(230 days)
This product is intended for delivery of respiratory gases to adult patients in a hospital.
This product is indicated for the delivery of nasal high flow (NHF) and low flow oxygen by appropriately qualified healthcare professionals.
This product can be used for pre-oxygenation, short-term supplemental oxygenation (up to 10 minutes) during intubation, and allows an anesthesia mask to be placed over the nasal interface to perform mask ventilation. by individuals who perform anesthesia care or airway management.
This product is not intended for apneic ventilation
This product is not indicated for use during CPR.
Fisher & Paykel Healthcare has designed the F&P Optiflow™ System with Optiflow Switch interface that allows for mask ventilation without the need to remove the nasal interface from the patient during therapy.
To support this function, an Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility and Flow Diverter is required. The subject device in this 510(k) is the Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility that is also referred to in this submission as the Optiflow Switch interface.
The product is intended for delivery of respiratory gases to adult patients in a hospital. The product is indicated for the delivery of nasal high flow (NHF) and low flow oxygen by appropriately qualified healthcare professionals.
This is a prescription-only device provided in a non-sterile state. It has a flow range of 5 to 70 L/min. The device will be offered in three sizes, small (S), medium (M), and large (L).
It is intended to be used in combination with a compatible respiratory humidifier. Optiflow Oxygen Kit and the Optiflow Flow Diverter (AA520J).
This document is a 510(k) Premarket Notification from Fisher & Paykel Healthcare Ltd for a medical device called the F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J). The purpose of this submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (Optiflow Nasal Oxygen Cannula with CO2 Sampling, K201723).
The document details the device's indications for use, its design and technological characteristics, and provides a summary of non-clinical tests performed to support its substantial equivalence. It does not contain information about acceptance criteria or a study that specifically "proves the device meets acceptance criteria" in terms of performance metrics like sensitivity, specificity, or reader improvement with AI assistance, as this is a medical device for respiratory gas delivery, not an AI/software device with diagnostic capabilities.
Therefore, many of the requested items (e.g., effect size of human readers with AI, standalone algorithm performance, number of experts for ground truth establishment) are not applicable to this type of device submission.
Here's an analysis based on the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in the format of performance metrics against a target value for a diagnostic device. Instead, substantial equivalence is claimed based on non-clinical testing against relevant international and national standards, and a comparison of technological characteristics with the predicate device. The performance data is summarized as conforming to these standards.
| Acceptance Criteria (Implied by Standards Compliance) | Reported Device Performance (Summary) |
|---|---|
| Biological Evaluation (ISO 10993-1:2018) | Conforms to requirements |
| Basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2-74:2017) | Conforms to requirements |
| General requirements for basic safety and essential performance (IEC 60601-1 Ed 3.2:2020) | Conforms to requirements |
| Anaesthetic and respiratory equipment - Conical connectors (ISO 5356-1:2015) | Conforms to requirements |
| Usability engineering (IEC 62366-1:2015 + A1:2020) | Conforms to requirements |
| Flow Range: 5 to 70 L/min | Achieves 5 to 70 L/min (Identical to predicate) |
| Shelf Life: 18 months | Achieves 18 months (Identical to predicate) |
| Storage Temperature: -10 °C to +50 °C | Achieves -10 °C to +50 °C (Identical to predicate) |
| Reusability and Duration of Use: Single patient use only for a maximum period of 24 hours | Complies (Identical to predicate) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document refers to "performance testing" and "non-clinical tests" but does not detail the number of units tested.
- Data Provenance: Not specified. Given the nature of the tests (biological evaluation, safety, performance, usability), the data would likely be from manufacturer-conducted in-house or contracted laboratory testing rather than patient data from a specific country. This would be prospective testing of device samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the device is not an AI/diagnostic software. Ground truth in this context would be defined by the technical specifications and standards it must meet, not by expert consensus on diagnostic images or clinical outcomes.
