(170 days)
The Airgle Room Air Purifier is a free standing, air purifying device utilizing germicidal ultraviolet light (UV-C wavelengths near 254nm) intended for inactivation of indoor airborne aerosols including bacteria and virus in medical facilities and occupied spaces.
The Airgle® Air Purifier has been demonstrated to destroy MS2 bacteriophage bioaerosol entrained on the filter of the subject device in the following exposure/working conditions:
| Test Item(s) | Test Results (Average Maximum Log Reduction / Entrainment Time at Fan Speed 5) |
|---|---|
| MS2 Bacteriophage | Model AG300: >4.0 Logs / 120 minutes |
| MS2 Bacteriophage | Model AG600: >4.0 Logs / 120 minutes |
| MS2 Bacteriophage | Model AG900: >4.0 Logs / 120 minutes |
Airgle Room Air Purificr is an air purification device that employs an ultraviolet air purification technology to inactivate viral aerosols. It is a free-standing device, which has a sealed main housing including a Carbon filter, a cHEPA filter and Titanium Pro (UV-C) module. Model AG300 use a 2-in-1 filter which combine the Carbon filter and cHEPA filter.
The operation of the device is as follows:
- Room air is drawn into the device via the rear grill.
- The process begins when air moves through the Carbon filter, which captures the large particles
- Next, the air moves through the cHEPA filter, which captures a particle size greater than 0.3 microns. The filter is an ultra-high performance cHEPA filter, which filters respirable particulate matter with an efficiency reaching 99.3% at least.
- Then the air moves through the Titanium Pro® module, where viral organisms are inactivated by UV-C light.
- Purified air is then returned to the room via the front grill.
The Airgle Room Air Purifier (Models AG300, AG600, AG900) is a medical ultraviolet air purifier designed to inactivate indoor airborne aerosols, including bacteria and viruses, in medical facilities and occupied spaces. The device's performance was assessed through non-clinical testing to demonstrate its ability to destroy MS2 bacteriophage bioaerosols.
Here's an overview of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Name of Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| IEC 60601-1, IEC 60601-1-2 | Demonstration of basic safety and essential performance | Meets criteria for CISPR Group 1A | PASS |
| AAMI TIR69:2017, ANSI C63.27-2017 | Wireless coexistence test | Wireless System ability to coexist with interfering networks in the 2.4G band. | PASS |
| Bacteriophage Test | Demonstration of log reduction of viral load | At least 99.99% reduction of MS2 bacteriophage after 2 hours (>4.0 Log Reduction) | PASS: Model AG300: >4.0 Logs / 120 minutesModel AG600: >4.0 Logs / 120 minutesModel AG900: >4.0 Logs / 120 minutes |
| ANSI/ASHRAE Standard 52.2 | Demonstration of filter efficiency | At least 99.3% for 0.3-10 um | PASS |
| Software validation | Demonstration of software security and good design | Meets design criteria | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical laboratory testing. The sample size for the "Bacteriophage Test" is not explicitly stated as a number of devices or runs within the provided text. However, the results indicate testing was performed for each model (AG300, AG600, AG900).
The data provenance is not explicitly stated in terms of country of origin, but it is implied to be from laboratory testing conducted as part of the device's clearance process. The studies were retrospective in the sense that they were designed to evaluate the finalized product against pre-defined criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes non-clinical performance testing (e.g., viral inactivation, filter efficiency, electrical safety), not a study involving human experts establishing ground truth from medical images or clinical observations. Therefore, this section is not applicable in the context of this device's non-clinical evaluation. The "ground truth" here is established by the well-defined scientific and engineering standards and methodologies for air purification testing.
4. Adjudication Method for the Test Set
Not applicable, as this was non-clinical laboratory testing rather than a study requiring expert adjudication of data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is an air purifier, and its efficacy is measured by its ability to inactivate pathogens and filter air, not by its impact on human reader performance in interpreting medical data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance data presented is inherently "standalone" in this context. The device (Airgle Room Air Purifier) is the "algorithm" or system being evaluated for its direct efficacy in air purification, without human intervention in its primary function of germicidal UV light and filtration. The reported log reduction of viral load and filter efficiency are direct measurements of the device's standalone performance.
7. The Type of Ground Truth Used
The ground truth for the performance claims (e.g., viral inactivation) was established through laboratory testing using scientifically recognized and standardized methods.
- MS2 Bacteriophage: A widely accepted surrogate virus for airborne viral studies due to its non-pathogenic nature and environmental robustness.
- ANSI/ASHRAE Standard 52.2: A standard method for testing general ventilation air-cleaning devices for removal efficiency by particle size.
