(239 days)
AirKEE P900 is a medical ultraviolet air purifier intended for medical purposes to capture and destroy bacteria, mold, and viruses in the air through the multi-stage air filtration system and exposure to ultraviolet radiation.
AirKEE P900 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) (in a 20m3 chamber) |
|---|---|
| Bacteria Staphylococcus aureus | 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 |
| Bacteria Klebsiella pneumoniae | Log 4 (99.99%)/60 minutes @ high fan speedLog 4 (99.99%)/120 minutes @ low fan speed |
| Bacteria Pseudomonas aeruginosa | Log 4 (99.99%)/60 minutes @ high fan speedLog 4 (99.99%)/120 minutes @ low fan speed |
| Bacteria Serratia marcescens | Log 4 (99.99%)/60 minutes @ high fan speedLog 4 (99.99%)/120 minutes @ low fan speed |
| MoldAspergillus Niger | Log 4 (99.99%)/60 minutes @ high fan speedLog 4 (99.99%)/120 minutes @ low fan speed |
| VirusInfluenza A virus, H1N1 | Log 4 (99.99%)/60 minutes @ high fan speedLog 4 (99.99%)/120 minutes @ low fan speed |
| VirusInfluenza A virus, H3N3 | Log 4 (99.99%)/60 minutes @ high fan speedLog 4 (99.99%)/120 minutes @ low fan speed |
AirKEE P900 is a mobile multi-function 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 P900 is controlled via a touchscreen control panel on the machine.
AirKEE P900's main components consist of:
Multi-stage air treatment
- a filtration system with primary filter, HEPA filter, activated carbon filter, and nano- O material filter
- UV lamps that generate UV-C irradiation to inactivate and eliminate microorganisms o
- a motor/impeller to move air through the filtration system o
System control
- o a touch panel interface to indicate the working status of the device and consumables
AirKEE P900's multi-stage air treatment: Air enters through the bottommost chamber and fans direct the air in an upwards manner. Firstly, air passes through primary G4 filter, where large particulate matter will be removed. G4 filtered air then passes through patented nano-material filter for further removal. Microorganisms will be inactivated by UV, and photocatalysts. Air then passes through activated carbon filter. Lastly, HEPA H13 filter eliminates 99.99% of the remaining particles (0.1 microns in diameter). The treated air then exits through the top in an upwards manner.
The control panel allows reading, troubleshooting functions, and settings of various function. Its enhanced user interface with touchscreen function allows easier navigation of the system.
The AirKEE P900 is a medical ultraviolet air purifier that was tested to demonstrate its effectiveness in capturing and destroying bacteria, mold, and viruses in the air.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Microorganism Performance | 4 Log reduction (99.99%) | 4 Log reduction (99.99%) in 60 minutes at high fan speed; and 4 Log reduction (99.99%) in 120 minutes at low fan speed for Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Serratia marcescens, Aspergillus Niger, Influenza A virus, H1N1, and Influenza A virus, H3N3. |
| Fractional Efficiency | Per Standard (IEST-RP-CC001.6 - HEPA and ULPA Filters) | Filter fractional efficiency percentage of 99.99% at 0.1-0.2µm. |
| Electrical Safety and EMC | Per Standard (UL 507, IEC 60601-1-2) | Pass |
| Ozone | Per Standard (UL 867) | Operates at less than 0.05 ppm at its highest fan speed. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample size for each microorganism performance test (e.g., how many runs were performed for each microorganism). However, it does specify that the tests were conducted "in a 20m³ chamber" and "entrained on the filter of the subject device."
The data provenance is not explicitly mentioned as a country of origin. The submitter is "HealKee Medical Pte Ltd" from Singapore, suggesting the testing might have been conducted in Singapore or a location associated with the company's operations. The data appears to be prospective, as it describes tests conducted specifically for the AirKEE P900 device to demonstrate its performance against predefined criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The performance evaluation for microorganism reduction and other non-clinical tests likely relied on established laboratory protocols and standards, rather than expert consensus on individual "cases" in the typical sense of diagnostic imaging. For a medical UV air purifier, the "ground truth" would be the measurable reduction of microorganisms.
