F&P Optiflow+ Duet Nasal Cannula

K231956 · Fisher & Paykel Healthcare, Ltd. · BTT · Feb 7, 2024 · Anesthesiology

Device Facts

• Record ID: K231956
• Device Name: F&P Optiflow+ Duet Nasal Cannula
• Applicant: Fisher & Paykel Healthcare, Ltd.
• Product Code: BTT · Anesthesiology
• Decision Date: Feb 7, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

OPT96X Model: The F&P Optiflow+ Duet is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (10 years and up) and adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway. This device is designed to be used in a hospital, sub-acute facility, or long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional. MYDUETXXX Model: The F&P Optiflow+ Duet is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (10 years and up) and adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway. This device is designed to be used in a long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.

Device Story

Nasal cannula patient interface for delivery of high-flow warmed and humidified respiratory gases; used with compatible respiratory gas humidifiers (Airvo 2, myAirvo 2, Airvo 3, MR850, F&P 950). Device consists of tubing sub-assembly, headgear sub-assembly, and nasal prongs. Used in hospitals, sub-acute facilities, long-term care facilities, or home environments. Operated by healthcare professionals or lay users (home). Provides non-invasive respiratory support to spontaneously breathing patients. Benefits include improved patient comfort and airway hydration through warmed/humidified gas delivery. Single-patient use; disposable (up to 14 days hospital/sub-acute, 30 days home/long-term care).

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-1, ISO 18562-1), mechanical performance (ISO 5356-1), usability engineering (IEC 62366-1), and transit testing (ISTA 2A). No clinical data presented.

Technological Characteristics

Nasal cannula interface with tubing and headgear sub-assemblies. Features color-coded sizing (Small: Orange, Medium: Blue, Large: Green). Headgear uses loop-and-buckle adjustment. Compatible with various F&P humidifiers. Non-sterile. Shelf life: 3 years. Storage/transport: -10 °C to +50 °C. Flow ranges vary by humidifier model (5-70 L/min).

Indications for Use

Indicated for spontaneously breathing pediatric (10 years and up) and adult patients requiring high flow warmed and humidified respiratory gases delivered to the upper airway via nasal cannula.

Regulatory Classification

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.

Predicate Devices

• F&P Optiflow+ Nasal Cannula OPT94X (K162553)

Reference Devices

• Airvo 2 and myAirvo 2 (K131895)
• MR850 humidifier (K110019)
• Airvo 3 (K221338)
• F&P 950 Respiratory Humidifier (K220703)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.

February 7, 2024

Fisher & Paykel Healthcare Ltd Reena Daken Regulatory Affairs Manager 15 Maurice Paykel Place, East Tamaki Auckland, 2013 New Zealand

Re: K231956

Trade/Device Name: F&P Optiflow+ Duet Nasal Cannula Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT Dated: February 6, 2024 Received: January 8, 2024

Dear Reena Daken:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Ethan L. Nyberg -S

Ethan Nyberg, Ph.D. Assistant Director, Respiratory Devices Team DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia,

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Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K231956

### Device Name

F&P Optiflow+ Duet Nasal Cannula

# Indications for Use (Describe)

OPT96X Model:

The F&P Optiflow+ Duet is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (10 years and up) and adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway.

This device is designed to be used in a hospital, sub-acute facility, or long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.

## MYDUETXXX Model:

The F&P Optiflow+ Duet is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (10 years and up) and adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway.

This device is designed to be used in a long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.

Type of Use (Select one or both, as applicable)

| <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|----------------------------------------------|
| <span></span> | Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary

As Required by 21 CFR 807.92

| I.<br>SUBMITTER | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Company Name and Address | Fisher & Paykel Healthcare Limited<br>15 Maurice Paykel Place<br>East Tamaki<br>Auckland 2013, New Zealand<br>Telephone: [phone] |
| Prepared and Submitted by | Jung Yun Lee<br>Regulatory Affairs Associate |
| Contact Person | Reena Daken<br>Regulatory Affairs Manager<br>Telephone: [phone]<br>Email: [e-mail] |
| Date prepared | 30 June 2023 |
| II.<br>DEVICE | |
| Name of Device | F&P Optiflow+ Duet Nasal Cannula |
| Common/Usual Name | Nasal Cannula |
| Classification Name | Respiratory Gas Humidifier |
| Regulatory Class | Class II (21 CFR §868.5450) |
| Product Code | BTT |

#### III. PREDICATE DEVICE

- Predicate device: . o F&P Optiflow+ Nasal Cannula OPT94X, K162553
#### IV. DEVICE DESCRIPTION

The F&P Optiflow+ Duet Nasal Cannula is a nasal cannula interface for use with a respiratory gas humidifier and flow generator to deliver Nasal High Flow (NHF) therapy to spontaneously breathing patients.

The F&P Optiflow+ Duet Nasal Cannula is a prescription-only device, provided in a non-sterile state and intended to be used in a hospital, sub-acute facility, or long-term (managed) care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional. The device is single patient use only for up to 14 days in the hospital and up to 30 days in the home/long-term care facilities.

