(239 days)
Not Found
No
The description focuses on physical filtration and UV sterilization, with no mention of AI/ML components or functions.
Yes
The device is described as "a medical ultraviolet air purifier intended for medical purposes to capture and destroy bacteria, mold, and viruses in the air." By actively destroying pathogens, it functions to treat a condition (the presence of harmful microorganisms in the air) and improve health or mitigate disease risk, which aligns with the definition of a therapeutic device.
No
The device is an air purifier intended to capture and destroy bacteria, mold, and viruses in the air; it does not diagnose medical conditions.
No
The device description clearly outlines physical components such as filters, UV lamps, a motor/impeller, and a touchscreen control panel, indicating it is a hardware device with integrated software for control.
Based on the provided information, the AirKEE P900 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 P900 Function: The AirKEE P900 is an air purifier. Its intended use is to clean the air in a room by capturing and destroying microorganisms. It does not analyze or interact with specimens from the human body.
- Intended Use/Indications for Use: The description clearly states its purpose is to "capture and destroy bacteria, mold, and viruses in the air." This is an environmental control function, not a diagnostic one.
- Device Description: The components and operation described relate to air filtration and UV sterilization, not laboratory analysis of biological samples.
- Performance Studies: The performance studies focus on the device's ability to reduce microorganisms in the air and its physical characteristics (filtration efficiency, electrical safety, ozone production). These are relevant to an air purifier, not an IVD.
In summary, the AirKEE P900 is a medical device used for environmental control (air purification) in healthcare settings, not for performing diagnostic tests on biological samples.
N/A
Intended Use / 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 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 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 |
| Bacteria Klebsiella pneumoniae | Log 4 (99.99%)/60 minutes @ high fan speed Log 4 (99.99%)/120 minutes @ low fan speed |
| Bacteria Pseudomonas aeruginosa | Log 4 (99.99%)/60 minutes @ high fan speed Log 4 (99.99%)/120 minutes @ low fan speed |
| Bacteria Serratia marcescens | Log 4 (99.99%)/60 minutes @ high fan speed Log 4 (99.99%)/120 minutes @ low fan speed |
| Mold Aspergillus Niger | Log 4 (99.99%)/60 minutes @ high fan speed Log 4 (99.99%)/120 minutes @ low fan speed |
| Virus Influenza A virus, H1N1 | Log 4 (99.99%)/60 minutes @ high fan speed Log 4 (99.99%)/120 minutes @ low fan speed |
| Virus Influenza A virus, H3N3 | Log 4 (99.99%)/60 minutes @ high fan speed Log 4 (99.99%)/120 minutes @ low fan speed |
Product codes (comma separated list FDA assigned to the subject device)
FRA
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.
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 Summary:
| Test Name | Applicable Standards | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| Microorganism Performance | Internal Standards | To understand the log reduction rate for Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Serratia marcescens, 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 P900 unit is able to operate at less than 0.05 ppm at its highest fan speed. |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Microorganism performance: 4 Log reduction (99.99%) for listed bacteria, mold, and viruses under specified conditions.
Fractional efficiency: 99.99% at 0.1-0.2µm particles.
