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.

Device Description

The F&P Optiflow™ Nasal Oxygen Cannula with CO2 Sampling is a medical device intended to deliver respiratory gases to the patient and provide a sample of the patient's exhaled respiratory gases through the CO2 sampling accessory to a CO2 sampling line and CO2 analyzer. The device is offered in three sizes being small (S), medium (M) and large (L). The F&P Optiflow™ Nasal Oxygen Cannula with CO2 Sampling is a prescription only device, provided in a non-sterile state.

AI/ML Overview

The requested information, based on the provided document, is as follows:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria for specific performance metrics alongside reported numerical device performance values in the way one might expect for a diagnostic or AI device. Instead, it describes a series of non-clinical performance tests conducted to ensure safety and effectiveness and demonstrate substantial equivalence. The 'reported device performance' is generally stated as having met the requirements or demonstrating functionality.

Here's a summary of the performance tests performed, which imply the acceptance criteria were met if the tests were successful:

Test Category	Implied Acceptance Criteria (Met if successful)	Reported Device Performance
Shelf Life Testing (as per ASTM F1980-16)	Product requirements continue to be met after 18 months of storage.	Demonstrated product requirements continue to be met after 18 months.
Transportation Testing (as per ISTA 2A:2011)	Device integrity and functionality maintained after transportation.	Performed following transportation to ISTA 2A:2011.
Nasal Cannula Leak Test	No unacceptable leaks.	Completed.
CO2 Sampling Tube Leak Test	No unacceptable leaks.	Completed.
Resistance to flow of the CO2 Sampling Tube	Resistance within acceptable limits.	Completed.
Resistance to flow during compression of the CO2 Sampling Tube	Resistance within acceptable limits during compression.	Completed.
Functional Requirements Testing	Functional requirements met after transport, storage, simulated use.	Performed to ensure functional requirements were met.
Strength Testing of CO2 Sampling Tube's permanent connections	Connections maintain strength after transport, storage, simulated use.	Performed after transport, storage, and simulated use conditioning.
CO2 Sampling functionality validation	Device accurately samples CO2 as intended.	Performed to validate the device's CO2 Sampling functionality.
Usability testing	CO2 Sampling feature and related warnings/directions for use are usable.	Conducted on the use of the CO2 Sampling feature and warnings/directions.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes non-clinical performance data (laboratory testing) rather than clinical study data involving patient samples in the typical sense of a "test set" for a diagnostic device. Therefore, a "sample size for the test set" is not applicable in this context. The tests were performed on the device itself and its components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The document describes laboratory-based performance testing, not a study requiring expert-established ground truth from medical images or patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no adjudication method described as it refers to performance testing of a physical device against engineering specifications and standards, not a diagnostic assessment by multiple readers.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical performance tests are the engineering specifications, relevant ISO standards (e.g., ISO 594-2, ISO 5356-1, ISO 5361, ISO 10993-1, ISO 18562-1), and the device's own design requirements. For example, a leak test would compare the device's leak rate to an acceptable industry standard or internal specification.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

March 16, 2021

Fisher & Paykel Healthcare Ltd. Reena Daken Senior Regulatory Affairs Specialist 15 Maurice Paykel Place, East Tamaki Auckland, 2013 New Zealand

Re: K201723

Trade/Device Name: F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT Dated: February 12, 2021 Received: February 16, 2021

Dear Reena Daken:

We have reviewed vour 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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,

Todd Courtney Assistant Director DHT1C: Division of ENT. Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201723

Device Name

F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling

Indications for Use (Describe)

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.

