For the delivery of heated, humidified breathing gases to spontaneously breathing adult patients. This breathing set is suitable for use with Fisher & Paykel Healthcare MR850 Humidifiers in hospital and long-term care environments.

Device Description

The F&P 850 AirSpiral Adult NIV and NHF Circuit Kit (850A61) is designed to provide a gas conduit between respiratory support equipment and a patient interface such as a mask, nasal prongs or tracheostomy interface for a spontaneously breathing Adult patient.

The Inspiratory Limb is an extruded bubble tube design 1.6 metres in length, and is intended to connect the gas path from humidification chamber to the patient interface. Additionally, temperature sensor clips and a gown clip are included to aid in cable management and to affix the circuit to a gown or sheet. The subject device is single use, prescription only and is provided in a non-sterile state.

The Disposable Exhalation Port is an optional accessory for NIV applications. It features a perforated ventilation hole and a 22mm/15mm coaxial taper connectir for connecting to patient interfaces and a 22mm tapered male connector for connecting to the patient end of the Inspiratory Limb. It also features a capped port for connecting to the Pressure Line.

AI/ML Overview

I apologize, but the provided text does not contain information about an AI/ML-based medical device or any study related to its performance and acceptance criteria.

The document is an FDA 510(k) clearance letter for a medical device called the "F&P 850 AirSpiral Adult NIV and NHF Circuit Kit." This device is a heated breathing tube and associated components designed to deliver heated, humidified breathing gases to spontaneously breathing adult patients.

The 510(k) submission describes:

The device's intended use and indications for use.
A comparison of its technological characteristics with a predicate device (F&P AirSpiral Heated Breathing Tube K162553) and a secondary predicate (Philips Disposable Exhalation Port K982454).
A summary of non-clinical tests performed to demonstrate substantial equivalence to the predicate devices. These tests relate to:
- Compliance with various medical device standards (e.g., ISO, IEC).
- Exhalation port equivalence (flow rates).
- Pressure port equivalence (inspired volume).
- Inhalation path equivalence (tidal volumes).
- Human factors evaluation.

There is no mention of artificial intelligence, machine learning, deep learning, or any form of AI-based algorithm doing image analysis, risk prediction, or any other function that would require the kind of performance data usually associated with AI/ML device clearances (e.g., sensitivity, specificity, AUC).

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies, as the document clearly pertains to a non-AI medical device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

April 22, 2022

Fisher & Paykel Healthcare Ltd Reena Daken Regulatory Affairs Market Manager 15 Maurice Paykel Place, East Tamaki Auckland, 2013 New Zealand

Re: K212031

Trade/Device Name: F&P 850 AirSpiral Adult NIV and NHF Circuit Kit Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT Dated: March 22, 2022 Received: March 22, 2022

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 (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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

{1}------------------------------------------------

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 (OS) 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 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,

Brandon Blakely, Ph.D. Respiratory Devices Team DHT1C: Division of 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K212031

Device Name F&P 850 AirSpiral Adult NIV and NHF Circuit Kit

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Reproductive Use (Part 21 CFR 321 Subpart D) Source Tissue Use (21 CFR 1271 Subpart C)	Reproductive Use (Part 21 CFR 321 Subpart D)	Source Tissue Use (21 CFR 1271 Subpart C)
Reproductive Use (Part 21 CFR 321 Subpart D)	Source Tissue Use (21 CFR 1271 Subpart C)

X 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."

{3}------------------------------------------------

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 ZealandTelephone: +64 9 574 0100
Prepared and Submitted by	Nicholas YapRegulatory Affairs Specialist
Contact Person	Reena DakenRegulatory Affairs ManagerTelephone: +64 9 574 0100Email: reena.daken@fphcare.co.nz
Date Prepared	22 April 2022

DEVICE =

Device Name	F&P 850 AirSpiral Adult NIV and NHF Circuit Kit
Common/Usual Name	Heated Breathing Tube
Classification Name	Respiratory gas humidifier
Regulatory Class	Class II (21 CFR §868.5450)
Product Code	BTT

PREDICATE DEVICE III.

