(267 days)
AirKEE T900 is a medical ultraviolet air purifier intended for medical purposes to capture and destroy bacterial, mold, and viruses in the air through the multi-stage air filtration system and exposure to ultraviolet radiation.
AirKEE T900 has been demonstrated to eliminate the following test microorganisms entrained on the subject device under the following exposure conditions:
| Test Item | Avg. max Log Reduction/Entrainment Time (min) Room Temperature Test |
|---|---|
| Bacteria | Staphylococcus albus Log 4 (99.99%)/60 minutes @ high fan speed Log 4 (99.99%)/120 minutes @ low fan speed |
| Bacteria | Escherichia coli Log 4 (99.99%)/60 minutes @ high fan speed Log 4 (99.99%)/120 minutes @ low fan speed |
| Mold | Penicillium rocqueforti Log 4 (99.99%)/60 minutes @ high fan speed |
| Mold | Aspergillus Niger Log 4 (99.99%)/120 minutes @ low fan speed |
| Virus | Influenza A virus, H1N1 Log 4 (99.99%)/60 minutes @ high fan speed |
| Virus | Influenza A virus, H3N2 Log 4 (99.99%)/120 minutes @ low fan speed |
AirKEE T900 is a mobile medical ultraviolet air purifier. It is used to destroy bacteria in the air by exposure to ultraviolet radiation. It may be used for medical purposes which can include hospitals, medical facilities, medical clinics, nursing facilities, and dental facilities. AirKEE T900 is controlled via a touchscreen control panel on the machine.
AirKEE T900's main components consist of:
Multi-stage air treatment
- a filtration system with primary filter, medium efficiency filter, HEPA filter, activated O carbon filter, and nano-material filter
- UV lamps that generate UV-C irradiation to eliminate microorganisms о
- o a motor/impeller to move air through the filtration system
System control
- o an electronic control system to power and control the device
- a touch panel interface to indicate the working status of the device and consumables O
AirKEE T900's multi-stage air treatment: Air enters through the bottommost chamber and passes through primary G4 filter, where large particulate matter will be removed. G4 filtered air then passes through modified activated carbon and patented nano-material filter for further removal. Microorganisms will be inactivated by UV, and photocatalysts. Lastly, HEPA H14 filter eliminates 99.99% of the remaining particles (0.1 microns in diameter). The treated air then exits through the top of the machine.
The touch panel allows reading, troubleshooting functions, and settings of various function. Its enhanced user interface with touchscreen function allows easier navigation of the system.
The provided FDA 510(k) notification describes the AirKEE T900, a medical ultraviolet air purifier, and its performance. It outlines the device's indications for use and presents a summary of non-clinical tests to demonstrate its effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Microorganism Performance | 4 Log reduction (99.99%) | Bacteria:- Staphylococcus albus: Log 4 (99.99%) reduction in 60 minutes at high fan speed; Log 4 (99.99%) in 120 minutes at low fan speed- Escherichia coli: Log 4 (99.99%) reduction in 60 minutes at high fan speed; Log 4 (99.99%) in 120 minutes at low fan speedMold:- Penicillium rocqueforti: Log 4 (99.99%) reduction in 60 minutes at high fan speed- Aspergillus Niger: Log 4 (99.99%) reduction in 120 minutes at low fan speedVirus:- Influenza A virus, H1N1: Log 4 (99.99%) reduction in 60 minutes at high fan speed- Influenza A virus, H3N2: Log 4 (99.99%) reduction in 120 minutes at low fan speed |
| Fractional Efficiency | Per Standard particles | Filter fractional efficiency percentage of 99.99% at 0.1-0.2µm |
| Electrical Safety and EMC | Per Standard | Pass |
| Ozone | Per Standard (less than 0.05 ppm) | Testing demonstrates the AirKEE T900 unit is able to operate at less than 0.05 ppm at its highest fan speed. |
