(267 days)
Not Found
No
The description focuses on the physical filtration and UV sterilization process, controlled by a standard electronic system and touchscreen interface. There is no mention of adaptive learning, data analysis for optimization, or any other characteristic typically associated with AI/ML.
No
The device is an air purifier that captures and destroys microorganisms in the air, but it does not directly treat a disease or medical condition in a patient, which is the definition of a therapeutic device.
No
The AirKEE T900 is an air purifier designed to destroy microorganisms in the air. It does not perform any diagnostic function.
No
The device description clearly outlines multiple hardware components including filters, UV lamps, a motor/impeller, and an electronic control system. It is a physical air purifier with software controlling its functions, not a software-only device.
Based on the provided information, the AirKEE T900 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- AirKEE T900 Function: The AirKEE T900 is an air purifier. Its function is to clean the air in a room by filtering and using UV radiation to destroy microorganisms. It does not analyze any biological specimens from a patient.
- Intended Use: The intended use clearly states it's for "medical purposes to capture and destroy bacterial, mold, and viruses in the air". This is an environmental control function, not a diagnostic one.
- Device Description: The description focuses on the air filtration and UV sterilization components, not on any analytical or diagnostic capabilities.
- Performance Studies: The performance studies measure the device's ability to reduce microorganisms in the air and its filtration efficiency, not its ability to diagnose or analyze biological samples.
Therefore, the AirKEE T900 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
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: Bacteria, Staphylococcus albus, Avg. max Log Reduction/Entrainment Time (min) Room Temperature Test: Log 4 (99.99%)/60 minutes @ high fan speed; Log 4 (99.99%)/120 minutes @ low fan speed
Test Item: Bacteria, Escherichia coli, Avg. max Log Reduction/Entrainment Time (min) Room Temperature Test: Log 4 (99.99%)/60 minutes @ high fan speed; Log 4 (99.99%)/120 minutes @ low fan speed
Test Item: Mold, Penicillium rocqueforti, Avg. max Log Reduction/Entrainment Time (min) Room Temperature Test: Log 4 (99.99%)/60 minutes @ high fan speed
Test Item: Mold, Aspergillus Niger, Avg. max Log Reduction/Entrainment Time (min) Room Temperature Test: Log 4 (99.99%)/120 minutes @ low fan speed
Test Item: Virus, Influenza A virus, H1N1, Avg. max Log Reduction/Entrainment Time (min) Room Temperature Test: Log 4 (99.99%)/60 minutes @ high fan speed
Test Item: Virus, Influenza A virus, H3N2, Avg. max Log Reduction/Entrainment Time (min) Room Temperature Test: Log 4 (99.99%)/120 minutes @ low fan speed
Type of Use: X Over-The-Counter Use (21 CFR 801 Subpart C)
Product codes (comma separated list FDA assigned to the subject device)
FRA
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.
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
Healthcare Professional
Lay User
Hospitals, medical facilities, medical clinics, nursing facilities, and dental facilities.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests:
-
Microorganism Performance
- Study type: Internal Standards
- Purpose: To understand the log reduction rate for Staphylococcus albus, Escherichia coli, Penicillium roqueforti, Aspergillus Niger, and Influenza A virus
- Acceptance Criteria: 4 Log reduction (99.99%)
- Results: 4 Log reduction in 60 minutes at high fan speed; and 4 Log reduction in 120 minutes at low fan speed
-
Fractional Efficiency
- Study type: IEST-RP-CC001.6- HEPA and ULPA Filters
- Purpose: 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.
- Acceptance Criteria: Per Standard particles
- Results: Filter fractional efficiency percentage of 99.99% at 0.1-0.2µm
-
Electrical safety and electromagnetic compatibility testing
- Study type: UL 507 Standard for Electrical Fans; IEC 60601-1-2 EMC. EMC for Medical Devices
- Purpose: General requirements for basic safety and essential performance including UV light leakage and intensity
- Acceptance Criteria: Per Standard
- Results: Pass
-
Ozone
- Study type: UL 867 - Electrostatic Air Cleaners
- Purpose: Ozone testing was performed per UL 867 by monitoring the ozone concentration in a test chamber at the highest fan speed.
