(279 days)
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 HIN1 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 reduction / entrainment time (minutes) at Fan Speed 1. Room Temperature test: Log 4 (99.99%) / 120 minutes.
The Aura Storm is a multi-stage UV-C air purifier that delivers air purification for rooms up to 2700 square feet (*52ft x 52ft). The Storm inactivates and eliminates bacteria and viruses in the Aura Storm may be used for medical purposes which can include hospitals, medical facilities, medical clinics, nursing facilities, and dental facilities. The Aura Storm is a standalone device that is controlled via buttons on the top of the unit.
The Aura Storm is a dual-sided system with each side consisting of four-stage is a prefilter. The second stage is a HEPA H13+ filter. The third stage is a TiO2 cold photo-catalyst filter. Finally, the UV-C sterilization lamp emits a 253.7mm designed to activate the photo-catalyst filter and eliminate bacteria and viruses. The anion generator is used strictly to increase the size of the particulate molecules to increase the ability to capture and eliminate the bacteria and viruses. This designed system delivers a third-party tested 99.99% (4-log) sterilization in 60 minutes at the highest fan speed. The Aura storm was also tested at the lowest fan speed and delivered a 99.99% (4-log) sterilization in 120 minutes. The air flow diagram has been submitted in the 510(k) submission.
There is an internal fan which draws in air from both sides of the unit, filters it through the multi-stage system and outputs the filtered air through the top of the unit features a capacitive touch button control to operate the On/Off, fan speed (4 speeds), Auto mode, UV lamp, Anion generator, Child lock, timer, and filter reset. There is also a particulate matter sensor and color bar to indicate the level of clean air.
The Invictus Aura Storm Air Purifier (K212644) has been tested for its ability to reduce bacteria and inactivate viruses, and for its filtration efficiency.
1. Table of Acceptance Criteria and Reported Device Performance
| Title of the Test | Purpose of the Test | Acceptance Criteria and the Source of References | Reported Device Performance |
|---|---|---|---|
| Bacteria Reduction Test | To understand the log reduction rate for Staphylococcus albicans, Staphylococcus aureus, and Escherichia Coli | 4 Log reduction of the tested bacteria, 3rd party testing at an accredited laboratory | - Staphylococcus albicans: 99.99% elimination rate (4-Log reduction) in 60 minutes at highest fan speed. |
| - Staphylococcus aureus: 99.99% elimination rate (4-Log reduction) in 60 minutes at highest fan speed. | |||
| - Escherichia Coli: 99.99% elimination rate (4-Log reduction) in 60 minutes at highest fan speed. | |||
| - Overall (Bacteria): 4-LOG reduction in 60 minutes at highest fan speed; 4-LOG reduction in 120 minutes at lowest fan speed. | |||
| Virus Inactivation Test | To understand the log reduction rate for the A/PR8/34 H1N1 virus | 4 Log activation of the tested virus, 3rd party testing at an accredited laboratory | - A/PR8/34 H1N1: ≥ 99.99% (4-Log reduction) in 60 minutes at highest fan speed. |
| - Overall (Virus): 4-LOG reduction in 60 minutes at highest fan speed; 4-LOG reduction in 120 minutes at lowest fan speed. | |||
| Filtration Efficiency Testing | To understand the filtration efficiency of the HEPA filter | ISO 29463 H13 ISO 35H ≥ 99.975% filtration for particles ≥ 0.3 microns, 3rd party testing at an accredited laboratory | 99.98% filtration efficiency for particles greater than or equal to 0.3 microns. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective.
- Bacteria Reduction Test: For each of the three bacteria (Staphylococcus albicans, Staphylococcus aureus, and Escherichia Coli), three separate tests were conducted. Each test involved a control group and a test group, indicating a total of 3 samples per bacteria type, or 9 samples for bacteria reduction.
- Virus Inactivation Test: Three separate tests were conducted for the A/PR8/34 H1N1 virus.
- Filtration Efficiency Testing: The sample size for this test is not specified, but it was conducted by a 3rd party accredited laboratory.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The ground truth for these tests (bacterial/viral counts, filtration efficiency) is established through laboratory measurements and standardized protocols, not by expert consensus or interpretation of images.
4. Adjudication Method
Not applicable for these types of laboratory tests. The results are quantitative measurements obtained through direct testing, rather than subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. The device is an air purifier, and its performance is measured through direct laboratory tests for microbial reduction and filtration efficiency, not through human reader interpretation or clinical assessment that would require an MRMC study.
