The AirLife DuoTherm™ Heated Humidifier is intended to add moisture to, and warm, the breathing gases for administration to a patient. Gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract, or desiccate secretions of patients whose supraglottic airways have been bypassed. This product is non-sterile, reusable, and intended to be used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

The AirLife DuoTherm™ Humidification Chamber is intended to hold water required to humidify breathing gases delivered to patients ranging from neonates to adults using a heated humidifier. The product is a single use device, nonsterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

The AirLife DuoTherm™ Neonate Heated-Wire Circuits are intended to deliver and warm breathing gases before they enter the patient's airway. The Neonate Heated-Wire Circuits are used with a pediatric population, specifically the neonate (birth to 28 days) and infant (29 days to 2 years) pediatric subgroups with an ideal body weight of 0.5 to 8kg that requires mechanical ventilation, positive pressure breathing or general medical gases, respectively. The Neonate Heated-Wire Circuits are used for flow rates greater than 1 LPM. The product is single patient use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

The AirLife DuoTherm™ Pediatric Heated-Wire Circuits are intended to deliver and warm breathing gases before they enter the patient's airway. The Pediatric Heated-Wire Circuits are used with the pediation, specifically infant (29 days to 2 years) and children (2 years) with an ideal body weight of 6 to 42kg that requires mechanical ventilation, positive pressure breathing or general medical gases, respectively. The Pediatric Heated-Wire Circuits are used for flow rates greater than 2 LPM. The product is single use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

The AirLife DuoTherm™ Adult Heated-Wire Circuits are intended to deliver and warm breathing gases before they enter the patient's airway. The Adult Heated-Wire Circuits are used with the adult population and pediation, specifically those with an ideal body weight of 30kg or above, that requires mechanical ventilation, positive pressure breathing or general medical gases, respectively. The Adult Heated-Wire Circuits are used for flow rates greater than 3 LPM. The product is single-use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

The AirLife DuoTherm™ Adult Heated-Wire NIV Circuit is intended to deliver and warm breathing gases before they enter the patient's airway. The Adult Heated-Wire NV Circuit is used with the spontaneously breathing adult population (>21 years), specifically those with an ideal body weight of 30kg or above, that benefit from high flow therapy. The Adult Heated-Wire NIV Circuits are used for flow rates greater than 5 LPM. The product is single-use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

Device Description

The AirLife DuoTherm™ Humidification System is used to deliver heated, humidified breathing gases to a patient's airway when he/she is mechanically ventilated, receiving continuous noninvasive (NIV) positive airway pressure or high-flow oxygen therapy. The system is intended for use in a standard hospital or professional health care environment.

The AirLife DuoTherm™ Humidification System consists of:

A heated humidifier, which includes reusable temperature probes, heated wire adapters, and a power cord,
A humidification chamber, and
. Heated wire circuits, which include neonate, pediatric, and adult single and dual limb circuits, as well as an adult heated wire NIV circuit.

AI/ML Overview

Based on the provided text, the document is a 510(k) Premarket Notification for the AirLife DuoTherm™ Humidification System. This type of submission aims to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and efficacy from scratch through extensive clinical trials. Therefore, the information provided focuses on non-clinical performance testing and comparison to predicate devices, rather than a traditional clinical study with human data.

There is no clinical study data provided in this document that would define acceptance criteria for AI model performance (e.g., accuracy, sensitivity, specificity) against a ground truth established by experts using a test set, nor does it describe an MRMC study.

The document explicitly states:
"There was no clinical testing required to support the AirLife DuoTherm™ Humidification System, as the intended use and indications for use are equivalent to the primary predicate and reference devices. These types of devices, including the primary predicate device, have been on the market with a proven safety and efficacy record for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the AirLife DuoTherm™ Humidification System, and its safety and effectiveness."

Therefore, I cannot provide the requested information regarding acceptance criteria, training/test sets, expert adjudication, or MRMC studies as these were not part of the demonstrated substantial equivalence for this particular device.