4. Adjudication method for the test set:
Not applicable. There's no diagnostic component requiring adjudication of human-interpreted results. Test results are against engineering specifications and standard requirements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a respiratory gas delivery interface, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used:
The "ground truth" for this device would be defined by the technical specifications of the device itself and the requirements of the international and national standards (e.g., ISO 10993, ISO 80601-2-74, IEC 60601-1, ISO 5356-1, IEC 62366-1). For example, a flow range test would compare the device's actual flow output against its stated specification of 5-70 L/min.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 08, 2024
Fisher & Paykel Healthcare Ltd Reena Daken Regulatory Affairs Manager 15 Maurice Paykel Place, East Tamaki Auckland. 2013 New Zealand
Re: K234058
Trade/Device Name: F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT Dated: December 21, 2023 Received: December 22, 2023
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.
Bradley Q. Quinn -S
Bradley Ouinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia,
{2}------------------------------------------------
Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
Submission Number (if known)
Device Name
F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)
Indications for Use (Describe)
This product is intended for delivery of respiratory gases to adult patients in a hospital.
This product is indicated for the delivery of nasal high flow (NHF) and low flow oxygen by appropriately qualified healthcare professionals.
This product can be used for pre-oxygenation, short-term supplemental oxygenation (up to 10 minutes) during intubation, and allows an anesthesia mask to be placed over the nasal interface to perform mask ventilation. by individuals who perform anesthesia care or airway management.
This product is not intended for apneic ventilation
This product is not indicated for use during CPR.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
ne-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."
{4}------------------------------------------------
510(k) Summary
As Required by 21 CFR 807.92
SUBMITTER I.
| Company Name and Address | Fisher & Paykel Healthcare Limited15 Maurice Paykel PlaceEast TamakiAuckland 2013, New ZealandTelephone: +64 9 574 0100 |
|---|---|
| Prepared and Submitted by | Danica TungRegulatory Affairs Market Manager |
| Contact Person | Reena DakenRegulatory Affairs ManagerTelephone: +64 9 574 0100Email: reena.daken@fphcare.co.nz |
| Date Prepared | 9 July 2024 |
| II. DEVICE | |
| Name of Device | F&P Optiflow™ Filtered Nasal Interface with Anesthesia MaskCompatibility |
| Common/Usual Name | Nasal Cannula |
| Classification Name | Respiratory Gas Humidifier |
| Regulatory Class | Class II (21 CFR §868.5450) |
| Product Code | BTT |
PREDICATE DEVICE III.
Predicate Device: Optiflow Nasal Oxygen Cannula with CO2 Sampling, K201723
{5}------------------------------------------------
DEVICE DESCRIPTION IV.
Fisher & Paykel Healthcare has designed the F&P Optiflow™ System with Optiflow Switch interface that allows for mask ventilation without the need to remove the nasal interface from the patient during therapy.
To support this function, an Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility and Flow Diverter is required. The subject device in this 510(k) is the Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility that is also referred to in this submission as the Optiflow Switch interface.
The product is intended for delivery of respiratory gases to adult patients in a hospital. The product is indicated for the delivery of nasal high flow (NHF) and low flow oxygen by appropriately qualified healthcare professionals.
This is a prescription-only device provided in a non-sterile state. It has a flow range of 5 to 70 L/min. The device will be offered in three sizes, small (S), medium (M), and large (L).
It is intended to be used in combination with a compatible respiratory humidifier. Optiflow Oxygen Kit and the Optiflow Flow Diverter (AA520J).
INDICATIONS FOR USE V.
This product is intended for delivery of respiratory gases to adult patients in a hospital.
This product is indicated for the delivery of nasal high flow (NHF) and low flow oxygen by appropriately qualified healthcare professionals.
This product can be used for pre-oxygenation, short-term supplemental oxygenation (up to 10 minutes) during intubation, and allows an anesthesia mask to be placed over the nasal interface to perform mask ventilation, by individuals who perform anesthesia care and airway management.
This product is not intended for apneic ventilation.
This product is not indicated for use during CPR.
