The nebulizer adapter is a medical device accessory for single-patient use to facilitate aerosolization of Albuterol sulfate for inhalation to adult patients receiving high-flow humidified breathing gases via tracheostomy patient interface. Intended for use by healthcare professionals in hospitals or long-term care facilities.

When used without a nebulizer:

For use in hospitals and long-term care facilities, for the delivery of humidified respiratory gases to patients via nasal, tracheostomy and mask interfaces.

Device Description

The Airvo Nebulizer Adapter (hereafter named "nebulizer adapter") is a single use accessory device designed to facilitate aerosolization of a physician-prescribed solution for inhalation to patients receiving high flow humidified breathing gases. The nebulizer adapter is a prescription-only accessory device, provided in a non-sterile state.

The nebulizer adapter is kitted with the AirSpiral tube and MR290 humidification chamber cleared in K162553, to be used in conjunction with Airvo series humidifiers (K131895) along with patient interfaces cleared in K162553.

The device is labelled for use with Salbutamol/ Albuterol only.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Airvo Nebulizer Adapter, based on the provided FDA 510(k) summary:

This device is a nebulizer adapter, not an AI-powered diagnostic device, so many of the requested categories (like MRMC study, expert qualifications for ground truth, AI improvement effect size, standalone algorithm performance, or training set details) are not applicable. The "ground truth" for this type of medical device largely pertains to its physical and functional performance against established medical device standards and the predicate device, rather than a diagnostic label.

Acceptance Criteria and Reported Device Performance

Device Name: Airvo Nebulizer Adapter
Predicate Device: Aeroneb Solo Nebulizer System / Aeroneb Solo Adapter (K133360)

Acceptance Criteria / Feature	Subject Device (Airvo Nebulizer Adapter) Performance / Characteristic	Predicate Device (Aerogen T-piece) Performance / Characteristic	Comments / Proof of Meeting Criteria
Premarket Submission	510(k) K211560	K133360	Submitted as a 510(k)
Product Code	CAF	CAF	Identical
Device Classification	Class II (21 CFR §868.5630) Anesthesiology	Class II (21 CFR §868.5630) Anesthesiology	Identical
Intended Use	Attaching a nebulizer system to a breathing circuit for nebulized medication delivery	Attaching a nebulizer system to a breathing circuit for nebulized medication delivery	Identical
Indications for Use (with nebulizer)	Single-patient use to facilitate aerosolization of Albuterol sulfate for inhalation to adult patients receiving high-flow humidified breathing gases via tracheostomy patient interface. Intended for use by healthcare professionals in hospitals or long-term care facilities.	Portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance.	Equivalent to predicate. Subject device is a subset (Albuterol only, tracheostomy, high-flow) of the predicate's broader use.
Indications for Use (without nebulizer)	For use in hospitals and long-term care facilities, for the delivery of humidified respiratory gases to patients via nasal, tracheostomy and mask interfaces.	(N/A for predicate T-piece specifically, but predicate system is for general breathing assistance)	Addressed by the device's design to also function without a nebulizer.
Availability	Prescription Use (Part 21 CFR 801 Subpart D)	Prescription Use (Part 21 CFR 801 Subpart D)	Identical
Application	Nebulization within a humidified high flow therapy system	Nebulization within a non-specific breathing support system	Equivalent to predicate; subject device functions within a subset of predicate. Comparative testing done on the two systems shows equivalence of drug delivery to the patient.
Environment of Use	Hospital	Hospital	Identical
Connection to Breathing Circuit	Proprietary connectors (Airvo system)	T-piece with 22mm ISO medical tapers (Male inlet and Female outlet)	Different, but performance testing showed equivalence.
Nebulizer Port Orientation	15° above horizontal	15° above horizontal	Identical
Position in Circuit	Wet side of humidification chamber in single-limb circuit	End of inspiratory limb in a dual-limb circuit or dry side of humidification chamber in a single-limb circuit	Subject device functions within a subset (single-limb only). Comparative testing showed equivalence of drug delivery.
Sterility	Not provided sterile	Not provided sterile	Identical
Reusability	Single use	Single use	Identical
Maximum Duration of Use (with nebulized drugs)	7 days continuous use	7 days continuous use	Identical
Shelf Life	3 years	Not specified	Favorable (predicate shelf life not specified).
Flow Path Gas Flow Range (with Albuterol, tracheostomy)	10 – 30 L/min	Not defined	Favorable (predicate flow range not defined).
Flow Path Gas Pressure Range	Less than 25 cm H2O	Less than 90 cm H2O	Favorable (subject device range is within predicate range).
On-label Drugs for Delivery	Salbutamol/Albuterol only	General purpose nebulizer	Subject device is a subset of predicate, which is acceptable.
Respirable Dose (1-5 µm) from 2500 µg nebule (Albuterol, tracheostomy)	10 L/min: 1293.1 µg20 L/min: 949.5 µg30 L/min: 612.6 µg	10 L/min: 1339.3 µg20 L/min: 991.8 µg30 L/min: 624.4 µg	Equivalent to predicate based on comparative testing.
Median Mass Aerodynamic Diameter (MMAD) (Albuterol, tracheostomy)	10 L/min: 2.80 µm20 L/min: 2.73 µm30 L/min: 2.54 µm	10 L/min: 2.55 µm20 L/min: 2.63 µm30 L/min: 2.59 µm	Equivalent to predicate based on comparative testing.
Compatibility with Tracheal Patient Interface	Yes, Trache patient interface (OPT970)	Yes, when patient intubated through a trachea interface	Equivalent to predicate.
Shelf Life Simulation	Based on ASTM F1980-07, and ISO 291:2008(E).	(N/A - Not Specified)	Successfully completed.
Transportation Simulation	Based on ISTA 2A.	(N/A - Not Specified)	Successfully completed.
Compliance to Standards	ISO 80601-2-74, ISO 10993-1:2018, ISO 18562-1:2017	(N/A - Not Specified for the specific predicate T-piece)	Successfully completed.
Nebulizer Performance Testing	Equivalent nebulizing performance when using Airvo nebulizer adapter compared to Aerogen T-piece.	(N/A - Predicate's inherent performance)	Confirmed via performance testing.
ISO 80601-2-74 Compliance	Airvo system meets requirements when used with nebulizer adapter.	(N/A)	Confirmed via testing.
Usability	Safe and effective for intended users, uses, and environments.	(N/A)	Confirmed via testing.
Packaging Integrity	Wear and stresses of distribution do not cause damage.	(N/A)	Confirmed via testing.
No Adverse Effect on Airvo 2 or AirSpiral tube	Nebulization via port does not adversely affect Airvo 2 or AirSpiral tube.	(N/A)	Confirmed via testing.
Port Cap Stay in Place	Port cap stays in place during use with Airvo 2 system.	(N/A)	Confirmed via testing.
Condensate Volume	Total volume of condensate, with potential to reach patient, measured over 24 hours.	(N/A)	Confirmed via testing.

