(216 days)
No
The description focuses on the mechanical and electrical operation of a vibrating mesh nebulizer and mentions a companion app for display purposes only, with no indication of AI/ML functionality.
Yes
The device is a nebulizer designed to administer liquid medications for inhalation, which directly addresses a medical condition or ailment, classifying it as a therapeutic device.
No
A diagnostic device is used for identifying or determining the nature of a disease or condition. This device is described as a nebulizer that "nebulize liquid medications for inhalation by a patient," which is a treatment delivery function, not a diagnostic one.
No
The device description clearly outlines a hardware device (a vibrating mesh nebulizer) with a companion software application that is explicitly stated as not being a medical device. The 510(k) summary focuses on the hardware components and their performance.
Based on the provided information, the AireHealth™ Nebulizer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "nebulize liquid medications for inhalation by a patient." This is a therapeutic function, delivering medication to the body.
- Device Description: The description details how the device creates an aerosol from liquid medication for inhalation. This is a drug delivery mechanism.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. IVD devices are specifically designed for these purposes.
Therefore, the AireHealth™ Nebulizer is a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AireHealth™ Nebulizer electronic vibrating mesh nebulizer 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.
Product codes
CAF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The AireHealth™ Nebulizer may be used in adults or children 5 years of age and older.
Intended User / Care Setting
Home environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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 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.
| 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 Kelly |
| Head of Quality and Regulatory | |
| Address: | 3251 Progress Dr., Suite F |
| Orlando, 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 Czamanski |
| Regulatory Consultant | |
| Address: | 2790 Mosside Blvd #800 |
| Monroeville, 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
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.
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 | Proposed | |
| AireHealthTM Nebulizer | Predicate | |
| MicroVapor Devices POCKET | ||
| NEB | ||
| (K142541) | ||
| Classification | Class II | -same- |
| Product Code | CAF | -same- |
| Regulation | ||
| Number | §868.5630 | -same- |
| Regulation Name | Nebulizer | -same- |
| Intended Use | The AireHealthTM Nebulizer | |
| electronic vibrating mesh nebulizer | ||
| is designed to nebulize liquid | ||
| medications for inhalation by a | ||
| patient. The AireHealthTMNebulizer | ||
| may be used in adults or children 5 | ||
| years of age and older. The | ||
| AireHealthTM Nebulizer is a | ||
| portable Nebulizer for use in and | ||
| out of the home environment. | ||
| The AireHealthTM Nebulizer is not | ||
| intended as a life sustaining or life- | ||
| supporting device. | ||
| The AireHealthTM Nebulizer is not | ||
| intended for use with Pentamidine. | The Model, MVD-70, POCKET | |
| NEB electronic vibrating mesh | ||
| nebulizer is designed to nebulize | ||
| liquid medications for inhalation by | ||
| a patient. The POCKET NEB may | ||
| be used by children or adults. The | ||
| POCKET NEB is a portable unit for | ||
| use in and out of the home | ||
| environment. | ||
| The POCKET NEB is not intended | ||
| as a life sustaining or life- | ||
| supporting device. | ||
| The POCKET NEB is not intended | ||
| for use with Pentamidine. | ||
| Indications for Use | The AireHealthTM Nebulizer | |
| electronic vibrating mesh nebulizer | ||
| is designed to nebulize liquid | ||
| medications for inhalation by a | ||
| patient. The AireHealthTMNebulizer | ||
| may be used in adults or children 5 | ||
| years of age and older. The | ||
| AireHealthTM Nebulizer is a | ||
| portable Nebulizer for use in and | ||
| out of the home environment. | ||
| The AireHealthTM Nebulizer is not | ||
| intended as a life sustaining or life- | ||
| supporting device. | ||
| The AireHealthTM Nebulizer is not | ||
| intended for use with Pentamidine. | The Model, MVD-70 POCKET | |
| NEB electronic vibrating mesh | ||
| nebulizer is designed to nebulize | ||
| liquid medications for inhalation by | ||
| a patient. The POCKET NEB may | ||
| be used in adults or children 2 years | ||
| of age and older. The POCKET | ||
| NEB is a portable unit for use in | ||
| and out of the home environment. | ||
| The POCKET NEB is not intended | ||
| as a life sustaining or life- | ||
| supporting device. | ||
| The POCKET NEB is not intended | ||
| for use with Pentamidine. | ||
| Labeling for this device in | ||
| accordance with FDA regulations | ||
| and will read: | ||
| "Federal Law Restricts This devices | ||
| to sale By Or On the Order of A | ||
| Physician" | ||
| Environment of | ||
| Use | In Home or Out of Home Use | -same- |
| Product Features | Proposed | |
| AireHealthTM Nebulizer | Predicate | |
| MicroVapor Devices POCKET | ||
| NEB | ||
| (K142541) | ||
| Principle of | ||
| Operation | The AireHealthTM Nebulizer | |
| vibrating mesh nebulizer | ||
| incorporated a piezoelectric | ||
| transducer that vibrates at a | ||
| frequency (115kHz) when electrical | ||
| current is applied. The vibration of | ||
| the transducer is transmitted to a | ||
| metal allow 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. AireHealthTM | ||
| Nebulizer is battery operated. | The MVD-70, POCKET NEB | |
| vibrating mesh nebulizer | ||
| incorporated a piezoelectric | ||
| transducer that vibrates at a | ||
| frequency (115kHz) when electrical | ||
| current is applied. The vibration of | ||
| the transducer is transmitted to a | ||
| metal allow 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 POCKET | ||
| NEB is battery operated. | ||
| User Profile | Children 5 years of age or older and | |
| adults | Children 2 years of age or older and | |
| adults | ||
| Use Life Nebulizer | 3 years | 1 year |
| Use Life Medcup | 90 days | 45 days |
| Materials (patient- | ||
| contacting) | Mouthpiece: polyethylene | |
| Handset: polycarbonate | -same- | |
| Nebulization Rate | 0.25mL/min minimum | -same- |
| Single Use | Single Patient Use | -same- |
| Power Supply | Rechargeable Li Ion battery | -same- |
| Operating | ||
| Temperature | 5°C to 38°C | 5°C to 40°C |
| Operating | ||
| Humidity | 15% to 90% Relative Humidity | 15% to 93% Relative Humidity |
| Companion | ||
| Application | ||
| Connectivity | 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.
7
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.