- Acceptance Criteria: Per Standard
- Results: Testing demonstrates the AirKEE T900 unit is able to operate at less than 0.05 ppm at its highest fan speed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- 4 Log reduction (99.99%) of Staphylococcus albus, Escherichia coli, Penicillium roqueforti, Aspergillus Niger, Influenza A virus H1N1, and Influenza A virus H3N2.
- Filter fractional efficiency percentage of 99.99% at 0.1-0.2µm for particles.
- Ozone release level: less than 0.05 ppm at its highest fan speed.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
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).
1
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
2
Enclosure
3
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 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 |
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4
K232642 - 510(k) Summary
HealKEE Medical Pte Ltd
This 510(k) Summary is in conformance with 21CFR 807.92
| Submitter: | HealKEE Medical Pte Ltd
11 North Buona Vista Drive, Level 08-09
The Metropolis Tower 2, Singapore 138589 |
|----------------------|----------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Shanshan Liu, Consultant
Charles & International LLC
Email: sliu@charlieintl.com
Phone: 617-893-3456 |
| Company Contact: | William Tao
Title: Founder & CEO
Email: william.tao@healkee.com
Phone: +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 |
5
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 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 |
6
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 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:
Staphylococcus albus
Log 4 (99.99%)/ 60 minutes at high fan
speed/ 120 minutes at low fan speed;
Escherichia coli
Log 4 (99.99%)/ 60 minutes at high fan
speed/ 120 minutes at low fan speed;
Penicillium rocqueforti
Log 4 (99.99%)/ 60 minutes at fan high
speed: | The Aura Storm air purifier is a device
intended for medical
purposes that is used to capture and
destroy bacteria and viruses in the air
through the multi-stage filtration system
and exposure to ultraviolet radiation.
The Aura Storm air purifier has been
demonstrated to destroy
the following bacteria: Staphylococcus
albicans,
Staphylococcus aureus,
and Escherichia Coli; and virus:
A/PR8/34 H1N1 virus entrained on the
filter of the subject device under the
following exposure conditions:
Average Maximum log
reduction / entrainment time (minutes) at
Fan Speed 4. Room Temperature test:
Log 4
(99.99%) / 60 minutes.
Average Maximum log | Similar
The Indications
for use of the
devices are
identical. The
devices have
different
performance
metrics for the
chosen
microorganisms. |
| | Aspergillus Niger | reduction / entrainment time (minutes) at | |
| | Log 4 (99.99%)/ 120 minutes at low fan
speed; | Fan Speed 1. Room Temperature test:
Log 4
(99.99%) / 120 minutes. | |
| | Influenza A virus, H1N1
Log 4 (99.99%)/ 60 minutes at high fan
speed | | |
| | Influenza A virus, H3N2
Log 4 (99.99%)/ 120 minutes at low fan
speed | | |
| User | Healthcare Professional
Lay User | Healthcare Professional
Lay User | Identical |
| Environment for Use | Hospitals, medical
facilities, medical clinics,
nursing facilities, and
dental facilities. | Hospitals, medical
facilities, medical clinics,
nursing facilities, and
dental facilities. | Identical |
| Placement | AirKEE T900 can be placed anywhere in a
room for general air treatment.
AirKEE T900 is designed for rooms
up to 3000 ft3. | Aura Storm is designed for rooms up to
2773 square feet. | Similar |
| User Control | Touch panel with selection of operating
mode(Manual, Silent), 3 fan speeds, UV
lamp on/off, medical lighting on/off,. | Touch panel with 4 manual fan settings,
automode, UV Lamp on/off, Anion
on/off, lock and
timer. | 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 | UV light of sufficient energy (UV-C)
activates a TiO2 lined photocatalyst that
destroys microorganisms entrained on the | Identical |
| | filter through a photochemical reaction,
plus the addition of a pre-filter, activated
carbon and patented nano-material filter,
and HEPA filter. | filter through a photochemical reaction,
plus the addition of a pre-filter and
HEPA filter. | |
| -Installation | Free standing | Free standing | Identical |
| Filter | Primary Filter
G4 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) and
auto mode provide up to 370 CFM | Similar |
| Device Air Changes Per
Hour (ACH) | 13 ACH on high fan speed in a 3000 ft3
room | 5.5 ACH on high fan speed (speed 4), in
a 4000 ft3 room | Similar |
| Fan Exposure
Safety Features | Non-removable grill at air output to
prevent the user from accessing spinning
fan without tools. Safety feature confirmed
by UL 507. | Non-removable grill at air output and the
switch safety feature at the inlet prevent
the user from accessing spinning fan
without tools. Safety feature confirmed
by ETL tested to UL 507. | Similar |
| UV Light Exposure
Safety Features | Touchscreen monitor allows user to switch
off the UV lights prior to opening filter
doors. Besides, UV lights are also located
at the inner side of the machine which
prevents direct UV exposure. | There are two sets of Safety switches on
the Aura Storm. The first is on both outer
doors where the magnetic switch will
disengage and the unit will not turn on.