6. Standalone Performance
Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The reported performance metrics (log reduction, elimination rates, filtration efficiency) are direct measurements of the device's capability without human intervention in its operation or performance assessment.
7. Type of Ground Truth Used
The ground truth used is based on controlled laboratory measurements of:
- Bacterial colony-forming units (CFU/m3) for bacteria reduction tests.
- Viral activation/reduction measurements for virus inactivation tests.
- Particle counts for filtration efficiency tests.
These measurements are considered objective and quantitative.
8. Sample Size for the Training Set
Not applicable. The Invictus Aura Storm Air Purifier is a physical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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May 26, 2022
Invictus Lighting Neeraj Lal Vice President of Engineering and Marketing 1401 Main Ave. SW Hickory, North Carolina 28602
Re: K212644
Trade/Device Name: Aura Storm Regulation Number: 21 CFR 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: Class II Product Code: FRA Dated: April 13, 2022 Received: April 13, 2022
Dear Neeraj Lal:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212644
Device Name Aura Storm
Indications for Use (Describe)
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 HIN1 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 reduction / entrainment time (minutes) at Fan Speed 1. Room Temperature test: Log 4 (99.99%) / 120 minutes.
| 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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Image /page/3/Picture/0 description: The image shows the logo for Invictus Lighting LLC. The logo features the company name in a stylized font, with the word "Invictus" in a larger font than "Lighting LLC". Above the text is a graphic of a sunburst, with several rays of light emanating from a central point. The overall design is clean and professional, with a focus on the company's name and the association with light.
K212644
510(k) Summary:
Aura Storm
DATE: May 17, 2022
SUBMITTER:
Invictus Lighting 1401 Main Ave. SW Hickory, NC 28602 T: 828-855-9324
PRIMARY CONTACT PERSON:
Neeraj Lal Vice President of Engineering and Marketing Invictus Lighting, LLC T: 312-303-0176 Email: neeraj_lal@invictuslighting.com
SECONDARY CONTACT PERSON:
Kisa McMillan Vice President of Operations Invictus Lighting, LLC T: 828-320-4415 Email: kisa mcmillan@invictuslighting.com
DEVICE:
- Trade Name:
- Regulation Number:
- Regulation Name:
- Regulatory Class:
21 CFR 880.6500 Medical Ultraviolet Air Purifier Class II
Aura Storm
Image /page/3/Picture/17 description: The image shows a series of overlapping rectangles in different shades of yellow, orange, and brown. The rectangles are arranged in a descending order, with the largest rectangle at the bottom and the smallest at the top. The rectangles are slightly offset from each other, creating a layered effect. The background is white.
Invictus Lighting uc 1401 Main Ave SW, Hickory, NC 28602 (828) 855-9324 · invictuslighting.com
Image /page/3/Picture/19 description: The image shows a layered design with a gradient of colors. The layers are arranged in a step-like fashion, starting with a dark brown color at the bottom and transitioning to lighter shades of orange and yellow towards the top. The layers are stacked on top of each other, creating a three-dimensional effect. The overall design is simple and modern.
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Image /page/4/Picture/0 description: The image shows the logo for Invictus Lighting LLC. The logo features the company name in a serif font, with the word "Invictus" in a larger font size than "Lighting LLC". Above the company name is a stylized sunburst design with several rays emanating from a central point. The colors used in the logo are shades of orange and brown.
- Common Name:
- Air Purifier
- Classification Name: ●
- . Review Panel:
- Product Code:
Purifier, Air, Ultraviolet, Medical General Hospital FRA
PREDICATE DEVICE(S):
●
Molekule Air Pro RX Air Purifier, K200500 Molekule Air Mini Air Purifier, K202339
DEVICE DESCRIPTION:
The Aura Storm is a multi-stage UV-C air purifier that delivers air purification for rooms up to 2700 square feet (*52ft x 52ft). The Storm inactivates and eliminates bacteria and viruses in the Aura Storm may be used for medical purposes which can include hospitals, medical facilities, medical clinics, nursing facilities, and dental facilities. The Aura Storm is a standalone device that is controlled via buttons on the top of the unit.