Note: The term "acceptance criteria" is derived directly from the "Acceptance Criteria" column in the provided table.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the test set in terms of the number of individual devices tested or the number of replicates for each microbiological test. The provenance of the data is not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective, beyond "Internal Standards" for microorganism performance. These are non-clinical laboratory tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This document describes non-clinical performance testing of a physical device (air purifier) for its ability to filter and destroy microorganisms and to meet safety standards. It does not involve interpretation of medical images or diagnostic outputs that would typically require human experts to establish "ground truth" in the context of an AI/human reader study. Therefore, the concepts of "number of experts" and "qualifications of those experts" are not applicable to the studies described.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are relevant for studies involving human interpretation or subjective assessments, typically in diagnostic or imaging contexts. Since the described studies are non-clinical laboratory performance tests (e.g., measuring log reduction of microorganisms, filter efficiency, electrical safety), adjudication methods are not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-assisted diagnostic devices where the AI's impact on human reader performance is evaluated. The AirKEE T900 is an air purification device, and its performance is assessed through laboratory-based efficacy and safety tests, not through human reader interpretation of data or images.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, the studies described are essentially "standalone" performance evaluations of the device itself, without human-in-the-loop interaction in the context of a diagnostic or interpretive task. The performance metrics (e.g., log reduction of microorganisms, filter efficiency, ozone levels) are direct measurements of the device's function.
7. The Type of Ground Truth Used
The ground truth for the performance evaluations is established through:
- Quantitative Microbiological Assays: For microorganism performance, the "ground truth" is the measured reduction in viable microorganisms (bacteria, mold, viruses) under specific test conditions. This is an objective, laboratory-derived measurement.
- Physical Measurements and Engineering Standards: For fractional efficiency, electrical safety, and ozone release, the "ground truth" is defined by adherence to established industry standards (IEST-RP-CC001.6, UL 507, IEC 60601-1-2, UL 867) and direct physical measurements confirming compliance.
8. The Sample Size for the Training Set
This document details non-clinical performance and safety testing of a manufactured device, not a machine learning or artificial intelligence (AI) algorithm. Therefore, the concept of a "training set sample size" is not applicable, as there is no AI model being trained.
9. How the Ground Truth for the Training Set was Established
As noted above, this pertains to a physical medical device, not an AI model. Therefore, the concept of a "training set" and "established ground truth for the training set" is not relevant to this submission. The device's performance is based on its physical and functional design, which is validated through the non-clinical tests described.
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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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 23, 2024
HealKEE Medical Pte Ltd % Shanshan Liu Charles & International LLC 45 Ashford St Allston, Massachusetts 02134
Re: K232642
Trade/Device Name: AirKEE T900 Regulation Number: 21 CFR 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: Class II Product Code: FRA Dated: April 17, 2024 Received: April 22, 2024
Dear Shanshan Liu:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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, Digitally signed by Stephen Stephen A. A. Anisko -S Date: 2024.05.23 20:55:02 Anisko -S -04'00' for: Christopher Dugard Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Enclosure
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Indications for Use
510(k) Number (if known) K232642
Device Name AirKEE T900
Indications for Use (Describe)
AirKEE T900 is a medical ultraviolet air purifier intended for medical purposes to capture and destroy bacterial, mold, and viruses in the air through the multi-stage air filtration system and exposure to ultraviolet radiation.