Study Details

Given this is a 510(k) for a medical device accessory and not an AI/CADe/CADx device, the study information requested regarding human readers, AI assistance, ground truth experts, and training sets is not directly applicable in the context of this submission. The "studies" were primarily non-clinical, benchtop performance, and engineering tests to demonstrate substantial equivalence to the predicate device and compliance with relevant standards.

1. A table of acceptance criteria and the reported device performance:
See table above.

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 does not specify exact sample sizes for each non-clinical test (e.g., number of nebulizer adapters tested for respirable dose, number of cycles for shelf life, etc.). The provenance would be the manufacturing site laboratory in New Zealand, and the data is prospective, generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not Applicable. For this type of device, "ground truth" is established by adherence to recognized national and international consensus standards (e.g., ASTM, ISO), engineering specifications, and comparative testing against a legally marketed predicate. The "experts" are the engineers and medical device professionals who design and execute these tests and evaluate the results against the defined criteria. Their qualifications would involve expertise in medical device engineering, respiratory therapy, and regulatory affairs.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not Applicable. Adjudication methods like 2+1 or 3+1 refer to agreement among multiple human readers for diagnostic truth-finding in image-based AI studies. This is a non-clinical device performance study. Test results are typically reviewed and approved by internal quality and regulatory personnel.

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 a physical medical device, not an AI-powered diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not Applicable. This is a physical medical device, not an algorithm. The "standalone" performance would be its mechanical and functional characteristics as tested on a benchtop.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device is based on:

Adherence to recognized national and international consensus standards: (e.g., ISO 80601-2-74 for respiratory humidifying equipment, ISO 10993 for biocompatibility, ISO 18562 for breathing gas pathways).
Performance specifications and engineering requirements: The device's ability to reliably deliver the specified respirable dose and MMAD, maintain pressure, prevent condensate buildup, and ensure component integrity.
Direct comparative testing against a legally marketed predicate device: Demonstrating that the subject device's performance is equivalent to or better than the predicate's performance in critical aspects (e.g., respirable dose, MMAD).

