EOS Air Cleaner is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation in general medical environment.

The core technology components of the EOS Air Cleaner have been demonstrated to destroy MS2 bacteriophage bioaerosol entrained on the filter to achieve an average 4 log reduction over 4 hours in a 30 cubic meter chamber.

Device Description

EOS Air Cleaner employs an ultraviolet air purification technology that destroys bacteria and viruses in air in hospital, nursing homes, medical facilities, but not in specialized medical place such as operating rooms.

EOS Air Cleaner is a free-standing device, which has a well-sealed metal box including a fine filter, motor, two UV-C lamps, and a HEPA filter. By sucking surrounding air into the device, EOS Air cleaner can suction the air into the device and filtering the air by fine filter with UV-C light radiation, then the purified air is expelled from the cabinet.

The bacteriophage deposited onto the surface of EOA Air Cleaner's proprietary photocatalytic coated filter media will be killed after exposure to EOS Air Cleaner's UV-C light

UV-C light in 255 nm which is commonly called germicidal kills any remaining bacteria and viruses, as the radiation penetrates the cell walls of bacteria and is absorbed by the organic structures within the bacterial and virus, causing them to decompose and the cell to die.

AI/ML Overview

Here's the breakdown of the acceptance criteria and study information for the EOS Air Cleaner, based on the provided document:

Acceptance Criteria and Device Performance

Name of Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
IEC 60601-1 / IEC 60601-1-2	Demonstration of basic safety and essential performance	Meets criteria for CISPR Group 1A	Pass
Bacteriophage Test	Demonstration of log reduction of viral load	At least 4 log reduction of MS2 bacteriophage	Pass
Aging Test	Demonstration of continued function throughout service life	At least 4 log reduction of MS2 bacteriophage	Pass
Software Validation	Demonstration of software security and good design	Meets design criteria	Pass

Note regarding the Bacteriophage Test's Reported Performance: The "Indications for Use" section and the "Comparison of Technological Characteristics" table provide more specific performance details:

The core technology components have been demonstrated to destroy MS2 bacteriophage bioaerosol entrained on the filter to achieve an average 4 log reduction over 4 hours in a 30 cubic meter chamber.
Specific log reductions at different speeds (Speed 1: 4.05 / 4 hours, Speed 5: 4.22 / 4 hours, Speed 10: 4.45 / 4 hours) are also reported.

Study Details

Sample Size Used for the Test Set and Data Provenance:
- The document does not explicitly state the sample size for the bacteriophage tests (e.g., number of test runs or replicates).
- The data provenance is from non-clinical testing, likely conducted in a laboratory setting, and the manufacturer is Guangzhou Ajax Medical Equipment Co., Ltd. in China. The document does not specify if the data is retrospective or prospective, but it implies prospective testing for regulatory submission.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not mention individual experts or their qualifications for establishing ground truth for the non-clinical tests. These types of tests typically rely on standardized laboratory protocols and measurements rather than expert consensus on individual "cases."
Adjudication Method for the Test Set:
- Not applicable as this involves non-clinical laboratory testing against pre-defined performance metrics, not human expert interpretation requiring adjudication.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The device is an air cleaner, and its performance is measured mechanically and biologically, not through human reader interpretation of medical images or data.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, the provided studies are standalone evaluations. The "Bacteriophage Test," "Aging Test," and "Software Validation" all evaluate the device's inherent performance and functionality without human interaction beyond operating and monitoring the device.
Type of Ground Truth Used:
- For the Bacteriophage Test and Aging Test: Direct measurement of viral load reduction (specifically MS2 bacteriophage bioaerosol) in a controlled environment. This is a scientific and empirical ground truth.
- For IEC 60601-1/60601-1-2 and Software Validation: Adherence to established international standards and design criteria.
Sample Size for the Training Set:
- The document does not mention a training set or machine learning component for the EOS Air Cleaner. The device's function relies on physical processes (UV radiation, filtration) rather than an AI/ML algorithm that requires training data.
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no mention of a training set or AI/ML algorithm.

Summary

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June 11, 2021

Guangzhou Ajax Medical Equipment Co., Ltd. % Iris Fung Specialist SGS-CSTC Standards Technical Services Co., Ltd. 198 KEZHU Road, SCIENTECH Park Guangzhou Economic & Technology Deve Guangzhou, Guangdong China

Re: K202766

Trade/Device Name: EOS Air Cleaner Regulation Number: 21 CFR 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: Class II Product Code: FRA Dated: May 10, 2021 Received: May 14, 2021

Dear Iris Fung:

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.

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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 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 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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Indications for Use

510(k) Number (if known) K202766

Device Name EOS Air Cleaner

Indications for Use (Describe)

EOS Air Cleaner is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation in general medical environment.

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)	X

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510(k) Summary

510(k) Number: 202766

This 510(K) Summary is being submitted in accordance with the requirement of 21 CFR 807.92. This is a Traditional 510(K) submission, and there were no prior submissions for the subject device.

