(206 days)
This device is intended for the delivery of high flow respiratory gases (within the limits of its stated technical specifications) to patients in a hospital by appropriately qualified healthcare professionals.
This product is not intended to be used on patients with bypassed upper airways.
This product is not intended to be life-sustaining or life-supporting.
This product is not intended for apneic ventilation.
The F&P Optiflow Air/Oxygen Flow Source is a respiratory high flow therapy device designed to generate a flow of air and/or oxygen. The device allows selectable flow rates up to 70L/min with selectable oxygen concentrations ranging from 21% to 100%.
The subject device is a multi-patient use prescription only device, provided in a non-sterile state. It operates at flow ranges between 0 to 70 L/min and is intended to be used by appropriately qualified healthcare professionals in hospitals.
The provided FDA 510(k) clearance letter and summary for the "F&P Optiflow Air/Oxygen Flow Source" is for a hardware device, a breathing gas mixer, not a software or AI-driven diagnostic device. Therefore, the majority of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for AI/software performance is not applicable based on the provided document.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and compliance with general medical device standards. There is no information regarding AI-specific performance metrics, clinical studies involving human readers, or detailed ground truth establishment for diagnostic capabilities.
Below is a table summarizing the general performance data found, where applicable, according to the structure requested, along with an explanation for the absence of AI-specific information.
Acceptance Criteria and Device Performance for F&P Optiflow Air/Oxygen Flow Source
This device is a hardware breathing gas mixer, not an AI or software-driven diagnostic tool. As such, the typical acceptance criteria and study designs associated with AI performance (e.g., sensitivity, specificity, human reader improvement, adjudication, ground truth for AI training/testing) are not present in this 510(k) summary. The "performance data" section primarily refers to compliance with safety, electrical, and performance standards for medical electrical equipment and gas mixers.
- Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from recognized standards & predicate comparison) | Reported Device Performance (as per 510(k) Summary) |
|---|---|
| Flow Rate Accuracy: +/- 10% | Accuracy of +/- 10% (Identical to Primary Predicate) |
| Operating Temperature Range: (Comparable to predicates) | 64°F to 79°F (18 °C to 26 °C) |
| % Oxygen Control: 21 – 100% | 21 – 100% (Identical to Predicates) |
| % Oxygen Control Accuracy: (Based on ISO 11195:2018) | +/- 5% |
| Oxygen Supply Alarm: Triggers if pressure < 40psi | Issues alarm if < 40psi (Equivalent to Predicate) |
| FiO2 Alarm: Triggers if unable to achieve set FiO2 | Device alarms if unable to achieve set FiO2 |
| Power-fail Alarm: Audible alarm for t > 2 minutes | Audible alarm for time, t > 2 minutes |
| Disconnection Alarm: Activated in < 5 seconds | Activated in < 5 seconds |
| Obstruction Detected/Flow Alarm: Activated in < 5 seconds | Activated in < 5 seconds |
| General Alarm: For internal faults | Activated for internal faults |
| Compliance with ANSI/AAMI ES 60601-1:2005/A2:2021 | Tested and confirmed compliant |
| Compliance with IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 | Tested and confirmed compliant |
| Compliance with IEC 62304:2006 + A1:2015 (Software Lifecycle) | Tested and confirmed compliant |
| Compliance with IEC60601-1-6:2010+AMD1:2013+AMD2:2020 (Usability) | Tested and confirmed compliant |
| Compliance with ISO 17664-2:2021 (Processing of healthcare products) | Tested and confirmed compliant |
| Compliance with IEC 62366-1:2015 + A1:2020 (Usability Engineering) | Tested and confirmed compliant |
| Compliance with AIM 7351731 Rev 3:2021 (EMC for RFID Readers) | Tested and confirmed compliant |
| Compliance with ISO 80601-2-90:2021 (Respiratory high-flow equipment) | Tested and confirmed compliant |
| Compliance with ISO 11195:2018 (Gas mixers for medical use) | Tested and confirmed compliant (specifically for % O2 accuracy) |
| Compliance with ANSI/AAMI ST98:2022 (Cleaning validation) | Tested and confirmed compliant |
The remaining requested information is not applicable to this 510(k) submission as it pertains to an AI/software-driven diagnostic device, which the "F&P Optiflow Air/Oxygen Flow Source" is not. The document describes a physical medical device (breathing gas mixer) with its performance verified through non-clinical bench testing and compliance with relevant safety and performance standards for such equipment.
- Sample size used for the test set and the data provenance: Not applicable. The document describes non-clinical performance testing against engineering specifications and relevant standards for a hardware device, not a test set of data for AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic AI is not relevant for this hardware device.