Predicate Device	F&P AirSpiral Heated Breathing Tube	K162553
Secondary Predicate Device	Bipap Vision Ventilatory Support	K982454
Reference Device(s)	F&P RT380 Adult Evaqua 2 Dual HeatedBreathing Circuit	K122432
• Used to support claims ofsubstantial equivalence with respectto performance and system

compatibility

{4}------------------------------------------------

DEVICE DESCRIPTION

INDICATIONS FOR USE IV.

{5}------------------------------------------------

COMPARISON OF TECHNOLOGICAL CHARATCERISTICS WITH THE PREDICATE DEVICE V.

A comparison of intended use, features, and performance specifications demonstrate that the subject device is substantially equivalent to the predicate device.

Parameter	Subject DeviceF&P 850A61	Predicate DeviceF&P AirSpiral Heated Breathing Tube(K162553)	Comments
Classification
Manufacturer	Fisher & Paykel Healthcare Ltd.	Fisher & Paykel Healthcare Ltd.
Device Regulation	Class II, Regulation: 21 CFR 868.5270	Class II, Regulation: 21 CFR 868.5270	Identical
Product Code	BTT	BTT
Classification Panel	Anesthesiology	Anesthesiology
Intended Use and Indications for Use
Intended Use	Heated breathing tube for delivery ofhumidified respiratory gases	Heated breathing tube for delivery ofhumidified respiratory gases	Identical
Indications for Use	For the delivery of heated, humidifiedbreathing gases to spontaneously breathingadult patients. This breathing set is suitablefor use with Fisher & Paykel HealthcareMR850 Humidifiers in hospital and long-termcare environments.	Heated breathing tube for delivery ofhumidified respiratory gases. For use withAIRVO and AIRVO2 Series humidifiers inhospitals and long-term care facilities. Foruse at flows from 2 to 60 L/min depending onthe patient interface.	Equivalent
Availability	Prescription use(Part 21 CFR 801 Subpart D)	Prescription use(Part 21 CFR 801 Subpart D)	Identical
Patient Population	Spontaneously breathing adult patientsrequiring flows between 10 – 120 L/mindepending on the required therapy andpatient interface.	Spontaneously breathing patient requiringflows between 2 - 60 L/min.	Equivalent
Parameter	Subject DeviceF&P 850A61	Predicate DeviceF&P AirSpiral Heated Breathing Tube(K162553)	Comments
Operating Environment	Hospital and long-term care environments	Hospital and long-term care facilities	Identical
Reusability	Single use	Single use	Identical
Sterility	Device not provided sterile	Device not provided sterile	Identical
Life Supporting or LifeSustaining	No	No	Identical
Operation and Safety Features
Principle of Operation	Connects to a humidifier. Powered by thehumidifier to maintain heat as a conduit forhumidified heated respiratory gases.Connects the humidifier to the patientinterface.	Connects to a humidifier. Powered by thehumidifier to maintain heat as a conduit forhumidified heated respiratory gases.Connects the humidifier to the patientinterface.	Identical
Tube Dimensions	Length: 1.6 mInternal Diameter: 17 mm	Length: 1.8 mInternal Diameter: 13.1 mm	Equivalent
Design of the TubeConstruction	Heated tube to transport humidified gasbetween the humidification chamber and thePatient EndTwo-spiral wall tubing design:Insulating spiral made of Spiral-woundbubble tubingHeating spiral encapsulating heater wire	Heated tube to transport humidified gasbetween the Unit End and the Patient EndTwo-spiral wall tubing design:Insulating spiral made of Spiral-woundbubble tubingHeating spiral encapsulating heater wire	Identical
Temperature Sensor	A removable temperature and flow sensorare used at the humidification chamber outletport which is an accessory to the F&PMR850 humidifier.	An integrated temperature sensor at thepatient end of the tube eliminates the needfor external probes, cables or adaptors.	Similar
Parameter	Subject DeviceF&P 850A61	Predicate DeviceF&P AirSpiral Heated Breathing Tube(K162553)	Comments
	A removable temperature sensor is used atthe patient end port which is an accessory tothe F&P MR850 humidifier.
Heater Wire Lumen Design	Consists of filament conductor.Position in tube: Double helix woundmoulded into bead of tube wall.Filament insulation: Filament is moulded intothe bead. The bead provides thermalinsulation.	Consists of filament conductor.Position in tube: Double helix woundmoulded into bead of tube wall.Filament insulation: Filament is moulded intothe bead. The bead provides thermalinsulation.	Identical
Clips	Allows the breathing tube to be attached toclothing or bedding and to position the tubeto suit the clinician and patient	Allows the breathing tube to be attached toclothing or bedding and to position the tubeto suit the clinician and patient	Identical
Humidifier Compatibility	F&P MR850 Respiratory Humidifier	F&P AIRVO / AIRVO2 Series HumidifierF&P myAIRVO / myAIRVO2 SeriesHumidifier	Similar
Water ChamberCompatibility	MR290V autofill chamber• Single patient use only	900PT290E auto fill chamber,• Single patient use onlyHC360 manual fill chamber,• Single patient reuse	Identical
Patient InterfaceCompatibility	HF Indication:• Interface with 22 mm male connector(ISO 5356) e.g. OPT944 NasalCannula (K162553)NIV Indication:	HF Indication:• OPT942, OPT944, OPT946 NasalCannula• OPT970 Tracheostomy DirectConnection• OPT980 Mask Interface Adapter	Equivalent
Parameter	Subject DeviceF&P 850A61	Predicate DeviceF&P AirSpiral Heated Breathing Tube(K162553)	Comments
	Non-vented mask with 22 mm male connector (ISO 5356) and exhalation port e.g. RT045 Mask (K170367) Vented mask with 22 mm female connector (ISO 5366) e.g. RT047 Mask (K191624) All are single patient use only	OPT316, OPT318 Junior Nasal Cannula All are single patient use only
Performance
Flow Range	10 – 120 L/minHF (MR850 Invasive Mode):10 – 60 L/min NIV (MR850 Mask Mode): 10 – 120 L/min	2 – 60 L/minDefault Mode: 10 – 60 L/min Junior Mode: 2 – 5 L/min	The expanded flow raterange of the subject device issupported by the referencedevice (K122432), which isalso indicated for use up to120 L/min when used withMR850.
Shelf Life	2 Years	5 Years	Both devices werepreconditioned usingequivalent methods tosimulate shelf life andperformance was verifiedthereafter.
Useful Life	Single patient use – 14 days in Hospital /Long-term care facilities	Single patient use – 14 days in Hospital /Long-term care facilities	Identical
Humidity Delivery	Noninvasive Mode: > 12 mg/LInvasive Mode: > 33 mg/L	Noninvasive indications: >12 mg/L Default and Junior modes Invasive indications: > 33 mg/L Default and Junior modes	Identical