- IEC 60601-1, IEC 60601-1-2, AAMI TIR69:2017, ANSI C63.27-2017: Industry standards for electrical safety, electromagnetic compatibility, and wireless coexistence.
8. The Sample Size for the Training Set
Not applicable. This document describes the validation (testing) of a physical device. There is no mention of a "training set" in the context of an AI/ML algorithm being developed. The device's design and engineering would be based on established scientific principles and materials, not a data "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device's validation.
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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.
February 16, 2024
Airgle Corporation Jet Li Regulation manager 1170 Lincoln Avenue Unit 2 Holbrook, New York 11741
Re: K232645
Trade/Device Name: Airgle Room Air Purifier Regulation Number: 21 CFR 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: Class II Product Code: FRA Dated: January 16, 2024 Received: January 16, 2024
Dear Jet Li:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. Christopher K. Dugard -S
Christopher K. Dugard, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical
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and Infection Control 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) K232645
Device Name
Airgle Room Air Purifier
Indications for Use (Describe)
The Airgle Room Air Purifier is a free standing, air purifying device utilizing germicidal ultraviolet light (UV-C wavelengths near 254nm) intended for inactivation of indoor airborne aerosols including bacteria and virus in medical facilities and occupied spaces. The Airgle® Air Purifier has been demonstrated to destroy MS2 bacteriophage bioaerosol entrained on the filter of the subject device in the following exposure/working conditions:
| Test Item(s) | Test Results (Average Maximum Log Reduction / Entrainment Time at Fan Speed 5) |
|---|---|
| MS2 Bacteriophage | Model AG300: >4.0 Logs / 120 minutes |
| MS2 Bacteriophage | Model AG600: >4.0 Logs / 120 minutes |
| MS2 Bacteriophage | Model AG900: >4.0 Logs / 120 minutes |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED
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K232645
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. This is a Traditional 510(K) submission, and there were no prior submissions for the subject device.
Date of the summary prepared: February 15, 2024
1. Submitter's Information
Sponsor
- ♦ Applicant: Airgle Corporation
- ♦ Address: 1170 Lincoln Avenue Unit 2 Holbrook, NY 11741 USA
- Manufacturer: Shenzhen Airgle Corporation Limited �
- ♦ Factory address: Zone A&B, The 11th Floor, KeChuang Building, QuanZhi Science &
Technology Innovation Park, Houting Mao zhoushan Industrial Park, ShaJing Street,
Baoan District, Shenzhen Guangdong, CN 518000
- ◆ Phone: +86-755-86726696
- ♦ Email: jerry@airgle.com.cn
- ◆ Contact Person (including title): Jerry Liu (CTO)
Application Correspondent:
- ◆ . Airgle Corporation
- ♦ Address: 1170 Lincoln Avenue Unit 2 Holbrook, NY 11741 USA
- ♦ Contact Person: Mr. Jet Li
- ♦ Title: Regulation Manager
- ♦ Tel: +86-18588874857
- ♦ Email: jianda-lee@foxmail.com
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2. Subject Device Information
- Type of 510(k) submission: Traditional �
- � Classification: Medical Ultraviolet Air Purifier
- � Trade Name: Airgle Room Air Purifier
- � Model: AG300 /AG600 /AG900
- � Review Panel: General Hospital
- � Product Code: FRA
- � Regulation Number: 21 CFR 880.6500
- � Regulation Class: 2
3. Predicate / Reference Device Information
| Predicate Device | Reference Device | |
|---|---|---|
| 510(k) number | K202339 | K212824 |
| Sponsor | Molekule, Inc. | Bluezone Products, Inc. |
| Classification | Medical Ultraviolet Air Purifier | Medical Ultraviolet Air Purifier |
| Trade Name | Molekule Air Mini | Bluezone Model RX-450 Air Purifier |
| Review Panel | General Hospital | General Hospital |
| Product Code | FRA | FRA |
| Regulation Number | 21 CFR 880.6500 | 21 CFR 880.6500 |
| Regulation Class | 2 | 2 |
4. Device Description
Airgle Room Air Purificr is an air purification device that employs an ultraviolet air purification technology to inactivate viral aerosols. It is a free-standing device, which has a sealed main housing including a Carbon filter, a cHEPA filter and Titanium Pro (UV-C) module. Model AG300 use a 2-in-1 filter which combine the Carbon filter and cHEPA filter.
The operation of the device is as follows:
-
- Room air is drawn into the device via the rear grill.
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- The process begins when air moves through the Carbon filter, which captures the 2) large particles
-
- Next, the air moves through the cHEPA filter, which captures a particle size greater than 0.3 microns. The filter is an ultra-high performance cHEPA filter, which filters respirable particulate matter with an efficiency reaching 99.3% at least.