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A list of the subject device product codes can be found below:

| Model | Product Code | Product Description |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|------------------------------------------|
| OPT96X<br>This device is designed to be used in a hospital, sub-acute facility or long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional. | OPT962 | Nasal Cannula - Small |
| | OPT964 | Nasal Cannula - Medium |
| | OPT966 | Nasal Cannula - Large |
| MYDUETXXX<br>This device is designed to be used in a long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional. | MYDUETSMALL | myAirvo Small Duet Nasal Cannula 2-pack |
| | MYDUETMEDIUM | myAirvo Medium Duet Nasal Cannula 2-pack |
| | MYDUETLARGE | myAirvo Large Duet Nasal Cannula 2-pack |

#### V. INDICATIONS FOR USE

The indications for use for the OPT96X Model and the MYDUETXXX Model are below:

# OPT96X Model:

The F&P Optiflow+ Duet is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (10 years and up) and adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway.

This device is designed to be used in a hospital, sub-acute facility, or long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.

# MYDUETXXX Model:

The F&P Optiflow+ Duet is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (10 years and up) and adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway.

This device is designed to be used in a long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.

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| Design/Technological<br>Characteristic | Subject Device<br>(F&P Optiflow+ Duet Nasal Cannula) | Predicate Device (K162553)<br>(F&P Optiflow+ Nasal Cannula,<br>OPT94X) | Comments |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | | | |
| Product Code | BTT | BTT | |
| Device Classification | 21 CFR §868.5450 | 21 CFR §868.5450 | Identical |
| Classification Panel | Anesthesiology | Anesthesiology | |
| Indications for use | | | |
| Indications for use | OPT96X Model<br>The F&P Optiflow+ Duet is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (10 years and up) and adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway.<br><br>This device is designed to be used in a hospital, sub-acute facility or long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed | Nasal cannula patient interface for delivery of humidified respiratory gases. | The Indications for Use statement for the subject device is more specific than the predicate device.<br><br>Target population and operating environment have been defined for the subject devices, for clarity. |
| Design/Technological<br>Characteristic | Subject Device<br>(F&P Optiflow+ Duet Nasal Cannula) | Predicate Device (K162553)<br>(F&P Optiflow+ Nasal Cannula,<br>OPT94X) | Comments |
| | MYDUETXXX Model<br><br>The F&P Optiflow+ Duet is a nasal cannula<br>patient interface for use with specified<br>respiratory gas humidifiers to treat<br>spontaneously breathing pediatric (10 years<br>and up) and adult patients who would<br>benefit from receiving high flow warmed<br>and humidified respiratory gases to the<br>upper airway. | | |
| | This device is designed to be used in a long-<br>term care facility by appropriately qualified<br>healthcare professionals, or in the home by<br>lay users operating the device as prescribed<br>by a healthcare professional. | | |
| Availability | Prescription use.<br>(Part 21 CFR 801 Subpart D) | Prescription use.<br>(Part 21 CFR 801 Subpart D) | Identical |
| Patient Population | Pediatric (10 years and up) to adult. | Mainly Adult Patients. | Patient population for the subject device<br>is more specific than the predicate device. |
| Patient Acuity | Spontaneously breathing patients. | Spontaneously breathing patients. | Identical |
| Patient Monitoring | Appropriate patient monitoring must be<br>used at all times. | Appropriate patient monitoring must be<br>used at all times. | Identical |
| Use Environment | OPT96X Series:<br>Home and Hospital environment, sub-acute | Home and Hospital environment, long-term<br>(managed) care facilities | The addition of sub-acute facilities does<br>not affect / change the user group and<br>Identical |
| Design/Technological<br>Characteristic | Subject Device<br>(F&P Optiflow+ Duet Nasal Cannula) | Predicate Device (K162553)<br>(F&P Optiflow+ Nasal Cannula,<br>OPT94X) | Comments |
| | facilities, long-term (managed) care<br>facilities | | patient population compared to the<br>predicate. |
| | MYDUET Series:<br>Home and long-term (managed) care<br>facilities | | |
| Reusability | Single patient-use only, < 14 days in<br>hospital, including sub-acute facilities | Single patient-use only, < 14 days in<br>hospital | Identical |
| | Single patient-use only, < 30 days in home,<br>and long-term care facilities | Single patient-use only, < 30 days in home<br>and long-term care facilities | |
