(231 days)
Not Found
No
The device description and intended use clearly define it as a mechanical pressure relief device. There is no mention of AI, ML, data processing, or any computational elements that would suggest the use of these technologies.
No
The device is described as an "in-line pressure relief device" to limit system pressure, and its function is to divert respiratory gas flow, not to treat a medical condition or disease.
No
The device is described as an "in-line pressure relief device" that limits system pressure and diverts gas flow, not as a device for diagnosing medical conditions. Its function is to manage gas flow and pressure within a respiratory system.
No
The device description clearly states it is a physical "in-line pressure relief device" and a "multi-patient use prescription-only device," indicating it is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is as an "in-line pressure relief device" to limit system pressure. This is a mechanical function related to gas delivery, not the diagnosis of disease or other conditions based on in vitro examination of specimens.
- Device Description: The description reinforces its function as a pressure relief device placed in the gas pathway. It describes how it diverts gas flow, which is a physical process, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting analytes, or providing information for diagnosis, monitoring, or screening of diseases.
Therefore, this device falls under the category of a medical device used for respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This product is intended for use as an in-line pressure relief device, designed to limit the system pressure within the limits of its stated technical specifications.
This product is indicated for patients in a hospital for use by appropriately qualified healthcare professionals.
Product codes
CBP
Device Description
The F&P Optiflow Flow Diverter is intended for use as an in-line pressure relief device, designed to limit the system pressure when used with the compatible F&P Optiflow Oxygen Kits and nasal interfaces.
The F&P Flow Diverter is placed between the flow meter and the dryline during use. It is a multi-patient use prescription-only device, provided in a non-sterile state. It operates at flow rates between 5 to 70 L/min and is intended to be used by appropriately qualified healthcare professionals in hospitals.
When an anesthesia mask is applied over the Optiflow Switch interface, the respiratory gas no longer has a pathway to flow through the nasal interface to the patient. This will trigger respiratory gas flow to be diverted into the atmosphere.
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
Not Found
Intended User / Care Setting
appropriately qualified healthcare professionals / hospital
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
Performance testing of the Flow Diverter was completed and confirms the subject device does not raise new questions of safety and effectiveness. The testing provided demonstrates substantial equivalence of the Flow Diverter to the predicate device.
The Flow Diverter has been tested to the applicable requirements of the following standards:
- ISO 80601-2-74:2017 Part 2-74 Particular requirements for basic safety and essential performance of respiratory humidifying equipment
- CGA V-5: 2019 Standard for Diameter Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications)
- IEC 60601-1 Edition 3.2 (2020) Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- ISO 17664-2:2021 Processing of health care products - Information to be provided by medical device manufacturer for the processing of medical devices. Part 2: Non-critical medical devices
- ISO 80601-2-90:2021 Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment
- IEC 62366-1:2015 + A1:2020 Medical devices Part 1: Application of usability engineering to medical devices
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Fisher & Paykel Healthcare Ltd Reena Daken Regulatory Affairs Manager 15 Maurice Paykel Place, East Tamaki Auckland, 2013 New Zealand
Re: K234053
Trade/Device Name: F&P Optiflow Flow Diverter Regulation Number: 21 CFR 868.5870 Regulation Name: Nonrebreathing valve Regulatory Class: Class II Product Code: CBP 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" (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).
1
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 QS 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,
Digitally signed by John S. John S. Bender -S Bender -- S Date: 2024.08.09
10:36:12 -04'00'
for Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Enclosure
3
Indications for Use
510(k) Number (if known) K234053
Device Name F&P Optiflow Flow Diverter
Indications for Use (Describe)
This product is intended for use as an in-line pressure relief device, designed to limit the limits of its stated technical specifications.
This product is indicated for patients in a hospital for use by appropriately qualified healthcare professionals.
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 | 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 | 8 July 2024 |
| II. DEVICE | |
| Name of Device | F&P Optiflow™ Flow Diverter |
| Common/Usual Name | Nonrebreathing Valve |
| Classification Name | Nonrebreathing Valve |
| Regulatory Class | Class II (21 CFR §868.5870) |
| Product Code | CBP |
PREDICATE DEVICE III.
Predicate Device: OJR215 Pressure Relief Manifold, K173770
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DEVICE DESCRIPTION IV.
The F&P Optiflow Flow Diverter is intended for use as an in-line pressure relief device, designed to limit the system pressure when used with the compatible F&P Optiflow Oxygen Kits and nasal interfaces.
The F&P Flow Diverter is placed between the flow meter and the dryline during use. It is a multi-patient use prescription-only device, provided in a non-sterile state. It operates at flow rates between 5 to 70 L/min and is intended to be used by appropriately qualified healthcare professionals in hospitals.
When an anesthesia mask is applied over the Optiflow Switch interface, the respiratory gas no longer has a pathway to flow through the nasal interface to the patient. This will trigger respiratory gas flow to be diverted into the atmosphere.
INDICATIONS FOR USE V.
This product is intended for use as an in-line pressure relief device, designed to limit the system pressure within the limits of its stated technical specifications.
This product is indicated for patients in a hospital for use by appropriately qualified healthcare professionals.