However, I can summarize the non-clinical performance testing and the basis for the substantial equivalence claim as described in the document.

Summary of Acceptance Criteria and Device Performance (Non-Clinical):

The acceptance criteria for the AirLife DuoTherm™ Humidification System were met by demonstrating compliance with various national and international consensus standards for medical electrical equipment, respiratory humidifying equipment, biocompatibility, and software. The device performance is deemed acceptable because it met the requirements of these standards and was shown to be substantially equivalent to existing predicate devices with a proven safety and efficacy record.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Acceptance Criteria Category	Specific Standards / Requirements Met (Performance Demonstrated by Compliance)
Non-clinical Performance	- ISO 80601-2-74:2017: Basic safety and essential performance of respiratory humidifying equipment.
	- IEC 60601-1:2012: General requirements for basic safety and essential performance (electrical safety).
	- IEC 60601-1-2:2014: Electromagnetic disturbances (EMC/EMI).
	- IEC TR 60601-4-2: Electromagnetic immunity (guidance).
	- IEC 60601-1-6:2013-10: Usability.
	- IEC 60601-1-8:2012: Alarm systems.
	- IEC 62366-1:2015: Application of usability engineering.
	- IEC 62304:2015: Medical device software life cycle processes.
	- ISO 5356-1:2015: Conical connectors (anaesthetic and respiratory equipment).
	- ISO 5367:2014: Breathing sets and connectors (anaesthetic and respiratory equipment).
Biocompatibility	- ISO 18562 (Parts 1, 2, 3, 4): Biocompatibility evaluation of breathing gas pathways (risk management, particulate matter, VOCs, leachables).
	- ISO 10993 (Parts 1, 3, 5, 10, 11, 12, 17, 18, 23): Biological evaluation of medical devices (risk management, genotoxicity, cytotoxicity, sensitization, systemic toxicity, sample prep, allowable limits for leachables, chemical characterization, irritation).
	- ISO 21726:2019: Application of the threshold of toxicological concern (TTC).
Substantial Equivalence	- Intended Use: Similar to predicate (MR850 Heated Humidifier, K033710). Minor cosmetic verbiage differences with no impact on safety/effectiveness.
	- Principle of Operation: Similar to predicate; both heat and humidify respiratory gases.
	- Patient Population: Identical to predicate (Neonates to Adults).
	- Use Environment: Similar to predicate and reference devices (professional healthcare facility).
	- System Components: Identical to predicate and reference devices (Heated Humidifier, Humidification Chamber, Breathing Circuits).

Regarding the specific questions about an AI/Algorithm performance study:

A table of acceptance criteria and the reported device performance: As explained above, for the AirLife DuoTherm™ Humidification System, this refers to compliance with performance and safety standards for medical devices and demonstration of substantial equivalence to predicate devices, not AI performance metrics.
Sample sized used for the test set and the data provenance: Not applicable. No test set for an AI algorithm performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth established by experts for an AI algorithm.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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. No MRMC study was conducted or required.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm-driven device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable. No training set for an AI/algorithm.
How the ground truth for the training set was established: Not applicable.

In conclusion, this FDA 510(k) submission pertains to a physical medical device (a humidification system) and its components, demonstrating substantial equivalence to existing devices through non-clinical testing and comparison of fundamental characteristics. It does not involve AI or an algorithm whose diagnostic or prognostic performance would be evaluated through the types of studies described in the prompt.

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). 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.

August 10, 2023

Vyaire Medical, Inc. Megan Walsh Manager, Regulatory Affairs 26125 N. Riverwoods Blvd. Mettawa, Illinois 60045

Re: K231380

Trade/Device Name: AirLife DuoTherm™ Humidification System Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: Class II Product Code: BTT, BZE Dated: May 12, 2023 Received: May 12, 2023

Dear Megan Walsh:

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.

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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 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 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.

Ethan L. Nyberg -S

Ethan Nyberg, Ph.D. Assistant Director 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

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Indications for Use

510(k) Number (if known) K231380

Device Name AirLife DuoTherm™ Humidification System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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.