8. The sample size for the training set:
Not Applicable. This device is not an AI model, so there is no "training set."

9. How the ground truth for the training set was established:
Not Applicable.

Summary

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12/10/2021

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

Re: K211560

Trade/Device Name: Airvo Nebulizer Adapter Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: November 12, 2021 Received: November 12, 2021

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

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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 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) K211560

Device Name Airvo Nebulizer Adapter

Indications for Use (Describe)
--------------------------------	--

Indications for use - AIRVO nebulizer adapter:

When used with a nebulizer:

When used without a nebulizer:

For use in hospitals and long-term care facilities, for the delivery of humidified respiratory gases to patients via nasal, tracheostomy and mask interfaces.

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)

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510(k) Summary

As Required by 21 CFR 807.92(c)

SUBMITTER I.

Company Name and Address	Fisher & Paykel Healthcare Limited15 Maurice Paykel PlaceEast TamakiAuckland 2013, New ZealandTelephone: +64 9 574 0100
Contact Person	Reena DakenRegulatory Affairs ManagerTelephone: +64 9 574 0100Email: reena.daken@fphcare.co.nz
Date Prepared	10 December 2021

SUBJECT DEVICE II.

Name of Device	Airvo Nebulizer Adapter
Common/Usual Name	Airvo Nebulizer Adapter
Classification Name	Nebulizer (Direct Patient Interface)Class II (21 CFR §868.5630)
Product Code	CAF

III. PREDICATE DEVICE

Aeroneb Solo Nebulizer System / Aeroneb Solo Adapter (K133360)

DEVICE DESCRIPTION IV.

The device is labelled for use with Salbutamol/ Albuterol only.

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INDICATIONS FOR USE V.

Indications for use - AIRVO nebulizer adapter:

When used with a nebulizer:

When used without a nebulizer:

For use in hospitals and long-term care facilities, for the delivery of humidified respiratory gases to patients via nasal, tracheostomy and mask interfaces.

VI. NON-CLINICAL PERFORMANCE DATA

The following tests were completed:

Shelf life simulation was based on ASTM F1980-07, and ISO 291:2008(E). ●
Transportation simulation was based on ISTA 2A Packaged-Products weighing 1501b (68kg) or less.
. Additional performance testing has also been completed to confirm the safety and effectiveness of the nebulizer adapter.
- O Nebulizer performance testing to demonstrate that nebulizing performance is equivalent when using an Airvo nebulizer adapter to when using an Aerogen T-piece.
- Testing to verify that the Airvo system meets the requirements of ISO 80601-2-74 when used O with the nebulizer adapter
- Testing to establish that the usability of the Airvo nebulizer adapter is safe and effective for O its intended users, uses, and use environments.
- O Testing to verify that the wear and stresses associated with the distribution of the packaged product does not cause damage to either the product or packaging.
- Testing to verify that nebulization via the Airvo nebulizer port does not adversely affect the o Airvo 2 or AirSpiral tube.
- Testing to verify that the port cap will stay in place and not fall out of the nebulizer port during O use with the Airvo 2 system
- Testing to measure the total volume of condensate, with the potential to reach the patient, that O forms over 24 hours in an Airvo system when used with the Airvo nebulizer adapter.

The Airvo Nebulizer Adapter has been tested to applicable requirements of the following standards:

ISO 80601-2-74 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
. ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications, Part 1: Evaluation and testing within a risk management process.

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COMPARISON OF TECHNOLOGICAL CHARATCERISTICS WITH THE PREDICATE DEVICE VII.