- Adjudication method: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's performance would be the specified output values (e.g., flow rate, oxygen concentration) measured by calibrated equipment during engineering and validation testing, as required by the listed standards.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
July 14, 2025
Fisher & Paykel Healthcare Ltd
Reena Daken
Regulatory Affairs Manager
15 Maurice Paykel Place, East Tamaki
Auckland, 2013
New Zealand
Re: K243917
Trade/Device Name: F&P Optiflow Air/Oxygen Flow Source
Regulation Number: 21 CFR 868.5330
Regulation Name: Breathing Gas Mixer
Regulatory Class: Class II
Product Code: BZR
Dated: June 12, 2025
Received: June 12, 2025
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"
Page 2
K243917 - Reena Daken Page 2
(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 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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.
Page 3
K243917 - Reena Daken Page 3
See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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 Quinn
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
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K243917
Device Name
F&P Optiflow Air/Oxygen Flow Source
Indications for Use (Describe)
This device is intended for the delivery of high flow respiratory gases (within the limits of its stated technical specifications) to patients in a hospital by appropriately qualified healthcare professionals.
This product is not intended to be used on patients with bypassed upper airways.
This product is not intended to be life-sustaining or life-supporting.
This product is not intended for apneic ventilation.
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)
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."
Page 5
F&P Optiflow Air/Oxygen Flow Source - K243917
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
14 July 2025
II. DEVICE
Name of Device
F&P Optiflow™ Air/Oxygen Flow Source
Common/Usual Name
Breathing Gas Mixer
Classification
21 CFR §868.5330
Regulatory Class
II
Product Code
BZR
III. PREDICATE DEVICES
Primary Predicate Device: MaxBlend 2 and MaxBlend Lite, K161718
Secondary Predicate Device: Airvo 2 Humidifier and myAirvo 2 Humidifier, K131895
Page 6
F&P Optiflow Air/Oxygen Flow Source - K243917
IV. DEVICE DESCRIPTION
The F&P Optiflow Air/Oxygen Flow Source is a respiratory high flow therapy device designed to generate a flow of air and/or oxygen. The device allows selectable flow rates up to 70L/min with selectable oxygen concentrations ranging from 21% to 100%.
The subject device is a multi-patient use prescription only device, provided in a non-sterile state. It operates at flow ranges between 0 to 70 L/min and is intended to be used by appropriately qualified healthcare professionals in hospitals.
V. INDICATIONS FOR USE
This device is intended for the delivery of high flow respiratory gases (within the limits of its stated technical specifications) to patients in a hospital by appropriately qualified healthcare professionals.
This product is not intended to be used on patients with bypassed upper airways.
This product is not intended to be life-sustaining or life-supporting.
This product in not intended for apneic ventilation.
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F&P Optiflow Flow Diverter – K243917
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Design/technological characteristics | Subject Device (F&P Optiflow Air/Oxygen Flow Source) | Primary Predicate Device (MaxBlend 2 and MaxBlend Lite – K161718) | Secondary Predicate Device (Airvo 2 Humidifier and myAirvo 2 Humidifier – K131895) | Comments |
|---|---|---|---|---|
| Classification | ||||
| Device Classification | 21 CFR 868.5330 Class II | 21 CFR 868.5330 Class II | 21 CFR 868.5450 Class II | Identical |
| Classification Panel | Anesthesiology | Anesthesiology | Anesthesiology | Identical |
| Product Code | BZR | BZR | BTT | Identical |
| Indications for use and intended use | ||||
| Indications for Use | This device is intended for the delivery of high flow respiratory gases (within the limits of its stated technical specifications) to patients in a hospital by appropriately qualified healthcare professionals. This product is not intended to be used on patients with bypassed upper airways. This product is not intended to be life-sustaining or life-supporting. | The MaxBlend 2 and MaxBlend Lite are designed to provide a continuous air/oxygen gas mixture and to continuously monitor the concentration of oxygen being delivered to infant, pediatric, and adult patients. It is a restricted medical device intended for use by qualified, trained personnel, under the direction of a physician, in professional healthcare settings, i.e., hospital, sub-acute, and nursing-care facilities where the delivery and | The Airvo 2 Humidifier is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases. This includes patients who have had upper airways bypassed. The flow may be from 2 – 60 L/min depending on the patient interface. The Airvo 2 Humidifier is for patients in hospitals and longterm care facilities. | Equivalent |