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COMPARISON OF TECHNOLOGICAL CHARATCERISTICS WITH THE PREDICATE DEVICE VI.
| Design/Technological
Characteristics | Subject Device
(F&P Optiflow™ Flow Diverter) | Predicate Device
(OJR215 Pressure Relief Manifold – K173770) | Comments |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for use and intended use | | | |
| Indications for Use | This product is intended for use as an in-line
pressure relief device, designed to limit the system
pressure within the limits of its stated technical
specifications.
This product is indicated for patients in a hospital
for use by appropriately qualified healthcare
professionals. | The OJR215 Pressure Relief Manifold is designed
to protect neonates, infants and children from
excessive inspiratory pressure in the event of a
downstream occlusion occurring in continuous
flow breathing gas delivery systems via nasal
cannula. The device is intended for use with flow
rates greater than 0.5 L/min up to, and including,
36 L/min. The OJR215 is fitted upstream of the
patient. The OJR215 is single use only and is
prescription only. | Equivalent |
| Availability | Prescription use
(Part 21 CFR 801 Subpart D) | Prescription use
(Part 21 CFR 801 Subpart D) | Identical |
| Intended Use Environment | Hospital | Hospital/Institutional | Identical |
| Users | Qualified healthcare professionals | Qualified healthcare professionals | Identical |
| 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 |
| Shelf Life | Up to 7 years | 3 years | Different |
| Design/Technological
Characteristics | Subject Device
(F&P OptiflowTM Flow Diverter) | Predicate Device
(OJR215 Pressure Relief Manifold - K173770) | Comments |
| 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 |
| Operating Pressure
- Maximum Pressure | Maximum system pressure of 60cmH2O at
maximum rated flow rate of 70L/min | Maximum relief pressure is 75 cm H2O at
maximum rated flow of 36 L/min. | Equivalent |
| Flow Range | 5-70L/min | 0.5-36 L/min | Equivalent |
| Application/Therapy | Nasal High Flow Therapy | Nasal High Flow Therapy | Identical |
| Function and Design | | | |
| Principles of Operation | During normal use, the valve seals against the
valve body to create a seal, allowing gas to flow
through the device to the patient. When the relief
pressure is exceeded, the shaft is moved, allowing
the seal to open and pressure is relieved, diverting
flow from the gas path to atmosphere. | During normal use, the valve seals against the
valve body to create a seal, allowing gas to flow
through the device to the patient. When the relief
pressure is exceeded, the shaft is moved, allowing
the seal to open and pressure is relieved, diverting
flow from the gas path to atmosphere. | Equivalent |
| Inlet Connection | DISS 1240 | Inlet barb | Different |
| Outlet Connection | F&P female safety connection | 22mm female taper connection as per ISO 5356-1 | Different |
| Housing | The body and enclosure is moulded and includes
the inlet and the outlet connection and is
polycarbonate. | The manifold housing is ABS, and is moulded to
include the gas inlet barb, the 22mm chamber inlet
connection and the 15mm oxygen sensor port. | Equivalent |
| Design/Technological
Characteristics | Subject Device
(F&P OptiflowTM Flow Diverter) | Predicate Device
(OJR215 Pressure Relief Manifold – K173770) | Comments |
| Shaft | The shaft connects to the 2-piece valve seal | The manifold plunger shaft is a 2-piece valve seal. | |
| Plunger Seal | The valve seal rests on the valve body during
normal use and then accurately relieves pressure by
opening when the relief pressure is reached. | The seal on the manifold plunger seals the
manifold valve during normal use and then
accurately relieves pressure by opening when the
relief pressure is reached. | Equivalent |
| Spring Pressure Relief Valve | The shaft is moved by the valve seal that moves
when the set pressure is exceeded. | The shaft is moved by a spring pressure relief valve
that moves when the set pressure is exceeded. | |
| Manifold Shroud | The rear and front caps prevent any modification
by the user to the pressure relief that has already
been set during production. | The purpose of the manifold shroud is to prevent
access to the pre-set operating pressures and
tampering. | Equivalent |
| Accessories | | | |
| Breathing Circuit | F&P AA404 Optiflow Oxygen Kit
Clearance status: a modified version of AA403
cleared under K211096 | F&P RT330 OptiflowTM Junior Optiflow Tubing
Kit
Clearance status: cleared (K173770) | Equivalent |
| Patient Interface | Nasal cannula | Nasal cannula | Equivalent |
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VII. PERFORMANCE DATA
Summary of Non-Clinical Tests
Performance testing of the Flow Diverter was completed and confirms the subject device does not raise new questions of safety and effectiveness. The testing provided demonstrates substantial equivalence of the Flow Diverter to the predicate device.
The Flow Diverter has been tested to the applicable requirements of the following standards:
- ISO 80601-2-74:2017 Part 2-74 Particular requirements for basic safety and essential ● performance of respiratory humidifying equipment
- CGA V-5: 2019 Standard for Diameter Index Safety System (Noninterchangeable Low ● Pressure Connections for Medical Gas Applications)
- IEC 60601-1 Edition 3.2 (2020) Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance
- . ISO 17664-2:2021 Processing of health care products - Information to be provided by medical device manufacturer for the processing of medical devices. Part 2: Non-critical medical devices
- ISO 80601-2-90:2021 Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment
- IEC 62366-1:2015 + A1:2020 Medical devices Part 1: Application of usability ● engineering to medical devices
CONCLUSION VIII.
The Flow Diverter is substantially equivalent to the predicate based on intended use, 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.