(167 days)
The Bluezone Model RX-450 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, mold, and virus in medical facilities and occupied spaces.
The Bluezone Model Rx-450 Air Purifier has been demonstrated to entrain and destroy the following exposure/working conditions:
| Test Item | Average Net Log Reduction/Time @ High FanSpeed. Room Temperature Test | |
|---|---|---|
| Bacteria | Bacillus atrophaeus | 4.95 / 60 minutes |
| Bacteria | 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 |
The Bluezone Model RX-450 is an air purification device that uses germicidal UV bulbs to inactivate viral, bacterial or fungal aerosols. The operation of the device is as follows: ambient air containing microbial aerosols is drawn into the air purifier through a prefilter and two angled aluminum honeycomb light baffles. The infective aerosols in the air are then exposed to high intensity, germicidal, ultraviolet light where the contaminants receive a UV dose of at least 10 mW*second/cm². The bacterial, fungal and viral aerosols are inactivated through the breakdown of the microbial DNA or RNA. The cleaned air is exhausted back into the room from the Bluezone Model RX-450 through an axial fan.
The provided text describes the regulatory filing for the "Bluezone Model RX-450 Air Purifier." This device is an air purifier that uses UV-C light to inactivate airborne bacteria, mold, and viruses. The document details the device's technical specifications, indications for use, and the non-clinical testing performed to establish its performance and safety.
Here's the breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Completed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | Per UL 507: 2017 Ed. 10+R: 06Nov2018 Fans and Ventilators; CSA C22.2#113:2018 Ed. 11 | Passed |
| Electromagnetic Compatibility | Per IEC 60601-1-2:2014 (4th Edition) General Requirements for Safety- Collateral Electromagnetic Compatibility Requirements and Tests Medical Electrical Equipment | Passed |
| Safety of air-cleaning appliances | Per IEC 60335-2-65 Safety of household and similar electrical appliances Part 2: Particular requirements for air-cleaning appliances | Test specifications were met |
| Ozone Emissions Testing of Household Electrostatic Air Cleaners | Emittance of ozone not exceeding a concentration of 0.050 ppm (UL 867 Section 40, Fifth Edition; CSA 22-2 No. 187-15, Section 7) | Found in compliance with criteria |
| Zero Ozone Emission | Ozone < 0.005 ppm (UL 2998 Section 6) | Passed. Ozone < 0.001 ppm |
| UV Irradiance and Leakage in Occupied Spaces | Effective irradiance < 0.1 uW/cm² (UL 507-2017: Heating and Cooling Equipment) | Passed. Location 1 Effective irradiance 6.55E-02 uW/cm² and Location 2 3.13E-03 uW/cm² |
| Removal of Aerosolized MS2 Bacteriophage | 4.0 net LOG reduction | Produced a rapid reduction in viable MS2 within the 60-minute test period. The Bluezone RX-450 is estimated to reach a 4.0 net LOG reduction of viable MS2 bioaerosol in a 16m³ chamber at 35 minutes. |
| Removal of Bacterial Spores (Bacillus atrophaeus) | 99.99% reduction in active aerosolized bacterial spores | Achieved 99.99% reduction in active aerosolized bacterial spores in less than 48 minutes in a 735 cubic foot test chamber. |
| Removal of Mold Spores (Penicillium rocqueforti) | 99.99% reduction in active aerosolized molds | Achieved 99.99% reduction in active aerosolized molds in less than 1 hour in a 735 cubic foot test chamber. |
Additionally, the "Indications for Use" section (pages 2 and 4) provides specific performance targets for different microorganisms, which can also be considered acceptance criteria.
| Test Item | Acceptance Criteria (Average Net Log Reduction/Time @ High Fan Speed. Room Temperature Test) | Reported Device Performance |
|---|---|---|
| Bacteria (Bacillus atrophaeus) | 4.95 / 60 minutes | Achieved 99.99% reduction (equivalent to ~4.0 log reduction) in less than 48 minutes. |
| Bacteria (Bacillus atrophaeus) | 4.00 / 48 minutes | Achieved 99.99% reduction (equivalent to ~4.0 log reduction) in less than 48 minutes. |
| Mold (Penicillium rocqueforti) | 4.40 / 60 minutes | Achieved 99.99% reduction (equivalent to ~4.0 log reduction) in less than 1 hour. |
| Mold (Penicillium rocqueforti) | 4.00 / 52 minutes | Achieved 99.99% reduction (equivalent to ~4.0 log reduction) in less than 1 hour. |
| Virus (MS-2 bacteriophage) | 5.32 / 60 minutes | Reached a 4.0 net LOG reduction in 35 minutes (in 16m³ chamber). |
| Virus (MS-2 bacteriophage) | 4.00 / 40 minutes | Reached a 4.0 net LOG reduction in 35 minutes (in 16m³ chamber). |
Note: 99.99% reduction is equivalent to a 4.0 log reduction.
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical laboratory testing rather than human subject or image-based studies. Therefore, typical "sample sizes" for test sets in the context of AI/machine learning or human reader studies are not applicable directly.