The Aura Storm is a dual-sided system with each side consisting of four-stage is a prefilter. The second stage is a HEPA H13+ filter. The third stage is a TiO2 cold photo-catalyst filter. Finally, the UV-C sterilization lamp emits a 253.7mm designed to activate the photo-catalyst filter and eliminate bacteria and viruses. The anion generator is used strictly to increase the size of the particulate molecules to increase the ability to capture and eliminate the bacteria and viruses. This designed system delivers a third-party tested 99.99% (4-log) sterilization in 60 minutes at the highest fan speed. The Aura storm was also tested at the lowest fan speed and delivered a 99.99% (4-log) sterilization in 120 minutes. The air flow diagram has been submitted in the 510(k) submission.
There is an internal fan which draws in air from both sides of the unit, filters it through the multi-stage system and outputs the filtered air through the top of the unit features a capacitive touch button control to operate the On/Off, fan speed (4 speeds), Auto mode, UV lamp, Anion generator, Child lock, timer, and filter reset. There is also a particulate matter sensor and color bar to indicate the level of clean air.
Image /page/4/Picture/13 description: The image shows a series of overlapping rectangles that create a descending staircase pattern. The rectangles are in shades of yellow, orange, and brown, with the lightest yellow at the top and the darkest brown at the bottom. The rectangles are arranged in a way that creates a sense of depth and dimension. The background is white.
Invictus Lighting uc 1401 Main Ave SW, Hickory, NC 28602 (828) 855-9324 · invictuslighting.com
Image /page/4/Figure/15 description: The image shows a layered design with a gradient of colors. The layers are arranged in a step-like fashion, starting with a dark brown color at the bottom and transitioning to lighter shades of orange, yellow, and light yellow towards the top. The layers are slightly offset from each other, creating a subtle shadow effect that adds depth to the design. The background is white.
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Image /page/5/Picture/0 description: The image shows the logo for Invictus Lighting LLC. The logo features the company name in a serif font, with the word "Invictus" in a larger font size than "Lighting LLC". Above the company name is a stylized sunburst design with several rays emanating from a central point. The sunburst is colored in shades of yellow and orange, creating a warm and inviting feel.
INTENDED USE:
The Aura Storm may be used in hospitals, medical facilities, nursing facilities, and dental facilities. The Aura Storm can provide a 99.99% bacterial and virus elimination rate. The Aura Storm has been third-party certified tested on three bacteria (Staphylococcus albicans, Staphylococcus aureus, and Escherichia Coli) and the A/PR8/34 H1N1 virus. Testing shows our ability to eliminate 99.99% in 60 minutes at the highest fan speed. Data on our low fan speed is included in the Miscellaneous files.
| Control Group | Test Group | |||||||
|---|---|---|---|---|---|---|---|---|
| Test Strain | Test Time | TestNumber | OriginalBacteriaCount$V_0$ (cfu/m3) | Original BacteriaCount AfterTreatment$V_t$ (cfu/m3) | NaturalDecay Rate$N_t$ | OriginalBacteriaCount$V_1$ (cfu/m3) | OriginalBacteria CountAfter Treatment$V_2$ (cfu/m3) | BacterialEliminationRate$K$ (%) |
| Staphylococcusalbicans | 60 min. | 1 | 1.19x105 | 9.07x104 | 23.78 | 1.16x105 | 7 | 99.99% |
| 2 | 1.11x105 | 8.75x104 | 21.17 | 1.08x105 | 7 | 99.99% | ||
| 3 | 1.30x105 | 1.00x105 | 23.08 | 1.26x105 | 7 | 99.99% | ||
| Mean | 99.99% | |||||||
| Staphylococcusaureus | 60 min. | 1 | 1.05x105 | 8.54x104 | 18.67 | 1.02x105 | 7 | 99.99% |
| 2 | 1.22x105 | 9.76x104 | 20.00 | 1.18x105 | 7 | 99.99% | ||
| 3 | 1.09x105 | 8.82x104 | 19.08 | 1.12x105 | 7 | 99.99% | ||
| Mean | 99.99% | |||||||
| EscherichiaColi | 60 min. | 1 | 1.14x105 | 9.07x104 | 20.44 | 1.17x105 | 7 | 99.99% |
| 2 | 1.25x105 | 9.79x104 | 21.68 | 1.28x105 | 7 | 99.99% | ||
| 3 | 1.06x105 | 8.49x104 | 19.91 | 1.03x105 | 7 | 99.99% | ||
| Mean | 99.99% |
| Test Strain | Test Time | TestNumber | Control Group | Test Group | |||||
|---|---|---|---|---|---|---|---|---|---|
| OriginalBacteriaCountV0(cfu/m3) | Original BacteriaCount AfterTreatmentVt(cfu/m3) | NaturalDecay RateNt | OriginalBacteriaCountV1(cfu/m3) | OriginalBacteria CountAfter TreatmentV2(cfu/m3) | BacterialEliminationRateKt(%) | ||||
| A/PR8/34(H1N1) | 60 min. | 1 | 3.42x106 | 5.06x105 | 85.20 | 5.06x105 | / | ≥ 99.99% | |
| 2 | 3.42x106 | 5.55x105 | 83.77 | 5.06x105 | / | ≥ 99.99% | |||
| 3 | 1.6x106 | 3.42x105 | 78.63 | 1.60x105 | / | ≥ 99.99% | |||
| Mean | 99.99% |
Image /page/5/Picture/5 description: The image shows a series of overlapping rectangles in different shades of yellow, orange, and brown. The rectangles are arranged in a descending order, creating a layered effect. The colors transition from light yellow at the top to dark brown at the bottom. The right side of the image is mostly white space.