Feature/Function	Subject DeviceNebulizer Adapter	Predicate DeviceAerogen T-piece (cleared as part of AerogenSolo system K133360)	Comments
Product CodeDevice ClassificationClassification Panel	CAFClass II (21 CFR §868.5630)Anesthesiology	CAFClass II (21 CFR §868.5630)Anesthesiology	Identical
Intended Use	Used for attaching a nebulizer system toa breathing circuit to allow the deliveryof nebulized medication	Used for attaching a nebulizer system to a breathingcircuit to allow the delivery of nebulizedmedication	Identical
Indications for Use	Indications for use - AIRVO nebulizeradapter:When used with a nebulizer:The nebulizer adapter is a medicaldevice accessory for single-patient useto facilitate aerosolization of Albuterolsulfate for inhalation to adult patientsreceiving high-flow humidifiedbreathing gases via tracheostomy patientinterface. Intended for use by healthcareprofessionals in hospitals or long-termcare facilities.When used without a nebulizer:For use in hospitals and long-term carefacilities, for the delivery of humidifiedrespiratory gases to patients via nasal,tracheostomy and mask interfaces.	As the Aerogen T-piece was cleared as part of theAerogen Solo system K133360, it does not have itsown Indications for Use statement.The Indications for Use statement of the AerogenSolo system is:The Aerogen Solo Nebulizer System is a portablemedical device for single patient use that isintended to aerosolize physician-prescribedsolutions for inhalation to patients on and offventilation or other positive pressure breathingassistance.	Equivalent to predicateBoth, the subject device and predicate have the samegeneral intended use: to be used with an AerogenSolo nebulizer to introduce nebulized drug intorespiratory breathing circuit, however, onlySalbutamol/Albuterol can be delivered through thisadapter.
Availability	Prescription use.(Part 21 CFR 801 Subpart D)	Prescription use.(Part 21 CFR 801 Subpart D)	Identical
Feature/Function	Subject DeviceNebulizer Adapter	Predicate DeviceAerogen T-piece (cleared as part of AerogenSolo system K133360)	Comments
Application	Nebulization within a humidified highflow therapy system	Nebulization within a non-specific breathingsupport system	Equivalent to predicate.The subject device functions within a subset of thepredicate device.
Environment of Use	Hospital	Hospital	Identical
Connection to breathing circuit	Airvo nebulizer adapter has proprietaryconnectors	T-piece with 22mm ISO medical tapers (Maleinlet and Female outlet)	The subject device is proprietary to the Airvo systemwhile the predicate is a T-piece able to be connectedto any breathing circuit.
Nebulizer port orientation whenattached to a humidificationchamber	Nebulizer port at 15° above horizontal	Nebulizer port at 15° above horizontal	Identical
Position in circuit	Wet side of humidification chamber insingle-limb circuit	End of inspiratory limb in a dual-limb circuit ordry side of humidification chamber in a single-limb circuit	The subject device functions within a subset of thepredicate device (subject device has no dual-limbconfiguration). Comparative testing done on thetwo systems shows equivalence between the drugdelivery to the patient on both systems, whenpredicate is tested with "dry side of humidificationchamber" nebulizer positioning as per predicateInstructions For Use.
Sterility	Device not provided sterile	Device not provided sterile	Identical
Reusability	Single use	Single use	Identical
Maximum duration of use withnebulized drugs	7 days continuous use	7 days continuous use	Identical
Shelf life	3 years	Not specified	Shelf life is not specified for the predicate
Feature/Function	Subject Device	Predicate Device	Comments
	Nebulizer Adapter	Aerogen T-piece (cleared as part of AerogenSolo system K133360)
Flow path gas flow range whennebulizing albuterol via atracheostomy	10 – 30 L/min	Not defined	Flow range is not defined for predicate device
Flow path gas pressure range	Less than 25 cm H2O	Less than 90 cm H2O	The subject device's pressure range is within thepressure range of the predicate
On-label Drugs for Delivery	Salbutamol/Albuterol only	General purpose nebulizer	The on-label drugs for use with the subject device isa subset of the drugs for use on the predicate device.
Respirable dose (1 - 5 µm)when nebulizing albuterol via atracheostomy	From 2500 µg nebule:10 L/min - 1293.1 µg	From 2500 µg nebule:10 L/min - 1339.3 µg	Equivalent to predicate
	20 L/min – 949.5 µg	20 L/min – 991.8 µg
	30 L/min – 612.6 µg	30 L/min – 624.4 µg
		When nebulizer placed on dry side ofhumidification chamber
Median Mass AerodynamicDiameter (MMAD) whennebulizing albuterol via atracheostomy	10 L/min – 2.80 µm	10 L/min - 2.55 µm	Equivalent to predicate
	20 L/min – 2.73 µm	20 L/min - 2.63 µm
	30 L/min – 2.54 µm	30 L/min – 2.59 µm
		When nebulizer placed on dry side ofhumidification chamber
Compatibility with TrachealPatient Interface	Yes, Trache patient interface (OPT970)	Yes, when patient intubated through a tracheainterface	Equivalent to predicate

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VIII. ACCESSORIES

Port Cap Open and Nebulizer Fitted	Port Cap Closed
When the Port Cap is OPEN, and an Aerogen Solonebulizer is fitted and used to deliver nebulizedalbuterol, the Airvo Nebulizer Adapter will becompatible with the following patient interface:●OPT970 tracheostomy interface	When the Port Cap is CLOSED, and onlywarmed/humidified air/oxygen mixtures are deliveredto the patient WITHOUT nebulized medication, theAirvo Nebulizer Adapter will be compatible with thefollowing patient interfaces:● OPT970 tracheostomy interface● OPT942/OPT944/OPT946 Nasal Cannulas● OPT316/OPT318 Nasal Cannulas● OPT980 Mask Interface Adapter

CONCLUSIONS IX.

The comparison of features, performance, and intended use demonstrate that the Airvo nebulizer adapter is substantially equivalent to the predicate Aerogen T-piece (K133360). In addition, performance testing of the nebulizer adapter 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 nebulizer adapter to the predicate device.

Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).