CerroZone Mobile

K220298 · Cerrozone · FRF · Jul 1, 2022 · General Hospital

Device Facts

• Record ID: K220298
• Device Name: CerroZone Mobile
• Applicant: Cerrozone
• Product Code: FRF · General Hospital
• Decision Date: Jul 1, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5045
• Device Class: Class 2

Indications for Use

The CerroZone Mobile is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles (i.e., bacteria and viruses) from the air for medical purposes.

Device Story

CerroZone Mobile is a medical recirculating air cleaner for medical facilities; uses centrifugal fan to draw inlet air through an inline flow-through system; inactivates airborne bacteria and viruses via reactive oxidizing species (ozone) generated by high-output UVC lamp elements and ultraviolet radiation; traps particulates using particulate and activated carbon filters; includes proprietary catalyst substrate to convert ozone back to oxygen; features redundant external ozone sensors for automatic shutdown if ozone exceeds 0.03 ppm; provides 220 CFM airflow; achieves 4-log reduction of airborne particles in 30 minutes or less; benefits patients and staff by reducing airborne pathogen load in clinical environments.

Clinical Evidence

No clinical data provided. Bench testing only. Efficacy demonstrated via aerosolized MS2 bacteriophage reduction (5.67 log reduction in 60 minutes) and single-pass flow-through testing against Methicillin-Resistant Staphylococcus epidermidis (MRSE).

Technological Characteristics

Medical recirculating air cleaner; centrifugal fan; high-output UVC lamp elements for ozone/UV generation; activated carbon filter and proprietary catalyst substrate for ozone removal; redundant external ozone sensors; 120V input; free-standing form factor; tested to EN/IEC 60601-1-2, UL 867, and CSA C22.2#187.

Indications for Use

Indicated for use as a room recirculating air cleaner to filter and inactivate airborne bacteria and viruses for medical purposes.

Regulatory Classification

Identification

A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.

Predicate Devices

• Novaerus NV1050 (K200321)

Reference Devices

• AEROCURE-MD (K203189)

Submission Summary (Full Text)

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July 1, 2022

CerroZone % Matthieu Kirkland Regulatory Specialist Ram+ 2251 San Diego Avenue, Ste B-257 San Diego, California 92110

Re: K220298

Trade/Device Name: CerroZone Mobile Regulation Number: 21 CFR 880.5045 Regulation Name: Medical Recirculating Air Cleaner Regulatory Class: Class II Product Code: FRF Dated: May 23, 2022 Received: May 24, 2022

Dear Matthieu Kirkland:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control 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) K220298

Device Name CerroZone Mobile

Indications for Use (Describe)

The CerroZone Mobile is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles (i.e., bacteria and viruses) from the air for medical purposes.

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for "CERR*ZONE". The word "CERR" is in black, and the word "ZONE" is in blue. There is a star symbol between the two words. The letters are all capitalized, and there is a trademark symbol in the upper right corner of the word "ZONE".

# 510(k) Summary K220298

### DATE PREPARED

July 01, 2022

### MANUFACTURER AND 510(k) OWNER

CerroZone P.O Box 66800, St. Louis, MO 63166 [phone] Telephone: Official Contact: Marlon E. Robinson, Director of Operations

### REPRESENTATIVE/CONSULTANT

Matthieu Kirkland, M.S. Allison C. Komiyama, Ph.D., RAC RQM+ Telephone: [phone] [e-mail], [e-mail] Email:

#### DEVICE INFORMATION

| Proprietary Name/Trade Name: | CerroZone Mobile |
|------------------------------|-------------------------------------------------------|
| Common Name: | Medical Recirculating Air Cleaner |
| Regulation Number: | 21 CFR 880.5045 |
| Class: | II |
| Product Code: | FRF |
| Premarket Review: | Infection Control and Plastic Surgery Devices (DHT4B) |
| Review Panel: | General Hospital |

#### PREDICATE DEVICE IDENTIFICATION

The CerroZone Mobile is substantially equivalent to the following predicate:

| 510(k)<br>Number | Predicate Device Name / Manufacturer | Primary<br>Predicate | Reference<br>Device |
|------------------|--------------------------------------|----------------------|---------------------|
| K200321 | Novaerus NV1050 / Novaerus US Inc | ✓ | |
| K203189 | AEROCURE-MD / Aerobiotix, Inc. | | ✓ |

The predicate and reference devices have not been subject to a design related recall.

