(230 days)
Not Found
No
The summary describes a mechanical respiratory interface and does not mention any AI or ML components or functions.
No.
The device delivers respiratory gases and oxygen, which supports respiration but does not treat a specific disease or condition. Its functions include pre-oxygenation and short-term supplemental oxygenation, which are supportive functions rather than therapeutic treatments.
No
The device is intended for the delivery of respiratory gases and oxygen, and for use during intubation and mask ventilation. Its functions are therapeutic and supportive, not diagnostic.
No
The device description clearly describes a physical medical device (nasal interface, flow diverter) intended for the delivery of respiratory gases, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "delivery of respiratory gases to adult patients in a hospital." This is a therapeutic function, not a diagnostic one.
- Indications for Use: The indications are for "delivery of nasal high flow (NHF) and low flow oxygen," "pre-oxygenation," "short-term supplemental oxygenation," and allowing "an anesthesia mask to be placed over the nasal interface to perform mask ventilation." These are all related to respiratory support and management, not the diagnosis of a condition.
- Device Description: The description focuses on the physical components and how they facilitate the delivery of gases and compatibility with an anesthesia mask. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro analysis.
The device is clearly designed for delivering respiratory support to patients, which falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
BTT
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
appropriately qualified healthcare professionals.
individuals who perform anesthesia care or airway management.
Hospital Environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Optiflow Nasal Oxygen Cannula with CO2 Sampling, K201723
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
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)
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4
510(k) Summary
As Required by 21 CFR 807.92
SUBMITTER I.
| 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 | Danica Tung
Regulatory Affairs Market Manager |
| Contact Person | Reena Daken
Regulatory Affairs Manager
Telephone: +64 9 574 0100
Email: reena.daken@fphcare.co.nz |
| Date Prepared | 9 July 2024 |
| II. DEVICE | |
| Name of Device | F&P Optiflow™ Filtered Nasal Interface with Anesthesia Mask
Compatibility |
| 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/Technological
Characteristics | Subject Device
(F&P OptiflowTM Filtered Nasal Interface with
Anesthesia Mask Compatibility) | Predicate Device
(Optiflow Nasal Oxygen Cannula with CO2
Sampling - K201723) | Comments |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Indications for use and intended use | | | |
| Indications for Use | 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 appropriatelyThis 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. | This product is a single-patient-use device that delivers
respiratory gases to adult patients in hospitals and long-
term care facilities.
This product is indicated for the delivery of Nasal High
Flow (NHF) and low flow oxygen to spontaneously
breathing patients by appropriately qualified healthcare
professionals.
Qualitative carbon dioxide sampling can be used at
nasal cannula flow rates from 5 to 50 L/min in
operating and procedure rooms.
This product can be used for pre-oxygenation and
short-term supplemental oxygenation (up to 10
minutes) during intubation in operating rooms under
the 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/Technological
Characteristics | Subject Device
(F&P Optiflow™ Filtered Nasal Interface with
Anesthesia Mask Compatibility) | Predicate Device
(Optiflow Nasal Oxygen Cannula with CO2
Sampling - 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 24
hours. | Single patient use only for a maximum period of 24
hours. | Identical |
| Sizes | AA041JS -Small
AA041JM- Medium
AA041JL- Large | AA030S -Small
AA030M- Medium
AA030L- Large | Identical |
| Disposal | Dispose of product safely in accordance with standard
hospital procedure. | Dispose of product safely in accordance with standard
hospital procedure. | Identical |
| Nasal Interface Function and Design | | | |
| Connector | Included | Included | Identical |
| Headgear attachment | Included | Included | Equivalent |
| Design/Technological
Characteristics | Subject Device
(F&P Optiflow™ Filtered Nasal Interface with
Anesthesia Mask Compatibility) | Predicate Device
(Optiflow Nasal Oxygen Cannula with CO2
Sampling - K201723) | Comments |
| Interface Collapsible Section | Included | Not applicable | The collapsible section design on the interface is not
applicable 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.