The Aerus Medical Guardian, model F170A is a device intended for medical purposes that is used for the reduction of staphylococcus epidermidis and erwinia herbicola bacteria, MS2 and Phi-X174 viruses and aspergillus niger fungal spores and bacillus globigii bacterial spores from the air in a temperature-controlled professional healthcare environment of 70~~71°F, 40~~45% RH.

Device Description

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AI/ML Overview

The provided document describes the Aerus Medical Guardian, model F170A, a medical ultraviolet air purifier intended for the reduction of specific bacteria, viruses, and fungal/bacterial spores in professional healthcare environments.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The acceptance criteria are implicitly defined by the reported performance of the device in demonstrating the reduction of various microorganisms. The device must achieve a certain "Log-Reduction" for each organism. The table below outlines these:

Organism Type	Organism Name	Acceptance Criteria (Log-Reduction)	Reported Device Performance (Avg Log-Reduction)
Bacteria	Staphylococcus epidermidis	Not explicitly stated but implied >= 5.95	5.95
Bacteria	Erwinia herbicola	Not explicitly stated but implied >= 5.12	5.12
Virus	MS2	Not explicitly stated but implied >= 5.58	5.58
Virus	Phi-X174	Not explicitly stated but implied >= 4.19	4.19
Fungal Spore	Aspergillus niger	Not explicitly stated but implied >= 4.12	4.12
Bacterial Spore	Bacillus globigii	Not explicitly stated but implied >= 4.22	4.22

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). The table simply presents "Avg Log-Reduction," suggesting a summary of experimental results.

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

This information is not applicable. The "ground truth" in this context refers to the measured reduction of microorganisms in a controlled laboratory setting, not to expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the "ground truth" is a direct measurement, not an expert consensus process requiring adjudication.

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

This information is not applicable. The device is an air purifier, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable. The device's performance is standalone in its function as an air purifier; there is no "human-in-the-loop" component in its direct operation for microorganism reduction.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for this device's performance is based on direct laboratory measurements of microorganism reduction. This involves culturing and quantifying the specific bacteria, viruses, and spores before and after exposure to the device in a controlled environment. The "Log-Reduction" is a quantitative measure derived from these laboratory experiments.

8. The sample size for the training set

This information is not applicable. This is a physical device (air purifier), not a machine learning model that requires a training set.

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

This information is not applicable for the reason stated above.

Summary

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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: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of an eagle, while the text on the right is written in blue. The text is arranged in three lines, with "FDA" on the top line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.

June 17, 2020

Aerus Medical LLC % Dave Yungvirt Responsible Third Party Official Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K201220

Trade/Device Name: Aerus Medical Guardian, model F170A Regulation Number: 21 CFR 880.6500 Regulation Name: Medical ultraviolet air purifier Regulatory Class: Class II Product Code: FRA Dated: June 13, 2020 Received: June 16, 2020

Dear Dave Yungvirt:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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 -S

For Elizabeth Claverie, M.S. 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) K201220

Device Name

Aerus Medical Guardian, model F170A

Indications for Use (Describe)

The Aerus Medical Guardian, model F170A demonstrated the reduction of staphylococcus epidermidis and erwinia herbicola bacteria, MS2 and Phi-X174 viruses and aspergillus niger fungal spores and bacillus globigii bacterial spores under the following conditions.

Organism Type	Organism Name	Test Temp/RH	Exposure Time (m)	Avg Log-Reduction
Bacteria	Staphylococcus epidermidis	72°F / 50%	60	5.95
Bacteria	Erwinia herbicola	72°F / 50%	60	5.12
Virus	MS2	72°F / 50%	60	5.58
Virus	Phi-X174	72°F / 50%	60	4.19
Fungal Spore	Aspergillus niger	72°F / 50%	60	4.12
Bacterial Spore	Bacillus globigii	72°F / 50%	60	4.22

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Regulation Number and Section

§ 880.6500 Medical ultraviolet air purifier.

(a)
Identification. A medical ultraviolet air purifier is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation.(b)
Classification. Class II (performance standards).