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

Technical Characteristic	Secondary Predicate DevicePhilips Disposable Exhalation Port (K982454)	Subject DeviceF&P Disposable Exhalation Port	Comments
Indications for Use	This item is supplied as a component in a complete breathing system and supports the respective indications for use.	This item is supplied as a component in the circuit kit and supports the respective indications for use.
Availability	Prescription only	Prescription only
Patient Population	Adult	Adult
Patient State	Spontaneously breathing	Spontaneously breathing
Patient Monitoring	Appropriate patient monitoring	Appropriate patient monitoring	Identical
Operating Environment	Hospital and long-term care	Hospital and long-term care
User Group	Respiratory therapists, sleep lab technicians or nurses under the supervision or direction of a physician	Under the supervision of trained medical personnel
Reusability	Single Patient Use	Single Patient Use
Useful Life	-	14 days
Technical Specifications and Features
Connection to interface	ISO 5356-1 Conical connectors (22mm male and 15mm female)	ISO 5356-1 Conical connectors (22mm male and 15mm female)
Connection to circuit	ISO 5356-1 Conical connectors (22mm male)	ISO 5356-1 Conical connectors (22mm male)	Identical
Connection to pressure port	Compatible with 1/8" pressure line and port cap	Compatible with 1/8" pressure line and port cap
Inhalation Path Diameter (min)	15.2 mm	15.2 mm
Exhalation Port functional performance	>15 L/min @ 4 cmH2O	>15 L/min @ 4 cmH2O	Equivalent
Pressure port functional performance	3 mL air volume	3.5 mL air volume	Equivalent
Inhalation Path functional performance	17% Tidal volume discrepancy	13% Tidal volume discrepancy	Equivalent
Materials
Materials	Polycarbonate	Polycarbonate	Identical