4. Adjudication Method for the Test Set:
This information is not applicable in the context of this device and testing. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving reader interpretations (e.g., radiologists reviewing images) to establish a consensus ground truth. For a device like an air purifier, performance is measured quantitatively through laboratory tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not done. This type of study assesses the performance of human readers, with and without AI assistance, which is not relevant for an air purifier.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
For the microorganism performance, the study can be considered a standalone performance study of the device (AirKEE P900) operating independently. The device's ability to destroy microorganisms is measured directly in a controlled environment without human intervention during the process itself (though humans operate and set up the device and tests).
7. Type of Ground Truth Used:
The ground truth used for the microorganism performance is quantitative laboratory measurement (direct bacterial/viral/mold count reduction). This involves culturing and counting microorganisms before and after exposure to the device in a controlled chamber, and computing the log reduction.
For fractional efficiency, electrical safety, EMC, and ozone, the ground truth is established by conformance to recognized standards (IEST-RP-CC001.6, UL 507, IEC 60601-1-2, UL 867).
8. Sample Size for the Training Set:
This information is not applicable. The AirKEE P900 is an electromechanical device with filtration and UV-C technology, not an AI/ML-driven diagnostic or analytical tool that requires a "training set" of data in the typical sense for algorithm development. Its performance is based on its physical design and operation, which are then tested for efficacy.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no "training set" for this type of device. The device's design principles and expected performance are based on established scientific principles of filtration, UV-C radiation, and photocatalysis. The validation occurred 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 and 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 16, 2024
HealKEE Medical Pte Ltd % Shanshan Liu Charles & International LLC 45 Ashford St Allston, Massachusetts 02134
Re: K232933
Trade/Device Name: AirKEE P900 Regulation Number: 21 CFR 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: Class II Product Code: FRA Dated: April 20, 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"
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(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).
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 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, Stephen A. Digitally signed by Stephen A. Anisko -S Date: 2024.05.16 Anisko -S 15:31:19 -04'00'
for: Christopher Dugard Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
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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) K232933
Device Name AirKEE P900
Indications for Use (Describe)
AirKEE P900 is a medical ultraviolet air purifier intended for medical purposes to capture and destroy bacteria, mold, and viruses in the air through the multi-stage air filtration system and exposure to ultraviolet radiation.
AirKEE P900 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/EntrainmentTime (min) (in a 20m3 chamber) |
|---|---|
| Bacteria Staphylococcus aureus | 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 |
| Bacteria Klebsiella pneumoniae | Log 4 (99.99%)/60 minutes @ high fan speedLog 4 (99.99%)/120 minutes @ low fan speed |
| Bacteria Pseudomonas aeruginosa | Log 4 (99.99%)/60 minutes @ high fan speedLog 4 (99.99%)/120 minutes @ low fan speed |
| Bacteria Serratia marcescens | Log 4 (99.99%)/60 minutes @ high fan speedLog 4 (99.99%)/120 minutes @ low fan speed |
| MoldAspergillus Niger | Log 4 (99.99%)/60 minutes @ high fan speedLog 4 (99.99%)/120 minutes @ low fan speed |
| VirusInfluenza A virus, H1N1 | Log 4 (99.99%)/60 minutes @ high fan speedLog 4 (99.99%)/120 minutes @ low fan speed |
| VirusInfluenza A virus, H3N3 | Log 4 (99.99%)/60 minutes @ high fan speedLog 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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510(k) Summary
K232933 - 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 1st, 2024 |
| Trade Name: | AirKEE P900 |
| 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 P900 is a mobile multi-function 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 P900 is controlled via a touchscreen control panel on the machine.