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K231380

510(k) Summary AirLife DuoTherm™ Humidification System

Date Prepared: August 8, 2023

This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR §807.92.

Submitter (21 CFR §807.92(a)(1)) l. Vyaire Medical, Inc. 26125 N. Riverwoods Blvd. Mettawa, IL 60045 USA Applicant: Aaron Lynch Title: Senior Regulatory Affairs Specialist aaron.lynch@vyaire.com Email: Official Correspondent: Megan Walsh Title: Manager, Regulatory Affairs Email: megan.walsh@vyaire.com II. Device Information (21 CFR §807.92(a)(2)) Device Name: AirLife DuoTherm™ Humidification System Proprietary Name: AirLife DuoTherm™ Device Classification: Class II Primary Product Code: BTT Regulation: Regulation Name:
21 CFR §868.5450 Respiratory gas humidifier 73 – Anesthesiology Humidifier

Secondary Product Code: Common Name:

Review Panel:

Common Name:

BZE Heated Breathing Circuits

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Image /page/5/Picture/0 description: The image shows the VyAire Medical logo. The logo consists of three overlapping circles in red and blue, followed by the word "vyaire" in a dark blue sans-serif font. Below "vyaire" is the word "MEDICAL" in a smaller, red sans-serif font.

III. Primary Predicate Device and Reference Device Information (21 CFR §807.92(a)(3))

Primary Predicate Device
Device Name	510(k) Number	Decision Date
MR850 Respiratory Humidifier, Model MR850JHU	K033710	April 13, 2004
Reference Devices
Device Name	510(k) Number	Decision Date
MODELS MR700/MR720/MR730 DUAL SERVORESP HUMID ACC	K913368	January 13, 1992
AirLife™ Autofill Humidification Chamber	K160764	August 25, 2016
AirLife™ Adult Heated Wire Circuit	K153234	July 7, 2016
AirLife™ Adult Heated Wire BiPAP/NIV Circuit	K170378	September 14, 2017
AirLife™ Infant Heated Wire Circuit	K151303	January 21, 2016

IV. Device Description (21 CFR §807.92(a)(4))

The AirLife DuoTherm™ Humidification System consists of:

A heated humidifier, which includes reusable temperature probes, heated wire adapters, and a power cord,
A humidification chamber, and
. Heated wire circuits, which include neonate, pediatric, and adult single and dual limb circuits, as well as an adult heated wire NIV circuit.

V. Intended Use (21 CFR §807.92(a)(5))

The AirLife DuoTherm™ Humidification System is intended to add moisture and warmth to breathing gases administered to patients that require assistance breathing or mucosal humidification. Gases that are available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract.

Indications for Use:

The AirLife DuoTherm™ Heated Humidifier is intended to add moisture to, and to warm, the breathing gases for administration to a patient. Gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract, or desiccate secretions of

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Image /page/6/Picture/0 description: The image is a logo for Vyaire Medical. The logo features a red and blue overlapping circle design on the left, followed by the word "Vyaire" in a stylized, sans-serif font. Below "Vyaire" is the word "MEDICAL" in a smaller, sans-serif font.

K231380

patients whose supraglottic airways have been bypassed. This product is non-sterile, reusable, and intended to be used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

The AirLife DuoTherm™ Humidification Chamber is intended to hold water required to humidify breathing gases delivered to patients ranging from neonates to adults using a heated humidifier. The product is a single-use device, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

The AirLife DuoTherm™ Pediatric Heated-Wire Circuits are intended to deliver and warm breathing gases before they enter the patient's airway. The Pediatric Heated-Wire Circuits are used with the pediatric patient population, specifically infant (29 days to 2 years) and children (2 years to 12 years) with an ideal body weight of 6 to 42kg that requires mechanical ventilation, positive pressure breathing or general medical gases, respectively. The Pediatric Heated-Wire Circuits are used for flow rates greater than 2 LPM. The product is single-use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

