(134 days)
Not Found
No
The description mentions software control and monitoring of parameters, but there is no indication of AI or ML being used for learning, prediction, or complex pattern recognition.
Yes
The device is described as treating patients by providing warmed and humidified respiratory gases, which directly addresses a health condition (spontaneous breathing patients who benefit from such gases). This aligns with the definition of a therapeutic device.
No
The device is a humidifier that delivers warmed and humidified respiratory gases to patients; it does not diagnose medical conditions.
No
The device description clearly outlines hardware components such as a motorized fan assembly, a heated passover humidifier, a heaterplate, and a heated breathing tube. While software controls some functions, the device is fundamentally a hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The AIRVO and myAIRVO Humidifiers are designed to deliver warmed and humidified respiratory gases directly to the patient's airways. They are a form of respiratory support.
- Lack of Specimen Analysis: The device does not collect or analyze any biological specimens from the patient. It provides a therapeutic intervention (humidified gas delivery).
- Intended Use: The intended use is to treat spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases. This is a treatment, not a diagnostic process.
The device description and intended use clearly indicate that it is a respiratory therapy device, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The AIRVO Series humidifiers are to treat spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases. This includes patients who have their upper airways bypassed. The AIRVO is for patients in hospitals, and the myAIRVO is for home patients.
The AIRVO and myAIRVO Humidifiers are to treat patients spontaneously breathing who would benefit from receiving high flow warmed and humidified respiratory gases . This includes patients who have upper airways bypassed.
The AIRVO is for patients in hospitals. The myAIRVO is for home patients.
Product codes (comma separated list FDA assigned to the subject device)
BTT
Device Description
The AIRVO Series humidifier system is a heated humidifier with integrated flow source and a heated breathing tube. The AIRVO Series comprises two similar devices; the AIRVO which is intended for use in hospitals and myAlRVO which is intended for home use. The AIRVO Series humidifiers are intended to treat spontaneously breathing patients who would benefit from receiving high flow, warmed and humidified respiratory gases.
The AIRVO 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. The blower assembly output connects directly to a humidification chamber at the front of the device.
The second functional unit of the AIRVO is a heated passover humidifier. The water is contained in a humidification chamber positioned on a heaterplate at the front of the unit. The chamber connects directly to the blower assembly via a port at 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 either a nasal cannula or tracheostomy interface either in the hospital or home environment.
The AIRVO device 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
AIRVO: for patients in hospitals.
myAIRVO: for home patients.
The device may be operated by nurses, respiratory therapists, doctors or patients.
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)
Non-clinical testing of the AIRVO Series Humidifier has been carried out covering mechanical, electrical and thermal safety, environmental conditions, electromagnetic compatibility, functional verification and performance. Copies of these test reports are included in Appendix E.
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.
K073706 Fisher & Paykel Healthcare MR850 Humidifier, K041900 Fisher & Paykel Healthcare HC604 CPAP Humidifier
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
SECTION 5 - 5.10K Summary
Image /page/0/Picture/3 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are on the top line, with the "&" symbol between the two words. The word "HEALTHCARE" is on the second line, and there is a line above it.
ﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place, East Tamaki
15 Maurice P O Box 14 348, Panmure Telephone: +64 9 574 0100 Facsimile: +64 9 574 0158 Website: www.fphcare.com
| Contact person | James Thompson |
|---|---|
| Date prepared | 8 September 2009 |
| Trade name | AIRVO Series Humidifier |
| Classification | |
| name | Humidifier, Respiratory Gas, (Direct Patient Interface) |
| (21 CFR § 868.5450, product code BTT) | |
| Predicate device | K073706 Fisher & Paykel Healthcare MR850 Humidifier |
| K041900 Fisher & Paykel Healthcare HC604 CPAP Humidifier |
JAN 2 7 2010
Page 5 - 1
1
5.1 Description
The AIRVO Series humidifier system is a heated humidifier with integrated flow source and a heated breathing tube. The AIRVO Series comprises two similar devices; the AIRVO which is intended for use in hospitals and myAlRVO which is intended for home use. The AIRVO Series humidifiers are intended to treat spontaneously breathing patients who would benefit from receiving high flow, warmed and humidified respiratory gases.
The AIRVO 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. The blower assembly output connects directly to a humidification chamber at the front of the device.
The second functional unit of the AIRVO is a heated passover humidifier. The water is contained in a humidification chamber positioned on a heaterplate at the front of the unit. The chamber connects directly to the blower assembly via a port at 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 either a nasal cannula or tracheostomy interface either in the hospital or home environment.
The AIRVO device 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 Series humidifiers are to treat spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases. This includes patients who have their upper airways bypassed. The AIRVO is for patients in hospitals, and the myAIRVO is for home patients.
Technological Characteristics Comparison 5.3
The fundamental technological characteristics of the AIRVO Series Humidifier are equivalent to the predicate devices listed above. Technological differences between the proposed device and listed predicates include; .
The AIRVO Series is the first Fisher & Paykel Healthcare Humidifier with an integrated flow source. It provides substantially equivalent humidification therapy to the predicate Fisher & Paykel Healthcare MR850 Humidifier though the MR850 requires connection to an extemal flow source. The integrated blower allows the AIRVO Series to be used in homes or hospital wards without flow sources. The flow rate can be adjusted between 15 and 45L/min in 5L/min steps.
The AIRVO Series is based on the design of the predicate Fisher & Paykel Healthcare । HC604 CPAP Humidifier and shares substantially equivalent fundamental technological characteristics and manufacturing processes. The blower module hardware which generates the air flow is identical to that used in the predicate Fisher & Paykel Healthcare HC604 CPAP Humidifier.
The AIRVO Series allows for supplemental oxygen to be provided at the input air i stream.
2
The AIRVO Series heated breathing tube features an end of hose temperature sensor integrated into the tube design.
5.4 Non-Clinical Tests
Non-clinical testing of the AIRVO Series Humidifier has been carried out covering mechanical, electrical and thermal safety, environmental conditions, electromagnetic compatibility, functional verification and performance. Copies of these test reports are included in Appendix E.
The AIRVO Humidifier complies with the requirements of IEC 60601-1 Electrical Safety and IEC 60601-1-2 EMC. Copies of these test reports are included in Appendix D.
5.5 Conclusion
Testing carried out on the AIRVO Series Humidifiers indicates that they meet design and performance functional requirements. The proposed device meets the requirements of medical electrical equipment and humidifier standards for safety and performance. The AIRVO Series Humidifiers are substantially equivalent to the predicate devices in terms of safety, effectiveness and performance.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized bird or eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. James Thompson Regulatory Affairs Manager - OSA Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place, East Tamaki Auckland 2013 NEW ZEALAND
JAN 2 7 2010
Re: K092846
Trade/Device Name: AIRVO Series Humidifiers Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: January 18, 2010 Received: January 22, 2010
Dear Mr. Thompson:
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. 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.
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.
4
Page 2 - Mr. Thompson
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
th to
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SECTION 4 - Indications for Use Statement
510(k) Number:
Device Name: AIRVO Series Humidifiers
Indications for Use:
The AIRVO and myAIRVO Humidifiers are to treat patients spontaneously breathing who would benefit from receiving high flow warmed and humidified respiratory gases . This includes patients who have upper airways bypassed.
The AIRVO is for patients in hospitals. The myAIRVO is for home patients.
Prescription Use (21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Schulthess
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K892846