- Sample Size: The data for the efficacy tests (microorganism removal) are based on controlled laboratory experiments using specific volumes (e.g., 16m³ chamber for MS2, 735 cubic foot chamber for bacterial/mold spores). The precise number of replicate tests or experimental runs is not specified in this summary document.
- Data Provenance: The tests are described as non-clinical testing, implying lab-based experiments. No information is provided regarding the country of origin of the data collectors/labs, nor is it specified if the data is retrospective or prospective, as these terms typically apply to clinical studies. Given it's a device efficacy test, it would inherently be prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable: This filing describes physical device performance testing (e.g., electrical safety, UV irradiance, germicidal efficacy against lab-cultured microorganisms), not AI/machine learning performance requiring human expert ground truth labeling. Therefore, there is no mention of experts establishing ground truth in this context.
4. Adjudication Method for the Test Set
- Not Applicable: As this is non-clinical device performance testing, adjudication methods typically used for human expert review in diagnostic studies are not relevant. The results are obtained from direct measurements and observations in a laboratory setting.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable: The document explicitly states "Summary of Clinical Testing: Not applicable." This is a premarket notification (510(k)) for an air purification device, and its safety and efficacy were demonstrated through non-clinical laboratory tests, not comparative human clinical trials or diagnostic performance studies involving human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- Not Applicable: This is a physical device (air purifier), not a software algorithm or AI. Its performance is inherent to its design and function.
7. Type of Ground Truth Used
The ground truth for this device's performance is established through laboratory measurements and direct observation of microbial inactivation.
- Microorganism Inactivation: The ground truth for efficacy (e.g., log reduction of bacteria, mold, virus) is determined by standard microbiological testing methods, likely involving quantifying viable microorganisms before and after exposure to the device in a controlled chamber. This is analogous to outcomes data in a very specific, controlled laboratory environment.
- Safety Parameters: Ground truth for electrical safety, ozone emission, and UV leakage are based on adherence to recognized safety standards (e.g., UL, IEC) through direct measurement by specialized equipment.
8. Sample Size for the Training Set
- Not Applicable: This is a physical device, and the concept of a "training set" (used for machine learning models) does not apply here. The device's design and operating parameters are not "trained" on data in the same way an algorithm would be. Its performance is a result of its engineering.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no "training set" for a physical device, the method of establishing ground truth for it is not relevant. The device is built based on established principles of UV-C germicidal action, and its performance is
verified through empirical testing as detailed above.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 17, 2022
Bluezone Products, Inc. % Maureen O'connell President O'Connell Regulatory Consultant, Inc. 44 Oak Street Stoneham, Massachusetts 02180
Re: K212824
Trade/Device Name: Bluezone Model RX-450 Air Purifier Regulation Number: 21 CFR 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: Class II Product Code: FRA Dated: January 7, 2022 Received: January 10, 2022
Dear Maureen O'connell:
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
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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,
Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical 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) K212824
Device Name Bluezone Model Rx-450 Air Purifier
Indications for Use (Describe)
The Bluezone Model Rx-450 Air Purifying device utilizing device utilizing germicidal ultraviolet light (UV-C wavelengths near 254nm) intended for inactivation of indoor airborne aerosols including bacteria, mold, and virus in medical facilities and occupied spaces.
The Bluezone Model Rx-450 Air Purifier has been demonstrated to entrain and destroy the following exposure/working conditions:
| Test Item | Average Net Log Reduction/Time @ High FanSpeed. Room Temperature Test | |
|---|---|---|
| Bacteria | Bacillus atrophaeus | 4.95 / 60 minutes |
| Bacteria | 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 |
| 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)
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K212824 510(k) SUMMARY
Bluezone Products, Inc. Bluezone Model RX-450 Air Purifier
510(k) Owner
Bluezone Products, Inc. 225 Wildwood Avenue Woburn. MA 01801
Submission Correspondent
Maureen O'Connell O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham. MA 02180 Phone: 978-207-1245
Date Prepared: February 15, 2022
Trade Name of Device
Bluezone Model RX-450 Air Purifier
Common or Usual Name Air Purifier
Classification Name
Medical UV Air Purifier, 21 C.F.R. §880.6500 Class II Product Code: FRA
Review Panel General Hospital
Predicate Device ECO-Rx Air Purifier with UV Light Model Rx-400 cleared in K062716
Device Description
The Bluezone Model RX-450 is an air purification device that uses germicidal UV bulbs to inactivate viral, bacterial or fungal aerosols. The operation of the device is as follows: ambient air containing microbial aerosols is drawn into the air purifier through a prefilter and two angled aluminum honeycomb light baffles. The infective aerosols in the air are then exposed to high intensity, germicidal, ultraviolet light where the contaminants receive a UV dose of at least 10 mW*second/cm². The bacterial, fungal and viral aerosols are inactivated through the breakdown of the microbial DNA or RNA. The cleaned air is exhausted back into the room from the Bluezone Model RX-450 through an axial fan.
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Indications for Use
The Bluezone Model RX-450 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, mold, and virus in medical facilities and occupied spaces.