{6}------------------------------------------------
COMPARISON OF TECHNOLOGICAL CHARATCERISTICS WITH THE PREDICATE DEVICE VI.
| Design/TechnologicalCharacteristics | Subject Device(F&P OptiflowTM Filtered Nasal Interface withAnesthesia Mask Compatibility) | Predicate Device(Optiflow Nasal Oxygen Cannula with CO2Sampling - K201723) | Comments |
|---|---|---|---|
| Indications for use and intended use | |||
| Indications for Use | This product is intended for delivery of respiratorygases to adult patients in a hospital.This product is indicated for the delivery of nasal highflow (NHF) and low flow oxygen by appropriatelyThis product can be used for pre-oxygenation, short-term supplemental oxygenation (up to 10 minutes)during intubation, and allows an anesthesia mask to beplaced over the nasal interface to perform maskventilation, by individuals who perform anesthesia careand airway management.This product is not intended for apneic ventilation.This product is not indicated for use during CPR. | This product is a single-patient-use device that deliversrespiratory gases to adult patients in hospitals and long-term care facilities.This product is indicated for the delivery of Nasal HighFlow (NHF) and low flow oxygen to spontaneouslybreathing patients by appropriately qualified healthcareprofessionals.Qualitative carbon dioxide sampling can be used atnasal cannula flow rates from 5 to 50 L/min inoperating and procedure rooms.This product can be used for pre-oxygenation andshort-term supplemental oxygenation (up to 10minutes) during intubation in operating rooms underthe direction of a physician anesthesiologist.This product is not intended for apneic ventilation. | Equivalent |
| Availability | Prescription use(Part 21 CFR 801 Subpart D) | Prescription use(Part 21 CFR 801 Subpart D) | Identical |
| Patient Population | Adult patients | Adult patients | Identical |
| Design/TechnologicalCharacteristics | Subject Device(F&P Optiflow™ Filtered Nasal Interface withAnesthesia Mask Compatibility) | Predicate Device(Optiflow Nasal Oxygen Cannula with CO2Sampling - K201723) | Comments |
| Intended Use Environment | Hospital Environment | Hospitals and long-term care facilities | Equivalent |
| Operation and safety features | |||
| Ambient Operating Temperature | 18 to 26 °C (64.4 to 78.8°F) | 18 to 26 °C (64.4 to 78.8°F) | Identical |
| System Specifications | Flow Range: 5 to 70 L/min | Flow Range: 5 to 70 L/min | Identical |
| Shelf Life | 18 months | 18 months | Identical |
| Storage Temperature | -10 °C to +50 °C (14 to 122 °F) | -10°C to +50 °C (14 to 122 °F) | Identical |
| Sterility | Device not provided sterile. | Device not provided sterile. | Identical |
| Reusability and Duration of Use | Single patient use only for a maximum period of 24hours. | Single patient use only for a maximum period of 24hours. | Identical |
| Sizes | AA041JS -SmallAA041JM- MediumAA041JL- Large | AA030S -SmallAA030M- MediumAA030L- Large | Identical |
| Disposal | Dispose of product safely in accordance with standardhospital procedure. | Dispose of product safely in accordance with standardhospital procedure. | Identical |
| Nasal Interface Function and Design | |||
| Connector | Included | Included | Identical |
| Headgear attachment | Included | Included | Equivalent |
| Design/TechnologicalCharacteristics | Subject Device(F&P Optiflow™ Filtered Nasal Interface withAnesthesia Mask Compatibility) | Predicate Device(Optiflow Nasal Oxygen Cannula with CO2Sampling - K201723) | Comments |
| Interface Collapsible Section | Included | Not applicable | The collapsible section design on the interface is notapplicable to the predicate device. |
| Filter | Included | Not applicable | Predicate does not include a filter. |
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
VII. PERFORMANCE DATA
Summary of Non-Clinical Tests
Performance testing was completed and confirms the subject device does not raise new questions of safety and effectiveness. The testing provided demonstrates substantial equivalence of the subject device to the predicate device.
The subject device has been tested to the applicable requirements of the following standards:
- ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- . ISO 80601-2-74:2017 Part 2-74 Particular requirements for basic safety and essential performance of respiratory humidifying equipment
- . IEC 60601-1 Edition 3.2 (2020) Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
- IEC 62366-1:2015 + A1:2020 Medical devices - Part 1: Application of usability engineering to medical devices
VIII. CONCLUSION
The subject device 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.
§ 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).