### DEVICE DESCRIPTION

The CerroZone Mobile is a medical recirculating air cleaner that uses multiple inactivation processes consisting of reactive oxidizing species (ozone) and ultraviolet radiation to inactivate bacteria and viruses in the air. The CerroZone Mobile may be used in medical facilities. Once turned on, inlet air is passed through CerroZone Mobile's inline flow-through design which inactivates bacteria and viruses in a single pass flow-through. The device generates 220 cubic feet of air per minute (CFM), or 2.36 air changes per hour (ACH) in a standard 5,600 cu. Ft room. This process of air being inlet, purified, then outlet, lasts approximately 1.2 seconds. A 4 LOG reduction of airborne particles in a standard 579 cu. Ft room is achieved in 30 minutes or

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less. A 5.67 LOG, or 99.9998%, reduction is achieved in 45 minutes or less.

## INDICATIONS FOR USE

The CerroZone Mobile is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles (i.e., bacteria and viruses) from the air for medical purposes.

# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The following table summarizes the similarities and differences between the subject and predicate device.

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| | Subject Device | Primary Predicate Device | Comparison |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | CerroZone | Novaerus US Inc. | |
| | CerroZone Mobile<br>Current | Novaerus NV1050<br>K200321 | |
| Image | Image: CerroZone Mobile Current | Image: Novaerus NV1050 | |
| Indications for Use | The CerroZone Mobile is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles (i.e., viruses and bacteria) from the air for medical purposes | The Novaerus NV1050 is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical purposes | Similar |
| Product Codes /<br>Regulation Number | FRF/ 21 CFR 880.5045 | FRF/ 21 CFR 880.5045 | Identical |
| Regulation Description | Medical recirculating air cleaner | Medical recirculating air cleaner | Identical |
| Type of Use | Over-the-Counter Use | Over-the-Counter Use | Identical |
| Mechanism of Action | Microorganisms including viruses and bacteria, are inactivated by the device via damage by multiple inactivation processes:<br><br>Reactive Oxidizing Species (ozone)<br>Ultraviolet Radiation<br><br>Also, a filter to trap the resulting virus/bacteria particulates:<br><br>Particulate Filter<br>Activated Carbon Filter | Microorganisms including viruses and bacteria, are inactivated by the device via damage by multiple inactivation processes:<br><br>Reactive Oxidizing Species (ozone)<br>Ultraviolet Radiation<br>Ions<br>Electrons<br>High Electric Fields<br><br>Also, a filter to trap the resulting virus/bacteria particulates:<br><br>Particulate Filter<br>Activated Carbon Filter | Similar |
| Reduction of Biological<br>Agents | MS2 phage reduced by 4 log reduction in 30 minutes or less and 5.67 log reduction in 45 minutes or less when operating at full fan speed in a standard room of 579 ft³ (16 m³) | MS2 phage reduced by 3 log reduction in 10 minutes and 4 log reduction in 15 minutes when operating at full fan speed in a room of 580ft³ (16.4 m³) | Similar |
| Ozone Emitted | Within the maximum acceptable level of ozone given in 21 CFR 801.415 | Within the maximum acceptable level of ozone given in 21 CFR 801.415 | Identical |
| Installation | Free standing | Free standing | Identical |
| Reactive Oxidizing Species<br>(Ozone) Source | High-output UVC generating lamp elements | High-output Plasma Field generating coil elements | Similar |
| Reactive Oxidizing Species<br>(Ozone) Removal | Activated Carbon Filter<br>Proprietary Catalyst Substrate | Activated Carbon Filter | Similar |
| Air Source | Centrifugal Fan | Centrifugal Fan | Identical |
| Device Air Changes Per<br>Hour (ACH) | 2.36 device air changes per hour in a 5,600 ft³ room | 2 device air changes per hour in a 3,200 – 16,000 ft³ room | Similar |
| UV Light or Reactive<br>Oxidative Species (Ozone)<br>Exposure Safety Features | A catalyst substrate converts any ozone generated back into oxygen. An activated carbon filter absorbs any remaining ozone.<br><br>If > 0.03 ppm of ozone is measured the external ozone sensors, the CerroZone Mobile will automatically shut down. The CerroZone Mobile also utilizes a second and redundant external | An activated carbon filter absorbs any ozone generated. | Similar |
| | ozone sensor that runs on a different circuit. As<br>such, if one external ozone senor were to stop<br>functioning, another sensor will be active.<br>Safety feature confirmed by UL 867 & CSA<br>C22.2#187 | | |
| Input Voltage | 120 Volt | 110 Volt | Different |
| Dimensions | Unit Dimensions:<br>Height: 59 in<br>Width: 29 in<br>Depth: 17 in | Unit Dimensions:<br>Height: 59 in<br>Width: 27.5 in<br>Diameter: 8.27 in | Different |