AirKEE T900 has been demonstrated to eliminate the following test microorganisms entrained on the subject device under the following exposure conditions:
| Test Item | Avg. max Log Reduction/Entrainment Time(min) Room Temperature Test |
|---|---|
| Bacteria | Staphylococcus albusLog 4 (99.99%)/60 minutes @ high fan speedLog 4 (99.99%)/120 minutes @ low fan speed |
| Bacteria | Escherichia coliLog 4 (99.99%)/60 minutes @ high fan speedLog 4 (99.99%)/120 minutes @ low fan speed |
| Mold | Penicillium rocquefortiLog 4 (99.99%)/60 minutes @ high fan speed |
| Mold | Aspergillus NigerLog 4 (99.99%)/120 minutes @ low fan speed |
| Virus | Influenza A virus, H1N1Log 4 (99.99%)/60 minutes @ high fan speed |
| Virus | Influenza A virus, H3N2Log 4 (99.99%)/120 minutes @ low fan speed |
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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K232642 - 510(k) Summary
HealKEE Medical Pte Ltd
This 510(k) Summary is in conformance with 21CFR 807.92
| Submitter: | HealKEE Medical Pte Ltd11 North Buona Vista Drive, Level 08-09The Metropolis Tower 2, Singapore 138589 |
|---|---|
| Primary Contact: | Shanshan Liu, ConsultantCharles & International LLCEmail: sliu@charlieintl.comPhone: 617-893-3456 |
| Company Contact: | William TaoTitle: Founder & CEOEmail: william.tao@healkee.comPhone: +65 6808 7770 |
| Date Prepared: | May 21st, 2024 |
| Trade Name: | AirKEE T900 |
| Regulation Number: | 21 CFR 880.6500 |
| Regulation Name: | Medical Ultraviolet Air Purifier |
| Regulatory Class: | Class II |
| Common Name: | Air Purifier |
| Classification Name: | Purifier, Air, Ultraviolet, Medical |
| Review Panel: | General Hospital |
| Product Code: | FRA |
Predicate Device(s):
| Predicate | |
|---|---|
| Trade Name | Aura Storm |
| 510(k) Submitter / Holder | Invictus Lighting |
| 510(k) Number | K212644 |
| Regulation Number | 21 CFR 880.6500 |
| Classification | Class II |
| Classification Panel | General Hospital |
| Product Code | FRA |
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Device Description:
AirKEE T900 is a mobile medical ultraviolet air purifier. It is used to destroy bacteria in the air by exposure to ultraviolet radiation. It may be used for medical purposes which can include hospitals, medical facilities, medical clinics, nursing facilities, and dental facilities. AirKEE T900 is controlled via a touchscreen control panel on the machine.
AirKEE T900's main components consist of:
Multi-stage air treatment
- a filtration system with primary filter, medium efficiency filter, HEPA filter, activated O carbon filter, and nano-material filter
- UV lamps that generate UV-C irradiation to eliminate microorganisms о
- o a motor/impeller to move air through the filtration system
System control
- o an electronic control system to power and control the device
- a touch panel interface to indicate the working status of the device and consumables O
AirKEE T900's multi-stage air treatment: Air enters through the bottommost chamber and passes through primary G4 filter, where large particulate matter will be removed. G4 filtered air then passes through modified activated carbon and patented nano-material filter for further removal. Microorganisms will be inactivated by UV, and photocatalysts. Lastly, HEPA H14 filter eliminates 99.99% of the remaining particles (0.1 microns in diameter). The treated air then exits through the top of the machine.
The touch panel allows reading, troubleshooting functions, and settings of various function. Its enhanced user interface with touchscreen function allows easier navigation of the system.
Indications for Use:
AirKEE T900 is a medical ultraviolet air purifier intended for medical purposes to capture and destroy bacterial, mold, and viruses in the air through the multi-stage air filtration system and exposure to ultraviolet radiation.