ー Submitter's Information Sponsor

� Company Name: Guangzhou Ajax Medical Equipment Co., Ltd.
� Address: Building No.2 Dagang industrial zone, Shilou Town, Panyu District, Guangzhou City, Guangdong Province, 511447, P.R. China
� Phone: +86 20 84847938
� Email: ella@ajaxdent.com
� Contact Person (including title): Atwood Lee (General Manager)

Application Correspondent:

♦ SGS-CSTC Standards Technical Services Co., Ltd.
♦ Address: 198 KEZHU Road, SCIENTECH Park Guangzhou Economic & Technology Development

District, Guangzhou, Guangdong, CHINA

♦ Contact Person: Ms. Iris Fung
♦ Tel: +86-20-32136908
♦ Email: Iris.Fung@sgs.com

ﻨ Subject Device Information

� Type of 510(k) submission: Traditional
Regulation Name: Medical Ultraviolet Air Purifier �
� Trade Name: EOS Air Cleaner
� Review Panel: General Hospital
� Product Code: FRA
� Regulation Number: 21 CFR 880.6500
� Regulation Class: II

3. Date Prepared:

June 9, 2021

4. Predicate Device

� 510(k) number: K200500
� Sponsor: Molekule, Inc.
� Regulation Name: Medical Ultraviolet Air Purifier
� Trade Name: Molekule Air ProRX
� Review Panel: General Hospital
� Product Code: FRA
� Regulation Number: 21 CFR 880.6500

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� Regulation Class: II

5. Device Description

The bacteriophage deposited onto the surface of EOA Air Cleaner's proprietary photocatalytic coated filter media will be killed after exposure to EOS Air Cleaner's UV-C light

6. Indications for Use

EOS Air Cleaner is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation in general medical environment.

The core technology components of the EOS Air Cleaner have been demonstrated to destroy MS2 bacteriophage bioaerosol entrained on the filter to achieve an average 4 log reduction over 4 hours in a

	Subject Device	Primary Predicate Device	Comparison
510(k)Number	K202766	K200500
Manufacturer	GUANGZHOU AJAX MEDICALEQUIPMENT CO., LTD.	Molekule, Inc.	--
Product Name	EOS Air Cleaner	Molekule Air Pro RX	--
Classification	Class II, FRA (21 CFR880.6500)	Class II, FRA (21 CFR880.6500)	Same
Indications for Use	EOS Air Cleaner is a device intended for medical purposes thatis used to destroy bacteria and viruses in the air by exposure toultraviolet radiation in general medical environment.The core technology components of the EOS Air Cleaner have beendemonstrated to destroy MS2 bacteriophage bioaerosol entrainedon the filter to achieve an average 4 log reduction over 4 hours in a 30cubic meter chamber.	The Molekule Air Pro RX air purifier is a device intended for medical purposesthat is used to destroy bacteria and viruses in the air by exposure toultraviolet radiation.The core technology components of the Molekule Air Pro RX air purifier havebeen demonstrated to destroy the following MS2 bacteriophage bioaerosolentrained on the filter of the subject device under the following exposureconditions:	Similar
Light Source	2 UV-C Xenon Flash lampsWavelength 255 nm	UV Light Source, LED Wavelength, 320-400nmPower per Lamp/ String, 11.4W Numberof Lamps/ String, 6 Total UV Power,68.4WFilter Irradiance (Minimum), 30W/m²	Different
MS2Bacteriophageinactivation	Average Log reduction/exposuretime (hours)Speed 1: 4.05 / 4 hoursSpeed 5: 4.22 / 4 hoursSpeed 10: 4.45 / 4 hours	Average Maximum log reduction/exposure time (hours) Room temperaturetest 5.21 / 24 hours	Similar
Environmentof Use	Hospital, nursing homes, medicalfacilities (not surgery setting)	Hospital and general surgery setting	Similar
User Control	4 Buttons to control the device:Power button to turn on/off.Start/Stop button to start/stopdevice. Higher and Lower button toadjust theair suction velocity.	One knob controls the four speed fansetting One button turns the unit on andoff.	Similar
SafetyFeatures	UV lamps and centrifugal fan arecontained inside sealed metal box.	Safety switches exist in the followinglocations:PECO filter door, pre filter door, PECOfilter compartment, and pre filtercompartment. If any door is open or if afilter is missing, the unit will not operate.The purpose of these switches is toprotect the user from any possibility ofexposure to direct contact with UV light.Grill at outlet and inlet of fan with smallenough grating to block user fromaccessing spinning fan without tools.	Similar
Power Supply	AC110V, 60Hz 12-20A	120 Volt (plugs into standard singlephase 120 Volt outlet)Up to 3.72 amps	Similar
PowerConsumption	1300 Watts	Up to 450 Watts	Different
Dimensions	Main unit: 12.25" × 10.75"× 40"	22" × 22"× 52"	Similar
Safety andEMC	IEC 60601-1: PassIEC 60601-1-2 CISPR Group 1A: Pass	UL 507IEC 60601-1-2	Similar

7. Comparison of Technological Characteristics

30 cubic meter chamber.

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8. Summary for non-clinical test

The non-clinical testing was provided to demonstrate the subject device met the acceptance criteria of the test methodology or standards listed below.

EOS Air Cleaner complies with voluntary standards for electrical safety and electromagnetic

compatibility.

Name of TestMethodology	Purpose	Acceptance Criteria	Results
IEC 60601-1	Demonstration ofbasic safety and	Meets criteria forCISPR Group 1A	Pass

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IEC 60601-1-2	essential performance
Bacteriophage Test	Demonstration of logreduction of viral load	At least 4 logreduction of MS2bacteriophage	Pass
Aging Test	Demonstration ofcontinued functionthroughout service life	At least 4 logreduction of MS2bacteriophage	Pass
Software Validation	Demonstration ofsoftware security andgood design	Meets design criteria	Pass

9. Clinical Testing

Clinical testing was not performed.

10. Conclusion

The conclusion drawn from the nonclinical testes demonstrates that the subject device in 510(K) submission K202766, EOS Air Cleaner, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K202766.

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).