(167 days)
Not Found
No
The device description and performance studies focus solely on the physical process of UV-C light inactivation of airborne pathogens. There is no mention of any computational analysis, learning, or adaptive behavior that would indicate the presence of AI or ML.
No
The device is described as an "air purifying device utilizing germicidal ultraviolet light" intended for "inactivation of indoor airborne aerosols including bacteria, mold, and virus." While it impacts biological agents, its primary function is air purification, not direct treatment or diagnosis of a condition in a living organism, which aligns more with a general purpose infectious agent inactivator rather than a therapeutic device.
No
The device is an air purifier that inactivates airborne aerosols using UV light. Its intended use is to clean the air, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly outlines a physical air purification device utilizing UV bulbs, fans, and filters, indicating it is a hardware-based medical device, not software-only.
Based on the provided information, the Bluezone Model RX-450 Air Purifier is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Bluezone RX-450 Function: The Bluezone RX-450 is an air purification device. Its function is to inactivate airborne microorganisms within the air of a space, not to analyze biological samples from a patient.
- Intended Use: The intended use clearly states it's for "inactivation of indoor airborne aerosols including bacteria, mold, and virus in medical facilities and occupied spaces." This describes an environmental control function, not a diagnostic test.
- Device Description: The description details how the device draws in air and exposes it to UV light to inactivate microorganisms. This process does not involve analyzing biological samples.
Therefore, the Bluezone Model RX-450 Air Purifier falls under the category of an air purification device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 Speed. Room Temperature Test |
|---|---|
| Bacillus atrophaeus | 4.95 / 60 minutes |
| Bacillus atrophaeus | 4.00 / 48 minutes |
| Penicillium rocqueforti | 4.40 / 60 minutes |
| Penicillium rocqueforti | 4.00 / 52 minutes |
| MS-2 bacteriophage | 5.32 / 60 minutes |
| MS-2 bacteriophage | 4.00 / 40 minutes |
Product codes
FRA
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.
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
Not Found
Intended User / Care Setting
medical facilities and occupied spaces.
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
Non-Clinical Testing:
- Electrical Safety: UL 507: 2017 Ed. 10+R: 06Nov2018 Fans and Ventilators, CSA C22.2#113:2018 Ed. 11. Result: Passed.
- Electromagnetic Compatibility: IEC 60601-1-2:2014 (4th Edition) General Requirements for Safety- Collateral Electromagnetic Compatibility Requirements and Tests Medical Electrical Equipment. Result: Passed.
- Safety of air-cleaning appliances: IEC 60335-2-65 Safety of household and similar electrical appliances Part 2: Particular requirements for air-cleaning appliances. Result: Test specifications were met.
- Ozone Emissions Testing of Household Electrostatic Air Cleaners: Electrostatic Air Cleaners, UL 867 Section 40, Fifth Edition, CSA 22-2 No. 187-15, Section 7. Acceptance criteria: Emittance of ozone not exceeding a concentration of 0.050 ppm. Result: Found in compliance with criteria.
- Zero Ozone Emission: UL 2998 Section 6. Acceptance criteria: Ozone
§ 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).
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 (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
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
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)
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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: 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.
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
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 | |
| with UV Light Model | |||
| Rx-400 | Comparison | ||
| 510(k) Number | - | K062716 | - |
| Device Type | Medical Ultraviolet Air | ||
| Purifier | Medical Ultraviolet Air | ||
| Purifier | Same | ||
| Product Code | FRA | FRA | Same |
| Class | II | II | Same |
| Use Type | OTC | OTC | Same |
| Intended Use | Kill bacteria and virus in | ||
| the air | Kill bacteria and virus in | ||
| the air | Same | ||
| 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 | The ECO-Rx Air Purifier | ||
| with UV Light, Model | |||
| Rx-400 is a flow-through | |||
| indoor air-purification | |||
| system for the inactivation | |||
| of indoor airborne | |||
| bacteria. | Minor differences | ||
| in wording of | |||
| indications for use | |||
| statement do not | |||
| impact the intended | |||
| use |
Table 1
5
| | medical facilities and
occupied spaces.
The Bluezone Model
Rx-450 Air Purifier has
been demonstrated to
entrain and destroy the
following bioaerosols
under the following
exposure/working
conditions: (see
indications for use) | | |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|------|
| Mechanism of
Action | UV-C inactivation of
microorganisms | UV-C inactivation of
microorganisms | Same |
| Installation | Free standing | Free standing | Same |
| Elements of
Design | Fan circulates air
through a shielded
chamber where UV
light irradiates
microbial aerosols | Fan circulates air through
a shielded chamber where
UV light irradiates
microbial aerosols | Same |
| Filter | Yes | Yes | Same |
| Internal Fan | Yes | Yes | Same |
| Germicidal UV | Yes | Yes | Same |
| UV Optic Type | Quartz tube with low
pressure mercury vapor | Quartz tube with low
pressure mercury vapor | Same |
| UV Wavelength | 254 nm | 254 nm | Same |
| Ozone
Emission | No | No | Same |
| Chemical
Additives | No | No | Same |
| Standards
Compliance | | | |
| Electrical
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: | ||
| 06Nov2018 Fans and Ventilators | Per Standard | Passed | |
| CSA C22.2#113:2018 Ed. 11 | |||
| Electromagnetic | |||
| Compatibility | IEC 60601-1-2:2014 (4th Edition) | ||
| General Requirements for Safety- | |||
| Collateral Electromagnetic | |||
| Compatibility Requirements and | |||
| Tests Medical Electrical Equipment | Per Standard | Passed | |
| Safety of air-cleaning | |||
| appliances | IEC 60335-2-65 Safety of | ||
| household and similar electrical | |||
| appliances Part 2: Particular | |||
| requirements for air-cleaning | |||
| appliances | Per Standard | Test specifications | |
| were met | |||
| Ozone Emissions | |||
| Testing of Household | |||
| Electrostatic Air | |||
| Cleaners | Electrostatic Air Cleaners, UL 867 | ||
| Section 40, Fifth Edition | |||
| CSA 22-2 No. 187-15, Section 7 | Emittance of | ||
| ozone not | |||
| exceeding a | |||
| concentration of | |||
| 0.050 ppm | Found in compliance | ||
| with criteria | |||
| Zero Ozone Emission | UL 2998 Section 6 | Ozone |