AirKEE T900 has been demonstrated to eliminate the following test microorganisms entrained on the filter of the subject device under the following exposure conditions:
| Test Item | Avg. max Log Reduction/Entrainment Time (min) Room Temperature Test | |
|---|---|---|
| Bacteria | Staphylococcus albus | Log 4 (99.99%)/60 minutes @ high fan speedLog 4 (99.99%)/120 minutes @ low fan speed |
| Bacteria | Escherichia coli | Log 4 (99.99%)/60 minutes @ high fan speedLog 4 (99.99%)/120 minutes @ low fan speed |
| Mold | Penicillium rocqueforti | Log 4 (99.99%)/60 minutes @ high fan speed |
| Mold | Aspergillus Niger | Log 4 (99.99%)/120 minutes @ low fan speed |
| Virus | Influenza A virus, H1N1 | Log 4 (99.99%)/60 minutes @ high fan speed |
| Virus | Influenza A virus, H3N2 | Log 4 (99.99%)/120 minutes @ low fan speed |
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Comparison of Technological Characteristics with Predicate Device:
| Item | AirKEE T900(K232642)Subject Device | Aura Storm(K212644)Predicate | Comparison |
|---|---|---|---|
| Device Type | Medical Ultraviolet Air Purifier | Medical Ultraviolet Air Purifier | Identical |
| Product Code | FRA | FRA | Identical |
| Classification Regulation | 21 CFR 880.6500 | 21 CFR 880.6500 | Identical |
| Class | II | II | Identical |
| Rx/OTC | OTC | OTC | Identical |
| Indications for Use | AirKEE T900 is a medical ultraviolet airpurifier intended for medical purposes tocapture and destroy bacterial, mold, andviruses in the air through the multi-stageair filtration system and exposure toultraviolet radiation.AirKEE T900 has been demonstrated toeliminate the following testmicroorganisms entrained on the filter ofthe subject device under the followingexposure conditions:Staphylococcus albusLog 4 (99.99%)/ 60 minutes at high fanspeed/ 120 minutes at low fan speed;Escherichia coliLog 4 (99.99%)/ 60 minutes at high fanspeed/ 120 minutes at low fan speed;Penicillium rocquefortiLog 4 (99.99%)/ 60 minutes at fan highspeed: | The Aura Storm air purifier is a deviceintended for medicalpurposes that is used to capture anddestroy bacteria and viruses in the airthrough the multi-stage filtration systemand exposure to ultraviolet radiation.The Aura Storm air purifier has beendemonstrated to destroythe following bacteria: Staphylococcusalbicans,Staphylococcus aureus,and Escherichia Coli; and virus:A/PR8/34 H1N1 virus entrained on thefilter of the subject device under thefollowing exposure conditions:Average Maximum logreduction / entrainment time (minutes) atFan Speed 4. Room Temperature test:Log 4(99.99%) / 60 minutes.Average Maximum log | SimilarThe Indicationsfor use of thedevices areidentical. Thedevices havedifferentperformancemetrics for thechosenmicroorganisms. |
| Aspergillus Niger | reduction / entrainment time (minutes) at | ||
| Log 4 (99.99%)/ 120 minutes at low fanspeed; | Fan Speed 1. Room Temperature test:Log 4(99.99%) / 120 minutes. | ||
| Influenza A virus, H1N1Log 4 (99.99%)/ 60 minutes at high fanspeed | |||
| Influenza A virus, H3N2Log 4 (99.99%)/ 120 minutes at low fanspeed | |||
| User | Healthcare ProfessionalLay User | Healthcare ProfessionalLay User | Identical |
| Environment for Use | Hospitals, medicalfacilities, medical clinics,nursing facilities, anddental facilities. | Hospitals, medicalfacilities, medical clinics,nursing facilities, anddental facilities. | Identical |
| Placement | AirKEE T900 can be placed anywhere in aroom for general air treatment.AirKEE T900 is designed for roomsup to 3000 ft3. | Aura Storm is designed for rooms up to2773 square feet. | Similar |
| User Control | Touch panel with selection of operatingmode(Manual, Silent), 3 fan speeds, UVlamp on/off, medical lighting on/off,. | Touch panel with 4 manual fan settings,automode, UV Lamp on/off, Anionon/off, lock andtimer. | Similar |