Ozone release level: Able to operate at 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 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"
1
(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
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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/Entrainment
Time (min) (in a 20m3 chamber) |
|----------------------------------|------------------------------------------------------------------------------------------|
| Bacteria Staphylococcus aureus | 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 |
| Bacteria Klebsiella pneumoniae | Log 4 (99.99%)/60 minutes @ high fan speed
Log 4 (99.99%)/120 minutes @ low fan speed |
| Bacteria Pseudomonas aeruginosa | Log 4 (99.99%)/60 minutes @ high fan speed
Log 4 (99.99%)/120 minutes @ low fan speed |
| Bacteria Serratia marcescens | Log 4 (99.99%)/60 minutes @ high fan speed
Log 4 (99.99%)/120 minutes @ low fan speed |
| Mold
Aspergillus Niger | Log 4 (99.99%)/60 minutes @ high fan speed
Log 4 (99.99%)/120 minutes @ low fan speed |
| Virus
Influenza A virus, H1N1 | Log 4 (99.99%)/60 minutes @ high fan speed
Log 4 (99.99%)/120 minutes @ low fan speed |
| Virus
Influenza A virus, H3N3 | Log 4 (99.99%)/60 minutes @ high fan speed
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)
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4
510(k) Summary
K232933 - 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 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 |
5
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 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 | |
| Bacteria Klebsiella pneumoniae | Log 4 (99.99%)/60 minutes @ high fan speed |
| Log 4 (99.99%)/120 minutes @ low fan speed | |
| Bacteria Pseudomonas aeruginosa | Log 4 (99.99%)/60 minutes @ high fan speed |
| Log 4 (99.99%)/120 minutes @ low fan speed | |
| Bacteria Serratia marcescens | Log 4 (99.99%)/60 minutes @ high fan speed |
| Log 4 (99.99%)/120 minutes @ low fan speed | |
| Mold Aspergillus Niger | Log 4 (99.99%)/60 minutes @ high fan speed |
6
| 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 |
7
| Item | AirKEE P900
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 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:
Staphylococcus aureus
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;
Klebsiella pneumoniae
Log 4 (99.99%)/ 60 minutes at high fan
speed / 120 minutes at low fan 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. | Similar
The Indications for
use of the devices
are identical. The
devices have
different
performance metrics
for the chosen
microorganisms. |
| | Log 4 (99.99%)/ 60 minutes at high fan
speed / 120 minutes at low fan speed;
Serratia marcescens
Log 4 (99.99%)/60 minutes at high fan
speed / 120 minutes at low fan speed;
Aspergillus Niger
Log 4 (99.99%)/ 60 minutes at high fan
speed / 120 minutes at low fan speed;
Influenza A virus, H1N1
Log 4 (99.99%)/ 60 minutes at high fan
speed
Influenza A virus, H3N3
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. | |
| 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 P900 can be placed anywhere in a
room for general air treatment.
AirKEE P900 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 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 Filter
G4 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 with
single light intensity of 92µW/cm²
• Total light intensity: 552µW/cm² | • Total of 2 UV- C tube lamps (1 per
side)
• 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) 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"
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 in
HEPA Filter:
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 | Similar |
| 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 P900 has been demonstrated to
eliminate the following test microorganisms
entrained on the filter of the subject device
under the following exposure conditions:
Staphylococcus aureus
Log 4 (99.99%)/ 60 minutes at high fan
speed / 120 minutes at low fan 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 | Similar |
| | | | |
| | Escherichia coli
Log 4 (99.99%)/60 minutes at high fan
speed / 120 minutes at low fan speed;
Klebsiella pneumoniae
Log 4 (99.99%)/ 60 minutes at high fan
speed / 120 minutes at low fan speed;
Pseudomonas aeruginosa
Log 4 (99.99%)/ 60 minutes at high fan
speed / 120 minutes at low fan speed;
Serratia marcescens
Log 4 (99.99%)/60 minutes at high fan
speed / 120 minutes at low fan speed;
Aspergillus Niger
Log 4 (99.99%)/ 60 minutes at high fan
speed / 120 minutes at low fan speed;
Influenza A virus, H1N1
Log 4 (99.99%)/ 60 minutes at high fan
speed
Influenza A virus, H3N3
Log 4 (99.99%)/ 120 minutes at low fan
speed | 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
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 P900 has
done additional |
| | | | ozone testing to
demonstrate the
AirKEE P900 unit is
able to operate at
less than 0.05 ppm a
its highest fan speed. |
Comparison of Technological Characteristics with Predicate Device:
8
9
10
11
12
13
Summary of Non-Clinical Tests
| Test Name | Applicable Standards | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| Microorganism | ||||
| Performance | Internal Standards | To understand the log reduction | ||
| rate for Staphylococcus aureus, | ||||
| Escherichia coli, Klebsiella | ||||
| pneumoniae, Pseudomonas | ||||
| aeruginosa, Serratia marcescens, | ||||
| 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 | Per Standard | Testing demonstrates the | ||
| AirKEE P900 unit is able to |
14
| chamber at the highest fan | operate at less than 0.05 ppm | |
|---|---|---|
| speed. | at its highest fan speed. |
15
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.