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(c)

l. SUBMITTER

Company Name and Address	Fisher & Paykel Healthcare Limited15 Maurice Paykel PlaceEast TamakiAuckland 2013, New ZealandTelephone: +64 9 574 0100
Prepared and Submitted by	Amelia Ortiz RiosSenior Regulatory Affairs Specialist
Contact Person	Reena DakenRegulatory Affairs Market ManagerTelephone: +64 9 574 0100Email: reena.daken@fphcare.co.nz
Date Prepared	16 March 2021

II. DEVICE

Name of Device	F&P Optiflow™ Nasal Oxygen Cannula with CO2 Sampling
Common/Usual Name	Nasal Cannula
Classification Name	Respiratory gas humidifier
Regulatory Class	Class II (21 CFR §868.5450)
Product Code	BTT

PREDICATE DEVICE lll.

Predicate device: ●
- K162553 F&P Optiflow™+ Nasal Cannula o
. Reference device:
- K162343 Westmed Gas Sampling Cannula with O2 Delivery o

IV. DEVICE DESCRIPTION

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Principle of Operation

The subject device is an interface which delivers respiratory gases to the patient from a humidification system or a flow meter. The internal diameter of the tube and the geometry of the manifold, gas path connector and nasal prongs have been designed to reduce turbulent flow, allowing it to deliver respiratory gas at both low and high flows.

The F&P Optiflow™ Nasal Oxygen Cannula with CO2 Sampling may be connected to breathing circuits and a humidifier or it may also be used with a flow meter, such as, the Compensated Thorpe Tube Flowmeter. the Nasal Oxygen Cannula may be connected to breathing circuits through a male medical taper connector as per ISO 5356-1:2015 'Anaesthetic and respiratory equipment – Conical connectors - Part 1: Cones and sockets'.

The nasal cannula delivers respiratory gases from the inspiratory tube to the patient. The nasal cannula is fitted onto the patient and attached to the inspiratory tube using the above connector. The CO2 sampling component connects to a commercially available carbon dioxide sampling line (not included with this product) and is fitted on the patient to sample exhaled gas from either the nares, or mouth.

INDICATIONS FOR USE V.

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.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.

Design/technological	Subject device	Predicate device	Rationale for Substantial Equivalence
characteristic for	F& P Optiflow™ Nasal Oxygen	F&P Optiflow™+ Nasal Cannula
comparison	Cannula with CO2 Sampling
Indications for Use	This product is a single-patient-usedevice that delivers respiratory gases toadult patients in hospitals and long-termcare facilities.This product is indicated for the deliveryof Nasal High Flow (NHF) and Low FlowOxygen to spontaneously breathingpatients by appropriately qualifiedhealthcare professionals.Qualitative carbon dioxide sampling canbe used at nasal cannula flow rates from5 to 50 L/min in operating and procedurerooms.This product can be used for pre-oxygenation and short-termsupplemental oxygenation (up to 10minutes) during intubation in operatingrooms under the direction of a physiciananesthesiologist.This product is not intended for apneicventilation.	Nasal cannula patient interface fordelivery of humidified respiratory gases.	EquivalentThe intended uses are equivalent.The subject and predicate devices are bothintended to deliver high flow humidifiedrespiratory gases.The subject device has a carbon dioxidesampling functionality which is supportedthrough performance testing as per thereference device, K162343.
Availability	Prescription use.(Part 21 CFR 801 Subpart D)	Prescription use.(Part 21 CFR 801 Subpart D)	Identical.
Patient Population	Adult patients.	Mainly adult patients.	Equivalent.Patient population for the subject device is asubset of the patient population of the predicatedevice.
OperatingEnvironment	Hospitals and long term care facilities.	Hospitals and long term care facilities.	Identical.
Reusability andDuration of Use	Single patient use only for a maximumperiod of 24 hours.	Single patient use only,< 14 days hospitalSingle patient reusable,< 30 days home	Equivalent.
Sizes	AA030SAA030MAA030L	OPT942 SmallOPT944 MediumOPT946 Large	Identical.
Specifications
Ambient OperatingTemperature	18 – 26 °C	18 – 28 °C	EquivalentThe operating temperature range is within that ofthe predicate device.
SystemSpecifications	When assembled with 22 mm heatedinspiratory tube and chamber and acompatible F&P humidifier:	MR850 Humidifier in invasive mode, RTseries kit with 22 mm heated inspiratorytube and chamber.	EquivalentThe subject device is intended for use with alarger flow range.
	Flow Range:AA030S(Small) 5-70L/minAA030M(Medium) 5-70L/minAA030L(Large) 5-70L/min	Flow Range:OPT942 (Small) 10 - 60L/minOPT944 (Medium) 10 - 60 L/minOPT946 (Large) 10 - 60 L/min
Shelf Life	18 months	Shelf-life not claimed on labelling	The subject device claims an 18-month shelf life.
Storage Temperature	-10°C to +50°C	-10°C to +50°C	Identical
Sterility	Device not provided sterile	Device not provided sterile	Identical
Disposal	Dispose of product safely in accordancewith standard hospital procedure.	Disposal not defined.	Disposal information defined for subject devicein the User Instruction.
Nasal Cannula Function and Design
22 mm Male ISOTaper Connector	Included.	Included.	Identical.
Proprietary F&PConnector	Included.	Included.	Identical.
CO2 Sampling tube'sLuer connection	Included	Not Included	CO2 Sampling feature is only present in thesubject device and not available in the predicatedevice.The sampling functionality is equivalent to that ofthe reference device, K162343.

