(231 days)
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 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.
The medical device in question is the "F&P Optiflow™ Flow Diverter", a nonrebreathing valve (Product Code: CBP).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly provide a table of acceptance (performance) criteria with numerical targets. Instead, it states that "Performance testing of the Flow Diverter was completed and confirms the subject device does not raise new questions of safety and effectiveness." It implies that the device met the safety and performance standards outlined in the listed ISO and IEC standards.
However, based on the comparison table with the predicate device, we can infer some key performance characteristics. The document emphasizes equivalence to the predicate device, the "OJR215 Pressure Relief Manifold (K173770)".
| Characteristic / Acceptance Criteria (Inferred) | F&P Optiflow™ Flow Diverter (Subject Device) Performance | OJR215 Pressure Relief Manifold (Predicate Device) Performance | Comments (for equivalence) |
|---|---|---|---|
| Indications for Use | In-line pressure relief, limits system pressure within stated specs, for hospital use by qualified professionals. | Protects neonates, infants, children from excessive inspiratory pressure in downstream occlusion in continuous flow systems via nasal cannula. For flow rates 0.5-36 L/min. Upstream of patient, single use, prescription only. | Equivalent (despite slight wording differences, the core function of pressure relief in a respiratory circuit is comparable). |
| 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 |
| 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 (Subject device has longer shelf life, which is generally a performance improvement from a user's perspective, but would have required stability testing). |
| 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 (Both devices are designed to provide pressure relief; the specific maximum pressures and flow rates differ but are within acceptable ranges for their respective claims. The subject device operates at a lower maximum pressure but at a higher maximum flow). |
| Flow Range | 5-70 L/min | 0.5-36 L/min | Equivalent (Both cover a range of flow rates, the subject device covers a higher range). |
| Application/Therapy | Nasal High Flow Therapy | Nasal High Flow Therapy | Identical |
| Principles of Operation | Valve seals, allows gas flow; if relief pressure exceeded, shaft moves, seal opens, pressure relieved, flow diverted to atmosphere. | Valve seals, allows gas flow; if relief pressure exceeded, shaft moves, seal opens, pressure relieved, flow diverted to atmosphere. | Equivalent |
| Inlet Connection | DISS 1240 | Inlet barb | Different (Requires compatibility verification) |
| Outlet Connection | F&P female safety connection | 22mm female taper connection as per ISO 5356-1 | Different (Requires compatibility verification) |
| Housing Material | Polycarbonate | ABS | Equivalent (Both are suitable medical-grade plastics). |
| Plunger Seal Function | Rests on valve body, accurately relieves pressure by opening when relief pressure is reached. | Seals manifold valve during normal use, accurately relieves pressure by opening when relief pressure is reached. | Equivalent |
| Spring Pressure Relief Valve Mechanism | Shaft moved by valve seal that moves when set pressure is exceeded. | Shaft moved by a spring pressure relief valve that moves when set pressure is exceeded. | Equivalent |
| Manifold Shroud / Tamper Prevention | Rear and front caps prevent user modification to preset pressure relief. | Prevents access to pre-set operating pressures and tampering. | Equivalent |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a sample size for a "test set" in the context of a clinical performance study. The testing described is non-clinical performance testing against standards. Therefore, concepts like sample size for clinical test data, country of origin, or retrospective/prospective data are not applicable here. The testing would have involved multiple units of the device under various conditions described by the cited standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This is not a clinical study involving expert interpretation or "ground truth" establishment in a diagnostic context. The performance is assessed against engineering and safety standards.
4. Adjudication Method for the Test Set:
Not applicable. There's no human interpretation or diagnostic assessment that would require an adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a mechanical pressure relief valve, 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-based device.
7. The type of ground truth used:
The "ground truth" for this device would be its performance against the objective criteria defined in the referenced industry standards (e.g., ISO 80601-2-74:2017 for respiratory humidifying equipment, IEC 60601-1 for basic safety and essential performance, ISO 80601-2-90:2021 for respiratory high-flow therapy equipment). This includes measurements such as maximum pressure relief, flow rates, temperature tolerances, and mechanical integrity, as well as adherence to design principles and safety features.
8. The sample size for the training set:
Not applicable. This is a medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable.
In summary:
The document describes a 510(k) submission for a non-AI, mechanical medical device. The "acceptance criteria" are primarily established by compliance with recognized international and national standards for medical devices and respiratory equipment (ISO, IEC, CGA), as well as demonstrating substantial equivalence to a predicate device. The "study" proving this is a series of non-clinical performance and safety tests conducted in accordance with these standards. The concepts of clinical test sets, ground truth by experts, and training sets for algorithms are not relevant to this type of device submission.
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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).
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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
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Enclosure
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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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510(k) Summary
As Required by 21 CFR 807.92
I. SUBMITTER
| Company Name and Address | Fisher & Paykel Healthcare Limited15 Maurice Paykel PlaceEast TamakiAuckland 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/TechnologicalCharacteristics | 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-linepressure relief device, designed to limit the systempressure within the limits of its stated technicalspecifications.This product is indicated for patients in a hospitalfor use by appropriately qualified healthcareprofessionals. | The OJR215 Pressure Relief Manifold is designedto protect neonates, infants and children fromexcessive inspiratory pressure in the event of adownstream occlusion occurring in continuousflow breathing gas delivery systems via nasalcannula. The device is intended for use with flowrates greater than 0.5 L/min up to, and including,36 L/min. The OJR215 is fitted upstream of thepatient. The OJR215 is single use only and isprescription 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 OperatingTemperature | 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/TechnologicalCharacteristics | 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 atmaximum rated flow rate of 70L/min | Maximum relief pressure is 75 cm H2O atmaximum 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 thevalve body to create a seal, allowing gas to flowthrough the device to the patient. When the reliefpressure is exceeded, the shaft is moved, allowingthe seal to open and pressure is relieved, divertingflow from the gas path to atmosphere. | During normal use, the valve seals against thevalve body to create a seal, allowing gas to flowthrough the device to the patient. When the reliefpressure is exceeded, the shaft is moved, allowingthe seal to open and pressure is relieved, divertingflow 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 includesthe inlet and the outlet connection and ispolycarbonate. | The manifold housing is ABS, and is moulded toinclude the gas inlet barb, the 22mm chamber inletconnection and the 15mm oxygen sensor port. | Equivalent |
| Design/TechnologicalCharacteristics | 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 duringnormal use and then accurately relieves pressure byopening when the relief pressure is reached. | The seal on the manifold plunger seals themanifold valve during normal use and thenaccurately relieves pressure by opening when therelief pressure is reached. | Equivalent |
| Spring Pressure Relief Valve | The shaft is moved by the valve seal that moveswhen the set pressure is exceeded. | The shaft is moved by a spring pressure relief valvethat moves when the set pressure is exceeded. | |
| Manifold Shroud | The rear and front caps prevent any modificationby the user to the pressure relief that has alreadybeen set during production. | The purpose of the manifold shroud is to preventaccess to the pre-set operating pressures andtampering. | Equivalent |
| Accessories | |||
| Breathing Circuit | F&P AA404 Optiflow Oxygen KitClearance status: a modified version of AA403cleared under K211096 | F&P RT330 OptiflowTM Junior Optiflow TubingKitClearance 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.
§ 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).