AirKEE P900's main components consist of:
Multi-stage air treatment
- a filtration system with primary filter, HEPA filter, activated carbon filter, and nano- O material filter
- UV lamps that generate UV-C irradiation to inactivate and eliminate microorganisms o
- a motor/impeller to move air through the filtration system o
System control
- o a touch panel interface to indicate the working status of the device and consumables
AirKEE P900's multi-stage air treatment: Air enters through the bottommost chamber and fans direct the air in an upwards manner. Firstly, air passes through primary G4 filter, where large particulate matter will be removed. G4 filtered air then passes through patented nano-material filter for further removal. Microorganisms will be inactivated by UV, and photocatalysts. Air then passes through activated carbon filter. Lastly, HEPA H13 filter eliminates 99.99% of the remaining particles (0.1 microns in diameter). The treated air then exits through the top in an upwards manner.
The control 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 P900 is a medical ultraviolet air purifier intended for medical purposes to capture and destroy bacteria, mold, and viruses in the air through the multi-stage air filtration system and exposure to ultraviolet radiation.
AirKEE P900 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) (in a 20m³ chamber) |
|---|---|
| Bacteria Staphylococcus aureus | 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 |
| Bacteria Klebsiella pneumoniae | Log 4 (99.99%)/60 minutes @ high fan speedLog 4 (99.99%)/120 minutes @ low fan speed |
| Bacteria Pseudomonas aeruginosa | Log 4 (99.99%)/60 minutes @ high fan speedLog 4 (99.99%)/120 minutes @ low fan speed |
| Bacteria Serratia marcescens | Log 4 (99.99%)/60 minutes @ high fan speedLog 4 (99.99%)/120 minutes @ low fan speed |
| Mold Aspergillus Niger | Log 4 (99.99%)/60 minutes @ high fan speed |
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| 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, H3N3 | Log 4 (99.99%)/120 minutes @ low fan speed |
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| Item | AirKEE P900Subject 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 P900 is a medical ultraviolet airpurifier intended for medical purposes tocapture and destroy bacteria, mold, andviruses in the air through the multi-stage airfiltration system and exposure to ultravioletradiation.AirKEE P900 has been demonstrated toeliminate the following test microorganismsentrained on the filter of the subject deviceunder the following exposure conditions:Staphylococcus aureusLog 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;Klebsiella pneumoniaeLog 4 (99.99%)/ 60 minutes at high fanspeed / 120 minutes at low fan speed; | 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/PR8/34H1N1 virus entrained on the filter of thesubject device under the followingexposure conditions:Average Maximum logreduction / entrainment time (minutes) atFan Speed 4. Room Temperature test: Log4(99.99%) / 60 minutes. | SimilarThe Indications foruse of the devicesare identical. Thedevices havedifferentperformance metricsfor the chosenmicroorganisms. |
| Log 4 (99.99%)/ 60 minutes at high fanspeed / 120 minutes at low fan speed;Serratia marcescensLog 4 (99.99%)/60 minutes at high fanspeed / 120 minutes at low fan speed;Aspergillus NigerLog 4 (99.99%)/ 60 minutes at high fanspeed / 120 minutes at low fan speed;Influenza A virus, H1N1Log 4 (99.99%)/ 60 minutes at high fanspeedInfluenza A virus, H3N3Log 4 (99.99%)/ 120 minutes at low fanspeed | reduction / entrainment time (minutes) atFan Speed 1. Room Temperature test: Log4(99.99%) / 120 minutes. | ||
| 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 P900 can be placed anywhere in aroom for general air treatment.AirKEE P900 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 other administrative functions (timer, UV) | Basic Firmware, used to turn the unit on, off, and change fan speed. | Similar |
| Mechanism of Action | UV light of sufficient energy (UV-C) activates a TiO2 lined photocatalyst that destroys microorganisms entrained on the filter through a photochemical reaction, plus the addition of a pre-filter, activated carbon and patented nano-material filter, and HEPA filter. | UV light of sufficient energy (UV-C) activates a TiO2 lined photocatalyst that destroys microorganisms entrained on the filter through a photochemical reaction, plus the addition of a pre-filter and HEPA filter. | Identical |
