The AireHealth™ Nebulizer electronic vibrating mesh nebulize liquid medications for inhalation by a patient. The AireHealth™ Nebulizer may be used in adults or children 5 years of age and older. The AireHealth™ Nebulizer is a portable Nebulizer for use in and out of the home environment.

The AireHealth™ Nebulizer is not intended as a life sustaining or life-supporting device.

The AireHealth™ Nebulizer is not intended for use with Pentamidine.

Device Description

The AireHealth" Nebulizer, model AH-04, is a portable electronic vibrating mesh nebulizer is designed to nebulize liquid medications for inhalation by a patient in and out of the home environment. The Nebulizer may be used in adults or children 5 years of age and older.

The AireHealth™Nebulizer vibrating mesh nebulizer incorporates a piezoelectric transducer that vibrates at a nominal frequency (115kHz) when electrical current is applied. The vibration of the transducer is transmitted to a metal alloy mesh vapor disk that contains approximately 5,000 holes that are in contact with the liquid to be nebulized. An electrical charge applied to the piezoelectric transducer, in turn, leads to vibration (inward and outward movement of the mesh vapor disk), passing the liquid through the holes to form an aerosol. The AireHealth™ Nebulizer is battery operated. The handset in the AireHealth 100 Nebulizer has a use life of 3 years.

Liquid medication is placed in the medicine cup which should be cleaned after every use. The medicine cup should be replaced every 90 days.

The Nebulizer is capable of providing use and status information to a companion application wirelessly via Bluetooth connection. The companion application is an optional accessory for displaying purposes only and will not allow operation or control of the nebulizer. The companion application is not a medical device.

AI/ML Overview

This document describes the AireHealth™ Nebulizer, a device that nebulizes liquid medications for inhalation. It primarily focuses on demonstrating substantial equivalence to a predicate device, the MicroVapor Devices POCKET NEB (K142541), rather than presenting a study proving that the device meets specific acceptance criteria with associated performance metrics.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types is largely not available in the provided text. The document details non-clinical testing to support substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state a table of acceptance criteria with corresponding device performance metrics in the format you requested for a novel device proving its own performance. Instead, it demonstrates performance through various non-clinical tests to show substantial equivalence to a predicate device.

However, some performance parameters are mentioned in the "Comparison of Technological Characteristics" and "Performance Testing - Bench" sections:

Parameter	Acceptance Criteria (Implied / Predicate)	Reported Device Performance (AireHealth™ Nebulizer)
Nebulization Rate	0.25 mL/min minimum (same as predicate)	0.25 mL/min minimum
Handset Use Life	1 year (predicate)	3 years
Medication Cup Use Life	45 days (predicate)	90 days
Operating Temperature	5°C to 40°C (predicate)	5°C to 38°C
Operating Humidity	15% to 93% Relative Humidity (predicate)	15% to 90% Relative Humidity

Note: The "Acceptance Criteria" column above is inferred from the predicate device's specifications or stated requirements for the proposed device.

2. Sample Sizes Used for the Test Set and Data Provenance:

Test Set Sample Size: Not explicitly stated for each test. For "Use Life Testing for Medication Cup and Handset," it states "these components were subjected to continuous use, equivalent to maximum possible use during a 3-year and 90-day period." This implies functional testing over time on a device or components, but the number of units tested is not specified.
Data Provenance: The testing appears to be internal bench testing ("Performance Testing - Bench") conducted by MicroVapor Devices (for biocompatibility and potentially other aspects leveraged by AireHealth Inc.) or AireHealth Inc. itself. There is no indication of country of origin for specific test data, and it is entirely retrospective as it's part of a 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. The document does not describe a study involving expert-established ground truth for a test set, as this is a medical device hardware submission, not an AI/software diagnostic tool requiring such validation.

4. Adjudication Method for the Test Set:

Not applicable, for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement:

No, an MRMC comparative effectiveness study was not done. This device is a nebulizer, not an AI-assisted diagnostic or treatment system involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone algorithm performance study was not done. The device is a physical nebulizer, and while it has optional Bluetooth connectivity to a companion application, the application is explicitly stated as "an optional accessory for displaying purposes only and will not allow operation or control of the nebulizer. The companion application is not a medical device." Therefore, there is no AI algorithm performing a medical function in standalone or human-in-the-loop mode.

7. The Type of Ground Truth Used:

For the performance tests described (e.g., nebulization rate, use life), the "ground truth" would be objective measurements in a laboratory setting against established engineering or performance specifications. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

Not applicable. There is no AI algorithm being trained, so no training set is relevant.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, for the same reasons as point 8.