- Then the air moves through the Titanium Pro® module, where viral organisms are 4) inactivated by UV-C light.
- Purified air is then returned to the room via the front grill. 5)
5. Intended Use / Indications for Use (For models: AG300/AG600/AG900)
The Airgle Room Air Purifier is a free standing, air purifying device utilizing germicidal ultraviolet light (UV-C wavelengths near 254nm) intended for inactivation of indoor airborne aerosols including bacteria and virus in medical facilities and occupied spaces.
The Airgle® Air Purifier has been demonstrated to destroy the following MS2 bacteriophage bioaerosol entrained on the filter of the subject device under the following exposure/working conditions:
| Test Item(s) | Test Results (Average Maximum Log Reduction /Entrainment Time at Fan Speed 5) |
|---|---|
| MS2 | Model AG300: >4.0 Logs / 120 minutes |
| Bacteriophage | Model AG600: >4.0 Logs / 120 minutesModel AG900: >4.0 Logs / 120 minutes |
6. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, and intended use of Airgle Room Air Purifier are shown below in tabular form.
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| Device | Proposed Device | Primary PredicateDevice 1 | Reference Device 1 | Comment |
|---|---|---|---|---|
| K202339 | K212824 | |||
| Manufacturer | Airgle Corporation | Molekule, Inc. | Bluezone Products, Inc. | None |
| Product Name | Airgle Room AirPurifierAG300/AG600/AG900 | Molekule Air Mini, | Bluezone Model RX-450Air Purifier | None |
| Device type | Medical Ultraviolet AirPurifier | Purifier, Air, Ultraviolet,Medical | Medical Ultraviolet AirPurifier | Same |
| Classification | Class II, FRA (21CFR880.6500) | Class II, FRA (21CFR880.6500) | Class II, FRA (21CFR880.6500) | Same |
| Use type | OTC | OTC | OTC | Same |
| Intended Use | Destroy bacteria andviruses by exposure toultraviolet radiation. | Destroy bacteria andviruses by exposure toultraviolet radiation. | Kill bacteria and virus inthe air | Same |
| Indications for use | The Airgle Room AirPurifier is a freestanding, air purifyingdevice utilizinggermicidal ultravioletlight intended forinactivation of indoorairborne aerosolsincluding bacteria andvirus in medicalfacilities and occupiedspaces.The Airgle® AirPurifier has beendemonstrated todestroy the followingMS2 bacteriophagebioaerosol entrainedon the filter of thesubject device underthe followingexposure/workingconditions: | The Molekule Air Mini airpurifier is a deviceintended for medicalpurposes that is usedto capture 95% ofparticulate matter anddestroy bacteria andviruses by exposure toultraviolet radiation.The Molekule Air Mini airpurifier has beendemonstrated to destroythe following MS2bacteriophagebioaerosol entrained onthe filter of the subjectdevice under thefollowingexposure/workingconditions: | The Bluezone ModelRX-450 Air Purifier is afree standing, airpurifying device utilizinggermicidal ultravioletlight (UV-C wavelengthsnear 254nm) intendedfor inactivation of indoorairborne aerosolsincluding bacteria, mold,and virus in medicalfacilities and occupiedspaces.The Bluezone Model Rx-450 Air Purifier has beendemonstrated to entrainand destroy the followingexposure/workingconditions: | Subject and PredicateDevices tested against thesame organismReference Device testedagainst additionalorganisms |
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| Test Item(s) | Test Results (Average Maximum Log Reduction / Entrainment Time at Fan Speed 5) |
|---|---|
| MS2 Bacteriophage | Model AG300: >4.0 Logs / 120 minutesModel AG600: >4.0 Logs / 120 minutesModel AG900: >4.0 Logs / 120 minutes |
| Test Item | Test Result |
| Virus | MS2 bacteriophage$5.09\pm0.42$ / 120 mins |
| Particulate matter | 0.3 to 1.0 micron size particles95% or greater according to ASHRAE 52.2 |
| Test item | Average Net Log Reduction/Time @ High Fan Speed. Room Temperature Test |
| Bact Bacillus atrophaeus | 4.95 / 60 minutes |
| Bact Bacillus atrophaeus | 4.00 / 48 minutes |
| Mold Penicillium rocqueforti | 4.40 / 60 minutes |
| Mold Penicillium rocqueforti | 4.00 / 52 minutes |
| Virus MS-2 bacteriophage | 5.32 / 60 minutes |
| Virus MS-2 bacteriophage | 4.00 / 40 minutes |
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| Device | Proposed Device | Primary PredicateDevice 1K202339 | Reference Device 1K212824 | Comment |
|---|---|---|---|---|