The Bluezone Model Rx-450 Air Purifier has been demonstrated to entrain and destroy the following exposure/working conditions:
| Test Item | Average Net Log Reduction/Time @ High FanSpeed. Room Temperature Test | |
|---|---|---|
| Bacteria | Bacillus atrophaeus | 4.95 / 60 minutes |
| Bacteria | 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 |
Technological Characteristics Comparison
| Bluezone Model RX-450 Air Purifier Technological Characteristics Comparison | |||
|---|---|---|---|
| Characteristic | Bluezone Model RX-450 Air Purifier | ECO-Rx Air Purifierwith UV Light ModelRx-400 | Comparison |
| 510(k) Number | - | K062716 | - |
| Device Type | Medical Ultraviolet AirPurifier | Medical Ultraviolet AirPurifier | Same |
| Product Code | FRA | FRA | Same |
| Class | II | II | Same |
| Use Type | OTC | OTC | Same |
| Intended Use | Kill bacteria and virus inthe air | Kill bacteria and virus inthe air | Same |
| Indications forUse | The Bluezone ModelRX-450 Air Purifier is afree standing, airpurifying deviceutilizing germicidalultraviolet light (UV-Cwavelengths near254nm) intended forinactivation of indoorairborne aerosolsincluding bacteria,mold, and virus in | The ECO-Rx Air Purifierwith UV Light, ModelRx-400 is a flow-throughindoor air-purificationsystem for the inactivationof indoor airbornebacteria. | Minor differencesin wording ofindications for usestatement do notimpact the intendeduse |
Table 1
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| medical facilities andoccupied spaces.The Bluezone ModelRx-450 Air Purifier hasbeen demonstrated toentrain and destroy thefollowing bioaerosolsunder the followingexposure/workingconditions: (seeindications for use) | |||
|---|---|---|---|
| Mechanism ofAction | UV-C inactivation ofmicroorganisms | UV-C inactivation ofmicroorganisms | Same |
| Installation | Free standing | Free standing | Same |
| Elements ofDesign | Fan circulates airthrough a shieldedchamber where UVlight irradiatesmicrobial aerosols | Fan circulates air througha shielded chamber whereUV light irradiatesmicrobial aerosols | Same |
| Filter | Yes | Yes | Same |
| Internal Fan | Yes | Yes | Same |
| Germicidal UV | Yes | Yes | Same |
| UV Optic Type | Quartz tube with lowpressure mercury vapor | Quartz tube with lowpressure mercury vapor | Same |
| UV Wavelength | 254 nm | 254 nm | Same |
| OzoneEmission | No | No | Same |
| ChemicalAdditives | No | No | Same |
| StandardsCompliance | |||
| ElectricalSafety | Per UL 507 | Per UL 507 | Same |
| EMC | Per IEC 60601-1-2 | Per IEC 60601-1-2 | Same |
Summary of Non-Clinical Testing
Table 2 shows the non-clinical testing that was performed.
| Test Completed | Standard Followed | Acceptance Criteria | Result |
|---|---|---|---|
| Electrical Safety | UL 507: 2017 Ed. 10+R:06Nov2018 Fans and Ventilators | Per Standard | Passed |
| CSA C22.2#113:2018 Ed. 11 | |||
| ElectromagneticCompatibility | IEC 60601-1-2:2014 (4th Edition)General Requirements for Safety-Collateral ElectromagneticCompatibility Requirements andTests Medical Electrical Equipment | Per Standard | Passed |
| Safety of air-cleaningappliances | IEC 60335-2-65 Safety ofhousehold and similar electricalappliances Part 2: Particularrequirements for air-cleaningappliances | Per Standard | Test specificationswere met |
| Ozone EmissionsTesting of HouseholdElectrostatic AirCleaners | Electrostatic Air Cleaners, UL 867Section 40, Fifth EditionCSA 22-2 No. 187-15, Section 7 | Emittance ofozone notexceeding aconcentration of0.050 ppm | Found in compliancewith criteria |
| Zero Ozone Emission | UL 2998 Section 6 | Ozone <0.005ppm | Passed. Ozone<0.001 ppm |
| UV Irradiance andLeakage in OccupiedSpaces | UL 507-2017: Heating and CoolingEquipment | Effectiveirradiance <0.1$uW/cm^2$ | Passed. Location 1Effective irradiance6.55E-02 $uW/cm^2$and Location 23.13E-03 $uW/cm^2$ |
| Removal ofAerosolized MS2Bacteriophage | Not applicable | 4.0 netLOG reduction | Produced a rapidreductionin viable MS2 withinthe 60-minute testperiod. The BluezoneRX-450 is estimated toreach a 4.0 netLOG reduction ofviable MS2 bioaerosolin a 16m3 chamber at35 minutes. |
| Removal of BacterialSpores | Not applicable | 99.99%reduction inactiveaerosolizedbacterial spores | Achieved 99.99%reduction in activeaerosolized bacterialspores in less than 48minutes in a 735cubic foot testchamber |
| Removal of MoldSpores | Not applicable | 99.99%reduction inactiveaerosolizedmolds | Achieved 99.99%reduction in activeaerosolized molds inless then 1 hour in a |
| 735 cubic foot testchamber |
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Summary of Clinical Testing
Not applicable
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
§ 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).