Image /page/5/Figure/7 description: The image shows a series of overlapping rectangles that create a layered effect. The rectangles are arranged in a step-like pattern, ascending from the bottom left to the top right. The colors of the rectangles vary, transitioning from darker shades at the bottom to lighter shades at the top, creating a gradient effect. The color scheme includes shades of brown, orange, and yellow.
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Image /page/6/Picture/0 description: The image shows the logo for Invictus Lighting LLC. The logo features the company name in a serif font, with "Invictus Lighting" in a larger font size than "LLC". Above the company name is a stylized sunburst design with several rays emanating from a central point. The colors used in the logo are shades of orange and brown.
CHARACTERISTIC COMPARISON:
The following table summarizes the similarities and differences between the subject and predicate devices
| Invictus Aura Storm AirPurifier | Molekule Air Pro RX(K200500) | Molecule Air Mini(K202339) | |
|---|---|---|---|
| 510(k) Holder | Molekule | Molekule | |
| Device Type | Medical Ultraviolet AirPurifier | Medical Ultraviolet AirPurifier | Medical Ultraviolet AirPurifier |
| Product Code | FRA | FRA | FRA |
| ClassificationRegulation | 21 C.F.R. § 880.6500 | 21 C.F.R. § 880.6500 | 21 C.F.R. § 880.6500 |
| Class | II | II | II |
| Rx/OTC | OTC | OTC | OTC |
| User | Healthcare ProfessionalLay User | Healthcare ProfessionalLay User | Healthcare ProfessionalLay User |
| Invictus Aura Storm AirPurifier | Molekule Air Pro RX(K200500) | Molecule Air Mini(K202339) | |
| Indications of Use | The Aura Storm airpurifier is a deviceintended for medicalpurposes that is used tocapture and destroybacteria and viruses inthe air through the multi-stage filtration systemand exposure toultraviolet radiation.The Aura Storm airpurifier has beendemonstrated to destroythe following bacteria:Staphylococcus albicans,Staphylococcus aureus,and Escherichia Coli; andvirus: A/PR8/34 H1N1 virusentrained on the filter ofthe subject device underthe following exposureconditions:Average Maximum logreduction / entrainmenttime (minutes) at FanSpeed 4. RoomTemperature test: Log 4(99.99%) / 60 minutes.Average Maximum logreduction / entrainmenttime (minutes) at FanSpeed 1. RoomTemperature test: Log 4(99.99%) / 120 minutes. | The Molekule Air Pro RXair purifier is a deviceintended for medicalpurposes that is used todestroy bacteria andviruses in the air byexposure to ultravioletradiation.The core technologycomponents of theMolekule Air Pro RX airpurifier have beendemonstrated to destroythe following MS2bacteriophage bioaerosolentrained on the filter ofthe subject device underthe following exposureconditions:Average Maximum logreduction/exposure time(hours)Room temperature Virus,MS2 bacteriophage5.21/24 hours | The Molekule Air Miniair purifier is a deviceintended for medicalpurposes that are used tocapture 95% ofparticulate matter anddestroy bacteria andviruses by exposure toultraviolet radiation.The Molekule Air Miniair purifier has beendemonstrated to destroythe following MS2bacteriophage bioaerosolentrained on the filter ofthe subject device underthe following exposureconditions:Average maximum logreduction / entrainmenttime (hours) at FanSpeed 5. Roomtemperature test for MS2bacteriophage virus:5.09 ± 0.42 120 minsSingle Pass MechanicalFiltration Efficiency:95% or greater accordingto ASHRAE 52.2 |
| Environment of Use | Hospitals, medicalfacilities, medical clinics,nursing facilities, anddental facilities. | Hospital, includinggeneral, surgery, criticalcare, and radiology.Inpatient and generalnursing facilities,diagnostic and radiologyrooms. | Hospital and otherhealthcare setting.Home healthcare. |