The AirLife DuoTherm™ Adult Heated-Wire Circuits are intended to deliver and warm breathing gases before they enter the patient's airway. The Adult Heated-Wire Circuits are used with the adult population and pediatric population, specifically those with an ideal body weight of 30kg or above, that requires mechanical ventilation, positive pressure breathing or general medical gases, respectively. The Adult Heated-Wire Circuits are used for flow rates greater than 3 LPM. The product is single-use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

The AirLife DuoTherm™ Adult Heated-Wire NIV Circuit is intended to deliver and warm breathing gases before they enter the patient's airway. The Adult Heated-Wire NIV Circuit is used with the spontaneously breathing adult population (>21 years), specifically those with an ideal body weight of 30kg or above, that benefit from high flow therapy. The Adult Heated-Wire NIV Circuits are used for flow rates greater than 5 LPM. The product is single-use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

VI. Summary of Substantial Equivalence (21 CFR §807.92(a)(6))

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Image /page/7/Picture/0 description: The image shows the VyAire Medical logo. The logo consists of a stylized letter "V" in dark blue, followed by the rest of the company name in the same color. To the left of the name is a graphic of overlapping red and blue circles. The word "MEDICAL" is written in smaller, red letters below the company name.

See below for a device comparison table for the AirLife DuoTherm™ Humidification System, which compares the system (subject device) to its primary predicate device (MR850 Heated Humidifier, K033710) and reference device (MR730 Heated Humidifier, K913368) with respect to intended use, technological characteristics, and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

Device Comparison Table – AirLife DuoTherm™ Humidification System

	Subject Device	Primary PredicateDevice	Reference Device	Comparison
	AirLifeDuoTherm™HumidificationSystem	MR850 HeatedHumidifier	MR730 HeatedHumidifier
	Manufacturer:Vyaire Medical, Inc.	Manufacturer:Fisher & PaykelHealthcare, Ltd.(K033710)	Manufacturer:Fisher & PaykelElectronics, Ltd.(K913368)
	AirLife DuoTherm™ Humidification System
Intended Use	The AirLifeDuoTherm™HumidificationSystem is intendedto add moistureand warmth tobreathing gasesadministered topatients thatrequire assistancebreathing ormucosalhumidification.Gases that areavailable formedical use do notcontain sufficientmoisture and maydamage or irritatethe respiratorytract.	The MR850humidifier isintended to addmoisture to, andto warm, thebreathing gasesfor administrationto a patient. Gasesavailable formedical use do notcontain sufficientmoisture and maydamage or irritatethe respiratorytract, or desiccatesecretions ofpatients whosesupraglotticairways have beenbypassed.	Not published onthe FDA website	The subject deviceis similar to theprimary predicatedevice clearedunder K033710.Both are intendedto add moistureand warmth tobreathing gasesadministered topatients.Verbiagedifferencesbetween theintended use ofthe subject deviceand the primarypredicate deviceare only cosmeticin nature.These differenceshave no impact to
				K231380
	Subject Device	Primary Predicate Device	Reference Device	Comparison
	AirLifeDuoTherm™HumidificationSystem	MR850 HeatedHumidifier	MR730 HeatedHumidifier
	Manufacturer:Vyaire Medical, Inc.	Manufacturer:Fisher & PaykelHealthcare, Ltd.(K033710)	Manufacturer:Fisher & PaykelElectronics, Ltd.(K913368)
	AirLife DuoTherm™ Humidification System			safety andeffectiveness.
Principle ofOperation	The AirLifeDuoTherm™Heated Humidifierheats andhumidifiesrespiratory gasesthat are deliveredto patients viamechanicalventilation, thetrachea withassisted, positiveair pressure, or anose and/or facemask.	Heat is used toprovideevaporated watercontent to drybreathing gases.Heated orunheatedbreathing tubescan be used todeliver thehumidified gas tothe patient.Heated breathingtubes increaseoperatingefficiency andreduce excessivewater and heatloss.	Not available	The subject deviceis similar to theprimary predicatedevice clearedunder K033710.Both heat andhumidifyrespiratory gasesthat are deliveredto patients.
	The AirLifeDuoTherm™HumidificationChamber fits tothe heatedhumidifier andholds the waterrequired tohumidify thebreathing gasesthat are deliveredto patients.	The chamberslides onto theheater plate andcontains the watersupply for addinghumidity tobreathing gases.		Verbiagedifferencesbetween principleof operation of thesubject device andthe primarypredicate deviceare only cosmeticin nature.
	Resistance wireswithin the tubing	Resistance wireswithin the tubinggenerate heat to		These differenceshave no impact tosafety andeffectiveness.

