← Product Code [FRA](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA) · K202766 # EOS Air Cleaner (K202766) _Guangzhou Ajax Medical Equipment Co., Ltd. · FRA · Jun 11, 2021 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K202766 ## Device Facts - **Applicant:** Guangzhou Ajax Medical Equipment Co., Ltd. - **Product Code:** [FRA](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA.md) - **Decision Date:** Jun 11, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6500 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## 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 30 cubic meter chamber. ## Device Story Free-standing medical air purifier; uses motor to suction ambient air into sealed metal cabinet; air passes through fine filter and HEPA filter; UV-C radiation (255 nm) from two internal lamps irradiates filter media; photocatalytic coated filter media and UV-C light decompose organic structures of bacteria and viruses; purified air expelled from cabinet; operated by buttons for power and air velocity; intended for use in hospitals, nursing homes, and medical facilities; provides reduction of airborne pathogens; benefits patient/staff by reducing bioaerosol load in medical environments. ## Clinical Evidence No clinical data. Bench testing only. Performance validated via MS2 bacteriophage bioaerosol reduction testing in a 30 cubic meter chamber, achieving >4 log reduction over 4 hours. Aging tests confirmed continued performance over service life. ## Technological Characteristics Free-standing unit; sealed metal enclosure; two UV-C Xenon flash lamps (255 nm); fine filter and HEPA filter; photocatalytic coated filter media; centrifugal fan; AC110V/60Hz power; dimensions 12.25" x 10.75" x 40"; manual button controls; electrical safety per IEC 60601-1; EMC per IEC 60601-1-2. ## Regulatory 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. ## Predicate Devices - Molekule Air ProRX ([K200500](/device/K200500.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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. 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. 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 | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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 {4}------------------------------------------------ - � Regulation Class: II ### 5. 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. ### 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 MEDICAL
EQUIPMENT 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 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. | The Molekule Air Pro RX 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.
The core technology components of the Molekule Air Pro RX air purifier have
been demonstrated to destroy the following MS2 bacteriophage bioaerosol
entrained on the filter of the subject device under the following exposure
conditions: | Similar | | Light Source | 2 UV-C Xenon Flash lamps
Wavelength 255 nm | UV Light Source, LED Wavelength, 320-
400nm
Power per Lamp/ String, 11.4W Number
of Lamps/ String, 6 Total UV Power,
68.4W
Filter Irradiance (Minimum), 30W/m² | Different | | MS2
Bacteriophage
inactivation | Average Log reduction/exposure
time (hours)
Speed 1: 4.05 / 4 hours
Speed 5: 4.22 / 4 hours
Speed 10: 4.45 / 4 hours | Average Maximum log reduction
/exposure time (hours) Room temperature
test 5.21 / 24 hours | Similar | | Environment
of Use | Hospital, nursing homes, medical
facilities (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/stop
device. Higher and Lower button to
adjust the
air suction velocity. | One knob controls the four speed fan
setting One button turns the unit on and
off. | Similar | | Safety
Features | UV lamps and centrifugal fan are
contained inside sealed metal box. | Safety switches exist in the following
locations:
PECO filter door, pre filter door, PECO
filter compartment, and pre filter
compartment. If any door is open or if a
filter is missing, the unit will not operate.
The purpose of these switches is to
protect the user from any possibility of
exposure to direct contact with UV light.
Grill at outlet and inlet of fan with small
enough grating to block user from
accessing spinning fan without tools. | Similar | | Power Supply | AC110V, 60Hz 12-20A | 120 Volt (plugs into standard single
phase 120 Volt outlet)
Up to 3.72 amps | Similar | | Power
Consumption | 1300 Watts | Up to 450 Watts | Different | | Dimensions | Main unit: 12.25" × 10.75"× 40" | 22" × 22"× 52" | Similar | | Safety and
EMC | IEC 60601-1: Pass
IEC 60601-1-2 CISPR Group 1A: Pass | UL 507
IEC 60601-1-2 | Similar | ### 7. Comparison of Technological Characteristics 30 cubic meter chamber. {5}------------------------------------------------ ### 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 Test
Methodology | Purpose | Acceptance Criteria | Results | |-----------------------------|--------------------------------------|--------------------------------------|---------| | IEC 60601-1 | Demonstration of
basic safety and | Meets criteria for
CISPR Group 1A | Pass | {6}------------------------------------------------ | IEC 60601-1-2 | essential performance | | | |---------------------|-------------------------------------------------------------------|-----------------------------------------------------|------| | 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 | ### 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. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K202766](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K202766) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com