| Invictus Aura Storm AirPurifier | Molekule Air Pro RX(K200500) | Molecule Air Mini(K202339) | |
| User Control | Touch panel with 4manual fan settings, automode, UV Lamp on/off,Anion on/off, lock andtimer. | One knob controls thefour-speed fan settingOne button turns the uniton and off. | Touch panel with 5manual fan settings. |
| Software | Basic Firmware, used toturn the unit on, off, andchange fan speed. | Basic Firmware, used toturn the unit on, off, andchange fan speed. | Basic Firmware andApp, used to turn the uniton, off, and change fanspeed. |
| Mechanism of Action | UV light of sufficientenergy (UV-C) activatesa TiO2 lined photocatalystthatdestroys microorganismsentrained on the filterthrough a photochemicalreaction, plus the additionof a pre-filter and HEPAfilter. | UV light of sufficientenergy (UV-A) activatesphotocatalyst thatdestroysmicroorganismsentrainedon the filter through aphotochemical reaction. | UV light of sufficientenergy (UV-A) activatesphotocatalyst thatdestroys microorganismsentrained on the filterthrough a photochemicalreaction. |
| Installation | Free Standing | Free Standing | Free Standing |
| Pre-Filter | • Synthetic screen meshtype added prior to HEPA• Designed to trap largerparticles and keep themout of the HEPA• Dimensions: 14 in x15 in x 0.125 in | • Synthetic Media formechanical filtrationupstream of the PECOfilter.• Dimensions: 20 in x20 in x 4 in• Pleats per inch: 1.5• Total Filter surface area:4800 in2 | Not Applicable |
| HEPA Filter | • MERV 13• Dimensions: 14 in x15 in x 0.6875 in | Not Applicable | Not Applicable |
| Invictus Aura Storm AirPurifier | Molekule Air Pro RX(K200500) | Molecule Air Mini(K202339) | |
| Catalytic Filter | • Patent Pending HybridOxydizer with proprietaryDualaction Catalyst | • Proprietary multi-layerfilter media• Dimensions: 20 in x20 in x 4 in• Pleats per inch: 1.5• Total Filter surfacearea: 4800 in2• Filter coated withproprietaryphotocatalyst and ametal wire mesh• MERV16 | • Proprietary multilayerfilter media• Dimensions: 6.18 in(diameter), 6.55 inHeight.• Pleats per inch: 3pleats per inch ofouter circumference• Total Filter surfacearea: 616 in2• Filter coated withproprietaryphotocatalyst and ametal wire mesh• MERV16 |
| Carbon/Cold CatalystOxidier Filter | • Dimensions: 14' x 15" x0.625" | Not Applicable | Not Applicable |
| Photocatalyst | Proprietary Catalyst | Proprietary Catalyst | Proprietary Catalyst |
| Light Source | • UV-C Light Source:LED• Wavelength: 253.7nm• Total of 2 UV- C tubelamps (1 per side)• Total UV Power: 8.0 W | • UV Light Source:LED• Wavelength: 320-400nm• Total of 12 UV LEDssplit amongst 4 PCBs(3 LEDs per PCB)• Total UV Power: 6.8W• Filter Irradiance(Minimum): 20W/m2 | • UV Light Source:LED• Wavelength: 320-400nm• Total of 12 UV LEDssplit amongst 4 PCBs(3 LEDs per PCB)• Total UV Power: 6.8W• Filter Irradiance(Minimum): 20W/m2 |
| Air Source | Centrifugal Fan | Centrifugal Fan | Centrifugal Fan |
| Flow Control | 4 speeds (low, medium,high, boost) and automode provide up to 370CFM | Four speeds (low,medium, high, boost)provide 300-800 CFMflow. | 5 speeds (low-high)Provide 9-86 CFM |
| Invictus Aura Storm AirPurifier | Molekule Air Pro RX(K200500) | Molecule Air Mini(K202339) | |
| Air Changes Per Hour(ACH) | 5.5 ACHon high fan speed (speed4),in a 4000 ft³ room | 6-9 ACH when used inroom with volume of4000cubic feet (a typicalOperating Room Volume)with flowrates of 450-650CFM at settings 2 and 3. | 2.43 device air changesper hour on setting 5,roughly 86 CFM, in a250 ft² room |
| Particulate Sensor | Not applicable | Not Applicable | Not Applicable |