K2313		380

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Image /page/8/Picture/0 description: The image shows the VyAire Medical logo. The logo consists of a circular graphic on the left, with red and blue overlapping circles. To the right of the graphic is the company name, "VyAire" in a stylized, sans-serif font, with the word "MEDICAL" in smaller, red letters below it. The logo is clean and modern, with a focus on the company name.

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				K23138
	Subject DeviceAirLifeDuoTherm™HumidificationSystem	Primary PredicateDeviceMR850 HeatedHumidifier	Reference DeviceMR730 HeatedHumidifier	Comparison
	Manufacturer:Vyaire Medical,Inc.	Manufacturer:Fisher & PaykelHealthcare, Ltd.(K033710)	Manufacturer:Fisher & PaykelElectronics, Ltd.(K913368)
		AirLife DuoTherm™ Humidification System
	maintaintemperature andhumidity.	temperature andhumidity.
PatientPopulation	IDENTICAL TOK033710	Neonates toAdults	Not available	The subject deviceis identical to theprimary predicatedevice clearedunder K033710.
UseEnvironment	Hospital, subacutecare facilities andintra-hospitaltransfer by trainedpersonnel	Hospital intensivecare units bytrained personnel	Hospital use bytrained personnel	The subject deviceis similar to theprimary predicatedevice andreference devicecleared underK033710 andK913368,respectively. Allare intended to beused in aprofessionalhealthcare facility.Verbiagedifferences in useenvironmentbetween thesubject device andthe primarypredicate andreference deviceshave no impact tosafety andeffectiveness.

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Image /page/10/Picture/0 description: The image shows the logo for Vyaire Medical. The logo consists of a circular graphic on the left, with two overlapping circles in red and blue. To the right of the graphic is the word "Vyaire" in a stylized, sans-serif font, with the letters in dark blue. Below "Vyaire" is the word "MEDICAL" in a smaller, sans-serif font, with the letters in red.

	Subject Device	Primary Predicate	Reference Device	Comparison
	AirLife	Device	MR730 Heated
	DuoTherm™	MR850 Heated	Humidifier
	Humidification	Humidifier
	System		Manufacturer:
		Manufacturer:	Fisher & Paykel
	Manufacturer:	Fisher & Paykel	Electronics, Ltd.
	Vyaire Medical,	Healthcare, Ltd.	(K913368)
	Inc.	(K033710)
	AirLife DuoTherm™ Humidification System
SystemComponents(Comparisonon SubsequentPages)	IDENTICAL toK033710 &K913368	Heated humidifier(electricaladapters andtemperature/flowprobes),humidificationchamber, andbreathing circuits(multipleconfigurations)	Heated humidifier(electricaladapters andtemperature/flowprobes),humidificationchamber, andbreathing circuits(multipleconfigurations)	The subject deviceis identical to theprimary predicatedevice and thereference devicecleared underK033710 andK913368,respectively.

