(124 days)
Not Found
No
The summary describes a physical air purification device using ozone and UV radiation, with no mention of AI or ML in its operation or performance evaluation.
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." This directly indicates its use in a therapeutic context by addressing harmful airborne microorganisms.
No
This device is an air cleaner designed to inactivate airborne particles (bacteria and viruses) for medical purposes, not to diagnose a medical condition.
No
The device description clearly outlines a physical air cleaner that uses hardware components (ozone and UV radiation) to inactivate bacteria and viruses. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- CerroZone Mini Function: The CerroZone Mini is an air cleaner. Its function is to filter and inactivate airborne particles (bacteria and viruses) from the air in a room. It does not interact with or analyze specimens taken 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." This is an environmental control function, not a diagnostic function.
The device's purpose is to improve the air quality in a medical facility by reducing the presence of airborne pathogens, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The CerroZone Mini 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
FRF
Device Description
The CerroZone Mini is a medical recirculating air cleaner that uses multiple inactivation processes, including use of reactive oxidizing species (ozone) and ultraviolet radiation, to inactivate bacteria and viruses in the CerroZone Mini may be used in medical facilities. Once turned on, inlet air is passed through CerroZone Mini's inline flow-through design which inactivates bacteria and viruses in a single pass flow-through. The device generates 110 cubic feet of air per minute (CFM), or 2.00 air changes per hour (ACH) in a standard 5,600 cubic foot room. The process of air being inlet, purified, then outlet, lasts approximately 1.2 seconds. A 4 LOG reduction, or 99.99% reduction, of airborne particles in a standard 579 cubic foot room 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
Electromagnetic Compatibility and Electrical Safety: The subject device is equivalent to CerroZone Mobile that 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 No.187 Electrostatic Air Cleaners.
Ozone Emissions: Ozone Emissions of the CerroZone Mini have been assessed per Section 40 of UL 867 & CSA C22.2 No.187 Electrostatic Air Cleaners. Results of the test show that the CerroZone Mini emits between 0.000 and 0.002 ppm of Ozone with a measured absolute max of 0.002 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 Mini.
Purpose: To evaluate the efficacy of the CerroZone Mini at reducing viability of aerosolized MS2 bacteriophage by a combination of entrainment and destruction.
Acceptance Criteria: Greater than 4 log reduction (99.99%).
Results: Average net log reduction / time, MS2 bacteriophage, 5.76 +/- 0.20 / 45 mins.
Methicillin Resistant Staphylococcus epidermidis (MRSE) were aerosolized into a single-pass flow through chamber that modeled the CerroZone Mini.
Purpose: To evaluate the efficacy of the CerroZone Mini at reducing viability of aerosolized bacteria by a combination of entrainment and destruction.
Acceptance Criteria: Greater than 3 log reduction (99.99%) in single-pass testing.
Results: Demonstrated effectiveness against Staphylococcus epidermidis.
Key Metrics
Average net log reduction / time, MS2 bacteriophage, 5.76 +/- 0.20 / 45 mins.
Greater than 3 log reduction (99.99%) in single-pass testing against Staphylococcus epidermidis.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 19, 2024
CerroZone LLC % Erin Gontang Senior Consultant ROM+ 2790 Mosside Blvd., Suite 800 Monroeville, Pennsylvania 15146
Re: K242102
Trade/Device Name: CerroZone Mini Regulation Number: 21 CFR 880.5045 Regulation Name: Medical Recirculating Air Cleaner Regulatory Class: Class II Product Code: FRF Dated: July 18, 2024 Received: October 18, 2024
Dear Erin Gontang:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Katharine Segars -S
Katharine Segars, Ph.D. Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242102
Device Name CerroZone Mini
Indications for Use (Describe)
The CerroZone Mini 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.
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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510(k) Summary
DATE PREPARED
November 19, 2024
MANUFACTURER AND 510(k) OWNER
CerroZone LLC 113975 Riverport Place Drive, Suite 102 Maryland Heights, MO 63043 Telephone: Official Contact: Marlon E. Robinson, Director of Operations
REPRESENTATIVE/CONSULTANT
Erin A. Gontang, Ph.D. Allison C. Komiyama, Ph.D., RAC RQM+ Telephone: +1-412-816-8290 Email: egontang@rqmplus.com, akomiyama@rqmplus.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | CerroZone Mini |
|---|---|
| Common Name: | Medical Recirculating Air Cleaner |
| Regulation Number: | 21 CFR 880.5045 |
| Class: | II |
| Product Code: | FRF |
| Premarket Review: | Infection Control Devices (DHT4C) |
| Review Panel: | General Hospital |
PREDICATE DEVICE IDENTIFICATION
The CerroZone Mini is substantially equivalent to the following predicate:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K220298 | CerroZone Mobile / CerroZone LLC | ✓ |
DEVICE DESCRIPTION
The CerroZone Mini is a medical recirculating air cleaner that uses multiple inactivation processes, including use of reactive oxidizing species (ozone) and ultraviolet radiation, to inactivate bacteria and viruses in the CerroZone Mini may be used in medical facilities. Once turned on, inlet air is passed through CerroZone Mini's inline flow-through design which inactivates bacteria and viruses in a single pass flow-through. The device generates 110 cubic feet of air per minute (CFM), or 2.00 air changes per hour (ACH) in a standard 5,600 cubic foot
5
room. The process of air being inlet, purified, then outlet, lasts approximately 1.2 seconds. A 4 LOG reduction, or 99.99% reduction, of airborne particles in a standard 579 cubic foot room is achieved in 45 minutes or less.