| Software | Basic Firmware; used to turn the unit on,off, change fan speed, and otheradministrative functions (timer, UV) | Basic Firmware, used toturn the unit on, off, and change fanspeed. | Similar |
| Mechanism of Action | UV light of sufficient energy (UV-C)activates a TiO2 lined photocatalyst thatdestroys microorganisms entrained on the | UV light of sufficient energy (UV-C)activates a TiO2 lined photocatalyst thatdestroys microorganisms entrained on the | Identical |
| filter through a photochemical reaction,plus the addition of a pre-filter, activatedcarbon and patented nano-material filter,and HEPA filter. | filter through a photochemical reaction,plus the addition of a pre-filter andHEPA filter. | ||
| -Installation | Free standing | Free standing | Identical |
| Filter | Primary FilterG4 filter to trap larger particles HEPA Filter Double cylindrical design HEPA (H14) filter eliminates 99.99% of particles 0.1 microns in diameter Activated Carbon and Patented Nanomaterial Filter | Pre-Filter Synthetic screen mesh type added prior to HEPA Designed to trap larger particles and keep them out of the HEPA Dimensions:14 in x 15 in x 0.125 in HEPA Filter MERV 13 Dimensions:14 in x 15 in x 0.6875 in Catalytic Filter Patent Pending Hybrid Oxydizer with proprietary Dualaction Catalyst Carbon/Cold Catalyst Oxidier Filter Dimensions:14' x 15" x 0.625" | Similar |
| Photocatalyst | Titanium Dioxide | Proprietary Catalyst | Similar |
| Light Source | UV Type: UV-C UV Light Source: LED Wavelength: 254.7nm Total of 36 6W ultraviolet tubes with single light intensity of 92μW/cm2 Total light intensity: 552μW/cm2 | UV-C Light Source: LED Wavelength: 253.7nm Total of 2 UV- C tube lamps (1 per side) Total UV Power: 8.0 W | Identical |
| Air Source | Centrifugal Fan | Centrifugal Fan | Identical |
| Flow Control | Three speeds (low, medium, high) | 4 speeds (low, medium, high, boost) andauto mode provide up to 370 CFM | Similar |
| Device Air Changes PerHour (ACH) | 13 ACH on high fan speed in a 3000 ft3room | 5.5 ACH on high fan speed (speed 4), ina 4000 ft3 room | Similar |
| Fan ExposureSafety Features | Non-removable grill at air output toprevent the user from accessing spinningfan without tools. Safety feature confirmedby UL 507. | Non-removable grill at air output and theswitch safety feature at the inlet preventthe user from accessing spinning fanwithout tools. Safety feature confirmedby ETL tested to UL 507. | Similar |
| UV Light ExposureSafety Features | Touchscreen monitor allows user to switchoff the UV lights prior to opening filterdoors. Besides, UV lights are also locatedat the inner side of the machine whichprevents direct UV exposure. | There are two sets of Safety switches onthe Aura Storm. The first is on both outerdoors where the magnetic switch willdisengage and the unit will not turn on.A secondary switch in the Aura Stormfilter and if the filter is either improperlyinstalled orthe filter is missing, the unit will notoperate. The unit will not operate with ageneric filter and an Invictus filter mustbe used for the system to work. Theseswitches have been designed to protectthe user from any possibility of exposureto direct contact with UV light. Safetyfeature confirmed by ETL to UL 507safety standard. | Similar |
| Input Voltage | 110V ±10% | 120 V | Identical |
| Current | 3.6 Amps | 0.55 Amps | Similar |
| Power Consumption | 783W ±5W | Up to 65 W | Similar |
| Dimensions | Unit dimension:16.8"W x 26.4"L x 80.7"HHEPA Filter (cylindrincal):9.8" diameter x 10.0"HPrimary Filter:23.0"x 6.6" x 1.2" | Outer frame dimensions:23in(H) x 18.2in(W) x 10.6in(L)Filter dimensions:Pre-Filter:14 in x 15 in x 0.125 inHEPA Filter: | Similar |
| Activated Carbon / Nanomaterial Filter:23.4" x 10.7" x 1.1" | 14 in x 15 in x 0.6875 inCatalytic Filter:14 in x 15 in x 0.1875 inCarbon/Cold CatalystOxidizer Filter:14 in x 15in x 0.625 in | ||