Summary

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December 3, 2020

AireHealth Inc. % Jessica Czamanski Project Engineer Regulatory and Quality Solutions, LLC 2790 Mosside Blvd #800 Monroeville, Pennsylvania 15146

Re: K201167 Trade/Device Name: AireHealthTM Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: November 2, 2020 Received: November 3, 2020

Dear Jessica Czamanski:

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 medical devices and radiation-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 L. Blakely, Ph.D. Acting 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201167

Device Name AireHealth™ Nebulizer

Indications for Use (Describe)

The AireHealth™ Nebulizer is not intended as a life sustaining or life-supporting device.

The AireHealth™ Nebulizer is not intended for use with Pentamidine.

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

This 510(k) Summary is provided per the requirements of section 21 CFR 807.92 on December 3", 2020.

I. Submitter

Submitter's Name:	AireHealth Inc.
Contact Person:	Rusty KellyHead of Quality and Regulatory
Address:	3251 Progress Dr., Suite FOrlando, FL 32826
Telephone:	(407) 252-0414
Email:	rusty.kelly@aire.health

II. Application Correspondent

Contact's Name:	Regulatory and Quality Solutions, LLC
Contact Person:	Jessica CzamanskiRegulatory Consultant
Address:	2790 Mosside Blvd #800Monroeville, PA 15146
Telephone:	(877) 652-0830 ext. 208
Email:	jczamanski@rqteam.com

III. Device

Trade Name:	AireHealth™ Nebulizer
Common Name:	Nebulizer
Classification Name:	Nebulizer (Direct Patient Interface)
Product Classification:	Class II
Regulation Number:	868.5630
Product Code:	CAF

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IV. Predicate Device

MicroVapor Devices POCKET NEB, K142541 (MicroVapor Devices) FDA cleared on 01/22/2016.

V. Device Description

Liquid medication is placed in the medicine cup which should be cleaned after every use. The medicine cup should be replaced every 90 days.

VI. Intended Use and Indications for Use

The AireHealth "M Nebulizer electronic vibrating mesh nebulizer is designed to nebulize liquid medications for inhalation by a patient. The AireHealth™ Nebulizer may be used in adults or children 5 years of age and older. The AireHealth" Nebulizer is a portable Nebulizer for use in and out of the home environment.

The AireHealth™ Nebulizer is not intended as a life sustaining or life-supporting device.

The AireHealth™ Nebulizer is not intended for use with Pentamidine.

VII. Comparison of Technological Characteristics with the Predicate Devices

The proposed and predicate devices are nebulizers used to nebulize liquid medications for inhalation by a patient.

The following table (Table 7-1) provides an overview of general technological characteristics in comparison to the predicate device.

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	Table 7-1: General Technological Characteristics Comparison
Product Features	ProposedAireHealthTM Nebulizer	PredicateMicroVapor Devices POCKETNEB(K142541)
Classification	Class II	-same-
Product Code	CAF	-same-
RegulationNumber	§868.5630	-same-
Regulation Name	Nebulizer	-same-
Intended Use	The AireHealthTM Nebulizerelectronic vibrating mesh nebulizeris designed to nebulize liquidmedications for inhalation by apatient. The AireHealthTMNebulizermay be used in adults or children 5years of age and older. TheAireHealthTM Nebulizer is aportable Nebulizer for use in andout of the home environment.The AireHealthTM Nebulizer is notintended as a life sustaining or life-supporting device.The AireHealthTM Nebulizer is notintended for use with Pentamidine.	The Model, MVD-70, POCKETNEB electronic vibrating meshnebulizer is designed to nebulizeliquid medications for inhalation bya patient. The POCKET NEB maybe used by children or adults. ThePOCKET NEB is a portable unit foruse in and out of the homeenvironment.The POCKET NEB is not intendedas a life sustaining or life-supporting device.The POCKET NEB is not intendedfor use with Pentamidine.
Indications for Use	The AireHealthTM Nebulizerelectronic vibrating mesh nebulizeris designed to nebulize liquidmedications for inhalation by apatient. The AireHealthTMNebulizermay be used in adults or children 5years of age and older. TheAireHealthTM Nebulizer is aportable Nebulizer for use in andout of the home environment.The AireHealthTM Nebulizer is notintended as a life sustaining or life-supporting device.The AireHealthTM Nebulizer is notintended for use with Pentamidine.	The Model, MVD-70 POCKETNEB electronic vibrating meshnebulizer is designed to nebulizeliquid medications for inhalation bya patient. The POCKET NEB maybe used in adults or children 2 yearsof age and older. The POCKETNEB is a portable unit for use inand out of the home environment.The POCKET NEB is not intendedas a life sustaining or life-supporting device.The POCKET NEB is not intendedfor use with Pentamidine.Labeling for this device inaccordance with FDA regulationsand will read:"Federal Law Restricts This devicesto sale By Or On the Order of APhysician"
Environment ofUse	In Home or Out of Home Use	-same-
Product Features	ProposedAireHealthTM Nebulizer	PredicateMicroVapor Devices POCKETNEB(K142541)
Principle ofOperation	The AireHealthTM Nebulizervibrating mesh nebulizerincorporated a piezoelectrictransducer that vibrates at afrequency (115kHz) when electricalcurrent is applied. The vibration ofthe transducer is transmitted to ametal allow mesh vapor disk thatcontains approximately 5,000 holesthat are in contact with the liquid tobe nebulized. An electrical chargeapplied to the piezoelectrictransducer, in turn, leads tovibration (inward and outwardmovement of the mesh vapor disk),passing the liquid through the holesto form an aerosol. AireHealthTMNebulizer is battery operated.	The MVD-70, POCKET NEBvibrating mesh nebulizerincorporated a piezoelectrictransducer that vibrates at afrequency (115kHz) when electricalcurrent is applied. The vibration ofthe transducer is transmitted to ametal allow mesh vapor disk thatcontains approximately 5,000 holesthat are in contact with the liquid tobe nebulized. An electrical chargeapplied to the piezoelectrictransducer, in turn, leads tovibration (inward and outwardmovement of the mesh vapor disk),passing the liquid through the holesto form an aerosol. The POCKETNEB is battery operated.
User Profile	Children 5 years of age or older andadults	Children 2 years of age or older andadults
Use Life Nebulizer	3 years	1 year
Use Life Medcup	90 days	45 days
Materials (patient-contacting)	Mouthpiece: polyethyleneHandset: polycarbonate	-same-
Nebulization Rate	0.25mL/min minimum	-same-
Single Use	Single Patient Use	-same-
Power Supply	Rechargeable Li Ion battery	-same-
OperatingTemperature	5°C to 38°C	5°C to 40°C
OperatingHumidity	15% to 90% Relative Humidity	15% to 93% Relative Humidity
CompanionApplicationConnectivity	Optional connectivity via Bluetooth	N/A