VII. Performance Testing (21 CFR §807.92(b)(1))

The subject device was designed and tested in accordance with the consensus standards listed below:

. Non-clinical Performance Testing

Standard	Description
ISO 80601-2-74:2017	Medical electrical equipment – Part 2-74: Particular requirements for basicsafety and essential performance of respiratory humidifying equipment
IEC 60601-1:2012	Medical electrical equipment – Part 1: General requirements for basicsafety and essential performance
IEC 60601-1-2:2014	Medical electrical equipment – Part 1-2: General requirements for basicsafety and essential performance – Collateral standard: Electromagneticdisturbances – Requirements and tests
IEC TR 60601-4-2	Medical electrical equipment – Part 4-2: Guidance and interpretation –Electromagnetic immunity: Performance of medical electrical equipmentand medical electrical systems
IEC 60601-1-6:2013-10	Medical electrical equipment – Part 1-6: General requirements for basicsafety and essential performance – Collateral standard: Usability
IEC 60601-1-8:2012	Medical electrical equipment – Part 1-8: General requirements for basicsafety and essential performance – Collateral standard: General

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	requirements, tests and guidance for alarm systems in medical electricalequipment and medical electrical systems
IEC 62366-1:2015	Medical devices ">– Part 1: Application of usability engineering to medical
	devices
IEC 62304:2015	Medical device software – Software life cycle processes
ISO 5356-1:2015	Anaesthetic and respiratory equipment – Conical connectors – Part 1:
	Cones and sockets
ISO 5367:2014	Anaesthetic and respiratory equipment – Breathing sets and connectors

Biocompatibility ●

Standard	Description
ISO 18562-1:2017	Biocompatibility evaluation of breathing gas pathways in healthcareapplications – Part 1: Evaluation and testing within a risk managementprocess
ISO 18562-2:2017	Biocompatibility evaluation of breathing gas pathways in healthcareapplications - Part 2: Tests for emissions of particulate matter
ISO 18562-3:2017	Biocompatibility evaluation of breathing gas pathways in healthcareapplications – Part 3: Tests for emissions of volatile organic compounds
ISO 18562-4:2017	Biocompatibility evaluation of breathing gas pathways in healthcareapplications – Part 4: Tests for leachables in condensate
ISO 10993-1:2018	Biological evaluation of medical devices – Part 1: Evaluation and testingwithin a risk management process
ISO 10993-3:2014	Biological evaluation of medical devices - Part 3: Tests for genotoxicity,carcinogenicity and reproductive toxicity
ISO 10993-5:2009	Biological evaluation of medical devices – Part 5: Tests for in vitrocytotoxicity
ISO 10993-10:2021	Biological evaluation of medical devices - Part 10: Tests for skinsensitization
ISO 10993-11:2017	Biological evaluation of medical devices - Part 11: Tests for systemictoxicity
ISO 10993-12:2021	Biological evaluation of medical devices – Part 12: Sample preparation andreference materials
ISO 10993-17:2002	Biological evaluation of medical devices – Part 17: Establishment ofallowable limits for leachable substances
ISO 10993-17:2022(draft)	Biological evaluation of medical devices – Part 17: Establishment ofallowable limits for leachable substances (draft)
ISO 10993-18:2020	Biological evaluation of medical devices – Part 18: Chemicalcharacterization of medical device materials within a risk managementprocess
ISO 10993-23:2021	Biological evaluation of medical devices - Part 23: Tests for irritation

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ISO 21726:2019	Biological evaluation of medical devices – Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
K23138

Clinical Performance Data (21 CFR §807.92(b)(2)): There was no clinical testing required to . support the AirLife DuoTherm™ Humidification System, as the intended use and indications for use are equivalent to the primary predicate and reference devices. These types of devices, including the primary predicate device, have been on the market with a proven safety and efficacy record for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the AirLife DuoTherm™ Humidification System, and its safety and effectiveness.

VIII. Substantial Equivalence Conclusion (21 CFR §807.92(b)(2))

The AirLife DuoTherm™ Humidification System is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed device in commercial distribution: MR850 Heated Humidifier (K033710). The AirLife DuoTherm™ Humidification System met all specified criteria and did not raise new safety and/or effectiveness questions. The substantial equivalence of the subject device is based on similar indications for use, fundamental technology, including design, and operational principles. Based on the similarities to the primary predicate device, reference devices, and performance data, the AirLife DuoTherm™ Humidification System is substantially equivalent to its primary predicate device (K033710) and reference devices.

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).