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### SUMMARY OF NON-CLINICAL TESTING

The following tests were performed to demonstrate safety based on current industry standards:

Electromagnetic Compatibility and Electrical Safety: The subject device was tested in compliance to EN/IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests and UL 867 & CSA C22.2#187 Standard for Electrostatic Air Cleaners.

Determination of Turbulent Air Flow and/or Site Contamination: Risk of turbulent air flow and/or potential site contamination in areas that have a sterile field or controlled air flow has been assessed via computational fluid dynamics per ASHRAE/ASHE Standard 170-2017 Ventilation of Health Care Facilities.

Ozone Emissions: Ozone Emissions of the CerroZone Mobile have been assessed per Section 40 of UL 867 & CSA C22.2#187 Electrostatic Air Cleaners. Results of the test show that the CerroZone Mobile emits between 0.000 and 0.010 ppm of Ozone with a measured absolute max of 0.036 ppm. All Ozone emissions measured fall within the maximum acceptable level of ozone, 0.050 ppm, given in 21 CFR 801.415.

| Test Methodology | Purpose | Acceptance Criteria | Results |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| MS2 bacteriophage were<br>aerosolized into a sealed<br>environmental bioaerosol<br>chamber containing the<br>CerroZone Mobile. | To evaluate the efficacy of<br>the CerroZone Mobile at<br>reducing viability of<br>aerosolized MS2<br>bacteriophage by a<br>combination of<br>entrainment and<br>destruction | Greater than 4 log<br>reduction (99.99%) | Average net log reduction /<br>time<br><br>MS2 bacteriophage,<br>$5.67 \pm 0.19$ / 60 mins |
| Methicillin Resistant<br><i>Staphylococcus epidermidis</i><br>(MRSE) were aerosolized<br>into a single-pass flow<br>through chamber<br>connected to the<br>CerroZone Mobile. | To evaluate the efficacy of<br>the CerroZone Mobile at<br>reducing viability of<br>aerosolized bacteria by a<br>combination of<br>entrainment and<br>destruction | Greater than 3 log<br>reduction (99.9%) in single-<br>pass testing | Demonstrated<br>effectiveness against<br><i>Staphylococcus epidermidis</i> |

# SUMMARY OF CLINICAL TESTING

No clinical data were provided in order to demonstrate substantial equivalence.

# CONCLUSION

CerroZone Inc. concludes that the nonclinical tests demonstrate that the CerroZone Mobile is as safe, as effective, and performs as well as or better than the legally marketed predicate device.