| Conformance withStandards | UL 507 Standard forElectrical FansIEC 60601-1 Basic Safetyand Essential PerformanceIEC 60601-1-2 EMC. EMC forMedical DevicesIEST-RP-CC001.6 HEPA andULPA Filters | UL 507 Standard forElectrical FansIEC 60601-1-2 EMCEMC for MedicalDevices | Similar |
| Device Performancemicroorganism | AirKEE T900 has been demonstrated toeliminate the following testmicroorganisms entrained on the filter ofthe subject device under the followingexposure conditions:Staphylococcus albusLog 4 (99.99%)/ 60 minutes at high fanspeed/ 120 minutes at low fan speed;Escherichia coliLog 4 (99.99%)/ 60 minutes at high fanspeed/ 120 minutes at low fan speed;Penicillium rocquefortiLog 4 (99.99%)/ 60 minutes at fan highspeed; | The Aura Storm air purifier has beendemonstrated to destroythe following bacteria: Staphylococcusalbicans,Staphylococcus aureus,and Escherichia Coli; and virus:A/PR8/34 H1N1 virus entrained on thefilter of the subject device under thefollowing exposure conditions:Average Maximum logreduction / entrainment time (minutes) atFan Speed 4. Room Temperature test:Log 4(99.99%) / 60 minutes.Average Maximum log | Similar |
| Aspergillus NigerLog 4 (99.99%)/ 120 minutes at low fan speed;Influenza A virus, H1N1Log 4 (99.99%)/ 60 minutes at high fan speedInfluenza A virus, H3N2Log 4 (99.99%)/ 120 minutes at low fan speed | reduction / entrainment time (minutes) atFan Speed 1. Room Temperature test:Log 4(99.99%) / 120 minutes. | ||
| Device PerformanceElectrical and EMC | UL 507 Standard forElectrical FansIEC 60601-1-2 EMC. EMC forMedical DevicesIEST-RP-CC001.6 HEPA andULPA Filters | UL 507 Standard forElectrical FansIEC 60601-1-2 EMC.EMC for Medical Devices.ISO 29463 H13 ISO 35HFiltration testing | Similar |
| Device PerformanceOzone release level | UL 867 - Electrostatic Air Cleaners | Unknown, not mentioned | DifferentAirKEE T900 hasdone additionalozone testing todemonstrate theAirKEE T900unit is able tooperate at lessthan 0.05 ppm atits highest fanspeed |
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Summary of Non-Clinical Tests
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| Test Name | Applicable Standards | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| Microorganism Performance | Internal Standards | To understand the log reduction rate for Staphylococcus albus, Escherichia coli, Penicillium roqueforti, Aspergillus Niger, and Influenza A virus | 4 Log reduction (99.99%) | 4 Log reduction in 60 minutes at high fan speed; and 4 Log reduction in 120 minutes at low fan speed |
| Fractional Efficiency | IEST-RP-CC001.6-HEPA and ULPA Filters | Fractional efficiency testing was performed on the AirKEE filter per IEST-RP-CC001.6 Type H test to determine the fractional efficiency percentage of varying size ranges. | Per Standard particles | Filter fractional efficiency percentage of 99.99% at 0.1-0.2µm |
| Electrical safety and electromagnetic compatibility testing | UL 507 Standard for Electrical FansIEC 60601-1-2 EMC.EMC for Medical Devices | General requirements for basic safety and essential performance including UV light leakage and intensity | Per Standard | Pass |
| Ozone | UL 867 - Electrostatic Air Cleaners | Ozone testing was performed per UL 867 by monitoring the ozone concentration in a test chamber at the highest fan speed. | Per Standard | Testing demonstrates the AirKEE T900 unit is able to operate at less than 0.05 ppm at its highest fan speed. |
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Conclusion
The conclusions drawn from the non-clinical testing demonstrate that the subject device, AirKEE T900 is as safe, as effective, and performs as well as or better than the legally marketed predicate, K212644 Class II (21 CFR 880.6500), product code FRA.
§ 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).