| Number of Cannula<br>Sizes | Both Hospital and Home models are<br>available in:<br>Small<br>Medium<br>Large | Both Hospital and Home models are<br>available in:<br>Small<br>Medium<br>Large | Identical |
| Compatibility with other devices | | | |
| Humidifier<br>Compatibility | Airvo 2 and myAirvo 2 (K131895)<br>Airvo 3 (K221338)<br>MR850 humidifier (K110019)<br>F&P 950 Respiratory Humidifier<br>(K220703) | Airvo 2 and myAirvo 2 (K131895)<br>MR850 humidifier (K110019) | The predicate was not cleared for use<br>with the Airvo 3 or the F&P 950 System. |
| Design/Technological<br>Characteristic | Subject Device<br>(F&P Optiflow+ Duet Nasal Cannula) | Predicate Device (K162553)<br>(F&P Optiflow+ Nasal Cannula,<br>OPT94X) | Comments |
| Nasal Cannula Design | | | |
| Overall Cannula<br>Construction | The F&P Optiflow+ Duet Nasal Cannula is<br>made up of two sub-assemblies that connect<br>to the Nasal Prong component. | The F&P Optiflow+ Nasal Cannula is made<br>up of two sub-assemblies that connect to the<br>Nasal Prong component. | Identical |
| | The two sub-assemblies are: | The two sub-assemblies are: | |
| | Tubing sub-assembly Headgear sub-assembly | Tubing sub-assembly Headgear sub-assembly | |
| Headgear Adjustment | The headgear size adjustment (i.e. headstrap<br>length and tightness adjustment) method<br>comprises of the Headstrap component<br>looping through (and being retained by) two<br>slots on the Headstrap Buckle component. | The headgear size adjustment (i.e. headstrap<br>length and tightness adjustment) method<br>comprises of the Headstrap component<br>looping through (and being retained by) two<br>slots on the Headstrap Buckle component. | Identical |
| Size Identification Color<br>Coding | Size Small: Orange<br>Size Medium: Blue<br>Size Large: Green | Size Small: Orange<br>Size Medium: Blue<br>Size Large: Green | Identical |
| Performance Specifications | | | |
| F&P Airvo 2 System<br>Flow Range | OPT962 (Small) 10 – 50 L/min<br>OPT964 (Medium) 10 – 60 L/min<br>OPT966 (Large) 10 – 60 L/min | OPT942 (Small) 10 – 50 L/min<br>OPT944 (Medium) 10 – 60 L/min<br>OPT946 (Large) 10 – 60 L/min | Identical |
| F&P Airvo 3 System<br>Flow Range | OPT962 (Small) 10 – 60 L/min<br>OPT964 (Medium) 10 – 70 L/min<br>OPT966 (Large) 10 – 70 L/min | OPT942 (Small) 10 – 60 L/min<br>OPT944 (Medium) 10 – 70 L/min<br>OPT946 (Large) 10 – 70 L/min | Identical |
| Design/Technological<br>Characteristic | Subject Device<br>(F&P Optiflow+ Duet Nasal Cannula) | Predicate Device (K162553)<br>(F&P Optiflow+ Nasal Cannula,<br>OPT94X) | Comments |
| MR850 System Flow<br>Range | OPT962 (Small) 5 - 60 L/min<br>OPT964 (Medium) 5-60 L/min<br>OPT966 (Large) 5 - 60 L/min | OPT942 (Small) 5 - 60 L/min<br>OPT944 (Medium) 5-60 L/min<br>OPT946 (Large) 5 - 60 L/min | Identical |
| F&P 950 System Flow<br>Range | OPT962 (Small) 5 - 70 L/min<br>OPT964 (Medium) 5 - 70 L/min<br>OPT966 (Large) 5 - 70 L/min | N/A | The predicate was not cleared for use<br>with the F&P 950 System. |
| F&P myAirvo System<br>Flow Range | MYDUETSMALL 10-50 L/min<br>MYDUETMEDIUM 10-60 L/min<br>MYDUETLARGE 10-60 L/min | OPT942E (Small) 10-50 L/min<br>OPT944E (Medium) 10-60 L/min<br>OPT946E (Large) 10-60 L/min | Identical |
| Shelf life | 3 years | Shelf life not claimed on labeling | The subject device claims a 3-year shelf<br>life. |
| Transport and Storage<br>Temperature range | -10 °C to +50 °C | -10 °C to +50 °C | Identical |
| Sterility | Device not provided sterile | Device not provided sterile | Identical |

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVIC VI.

ison of features, performance data, and intended use demonstrate that the F&P Solo Mask Range is substantially equivals The com

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#### VII. PERFORMANCE DATA

# Summary of Non-Clinical Tests

The F&P Optiflow+ Duet Nasal Cannula has been tested to applicable requirements to the following standards:

- ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and ● testing within a risk management process
- ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare . applications - Part 1: Evaluation and testing within a risk management process
- ISO 5356-1:2015 Anesthetic and respiratory equipment Conical connectors: Part 1: ● Cones and sockets
- IEC 62366-1:2015+A1:2020 Medical devices Application of usability engineering to . medical devices
- ISTA 2A:2011 International Safety Transit Association Guidelines Procedure 2A: . Packaged-Products weighing 150 lb (68 kg) or less

# VIII. CONCLUSIONS

The F&P Optiflow+ Duet Nasal Cannula is substantially equivalent to the predicate based on patient population, intended uses, comparison of the technological characteristics, and performance. In addition, the conclusions drawn from the non-clinical tests demonstrate that the device is substantially equivalent to the legally marketed predicate device.