A secondary switch in the Aura Storm
filter and if the filter is either improperly
installed or
the filter is missing, the unit will not
operate. The unit will not operate with a
generic filter and an Invictus filter must
be used for the system to work. These
switches have been designed to protect
the user from any possibility of exposure
to direct contact with UV light. Safety
feature confirmed by ETL to UL 507
safety 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"H
HEPA Filter (cylindrincal):
9.8" diameter x 10.0"H
Primary 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 in
HEPA Filter: | Similar |
| | | | |
| | Activated Carbon / Nanomaterial Filter:
23.4" x 10.7" x 1.1" | 14 in x 15 in x 0.6875 in
Catalytic Filter:
14 in x 15 in x 0.1875 in
Carbon/Cold Catalyst
Oxidizer Filter:
14 in x 15in x 0.625 in | |
| Conformance with
Standards | UL 507 Standard for
Electrical Fans
IEC 60601-1 Basic Safety
and Essential Performance
IEC 60601-1-2 EMC. EMC for
Medical Devices
IEST-RP-CC001.6 HEPA and
ULPA Filters | UL 507 Standard for
Electrical Fans
IEC 60601-1-2 EMC
EMC for Medical
Devices | Similar |
| Device Performance
microorganism | AirKEE T900 has been demonstrated to
eliminate the following test
microorganisms entrained on the filter of
the subject device under the following
exposure conditions:
Staphylococcus albus
Log 4 (99.99%)/ 60 minutes at high fan
speed/ 120 minutes at low fan speed;
Escherichia coli
Log 4 (99.99%)/ 60 minutes at high fan
speed/ 120 minutes at low fan speed;
Penicillium rocqueforti
Log 4 (99.99%)/ 60 minutes at fan high
speed; | The Aura Storm air purifier has been
demonstrated to destroy
the following bacteria: Staphylococcus
albicans,
Staphylococcus aureus,
and Escherichia Coli; and virus:
A/PR8/34 H1N1 virus entrained on the
filter of the subject device under the
following exposure conditions:
Average Maximum log
reduction / entrainment time (minutes) at
Fan Speed 4. Room Temperature test:
Log 4
(99.99%) / 60 minutes.
Average Maximum log | Similar |
| | Aspergillus Niger
Log 4 (99.99%)/ 120 minutes at low fan speed;
Influenza A virus, H1N1
Log 4 (99.99%)/ 60 minutes at high fan speed
Influenza A virus, H3N2
Log 4 (99.99%)/ 120 minutes at low fan speed | reduction / entrainment time (minutes) at
Fan Speed 1. Room Temperature test:
Log 4
(99.99%) / 120 minutes. | |
| Device Performance
Electrical and EMC | UL 507 Standard for
Electrical Fans
IEC 60601-1-2 EMC. EMC for
Medical Devices
IEST-RP-CC001.6 HEPA and
ULPA Filters | UL 507 Standard for
Electrical Fans
IEC 60601-1-2 EMC.
EMC for Medical Devices.
ISO 29463 H13 ISO 35H
Filtration testing | Similar |
| Device Performance
Ozone release level | UL 867 - Electrostatic Air Cleaners | Unknown, not mentioned | Different
AirKEE T900 has
done additional
ozone testing to
demonstrate the
AirKEE T900
unit is able to
operate at less
than 0.05 ppm at
its highest fan
speed |
7
8
9
10
11
Summary of Non-Clinical Tests
12
| 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 Fans | |||
| IEC 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. |
13
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.