Who is the manufacturer of F&P Airvo 3?

Fisher & Paykel Healthcare filed the 510(k) submission for F&P Airvo 3 (K221338).

What is the FDA product code for F&P Airvo 3?

QAV. It is classified under 21 CFR 868.5454 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for F&P Airvo 3?

510(k) clearance (submission type: Traditional).

What are the predicate devices for F&P Airvo 3?

Precision Flow® HVNI (DEN170001); AIRVO 2 Humidifier (K131895).

Who can help prepare an FDA 510(k) submission like F&P Airvo 3?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

F&P Airvo 3

K221338 · Fisher & Paykel Healthcare · QAV · Jan 27, 2023 · Anesthesiology

Device Facts

Record ID	K221338
Device Name	F&P Airvo 3
Applicant	Fisher & Paykel Healthcare
Product Code	QAV · Anesthesiology
Decision Date	Jan 27, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5454
Device Class	Class 2
Attributes	Therapeutic, Pediatric

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.

Device Story

High-flow respiratory device; consists of blower and heated passover humidifier. Blower provides adjustable air flow; mixes with external oxygen source. Gas warmed/humidified in chamber; delivered via heated breathing tube to patient interface (nasal cannula, tracheostomy connector, mask adapter). Used in hospitals/sub-acute facilities by healthcare professionals. Integrated oxygen analyzer monitors air/oxygen mixture; visual display provides data. External pulse oximeter connectivity via USB port for SpO2/pulse rate display. Device augments breathing for patients with respiratory distress/hypoxemia; does not provide total ventilation. Benefits include warmed/humidified gas delivery to improve patient comfort and respiratory support.

Clinical Evidence

Bench testing only. Performance testing included blending accuracy, flow rate accuracy, continuous use thermal stability, and humidification output. Biocompatibility, electrical safety, EMC, and alarm system testing performed per recognized standards (ISO 10993, IEC 60601 series).

Technological Characteristics

Heated passover humidifier with integrated blower. Flow range 2-70 L/min. Oxygen input via high-pressure (280-600 kPa) or low-pressure ports. Heated breathing tube (single-lumen, spiral heater wires). Connectivity: USB port for external pulse oximeter. Power: 100-240 VAC, 50-60 Hz. Reprocessing: internal outlet elbow high-level disinfected; other components single-patient use. Standards: ISO 80601-2-74, ISO 80601-2-61, IEC 62304.

Indications for Use

Indicated for spontaneously breathing infant, child, adolescent, and adult patients in hospitals and sub-acute facilities suffering from respiratory distress and/or hypoxemia. Not intended for total ventilatory support or field transport.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the high flow humidified oxygen delivery device is subject to the following special controls:

*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.

Predicate Devices

Precision Flow® HVNI (DEN170001)
AIRVO 2 Humidifier (K131895)

Submission Summary (Full Text)

{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) | # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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 |…

F&P Airvo 3

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

F&P Airvo 3

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Connected apps

Welcome

Check your email

Welcome!