K Number
K131895
Device Name
AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER
Date Cleared
2013-10-24

(121 days)

Product Code
Regulation Number
868.5450
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AIRVO 2 and myAIRVO 2 humidifiers are 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 AIRVO 2 is for patients in hospitals and long-term care facilities. The myAIRVO 2 is for patients in homes and long-term care facilities.
Device Description
The AIRVO 2 Series Humidifier system is a heated humidifier with integrated flow source and a heated breathing tube to deliver conditioned respiratory gas flow to a patient. The AIRVO 2 Series comprises two similar devices; the AIRVO 2, is intended for use in hospitals and long term care facilities and myAIRVO 2, intended for home use and long term care facilities. The AIRVO 2 Series Humidifier is comprised of two connected functional units. One is a motorised fan assembly that provides air flow. The fan speed is directly related to delivered flow, and is controlled by software with a flow sensor. The blower assembly output connects directly to a humidification chamber at the front of the device. The second functional unit of the AIRVO 2 Series Humidifier 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 chamber connects directly to the blower assembly via a port at the back of the chamber. Software monitors ambient temperature and flow to optimise humidity delivery to the patient and minimise condensation. The device interfaces with the patient via a nasal cannula, tracheostomy interface, or face mask. The AIRVO 2 Series Humidifier is reusable and by using the high level disinfection kit it can be used on multiple patients. The interfaces, tubes and water chambers are disposable and are for single patient use only. The device may be operated by nurses, respiratory therapists, doctors or patients.
More Information

Not Found

No
The description focuses on standard control systems (software monitoring ambient temperature and flow) and does not mention AI or ML.

Yes
The device is described for the "treatment of spontaneously breathing patients" and delivers "warmed and humidified respiratory gases" for therapeutic benefit.

No

Explanation: The device is a humidifier used for delivering warmed and humidified respiratory gases for treatment, not for diagnosing conditions.

No

The device description clearly outlines physical components like a motorized fan assembly, a heated passover humidifier, a humidification chamber, a heater plate, and interfaces (nasal cannula, tracheostomy interface, face mask). While software controls some functions, it is integral to a hardware system.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for delivering 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 is a humidifier with an integrated flow source and heated breathing tube. It delivers gas directly to the patient's respiratory tract. It does not analyze biological samples.
  • Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is to condition and deliver gas for breathing support.

Therefore, the AIRVO 2 and myAIRVO 2 humidifiers are considered medical devices for respiratory support, not In Vitro Diagnostics.

N/A

Intended Use / Indications for Use

The AIRVO 2 and myAIRVO 2 humidifiers are 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 AIRVO 2 is for patients in hospitals and long-term care facilities. The myAIRVO 2 is for patients in homes and long-term care facilities.

Product codes (comma separated list FDA assigned to the subject device)

BTT

Device Description

The AIRVO 2 Series Humidifier system is a heated humidifier with integrated flow source and a heated breathing tube to deliver conditioned respiratory gas flow to a patient. The AIRVO 2 Series comprises two similar devices; the AIRVO 2, is intended for use in hospitals and long term care facilities and myAIRVO 2, intended for home use and long term care facilities.

The AIRVO 2 Series Humidifier is comprised of two connected functional units. One is a motorised fan assembly that provides air flow. The fan speed is directly related to delivered flow, and is controlled by software with a flow sensor. The blower assembly output connects directly to a humidification chamber at the front of the device.

The second functional unit of the AIRVO 2 Series Humidifier 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 chamber connects directly to the blower assembly via a port at the back of the chamber. Software monitors ambient temperature and flow to optimise humidity delivery to the patient and minimise condensation.

The device interfaces with the patient via a nasal cannula, tracheostomy interface, or face mask.

The AIRVO 2 Series Humidifier is reusable and by using the high level disinfection kit it can be used on multiple patients. The interfaces, tubes and water chambers are disposable and are for single patient use only. The device may be operated by nurses, respiratory therapists, doctors or patients.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Upper airways (bypassed)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Nurses, respiratory therapists, doctors or patients.
Hospitals and long-term care facilities (AIRVO 2).
Homes and long-term care facilities (myAIRVO 2).