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Table 7-1: General Technological Characteristics Comparison

VIII. Non-Clinical Data

The following performance data was considered in support of the substantial equivalence determination.

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Biocompatibility

The proposed AireHealth™ Nebulizer is manufactured by MicroVapor Devices using the same components and materials cleared under K142541. An authorization letter from MicroVapor Devices, granting authorization to AireHealth Inc. to use the biocompatibility information within submission K142541 is included within the biocompatibility section of this submission. The latter includes cytotoxicity, sensitization, and irritation testing per ISO 10993-1, as well as an assessment to demonstrate compliance to the ISO 18562 standard series, including volatile organic compounds, particulate testing, and extractables and leachables testing ..

Software Verification and Validation Testing

The proposed AireHealthTM Nebulizer contains firmware which was subjected to software verification testing and cybersecurity assessment.

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical Safety in compliance with IEC60601-1 and IEC 60601-1-11 and EMC testing in compliance with IEC 60601-1-2 have been completed for the AireHealth™M Nebulizer.

Performance Testing - Bench

The following tests were performed to demonstrate that the proposed AireHealth™ Nebulizer met the applicable design and performance requirements and support a determination of substantial equivalence. Where applicable, testing was done per applicable ISO and other international standards.

. Use Life Testing for Medication Cup and Handset was performed to demonstrate the handset has a use life of 3 years and the medication cup has a use life of 90 days. Respectively, these components were subjected to continuous use, equivalent to maximum possible use during a 3-year and 90-day period.
Usability Testing was completed to demonstrate compliance with IEC 60601-1-6. ●
Bluetooth Testing was performed to demonstrate successful pairing.
Cascade Impactor Testing from the predicate device was leveraged through a comparative analysis, demonstrating identicality of critical components among subject and predicate devices.
. Delivery and Residual Volume Testing were performed to demonstrate delivery rate among subject and predicate devices.
Cleaning Validation was performed to demonstrate functionality is not affected after ● maximum number of cleaning cycles.
Battery Capacity and Delivery Rate Testing was performed to ensure battery power . allows for appropriate delivery rate and time of use as stated in the device IFU.

Performance Testing - Animal

This submission does not include any animal performance testing. It was determined that no such testing was required to demonstrate substantial equivalence.

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Performance Testing - Clinical

This submission does not include any clinical performance testing. It was determined that no such testing was required to demonstrate substantial equivalence.

IX. Conclusion

The proposed AireHealth™ Nebulizer has the same intended use, environment, materials, operating principle, and fundamental technology as the predicate device. The differences in technology allow the subject device to connect to an optional, diary companion application via Bluetooth connectivity. Therefore, the information provided in this submission supports substantial equivalence of the subject device to its predicate for its intended use.

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).