(149 days)
No
The device description and performance studies focus on physical and chemical inactivation methods (ozone and UV radiation) and do not mention any AI or ML components for control, analysis, or decision-making.
Yes
The device is described as a "medical recirculating air cleaner" intended for "filtering out and inactivating airborne particles (i.e., bacteria and viruses) from the air for medical purposes," which directly falls under the definition of a therapeutic device due to its intended action of inactivating pathogens to improve air quality for health benefits.
No
Explanation: The device is described as an air cleaner/purifier intended to inactivate airborne particles, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly outlines physical components and processes (recirculating air cleaner, ozone generation, UV radiation, air flow, chambers) that are hardware-based, not software-only.
Based on the provided information, the CerroZone Mobile is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- CerroZone Mobile's Function: The CerroZone Mobile is an air cleaner designed to filter and inactivate airborne particles (bacteria and viruses) in the air of a room. It does not analyze specimens from the human body.
- Intended Use: The intended use clearly states it's a "room recirculating air cleaner" for "filtering out and inactivating airborne particles."
- Device Description: The description focuses on the air purification process within the device itself, not on analyzing biological samples.
- Performance Studies: The performance studies evaluate the device's ability to reduce airborne bacteria and viruses in a chamber, not its ability to diagnose or analyze human specimens.
Therefore, the CerroZone Mobile falls under the category of an air purification device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FRF
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.
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
MS2 bacteriophage were aerosolized into a sealed environmental bioaerosol chamber containing the CerroZone Mobile. The purpose was to evaluate the efficacy of the CerroZone Mobile at reducing viability of aerosolized MS2 bacteriophage by a combination of entrainment and destruction. Acceptance criteria was Greater than 4 log reduction (99.99%). Results showed Average net log reduction / time: MS2 bacteriophage, 5.67 +- 0.19 / 60 mins.
Methicillin Resistant Staphylococcus epidermidis (MRSE) were aerosolized into a single-pass flow through chamber connected to the CerroZone Mobile. The purpose was to evaluate the efficacy of the CerroZone Mobile at reducing viability of aerosolized bacteria by a combination of entrainment and destruction. Acceptance criteria was Greater than 3 log reduction (99.9%) in single-pass testing. Results showed Demonstrated effectiveness against Staphylococcus epidermidis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
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, 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
2
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)
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
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 | Primary
Predicate | Reference
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
4
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.
5
| Subject Device | Primary Predicate Device | Comparison | |
|---|---|---|---|
| CerroZone | Novaerus US Inc. | ||
| CerroZone Mobile | |||
| Current | Novaerus NV1050 | ||
| 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 / | |||
| 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 Radiation
Also, a filter to trap the resulting virus/bacteria particulates:
Particulate Filter
Activated Carbon Filter | Microorganisms including viruses and bacteria, are inactivated by the device via damage by multiple inactivation processes:
Reactive Oxidizing Species (ozone)
Ultraviolet Radiation
Ions
Electrons
High Electric Fields
Also, a filter to trap the resulting virus/bacteria particulates:
Particulate Filter
Activated Carbon Filter | Similar |
| Reduction of Biological
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
(Ozone) Source | High-output UVC generating lamp elements | High-output Plasma Field generating coil elements | Similar |
| Reactive Oxidizing Species
(Ozone) Removal | Activated Carbon Filter
Proprietary Catalyst Substrate | Activated Carbon Filter | Similar |
| Air Source | Centrifugal Fan | Centrifugal Fan | Identical |
| Device Air Changes Per
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
Oxidative 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. As
such, if one external ozone senor were to stop
functioning, another sensor will be active.
Safety feature confirmed by UL 867 & CSA
C22.2#187 | | |
| Input Voltage | 120 Volt | 110 Volt | Different |
| Dimensions | Unit Dimensions:
Height: 59 in
Width: 29 in
Depth: 17 in | Unit Dimensions:
Height: 59 in
Width: 27.5 in
Diameter: 8.27 in | Different |
6
7
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 | |||
| aerosolized into a sealed | |||
| environmental bioaerosol | |||
| chamber containing the | |||
| CerroZone Mobile. | 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 / | ||
| time |
MS2 bacteriophage,
$5.67 \pm 0.19$ / 60 mins |
| Methicillin Resistant
Staphylococcus epidermidis
(MRSE) were aerosolized
into 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 |
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.