{10}------------------------------------------------

PERFORMANCE DATA VI.

Summary of non-clinical tests

The F&P 850A61 has been tested to applicable requirements of the following standards:

Standards andDesignation Number	Standards Title
ISO 80601-2-74:2017	Medical electrical equipment - Part 2-74: Particular requirements forbasic safety and essential performance of respiratory humidifyingequipment
IEC 60601-1:2005+AMD1:2012	Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance
IEC 60601-1-2:2014	Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral Standard:Electromagnetic disturbances - Requirements and tests
AIM 7351731 Rev2.0:2017	Medical Electrical Equipment and System Electromagnetic ImmunityTest for Exposure to Radio Frequency Identification Readers
ISO 5356-1:2015	Anaesthetic and respiratory equipment - Conical connectors: Part 1:Cones and sockets
ISO 5367:2014	Anaesthetic and respiratory equipment - Breathing sets andconnectors
IEC 60601-1-6 ed3.1:2013	Medical electrical equipment - Part 1-6: General requirements forbasic safety and essential performance - Collateral Standard:Usability
IEC 62366-1:2015	Medical devices - Part 1: Application of usability engineering tomedical devices
ISO 10993-1:2018	Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management process
ISO 10993-3:2014	Biological evaluation of medical devices - Part 3: Tests forgenotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-18:2020	Biological evaluation of medical devices - Part 18: Chemicalcharacterization of medical device materials within a riskmanagement process
ISO 18562-1:2017	Biocompatibility evaluation of breathing gas pathways in healthcareapplications - Part 1: Evaluation and testing within a riskmanagement process
ISTA 3A	Packaged Products for Parcel Delivery System Shipment 70 kg (150lb) or Less

{11}------------------------------------------------

In addition to the standards listed above, the following testing has been completed to demonstrate substantial equivalence:

Exhalation Port Equivalence:

A comparison of the flow rates through the exhalation port for the subject and predicate DEP was tested. Testing showed there is minimal difference in flow rate between the predicate and subject DEP at any of the pressures tested.

Pressure Port Equivalence:

A comparison of the inspired volume required for the inspiration of a breath was performed using the subject and predicate DEP.

The comparative testing showed the tidal volumes of the subject DEP within 1 mL of the predicate DEP and can be considered to have an equivalent sensitivity to a breath being taken by the patient.

Inhalation Path Equivalence:

A comparison of the tidal volumes delivered to the patient in relation to the volumes set on the ventilator showed the configurations using the subject DEP have a smaller tidal volume difference than those using the predicate DEP, and hence allow equivalent accuracy of delivery of therapy to the patient.

Human Factors Evaluation

A Human Factors and Usability Engineering validation study was conducted, and documentation was provided as per FDA's Guidance for Industry and FDA Staff, "Applying Human Factors and Usability Engineering to Medical Devices". Validation study participants included 15 experienced, US Licensed Respiratory Therapists, and the report demonstrates that the critical tasks of the 850A61 breathing set can be completed by experienced respiratory therapists.

VII. CONCLUSIONS

The F&P 850A61 is substantially equivalent to the predicate device based on intended use, patient population, comparison of the technological characteristics and performance specifications. In addition, the conclusions drawn from the non-clinical tests demonstrate that the device is substantially equivalent to the legally marketed predicate device.

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).