| Mechanism of Action | UV-C inactivation ofmicroorganisms | UV light of sufficientenergy (UV-A) activatesphotocatalyst thatdestroysmicroorganismsentrained on the filterthrough a hotochemicalreaction. | UV-C inactivation ofmicroorganisms | Subject, Predicate andReference Devices allreduce viable and no-viableaerosols by entrainmentonto filter media andbiocidal action of UV Light |
| Installation | Free standing | Free standing | Free standing | Same |
| Elements of design | Fan circulates airthrough a shieldedchamber where UVlight irradiatesmicrobial aerosols | Fan circulates airthrough a shieldedchamber where UV lightirradiates microbialaerosols | Fan circulates airthrough a shieldedchamber where UV lightirradiates microbialaerosols | Same |
| Filter | Yes | Yes | Yes | Same |
| Filtration type | Particle filter | Particle filter | Particle filter | Same |
| Device | Proposed Device | Primary PredicateDevice 1K202339 | Reference Device 1K212824 | Comment |
| Internal Fan | Yes | Yes | Yes | Same |
| Fan speed | 5 speeds | 5 Speeds | 2 Speeds | No new safety or efficacyquestions raised bydifferences. Anyperformance differencesmitiagted by test results |
| Germicidal UV | Yes | Yes | Yes | Same |
| UV Optic type | Quartz tube with lowpressure mercuryvapor | UV Light Source:LED | Quartz tube with lowpressure mercury vapor | No new safety or efficacyquestions raised bydifferences. Anyperformance differencesmitiagted by test results. |
| UV wavelength | 254nm | 320-400 nm | 254nm | No new safety or efficacyquestions raised bydifferences. Any |
| Device | Proposed Device | Primary PredicateDevice 1K202339 | Reference Device 1K212824 | Comment |
| performance differencesmitigated by test results. | ||||
| Ozone Emission | Does not exceed aconcentration of 0.050ppm according to UL867 | Does not exceed aconcentration of 0.050ppm according to UL867 | Does not exceed aconcentration of 0.050ppm according to UL867 | Same |
| Removal of bacterialspores | Not claimed | Not claimed | 99.99% | No new safety or efficacyquestions raised bydifferences. Performancedifferences mitigated bylabeling claims. |
| Removal of moldspores | Not claimed | Not claimed | 99.99% | No new safety or efficacyquestions raised bydifferences. Performancedifferences mitigated bylabeling claims |
| Device | Proposed Device | Primary PredicateDevice 1K202339 | Reference Device 1K212824 | Comment |
| Removal ofAerosolized MS2Bacteriophage | 4.0 net LOG reductionin a 30 m3 space at120 minutes | 4 log reduction(99.99%) | 4.0 net LOG reduction ina 16m3 space at 35minutes. | No new safety or efficacyquestions raised bydifferences. Performancedifferences mitigated bylabeling claims |
| UV radiance andleakage in occupiedspaces | None | None | Effective irradiance <0.1uW/cm2 | Same |
| Chemical Additives | No | No | No | Same |
| Electrical safety | IEC 60601-1AAMI TIR69:2017ANSI C63.27-2017 | UL 507 | UL 507 | No new safety or efficacyquestions raised bydifferences in Standardsapplied. |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | Same |
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7. Summary for non-clinical test
The non-clinical testing was provided to demonstrate the subject device met the acceptance criteria of the test methodology or standards listed below. Airgle Room Air Purifier complies with voluntary standards for electrical safety and electromagnetic compatibility.
| Name of testmethodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| IEC 60601-1IEC 60601-1-2 | Demonstration of basic safety and essential performance | Meets criteria for CISPR Group 1A | PASS |
| AAMI TIR69:2017ANSI C63.27-2017 | wireless coexistence test | Wireless System ability to coexist with interfering networks in the 2.4G band. | PASS |
| Bacteriophage Test | Demonstration of log reduction of viral load | At least 99.99% reduction of MS2 bacteriophage after 2 hours | PASS |
| ANSI/ASHRAEStandard 52.2 | Demonstration of filter efficiency | At least 99.3% for 0.3-10 um | PASS |
| Software validation | Demonstration of software security and good design | Meets design criteria | PASS |
8. Summary for clinical test
Not applicable
9. Conclusion
The Conclusion drawn from the non-clinical testing demonstrates that the subject device, Airgle Room Air Purifier, is as safe, as effective, and performs as well for the documented intended use as the legally marketed predicate device cleared under K202339 and the reference device cleared under K212824.
§ 880.6500 Medical ultraviolet air purifier.
(a)
Identification. A medical ultraviolet air purifier is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation.(b)
Classification. Class II (performance standards).