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

AI/ML Overview

The CerroZone Mobile device is a medical recirculating air cleaner designed to filter out and inactivate airborne bacteria and viruses. The following information summarizes its acceptance criteria and the studies conducted.

1. Table of Acceptance Criteria and Reported Device Performance:

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
MS2 bacteriophage aerosolization in a sealed environmental bioaerosol chamber	To evaluate the efficacy of the CerroZone Mobile at reducing viability of aerosolized MS2 bacteriophage by a combination of entrainment and destruction	Greater than 4 log reduction (99.99%)	Average net log reduction for MS2 bacteriophage: 5.67 ± 0.19 / 60 minutes
Methicillin Resistant Staphylococcus epidermidis (MRSE) aerosolization in a single-pass flow-through chamber connected to the CerroZone Mobile	To evaluate the efficacy of the CerroZone Mobile at reducing viability of aerosolized bacteria by a combination of entrainment and destruction	Greater than 3 log reduction (99.9%) in single-pass testing	Demonstrated effectiveness against Staphylococcus epidermidis
Ozone Emissions	To assess ozone emissions	Emissions within the maximum acceptable level of ozone given in 21 CFR 801.415 (0.050 ppm)	Emits between 0.000 and 0.010 ppm of Ozone with a measured absolute max of 0.036 ppm. All emissions fall within the acceptable level.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes for the biological aerosolization tests (MS2 bacteriophage and MRSE). The studies appear to be laboratory-based non-clinical tests rather than human subject or field trials, so terms like "country of origin" and "retrospective/prospective" might not be strictly applicable in the same way they would be for clinical studies. The context implies these were controlled experiments conducted to assess device performance under specific conditions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The "ground truth" for these non-clinical tests would have been established by the direct measurement of reduction in viable microorganisms using standard microbiological techniques, rather than expert interpretation.

4. Adjudication Method for the Test Set:

Not applicable. The tests involved direct measurement of microbial reduction, not subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The CerroZone Mobile is a medical device for air cleaning, not an interpretative diagnostic tool, so such a study would not be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

These were standalone performance tests of the device itself (algorithm not applicable), evaluating its ability to reduce airborne pathogens directly.

7. The Type of Ground Truth Used:

The ground truth used for the efficacy studies was based on quantitative laboratory measurements of microbial viability (e.g., plaque assays for bacteriophages, colony counts for bacteria) before and after exposure to the device. For ozone emissions, the ground truth was direct quantitative measurement of ozone concentration.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical air cleaner, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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 +1-618-337-6000 Telephone: Official Contact: Marlon E. Robinson, Director of Operations

REPRESENTATIVE/CONSULTANT

Matthieu Kirkland, M.S. Allison C. Komiyama, Ph.D., RAC RQM+ Telephone: +1 (412) 899-7424 mkirkland@rqmplus.com, akomiyama@rqmplus.com 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)Number	Predicate Device Name / Manufacturer	PrimaryPredicate	ReferenceDevice
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

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

INDICATIONS FOR USE

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 MobileCurrent	Novaerus NV1050K200321
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 /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:Reactive Oxidizing Species (ozone)Ultraviolet RadiationAlso, a filter to trap the resulting virus/bacteria particulates:Particulate FilterActivated Carbon Filter	Microorganisms including viruses and bacteria, are inactivated by the device via damage by multiple inactivation processes:Reactive Oxidizing Species (ozone)Ultraviolet RadiationIonsElectronsHigh Electric FieldsAlso, a filter to trap the resulting virus/bacteria particulates:Particulate FilterActivated Carbon Filter	Similar
Reduction of BiologicalAgents	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(Ozone) Source	High-output UVC generating lamp elements	High-output Plasma Field generating coil elements	Similar
Reactive Oxidizing Species(Ozone) Removal	Activated Carbon FilterProprietary Catalyst Substrate	Activated Carbon Filter	Similar
Air Source	Centrifugal Fan	Centrifugal Fan	Identical
Device Air Changes PerHour (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 ReactiveOxidative Species (Ozone)Exposure Safety Features	A catalyst substrate converts any ozone generated back into oxygen. An activated carbon filter absorbs any remaining ozone.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. Assuch, if one external ozone senor were to stopfunctioning, another sensor will be active.Safety feature confirmed by UL 867 & CSAC22.2#187
Input Voltage	120 Volt	110 Volt	Different
Dimensions	Unit Dimensions:Height: 59 inWidth: 29 inDepth: 17 in	Unit Dimensions:Height: 59 inWidth: 27.5 inDiameter: 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 wereaerosolized into a sealedenvironmental bioaerosolchamber containing theCerroZone Mobile.	To evaluate the efficacy ofthe CerroZone Mobile atreducing viability ofaerosolized MS2bacteriophage by acombination ofentrainment anddestruction	Greater than 4 logreduction (99.99%)	Average net log reduction /timeMS2 bacteriophage,$5.67 \pm 0.19$ / 60 mins
Methicillin ResistantStaphylococcus epidermidis(MRSE) were aerosolizedinto a single-pass flowthrough chamberconnected to theCerroZone Mobile.	To evaluate the efficacy ofthe CerroZone Mobile atreducing viability ofaerosolized bacteria by acombination ofentrainment anddestruction	Greater than 3 logreduction (99.9%) in single-pass testing	Demonstratedeffectiveness againstStaphylococcus epidermidis

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.

Regulation Number and Section

§ 880.5045 Medical recirculating air cleaner.

(a)
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.(b)
Classification. Class II (performance standards).