The Aerobiotix AEROCURE-MD air purifier is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation. In addition, the device removes particles from the air via HEPA filtration.

Device Description

The AEROCURE-MD is a free-standing flow-through air purification device which uses germicidal ultraviolet light with supplemental HEPA filtration to remove airborne contamination. The AEROCURE-MD device has a wheeled metal housing with electrical controls and outer dimensions of 74 x 62 x 178 cm which is placed within a room. The device has a pleated pre-filter, ultraviolet photolytic chamber equipped with germicidal ultraviolet lamps, and a 99.97% HEPA filter. The AEROCURE-MD is for over-the-counter use.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called "AEROCURE-MD Medical Air Purifier." This document outlines the device's characteristics, its comparison to a predicate device, and the results of non-clinical testing.

Based on the provided information, here's a breakdown of the acceptance criteria and the study proving the device meets them:

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

Name of Test Methodology	Purpose	Acceptance Criteria	Results
Microorganism Reduction Testing	Demonstrate reduction of representative organisms in single-pass testing	Greater than 99.9% reduction in single-pass testing	Demonstrated effectiveness against MS2 virus, B. atropheus, S. epidermidis.
UL 507: 2017 Ed. 10	Electrical safety and mechanical integrity	PASS	PASS
IEC 60601-1-2 Ed. 4.0	Electromagnetic compatibility (EMC) for medical electrical equipment	PASS	PASS
Particulate Reduction Testing	Demonstrate ability to remove airborne particles	SIMILAR TO PREDICATE	SIMILAR TO PREDICATE

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

The document does not specify the exact sample size for each test (e.g., number of runs, amount of airflow, duration of test). It only states that the testing was "single-pass testing" for microorganism reduction.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that it is a 510(k) submission to the FDA, it is expected that the testing was conducted in a controlled, accredited environment to demonstrate the device's performance for regulatory clearance. It would be considered prospective testing as it was specifically done to support this submission.

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 to this type of device and study. The "ground truth" for the performance of an air purifier is established through objective, controlled laboratory measurements of its ability to filter particles and inactivate microorganisms, not through expert consensus or interpretation of images. The tests listed (Microorganism Reduction, UL, IEC, Particulate Reduction) are engineering and microbiology performance tests.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation of medical data (e.g., radiology reads) where there might be disagreement among experts. For performance testing of a physical device like an air purifier, the results are quantitative measurements, not subject to adjudication in the same way. The results are either PASS/FAIL or a measured reduction percentage.

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. This device is an air purifier, not an AI-assisted diagnostic tool or system that involves human readers. Therefore, an MRMC comparative effectiveness study involving human readers is irrelevant.

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

This information is not applicable. The device is a physical air purifier. Its performance is measured directly, not through an algorithm or AI.

7. The type of ground truth used

The ground truth for this device's performance is based on objective, quantitative laboratory measurements of:

Microorganism reduction: Measured effectiveness against specific viral and bacterial surrogates (MS2 virus, B. atropheus, S. epidermidis) in a controlled environment.
Electrical safety and performance: Compliance with established engineering standards (UL 507, IEC 60601-1-2).
Particulate reduction: Measured ability to remove airborne particles, demonstrated to be similar to the predicate device.

8. The sample size for the training set

This information is not applicable. This is a physical device, not a machine learning or AI algorithm that requires a training set. The device's operation is based on established principles of UV radiation and HEPA filtration, not on learned patterns from a dataset.

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

This information is not applicable as there is no training set for a physical air purifier.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo 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.

January 21, 2021

Aerobiotix, Inc. % Rafael Aguila Responsible Third-Party Official Accelerated Device Approval Services 6800 S.W. 40th Street, Ste. 403 Ludlum, Florida 33155

Re: K203189

Trade/Device Name: Aerocure-md Regulation Number: 21 CFR 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: Class II Product Code: FRA Dated: January 5, 2021 Received: January 6, 2021

Dear Rafael Aguila:

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, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K203189

Device Name

AEROCURE-MD Medical Air Purifier

Indications for Use (Describe)

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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510(k) SUMMARY: K203189

SUBMITTER INFORMATION:

Company Name:	Aerobiotix, Inc.
	444 Alexandersville Road
	Miamisburg, OH 45342
	Telephone (888) 978-7087
	FAX (937) 388-8145
Official Contact:David Kirschman, M.D.
	President
Date Prepared:January 21st, 2021
DEVICE INFORMATION:
Trade/Proprietary Name:AEROCURE-MD Medical Air Purifier
Common Name:Ultraviolet Medical Air Purifier
Device Class:Class II
Regulation Number:21 CFR 880.6500
Product Code:FRA
Classification Name:Medical Ultraviolet Air Purifier
Category:General Hospital

PREDICATE DEVICES:

Biological Controls MICROCON 800MUV K972064

INTENDED USE:

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DEVICE DESCRIPTION:

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

The AEROCURE-MD has the following technical characteristics as the Biological Controls MICROCON MAP-800M (K974682) predicate device:

Element ofComparison	Aerobiotix AEROCURE-MD	Biological ControlsMICROCONMAP-800M (K974682)	Comparison
Device Type	Medical UV Air Purifier	Medical UV Air Purifier	Same
Product Code	FRA	FRA	Same
Regulation #	21 CFR 880.6500	21 CFR 880.6500	Same
Indications for use	The AEROCURE-MD air purifier is a deviceintended for medical purposes that is usedto destroy bacteria and viruses in the air byexposure to ultraviolet radiation.In addition, the device removes particlesfrom the air via HEPA filtration.	Used for filteringairborne particlesfrom air for medicalpurposes.	Similar
First Mechanism ofAction	HEPA filtration	HEPA filtration	Same
Second Mechanismof Action	Ultraviolet germicidal lamps	Ultraviolet germicidallamps	Same
Construction	Wheeled portable enclosure	Wheeled portableenclosure	Same
Voltage	120V/60 Hz	120V/ 60 Hz	Same
Electricalcertification	Applicable UL Standardscompliant, IEC 60601-1-2	Applicable UL Standardscompliant	Similar, thesubject device iscompatible withIEC 60601-1-2
Clean air outflow	300-450 CFM ("Cubic Feet per Minute")	250-725 CFM ("CubicFeet per Minute")	Similar, thesubject devicehas higher flowsin worst casecondition

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SUMMARY OF NON-CLINICAL TESTING:

Shown below is the performance testing performed with the subject device to demonstrate the device can meet the acceptance criteria of the test methodology and standard.

Name of TestMethodology	Purpose	Acceptance Criteria	Results
Microorganism ReductionTesting	Demonstrate reductionof representativeorganisms in single-passtesting	Greater than 99.9%reduction in single-passtesting	Demonstratedeffectiveness againstMS2 virus, B. atropheus,S. epidermidis.

UL 507: 2017 Ed. 10	PASS
IEC 60601-1-2 Ed. 4.0	PASS
Particulate Reduction Testing	SIMILAR TO PREDICATE

CONCLUSION:

The conclusions drawn from the nonclinical tests demonstrate that the Aerocure-MD device is as safe, as effective, and performs as well as or better than legally marketed predicate device.

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).