| -Installation | Free standing | Free standing | Identical |
| Filter | Primary FilterG4 filter to trap larger particles HEPA Filter HEPA (H13) 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 | UV-C Light Source: LED Wavelength: 253.7nm | Identical |
| • Wavelength: 254.7nm• Total of 36 6W ultraviolet tubes withsingle light intensity of 92µW/cm²• Total light intensity: 552µW/cm² | • Total of 2 UV- C tube lamps (1 perside)• Total UV Power: 8.0 W | ||
| 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), in a4000 ft3 room | Similar |
| Fan ExposureSafety Features | Non-removable grill at air output to preventthe user from accessing spinning fanwithout tools. Safety feature confirmed byUL 507. | Non-removable grill at air output and theswitch safety feature at the inlet preventthe user from accessing spinning fanwithout tools. Safety feature confirmed byETL 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 located atthe 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 must beused 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"Activated Carbon / Nanomaterial Filter:23.4" x 10.7" x 1.1" | 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: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 | Similar |
| 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 P900 has been demonstrated toeliminate the following test microorganismsentrained on the filter of the subject deviceunder the following exposure conditions:Staphylococcus aureusLog 4 (99.99%)/ 60 minutes at high fanspeed / 120 minutes at low fan speed; | The Aura Storm air purifier has beendemonstrated to destroythe following bacteria: Staphylococcusalbicans.Staphylococcus aureus,and Escherichia Coli; and virus: A/PR8/34H1N1 virus entrained on the filter of the | Similar |
| Escherichia coliLog 4 (99.99%)/60 minutes at high fanspeed / 120 minutes at low fan speed;Klebsiella pneumoniaeLog 4 (99.99%)/ 60 minutes at high fanspeed / 120 minutes at low fan speed;Pseudomonas aeruginosaLog 4 (99.99%)/ 60 minutes at high fanspeed / 120 minutes at low fan speed;Serratia marcescensLog 4 (99.99%)/60 minutes at high fanspeed / 120 minutes at low fan speed;Aspergillus NigerLog 4 (99.99%)/ 60 minutes at high fanspeed / 120 minutes at low fan speed;Influenza A virus, H1N1Log 4 (99.99%)/ 60 minutes at high fanspeedInfluenza A virus, H3N3Log 4 (99.99%)/ 120 minutes at low fanspeed | subject device under the followingexposure conditions:Average Maximum logreduction / entrainment time (minutes) atFan Speed 4. Room Temperature test: Log 4(99.99%) / 60 minutes.Average Maximum logreduction / 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 P900 hasdone additional |
| ozone testing todemonstrate theAirKEE P900 unit isable to operate atless than 0.05 ppm aits highest fan speed. |
Comparison of Technological Characteristics with Predicate Device:
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Summary of Non-Clinical Tests
| Test Name | Applicable Standards | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| MicroorganismPerformance | Internal Standards | To understand the log reductionrate for Staphylococcus aureus,Escherichia coli, Klebsiellapneumoniae, Pseudomonasaeruginosa, Serratia marcescens,Aspergillus Niger, andInfluenza A virus. | 4 Log reduction (99.99%) | 4 Log reduction in 60minutes at high fan speed;and 4 Log reduction in 120minutes at low fan speed. |
| FractionalEfficiency | IEST-RP-CC001.6-HEPA and ULPAFilters | Fractional efficiency testing wasperformed on the AirKEE filterper IEST-RP-CC001.6 Type Htest to determine the fractionalefficiency percentage of varyingsize ranges. | Per Standard particles | Filter fractional efficiencypercentage of 99.99% at 0.1-0.2µm. |
| Electrical safetyandelectromagneticcompatibilitytesting | UL 507 Standard forElectrical FansIEC 60601-1-2 EMC.EMC for MedicalDevices | General requirements for basicsafety and essentialperformance including UV lightleakage and intensity | Per Standard | Pass |
| Ozone | UL 867 - ElectrostaticAir Cleaners | Ozone testing was performedper UL 867 by monitoring theozone concentration in a test | Per Standard | Testing demonstrates theAirKEE P900 unit is able to |
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| chamber at the highest fan | operate at less than 0.05 ppm | |
|---|---|---|
| speed. | at its highest fan speed. |
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Conclusion
The conclusions drawn from the non-clinical testing demonstrate that the subject device, AirKEE P900 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).