principle of the subject
device is identical to the secondary
predicate device (AIRVO 2 -
K131895). |
| Oxygen input sources | High-Pressure Oxygen (HPO) Inlet Port:
Via DISS inlet from wall supply 200-600
kPa (41-87 psi)
And
Low-Pressure Oxygen (LPO) Inlet Port:
low-pressure
connector
Via
(from | Via DISS inlet from wall supply only, 28-
586 kPa (4-85 psi) | The oxygen input via low-pressure
oxygen (LPO) port connector is
available in the previously- cleared
secondary predicate device (AIRVO
2 — K131895).
The rated flow range of the Low-
Pressure Oxygen Port is identical
between the Subject and secondary |
| | rotameter) | | predicate device. The oxygen source
of the subject device is a subset of the
secondary predicate device. |
| High Pressure Oxygen
Inlet (HPO Port) - Rated
Pressure Range | 280 kPa to 600 kPa
(41 PSI to 87 PSI) | 28 kPa to 586 kPa
(4 PSI to 85 PSI) | Similar
The maximum rated pressure of the
subject device is approximately 2 %
higher than the primary predicate
device. |
| Feature/Characteristic
for Comparison | Subject Device
F&P Airvo 3 Base Model | Primary Predicate Device
Precision Flow Hi-VNI (DEN170001) | Similarity of Subject Device to
Primary Predicate Device |
| | | | The minimum rated pressure of the
subject device is a subset of the
pressure range of the primary
predicate device. |
| High Pressure Oxygen
Inlet (HPO Port) –
Source of High Pressure
Oxygen | Medical Oxygen | Medical Oxygen | Identical |
| Humidity source | Heated humidification chamber. | Vapor Transfer Cartridge | The method of humidification used in
the Airvo 3 is identical to the
secondary predicate device, AIRVO
2, cleared in K131895. |
| 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 pulse
oximetry system are not corrupted
during communication to the Airvo 3
and are displayed accurately on the
user interface. |
| Performance Specifications | | | |
| Flow range | Infants: 2 - 25 L/min
Children: 2 - 36 L/min
Adolescents: 10 - 70 L/min
Adults: 20 - 70 L/min
The achievable flow range depends on the
patient interface selected. | 1 – 40 L/min | Flow rates of up to 60 L/min are
available in the secondary predicate
device, AIRVO 2 (K131895). The
use of flow rates above 60 L/min is
already common in the field using
standalone air/oxygen blenders in
combination with humidifiers. |
| Maximum O2 flowrate
(Low Pressure Oxygen | 60 L/min | 60 L/min | Identical |
| Feature/Characteristic
for Comparison | Subject Device
F&P Airvo 3 Base Model | Primary Predicate Device
Precision Flow Hi-VNI (DEN170001) | Similarity of Subject Device to
Primary Predicate Device |
| Inlet Port) | | | |
| Temperature range | 31 - 37 °C | 33 – 38 °C | The set temperature range of the
subject device is identical to that of
the secondary predicate device
AIRVO 2 (K131895). |
| Ambient operating
temperature range | 18 – 28 °C | 18 - 30 °C | Equivalent
The subject device's ambient
operating temperature range is a
subset of the primary predicate
devices ambient operating
temperature 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 VAC
220-240 VAC | 100-240 VAC | Identical |
| Accessories | | | |
| Patient interfaces | Nasal cannula
And
Unsealed tracheostomy connector
And
Unsealed mask adapter | Nasal cannula | Unsealed tracheostomy connector
and unsealed mask adapters are
available for use with the secondary
predicate device, AIRVO 2
(K131895). |
| Feature/Characteristic
for Comparison | Subject Device
F&P Airvo 3 Base Model | Primary Predicate Device
Precision Flow Hi-VNI (DEN170001) | Similarity of Subject Device to
Primary Predicate Device |
| Heated Breathing tube | Heated breathing tube: single-lumen,
spiral heater wires | Heated breathing tube: triple-lumen,
water filled | This tube construction has been
cleared for use with the secondary
predicate device, AIRVO 2
(K162553). |
| Duration of Use - Heated
Breathing Tube | 14 Days single patient use | 30 Days single patient use | Equivalent
The duration of use of the subject
device is shorter than that of the
primary 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 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 ES 60601- | |
| 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 | |
| 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: 2017 | 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 | |
| AAMI TIR30:2011 | A Compendium of Processes, Materials, Test Methods, And Acceptance |
| Criteria For Cleaning Reusable Medical Devices | |
| AAMI TIR12:2010 | Designing, testing, and labeling reusable medical devices for |
| reprocessing 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.