(263 days)
Not Found
No
The description focuses on UV-C light and filtration technology for air purification, with no mention of AI or ML components.
No.
The device is an air cleaner designed to destroy bacteria and viruses in the air within a general medical environment, rather than directly treating a patient's disease or condition.
No
The device is an air cleaner designed to destroy bacteria and viruses in the air using UV radiation and filtration. It does not perform any diagnostic functions by detecting, identifying, or monitoring medical conditions in patients.
No
The device description clearly outlines physical components like a metal box, filter, motor, and UV-C lamps, indicating it is a hardware device with integrated software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The EOS Air Cleaner's function is to purify air by destroying bacteria and viruses using UV-C radiation and filtration. It operates on the air in the environment, not on specimens taken from the human body.
- Intended Use: The intended use is to destroy bacteria and viruses in the air in general medical environments. This is an environmental control function, not a diagnostic function.
- Performance Studies: The performance studies focus on the device's ability to reduce viral load in the air, not on analyzing biological specimens.
Therefore, the EOS Air Cleaner falls under the category of an air purification device for medical environments, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
FRA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital, nursing homes, medical facilities, but not in specialized medical place such as operating rooms.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Bacteriophage Test: Demonstration of log reduction of viral load. Acceptance Criteria: At least 4 log reduction of MS2 bacteriophage. Results: Pass.
Aging Test: Demonstration of continued function throughout service life. Acceptance Criteria: At least 4 log reduction of MS2 bacteriophage. Results: Pass.
Software Validation: Demonstration of software security and good design. Acceptance Criteria: Meets design criteria. Results: Pass.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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.
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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.
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 |
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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
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.
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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 Test
| Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| IEC 60601-1 | Demonstration of | ||
| basic safety and | Meets criteria for | ||
| CISPR Group 1A | Pass |
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| 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.