Bluezone Model RX-450 Air Purifier

K212824 · Bluezone Products, Inc. · FRA · Feb 17, 2022 · General Hospital

Device Facts

• Record ID: K212824
• Device Name: Bluezone Model RX-450 Air Purifier
• Applicant: Bluezone Products, Inc.
• Product Code: FRA · General Hospital
• Decision Date: Feb 17, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6500
• Device Class: Class 2

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: [Table of log reduction data for bacteria, mold, and virus].

Device Story

Free-standing air purifier; uses germicidal UV-C light (254nm) to inactivate airborne microbial aerosols. Ambient air drawn through prefilter and aluminum honeycomb light baffles; air exposed to high-intensity UV light (dose ≥ 10 mW*s/cm²) within shielded chamber; microbial DNA/RNA breakdown inactivates contaminants; cleaned air exhausted via axial fan. Used in medical facilities and occupied spaces; operated by general users (OTC). Provides continuous air purification; reduces airborne pathogen load; benefits patients/staff by lowering infection risk.

Clinical Evidence

No clinical data. Bench testing only. Performance validated via microbial aerosol reduction studies (Bacillus atrophaeus, Penicillium rocqueforti, MS-2 bacteriophage) demonstrating ≥4.0 log reduction within 60 minutes. Electrical safety and EMC testing performed per UL 507 and IEC 60601-1-2.

Technological Characteristics

Free-standing air purifier; quartz tube low-pressure mercury vapor UV-C lamps (254 nm); aluminum honeycomb light baffles; axial fan; prefilter. No ozone emission (UL 2998 compliant). Electrical safety per UL 507/CSA C22.2#113; EMC per IEC 60601-1-2. Mechanical/physical inactivation principle.

Indications for Use

Indicated for inactivation of indoor airborne aerosols including bacteria, mold, and virus in medical facilities and occupied spaces.

Regulatory Classification

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.

Predicate Devices

• ECO-Rx Air Purifier with UV Light Model Rx-400 (K062716)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

# 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 Fan<br>Speed. 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 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: [phone]

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.

{4}------------------------------------------------

## 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 Fan<br>Speed. 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 Purifier<br>with UV Light Model<br>Rx-400 | Comparison |
| 510(k) Number | - | K062716 | - |
| Device Type | Medical Ultraviolet Air<br>Purifier | Medical Ultraviolet Air<br>Purifier | Same |
| Product Code | FRA | FRA | Same |
| Class | II | II | Same |
| Use Type | OTC | OTC | Same |
| Intended Use | Kill bacteria and virus in<br>the air | Kill bacteria and virus in<br>the air | Same |
| Indications for<br>Use | The Bluezone Model<br>RX-450 Air Purifier is a<br>free standing, air<br>purifying device<br>utilizing germicidal<br>ultraviolet light (UV-C<br>wavelengths near<br>254nm) intended for<br>inactivation of indoor<br>airborne aerosols<br>including bacteria,<br>mold, and virus in | The ECO-Rx Air Purifier<br>with UV Light, Model<br>Rx-400 is a flow-through<br>indoor air-purification<br>system for the inactivation<br>of indoor airborne<br>bacteria. | Minor differences<br>in wording of<br>indications for use<br>statement do not<br>impact the intended<br>use |

Table 1

{5}------------------------------------------------

| | medical facilities and<br>occupied spaces.<br>The Bluezone Model<br>Rx-450 Air Purifier has<br>been demonstrated to<br>entrain and destroy the<br>following bioaerosols<br>under the following<br>exposure/working<br>conditions: (see<br>indications for use) | | |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|------|
| Mechanism of<br>Action | UV-C inactivation of<br>microorganisms | UV-C inactivation of<br>microorganisms | Same |
| Installation | Free standing | Free standing | Same |
| Elements of<br>Design | Fan circulates air<br>through a shielded<br>chamber where UV<br>light irradiates<br>microbial aerosols | Fan circulates air through<br>a shielded chamber where<br>UV light irradiates<br>microbial aerosols | Same |
| Filter | Yes | Yes | Same |
| Internal Fan | Yes | Yes | Same |
| Germicidal UV | Yes | Yes | Same |
| UV Optic Type | Quartz tube with low<br>pressure mercury vapor | Quartz tube with low<br>pressure mercury vapor | Same |
| UV Wavelength | 254 nm | 254 nm | Same |
| Ozone<br>Emission | No | No | Same |
| Chemical<br>Additives | No | No | Same |
| Standards<br>Compliance | | | |
| Electrical<br>Safety | 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:<br>06Nov2018 Fans and Ventilators | Per Standard | Passed |
| | CSA C22.2#113:2018 Ed. 11 | | |
| Electromagnetic<br>Compatibility | IEC 60601-1-2:2014 (4th Edition)<br>General Requirements for Safety-<br>Collateral Electromagnetic<br>Compatibility Requirements and<br>Tests Medical Electrical Equipment | Per Standard | Passed |
| Safety of air-cleaning<br>appliances | IEC 60335-2-65 Safety of<br>household and similar electrical<br>appliances Part 2: Particular<br>requirements for air-cleaning<br>appliances | Per Standard | Test specifications<br>were met |
| Ozone Emissions<br>Testing of Household<br>Electrostatic Air<br>Cleaners | Electrostatic Air Cleaners, UL 867<br>Section 40, Fifth Edition<br>CSA 22-2 No. 187-15, Section 7 | Emittance of<br>ozone not<br>exceeding a<br>concentration of<br>0.050 ppm | Found in compliance<br>with criteria |
| Zero Ozone Emission | UL 2998 Section 6 | Ozone <0.005<br>ppm | Passed. Ozone<br><0.001 ppm |
| UV Irradiance and<br>Leakage in Occupied<br>Spaces | UL 507-2017: Heating and Cooling<br>Equipment | Effective<br>irradiance <0.1<br>$uW/cm^2$ | Passed. Location 1<br>Effective irradiance<br>6.55E-02 $uW/cm^2$<br>and Location 2<br>3.13E-03 $uW/cm^2$ |
| Removal of<br>Aerosolized MS2<br>Bacteriophage | Not applicable | 4.0 net<br>LOG reduction | Produced a rapid<br>reduction<br>in viable MS2 within<br>the 60-minute test<br>period. The Bluezone<br>RX-450 is estimated to<br>reach a 4.0 net<br>LOG reduction of<br>viable MS2 bioaerosol<br>in a 16m3 chamber at<br>35 minutes. |
| Removal of Bacterial<br>Spores | Not applicable | 99.99%<br>reduction in<br>active<br>aerosolized<br>bacterial spores | Achieved 99.99%<br>reduction in active<br>aerosolized bacterial<br>spores in less than 48<br>minutes in a 735<br>cubic foot test<br>chamber |
| Removal of Mold<br>Spores | Not applicable | 99.99%<br>reduction in<br>active<br>aerosolized<br>molds | Achieved 99.99%<br>reduction in active<br>aerosolized molds in<br>less then 1 hour in a |
| | | 735 cubic foot test<br>chamber | |

{6}------------------------------------------------

{7}------------------------------------------------

# 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.