(219 days)
No
The document describes a nasal cannula patient interface and does not mention any AI or ML capabilities.
Yes.
The device is used 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", indicating a therapeutic purpose.
No
Explanation: The device is described as a nasal cannula patient interface used to treat patients by delivering warmed and humidified respiratory gases. Its purpose is therapeutic, not to diagnose a condition or disease.
No
The device description explicitly states it is a "nasal cannula interface," which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver warmed and humidified respiratory gases to the upper airway of 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 nasal cannula interface used with a humidifier and flow generator. This is a medical device used for patient support, not for analyzing biological samples.
- No mention of in vitro testing: The description does not mention any testing of samples (blood, urine, tissue, etc.) outside of the body.
- Focus on patient interface: The device is described as a "patient interface" for delivering therapy.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
BTT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper airway (via nasal cannula)
Indicated Patient Age Range
Pediatric (10 years and up) and adult patients
Intended User / Care Setting
Appropriately qualified healthcare professionals, or lay users operating the device as prescribed by a healthcare professional.
Settings: hospital, sub-acute facility, long-term care facility, home.
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 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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K131895, K221338, K110019, K220703
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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"
1
(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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,
2
Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
3
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)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
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 | Jung Yun Lee |
| Regulatory Affairs Associate | |
| Contact Person | Reena Daken |
| Regulatory Affairs Manager | |
| Telephone: +64 9 574 0100 | |
| Email: reena.daken@fphcare.co.nz | |
| Date prepared | 30 June 2023 |
| II. | |
| 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.
5
A list of the subject device product codes can be found below:
| Model | Product Code | Product Description |
|---|---|---|
| OPT96X | ||
| 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 | ||
| 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.
6
| Design/Technological
Characteristic | Subject Device
(F&P Optiflow+ Duet Nasal Cannula) | Predicate Device (K162553)
(F&P Optiflow+ Nasal Cannula,
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
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 | 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.
Target population and operating environment have been defined for the subject devices, for clarity. |
| Design/Technological
Characteristic | Subject Device
(F&P Optiflow+ Duet Nasal Cannula) | Predicate Device (K162553)
(F&P Optiflow+ Nasal Cannula,
OPT94X) | Comments |
| | 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. | | |
| Availability | Prescription use.
(Part 21 CFR 801 Subpart D) | Prescription use.
(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
is more specific than the predicate device. |
| Patient Acuity | Spontaneously breathing patients. | Spontaneously breathing patients. | Identical |
| Patient Monitoring | Appropriate patient monitoring must be
used at all times. | Appropriate patient monitoring must be
used at all times. | Identical |
| Use Environment | OPT96X Series:
Home and Hospital environment, sub-acute | Home and Hospital environment, long-term
(managed) care facilities | The addition of sub-acute facilities does
not affect / change the user group and
Identical |
| Design/Technological
Characteristic | Subject Device
(F&P Optiflow+ Duet Nasal Cannula) | Predicate Device (K162553)
(F&P Optiflow+ Nasal Cannula,
OPT94X) | Comments |
| | facilities, long-term (managed) care
facilities | | patient population compared to the
predicate. |
| | MYDUET Series:
Home and long-term (managed) care
facilities | | |
| Reusability | Single patient-use only,