INDICATIONS FOR USE
The CerroZone Mini 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.
| Subject Device | Predicate Device | ||
|---|---|---|---|
| CerroZone LLC | CerroZone LLC | ||
| CerroZone Mini | CerroZone Mobile | Comparison | |
| K242102 | K220298 | ||
| Indications for Use | The CerroZone Mini is | The CerroZone Mobile is | Identical |
| intended as a room | intended as a room | ||
| recirculating air cleaner. The | recirculating air cleaner. The | ||
| system is used for filtering | system is used for filtering | ||
| out and inactivating airborne | out and inactivating airborne | ||
| particles (i.e., viruses and | particles (i.e., viruses and | ||
| bacteria) from the air for | bacteria) from the air for | ||
| medical purposes. | medical purposes. | ||
| Product Code / | FRF/ 21 CFR 880.5045 | FRF/ 21 CFR 880.5045 | Identical |
| Regulation Number | |||
| Regulation Description | Medical recirculating air | Medical recirculating air | Identical |
| cleaner | cleaner | ||
| Type of Use | Over-the-Counter Use | Over-the-Counter Use | Identical |
| Mechanism of Action | Microorganisms including | Microorganisms including | Identical |
| viruses and bacteria, are | viruses and bacteria, are | ||
| inactivated by the device via | inactivated by the device via | ||
| damage by multiple | damage by multiple | ||
| inactivation processes: | inactivation processes: | ||
| Reactive Oxidizing Species | Reactive Oxidizing Species | ||
| (ozone) | (ozone) | ||
| Ultraviolet Radiation | Ultraviolet Radiation | ||
| Also, a filter to trap the | Also, a filter to trap the | ||
| resulting virus/bacteria | resulting virus/bacteria | ||
| particulates: | particulates: | ||
| Particulate Filter | Particulate Filter | ||
| Activated Carbon Filter | Activated Carbon Filter | ||
| Reduction of Biological | MS2 phage reduced by 4 log | MS2 phage reduced by 4 log | Similar |
| Agents | reduction in 45 minutes or | reduction in 30 minutes or | |
| less when operating at full | less and 5.67 log reduction in | ||
| fan speed in a standard room | 45 minutes or less when |
6
| of 579 ft³ (16 m³) | operating at full fan speed in a std. room of 579 ft³ (16 m³) | ||
|---|---|---|---|
| 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 | Activated Carbon Filter | ||
| Proprietary Catalyst | |||
| Substrate | Activated Carbon Filter | ||
| Proprietary Catalyst | |||
| Substrate | Identical | ||
| Reactive Oxidizing Species (Ozone) Removal | Activated Carbon Filter | ||
| Proprietary Catalyst | |||
| Substrate | Activated Carbon Filter | ||
| Proprietary Catalyst | |||
| Substrate | Identical | ||
| Air Source | Centrifugal Fan | Centrifugal Fan | Identical |
| Device Air Changes Per Hour (ACH) | 2.00 device air changes per hour in a 5,600 ft³ room | 2.36 device air changes per hour in a 5,600 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 Mini will automatically shut down. The CerroZone Mini also utilizes a second and redundant external ozone sensor that runs on a different circuit. As such, if one external ozone sensor were to stop functioning, another sensor will be active.
Safety feature confirmed by UL 867 & CSA C22.2 No.187. | 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 Mini will automatically shut down. The CerroZone Mini also utilizes a second and redundant external ozone sensor that runs on a different circuit. As such, if one external ozone sensor were to stop functioning, another sensor will be active.
Safety feature confirmed by UL 867 & CSA C22.2 No.187. | Identical |
| Input Voltage | 120 Volt | 120 Volt | Identical |
| Dimensions | Unit Dimensions:
Height: 36 in
Width: 21 in
Depth: 17 in | Unit Dimensions:
Height: 59 in
Width: 29 in
Depth: 17 in | Different |
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 is equivalent to CerroZone Mobile that 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 No.187 Electrostatic Air Cleaners.
7
Ozone Emissions: Ozone Emissions of the CerroZone Mini have been assessed per Section 40 of UL 867 & CSA C22.2 No.187 Electrostatic Air Cleaners. Results of the test show that the CerroZone Mini emits between 0.000 and 0.002 ppm of Ozone with a measured absolute max of 0.002 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 Mini. | To evaluate the efficacy of | ||
| the CerroZone Mini 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, | |||
| $5.76 \pm 0.20$ / 45 mins. | |||
| Methicillin Resistant | |||
| Staphylococcus epidermidis | |||
| (MRSE) were aerosolized into | |||
| a single-pass flow through | |||
| chamber that modeled the | |||
| CerroZone Mini. | To evaluate the efficacy of | ||
| the CerroZone Mini at | |||
| reducing viability of | |||
| aerosolized bacteria by a | |||
| combination of entrainment | |||
| and destruction. | Greater than 3 log reduction | ||
| (99.99%) 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 concludes that the non-clinical tests demonstrate that the CerroZone Mini is as safe, as effective, and performs as well as or better than the legally marketed predicate device.