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F&P Optiflow Flow Diverter – K243917
| Design/technological characteristics | Subject Device (F&P Optiflow Air/Oxygen Flow Source) | Primary Predicate Device (MaxBlend 2 and MaxBlend Lite – K161718) | Secondary Predicate Device (Airvo 2 Humidifier and myAirvo 2 Humidifier – K131895) | Comments |
|---|---|---|---|---|
| This product is not intended for apneic ventilation. | monitoring of air/oxygen mixtures is required. This is not intended as a life supporting device. | |||
| Availability | ||||
| Prescription use (Part 21 CFR 801 Subpart D) | Prescription use (Part 21 CFR 801 Subpart D) | Prescription use (Part 21 CFR 801 Subpart D) | Identical | |
| Intended Use Environment | ||||
| Hospital | Professional healthcare settings, i.e., hospital, sub-acute, and nursing-care facilities, where the delivery and monitoring of air/oxygen mixtures is required. Not for use in MRI environments | Hospitals and long-term care facilities | Equivalent | |
| Users | ||||
| Qualified healthcare professionals | Qualified trained personnel, under the direction of a physician | Healthcare professionals | Identical to secondary predicate. | |
| Contraindications | ||||
| No contraindications | No contraindications | No contraindications | Identical | |
| Technological Characteristics | ||||
| Power/Energy Source | ||||
| Mains power | Battery (4 x AA Alkaline batteries) – Power source for the oxygen monitor only. | Mains power | Identical to secondary predicate | |
| Control & Monitoring | ||||
| Electronic flow and FiO2 control. | Mechanical flow and FiO2 control. Monitoring FiO2 output. | Electronic flow control. | Equivalent |
Page 9
F&P Optiflow Flow Diverter – K243917
| Design/technological characteristics | Subject Device (F&P Optiflow Air/Oxygen Flow Source) | Primary Predicate Device (MaxBlend 2 and MaxBlend Lite – K161718) | Secondary Predicate Device (Airvo 2 Humidifier and myAirvo 2 Humidifier – K131895) | Comments |
|---|---|---|---|---|
| Monitoring of flow and FiO2 output. | Monitoring of flow and FiO2 output. | |||
| Device User Interface | ||||
| Display with touch screen | Monitoring system has a display and push buttons for user input. Flow control is via rotary dial and a ball float for indicator | Display with push buttons | Different. Similar to the primary and secondary predicates, the subject device has a display screen. Input and control for the subject device is via the touch screen, whereas both predicates utilise push buttons and a rotary dial (primary predicate only). The difference in device user interface does not raise new questions of safety and effectiveness. | |
| Performance Specifications | ||||
| Flow Range | ||||
| 0 – 70 L/min | 0 – 100 L/min | 2 – 60 L/min | Equivalent | |
| Flow Meter Accuracy | ||||
| Accuracy of +/- 10% | Accuracy of +/- 10% | N/A | Identical | |
| Operating Temperature Range | ||||
| 64°F to 79°F (18 °C to 26 °C) | 59°F to 122°F (15°C to 50°C) | 64°F to 79°F (18 °C to 26 °C) | Equivalent |
Page 10
F&P Optiflow Flow Diverter – K243917
| Design/technological characteristics | Subject Device (F&P Optiflow Air/Oxygen Flow Source) | Primary Predicate Device (MaxBlend 2 and MaxBlend Lite – K161718) | Secondary Predicate Device (Airvo 2 Humidifier and myAirvo 2 Humidifier – K131895) | Comments |
|---|---|---|---|---|
| % Oxygen Control | ||||
| 21 – 100% | 21 – 100% | 21 – 100% | Identical | |
| % Oxygen Control Accuracy | ||||
| +/- 5% | +/- 3% | Not applicable | Different. The subject device's % oxygen control accuracy limit is based on ISO 11195:2018, that specifies the requirements for the performance and safety of stand-alone gas mixers (blenders). The difference in oxygen control accuracy does not raise new questions of safety and effectiveness. | |
| Alarms | ||||
| Alarm method | ||||
| Visual and audible alarm system. Mute button | Visual and audible alarm system. Mute button | Visual and audible alarm system. Mute button | Identical | |
| Oxygen Supply Alarm | ||||
| Issues alarm if the oxygen supply pressure is < 40psi | Air/oxygen mixer feature: Pressure supply differential alarm – Air/oxygen pressure must be < 20 psi an alarm sounds | Not Applicable | Equivalent |
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F&P Optiflow Flow Diverter – K243917
| Design/technological characteristics | Subject Device (F&P Optiflow Air/Oxygen Flow Source) | Primary Predicate Device (MaxBlend 2 and MaxBlend Lite – K161718) | Secondary Predicate Device (Airvo 2 Humidifier and myAirvo 2 Humidifier – K131895) | Comments |
|---|---|---|---|---|
| FiO2 Alarm | ||||
| Device alarms if it is unable to achieve set FiO2 FiO2: 21 - 100% | Oxygen monitor features: High alarm range – 16 – 100% | Issues alarm if oxygen fraction as measured by oxygen sensor is above or below user adjustable high/low limit. | Equivalent | |