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PERFORMANCE DATA VII.

Non-Clinical Performance Data

Performance testing of the F&P Optiflow™ Nasal Oxygen Cannula with CO2 Sampling was completed to determine that the differences between the subject device and the predicate device do not raise new questions of safety or effectiveness. These tests demonstrate substantial equivalence of the F&P Optiflow™ Nasal Oxygen Cannula with CO2 Sampling to the predicate device.

. Shelf life testing was performed following accelerated aging conditioning as per ASTM F1980-16 to demonstrate product requirements continue to be met after 18 months of storage.
. Transportation testing was performed following transportation to ISTA 2A:2011 Packaged-Products 150 lbs (68 kgs) or Less.
. The following additional performance testing has also been completed to confirm the safety and effectiveness of the Optiflow™ Nasal Oxygen Cannula with CO2 Sampling:
- Nasal Cannula Leak Test O
- O CO2 Sampling Tube Leak Test
- Resistance to flow of the CO2 Sampling Tube O
- Resistance to flow during compression of the CO2 Sampling Tube o
- Testing was performed to ensure functional requirements were met after transport, o storage, and simulated use conditioning.
- O Strength testing of CO2 Sampling Tube's permanent connections after transport, storage, and simulated use conditioning.
- Testing to validate the device's CO2 Sampling functionality O

Usability testing conducted on the use of the CO2 Sampling feature and the warnings and directions for use related to the CO2 Sampling feature only.

The Optiflow™ Nasal Oxygen Cannula with CO2 Sampling has been tested to applicable requirements of the following standards:

ISO 594-2. "Conical fitting with 6% (Luer) taper for syringes, needles and certain other . medical equipment- Part 2: Lock fittings".
ISO 5356-1:2004 "Anesthetic and Respiratory Equipment- Conical Connectors- Part 1: Cones ● and Sockets".
ISO 5361:2012 "Anesthetic and Respiratory Equipment-Tracheal tubes and connectors" ●
ISO 10993-1 Fifth Edition 2018-08 "Biological Evaluation of Medical Devices Part 1: . Evaluation and Testing Within a Risk Management Process".
. ISO 18562-1 First Edition 2017-03, "Biocompatibility evaluation of breathing gas pathways in healthcare applications- Part 1: Evaluation and testing within a risk management process".

Clinical Performance Data

Clinical performance data has not been relied upon in this marketing submission to demonstrate substantial equivalence between the subject and predicate devices.

CONCLUSIONS VIII.

The comparison of features, performance data and intended use demonstrate that the F&P Optiflow™ Nasal Oxygen Cannula with CO2 Sampling is substantially equivalent to the predicate, Optiflow™ + Nasal Cannula, (K162553).

Regulation Number and Section

§ 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).