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)

Assessment of non clinical performance data is used in the determination of substantial equivalence. The AIRVO 2 Series Humidifier has undergone non-clinical testing and risk management that covers mechanical, electrical and thermal safety, environmental conditions, electromagnetic compatibility, functional verification and performance.

Software and hardware is bench tested for the flow and temperature delivery, oxygen fraction measurement and accuracy, alarm conditions, over the stated flow and temperature ranges, in normal use and single fault situations. The testing examines the humidifier, water chamber, and breathing tube with patient interfaces, to test system performance. Patient contacting parts have been evaluated and tested for biocompatibility.

Testing carried out on the AIRVO 2 Series Humidifiers indicates that they meet design and performance functional requirements. The device complies with the standards for medical electrical equipment and respiratory humidifiers for safety and performance, and biocompatibility requirements.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K121975, AIRVO Series Humidifier, Fisher & Paykel Healthcare Ltd, K073706, MR850 Humidifier, Fisher & Paykel Healthcare Ltd

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

Airvo 2 Series Humidifier

510(k) Notification

510(k) Summary 5

Healthc Stewart Building 15 Maurice Paykel Place, East Tamaki P O Box 14 348, Panmure Auckland, New Zealand Telephone: +64 9 574 0100
Facsimile: +64 9 574 0158 Website: www.fphcare.com

Kr31895

Date prepared21 June 2013
SubmitterFisher & Paykel Healthcare
15 Maurice Paykel Place
East Tamaki
Auckland
New Zealand
Tel: +64 9 574 0100
Fax +64 9 574 0158OCT 2 4 2013
Contact personBrett Whiston
Regulatory Affairs
Trade or
proprietary nameAIRVO 2 Series Humidifier
Common nameRespiratory Humidifier
Classification nameHumidifier, Respiratory Gas, (Direct Patient Interface)
(21. CFR § 868.5450, product code BTT)
Predicate deviceK121975, AIRVO Series Humidifier, Fisher & Paykel Healthcare Ltd
K073706, MR850 Humidifier, Fisher & Paykel Healthcare Ltd

1

Device description 5.1

The AIRVO 2 Series Humidifier system is a heated humidifier with integrated flow source and a heated breathing tube to deliver conditioned respiratory gas flow to a patient. The AIRVO 2 Series comprises two similar devices; the AIRVO 2, is intended for use in hospitals and long term care facilities and myAIRVO 2, intended for home use and long term care facilities.

The AIRVO 2 Series Humidifier is comprised of two connected functional units. One is a motorised fan assembly that provides air flow. The fan speed is directly related to delivered flow, and is controlled by software with a flow sensor. The blower assembly output connects directly to a humidification chamber at the front of the device.

The second functional unit of the AIRVO 2 Series Humidifier 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 chamber connects directly to the blower assembly via a port at the back of the chamber. Software monitors ambient temperature and flow to optimise humidity delivery to the patient and minimise condensation.

The device interfaces with the patient via a nasal cannula, tracheostomy interface, or face mask.

The AIRVO 2 Series Humidifier is reusable and by using the high level disinfection kit it can be used on multiple patients. The interfaces, tubes and water chambers are disposable and are for single patient use only. The device may be operated by nurses, respiratory therapists, doctors or patients.

5.2 Intended use

The AIRVO 2 and mvAIRVO 2 humidifiers are 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 AIRVO 2 is for patients in hospitals and long-term care facilities. The myAIRVO 2 is for patients in homes and long-term care facilities.

5.3 Substantial equivalence

The following information presents summary technological features in the determination of substantial equivalence comparison of the proposed Airvo 2 Series Humidifier to the identified predicate devices.

Comparison to MR850 predicate 5.3.1

The MR850 is used as a predicate for flow range. The flow range of the AIRVO 2 Series Humidifier is within the flow range of the predicate MR850 humidifier.

| Feature | Proposed device
AIRVO 2 Series Humidifier | Predicate device
MR850 Humidifier |
|------------|----------------------------------------------|--------------------------------------|
| Flow range | 2 - 60 L/min |