| Power-fail Alarm | ||||
| Power out audible alarm for time, t > 2 minutes or until power is restored, or capacitor charge is depleted. | Unknown | Power out audible alarm for time, t > 2 minutes or until paused by user pushing alarm mute button, power is restored (non-latching alarm), or capacitor charge is depleted. | Equivalent | |
| Disconnection | ||||
| Disconnection alarm activated in < 5 seconds when no connection/disconnection has been detected | Unknown | 'Check tube' and 'Check for leaks' alarms are activated in < 5 seconds if the breathing tube is not plugged in correctly | Identical to secondary predicate | |
| Obstruction Detected/Flow Alarm | ||||
| Obstruction alarm will be activated in < 5 seconds when an obstruction has been detected | Unknown | 'Check for blockages' alarm in <10 seconds when the device has detected a blockage | Equivalent | |
| General | ||||
| General alarm warning is activated when internal faults, such as hardware, visual alarm, audio alarm and alarm systems has been detected. | Unknown | Fault alarm is activated when the unit has detected an internal fault and has shut itself down. | Equivalent |
Page 12
F&P Optiflow Flow Diverter – K243917
| Design/technological characteristics | Subject Device (F&P Optiflow Air/Oxygen Flow Source) | Primary Predicate Device (MaxBlend 2 and MaxBlend Lite – K161718) | Secondary Predicate Device (Airvo 2 Humidifier and myAirvo 2 Humidifier – K131895) | Comments |
|---|---|---|---|---|
| FiO2 Alarm | ||||
| Device alarms if it is unable to achieve set FiO2 FiO2: 21 - 100% | Oxygen monitor features: High alarm range – 16 – 100% | Issues alarm if oxygen fraction as measured by oxygen sensor is above or below user adjustable high/low limit. | Equivalent | |
| Power-fail Alarm | ||||
| Power out audible alarm for time, t > 2 minutes or until power is restored, or capacitor charge is depleted. | Unknown | Power out audible alarm for time, t > 2 minutes or until paused by user pushing alarm mute button, power is restored (non-latching alarm), or capacitor charge is depleted. | Equivalent | |
| Disconnection | ||||
| Disconnection alarm activated in < 5 seconds when no connection/disconnection has been detected | Unknown | 'Check tube' and 'Check for leaks' alarms are activated in < 5 seconds if the breathing tube is not plugged in correctly | Identical to secondary predicate | |
| Obstruction Detected/Flow Alarm | ||||
| Obstruction alarm will be activated in < 5 seconds when an obstruction has been detected | Unknown | 'Check for blockages' alarm in <10 seconds when the device has detected a blockage | Equivalent | |
| General | ||||
| General alarm warning is activated when internal faults, such as hardware, visual alarm, audio alarm and alarm systems has been detected. | Unknown | Fault alarm is activated when the unit has detected an internal fault and has shut itself down. | Equivalent | |
| Other | ||||
| Gas Supply Type & Pressure | ||||
| Room air: Ambient pressure External oxygen source : 40 – 87 psi | Air/Oxygen: 30 – 75 psi | Room air: Ambient pressure External oxygen source (optional) | Equivalent | |
| Materials in Gas Pathway | ||||
| Externally communicating – tissue contact, permanent duration. No exposure to humidified gases. VOC and PM2.5 | Externally communicating – tissue contact, permanent duration. No exposure to humidified gases. VOC and PM2.5 | Indirect contact - External communicating - tissue, bone, dentin | Identical |
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F&P Optiflow Flow Diverter – K243917
VII. PERFORMANCE DATA
Summary of Non-Clinical Tests
Performance testing of the Flow Source 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 devices.
The Flow Source has been tested to the applicable requirements to the following standards:
- ANSI/AAMI ES 60601-1:2005/A2:2021 Medical Electrical Equipment – Part 1: General Requirements For Basic Safety and Essential Performance – Amendments 2
- IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 62304:2006 + A1:2015 Medical device software – Software life cycle processes
- IEC60601-1-6:2010+AMD1:2013+AMD2:2020 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
- 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
- IEC 62366-1:2015 + A1:2020 Medical devices – Part 1: Application of usability engineering to medical devices
- AIM 7351731 Rev 3:2021 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers
- 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
- ISO 11195:2018 Gas mixers for medical use – Stand-alone gas mixers
- ANSI/AAMI ST98:2022 Cleaning validation of health care products – Requirements for development and validation of a cleaning process for medical devices.
VIII. CONCLUSION
The Flow Source is substantially equivalent to the predicates 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.
§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).