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.

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.

AI/ML Overview

The prompt requests information about a study proving that a medical device meets acceptance criteria. The provided text is an FDA 510(k) clearance letter for the CerroZone Mini, a medical recirculating air cleaner. The document details the device, its indications for use, comparison to a predicate device, and summarizes non-clinical testing.

However, the provided text does not contain the specifics of a study proving device acceptance criteria in the way one might expect for an AI/algorithm-driven medical device, which is what the prompt implies by asking about sample sizes for test and training sets, expert ground truth, adjudication methods, and MRMC studies. The device in question is an air cleaner, and the "studies" mentioned are laboratory tests assessing its ability to reduce airborne biological agents and ozone emissions, not clinical trials or AI performance evaluations involving human-in-the-loop scenarios.

Therefore, many of the requested points are not applicable to the data provided for this specific device. I will address only the points for which information is available in the text.

Here's the analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
MS2 bacteriophage 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 ± 0.20 / 45 mins.
Methicillin Resistant Staphylococcus epidermidis (MRSE) 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.
Ozone Emissions assessed per Section 40 of UL 867 & CSA C22.2 No.187.	To ensure that ozone emissions are within acceptable levels.	Within the maximum acceptable level of ozone, 0.050 ppm, given in 21 CFR 801.415.	Emits between 0.000 and 0.002 ppm of Ozone with a measured absolute max of 0.002 ppm.
Electromagnetic Compatibility and Electrical Safety (EN/IEC 60601-1-2, UL 867 & CSA C22.2 No.187).	To demonstrate safety regarding electromagnetic disturbances and electrical safety.	Compliance to EN/IEC 60601-1-2 and UL 867 & CSA C22.2 No.187.	The subject device is equivalent to a predicate device that tested in compliance.

2. Sample sizes used for the test set and the data provenance

The document does not specify exact "sample sizes" in terms of number of runs or specific data points for the biological agent reduction tests, nor does it explicitly state the precise "data provenance" (e.g., country of origin, retrospective/prospective). These are laboratory efficacy and safety tests, not clinical studies with human subjects or large datasets typical for AI model validation. The tests were performed in a controlled laboratory environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in the context of this device's testing refers to measured physical/biological parameters (e.g., log reduction of bacteria/viruses, ozone concentration), not expert interpretation of medical images or other data typically associated with AI/diagnostic devices. The results are based on quantitative laboratory measurements.

4. Adjudication method for the test set

Not applicable. There was no need for adjudication as the "ground truth" was established through direct laboratory measurements, not subjective evaluations or consensus processes.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an air cleaner, not an AI-assisted diagnostic or decision support tool for human readers. No MRMC study was performed.

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

Not applicable beyond the device's inherent standalone function as an air cleaner. There is no AI algorithm in the traditional sense that performs a diagnostic or interpretive function. The device's performance is its inherent physical and chemical action on airborne particles.

7. The type of ground truth used

The ground truth for the biological agent reduction tests was established through direct quantitative laboratory measurements of the reduction in viable MS2 bacteriophage and Staphylococcus epidermidis concentrations. For ozone emissions, the ground truth was direct measurement of ozone concentration in ppm. For electrical compatibility and safety, the ground truth was compliance with specified international and national standards (EN/IEC 60601-1-2, UL 867, CSA C22.2 No.187), verified through standard engineering tests.

8. The sample size for the training set

Not applicable. This device is an air cleaner with a physical mechanism of action, not a machine learning model that requires a "training set."

9. How the ground truth for the training set was established

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

Summary

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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.

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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

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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

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Indications for Use

510(k) Number (if known) K242102

Device Name CerroZone Mini

Indications for Use (Describe)

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

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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

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

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	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 FilterProprietary CatalystSubstrate	Activated Carbon FilterProprietary CatalystSubstrate	Identical
Reactive Oxidizing Species (Ozone) Removal	Activated Carbon FilterProprietary CatalystSubstrate	Activated Carbon FilterProprietary CatalystSubstrate	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 inWidth: 21 inDepth: 17 in	Unit Dimensions:Height: 59 inWidth: 29 inDepth: 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.

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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 wereaerosolized into a sealedenvironmental bioaerosolchamber containing theCerroZone Mini.	To evaluate the efficacy ofthe CerroZone Mini atreducing viability ofaerosolized MS2bacteriophage by acombination of entrainmentand destruction.	Greater than 4 log reduction(99.99%).	Average net log reduction /time, MS2 bacteriophage,$5.76 \pm 0.20$ / 45 mins.
Methicillin ResistantStaphylococcus epidermidis(MRSE) were aerosolized intoa single-pass flow throughchamber that modeled theCerroZone Mini.	To evaluate the efficacy ofthe CerroZone Mini atreducing viability ofaerosolized bacteria by acombination of entrainmentand destruction.	Greater than 3 log reduction(99.99%) in single-passtesting.	Demonstrated effectivenessagainst 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.

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).