| UV Light ExposureSafety Features | There are two sets ofSafety switches on theAura Storm. the first is onboth outer doors wherethe magnetic switch willdisengage and the unitwill not turn on.A secondary switch in theAura Storm filter and ifthe filter is eitherimproperly installed orthe filter is missing, theunit will not operate. Theunit will not operate witha generic filter and anInvictus filter must beused for the system towork.These switches havebeen designed to protectthe user from anypossibility of exposure todirect contact with UVlight. Safety featureconfirmed by ETL to UL507 safety standard. | Safety switches exist inthe following locations:PECO filter door, prefilter door, PECO filtercompartment, and prefilter compartment. Ifanydoor is open or if a filter ismissing, the unit will notoperate. The purpose ofthese switches is toprotectthe user from anypossibility of exposure todirect contact with UVlight. Safety featureconfirmed by UL 507. | If a validated, serialized,Molekule filter ismissing, the unit will notoperate. The unitauthenticates the filtervia NFC, before andduring operation.The purpose of thissystem is to protect theuser from any possibilityof exposure to directcontact with UV lightthat would occur withouta genuine MolekuleFilter being present. |
| Invictus Aura Storm AirPurifier | Molekule Air Pro RX(K200500) | Molecule Air Mini(K202339) | |
| Fan Exposure SafetyFeatures | Non-removable grill at airoutput and the switchsafety feature at the inletprevent the user fromaccessing spinning fanwithout tools. Safetyfeature confirmed by ETLtested to UL507. | Grill at outlet and inlet offan with small enoughgrating to block user fromaccessing spinning fanwithout tools. Safetyfeature confirmed by UL507. | Vanes at outlet andHoneycomb inlet of fanwith small enoughgrating to block userfrom accessing spinningfan without tools. Safetyfeature confirmed by UL507. |
| Input Voltage | 120 V | 120 V | 120 V |
| Current | 0.55 Amps | 0.55 Amps | 3.72 Amps |
| Power Consumption | Up to 65 W | Up to 450 W | Up to 55 W |
| Electronic DataInterface | Not Applicable | Not Applicable | NFCWLAN (2.4 GHZ) |
| Dimensions | Outer frame dimensions:23 in (H) x 18.2 in (W) x10.6 in (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 | Outer frame dimensions:22 in x 22 in x 52 inFilter dimensions:Filter: 20 in x 20 in x 4 inPre-Filter: 20 in x 20 in x4 in or 20 in x 20 in x 2 in | Unit Dimensions:Height: 12.04 inDiameter: 8.27 inFilter Dimensions:Diameter: 6.03 inHeight: 6.45 in |
| Standards | UL 507 Standard forElectrical FansIEC 60601-1-2 EMC.EMC for MedicalDevices. | UL 507 Standard forElectrical FansIEC 60601-1-2 EMC.EMC for MedicalDevices. | FCC Part 15 C RadioFrequency DevicesUL 507 Standard forElectrical FansIEC 60601-1-2 EMC.EMC for MedicalDevices. |
Image /page/6/Picture/4 description: The image shows a series of five overlapping rectangles that are stacked on top of each other. The rectangles are arranged in a descending order, with the largest rectangle at the bottom and the smallest rectangle at the top. The rectangles are colored in different shades of yellow, orange, and brown, with the darkest shade at the bottom and the lightest shade at the top. The bottom rectangle extends out to the right, creating a ramp-like shape.
Invictus Lighting шс 1401 Main Ave SW, Hickory, NC 28602 (828) 855-9324 · invictuslighting.com
Image /page/6/Figure/6 description: The image shows a layered design with a color gradient. The colors transition from dark brown at the bottom to light yellow at the top. The layers are arranged in a step-like fashion, creating a visual effect of depth and progression.
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Image /page/7/Picture/0 description: The image shows the logo for Invictus Lighting LLC. The logo features the company name in a brown serif font, with the word "Invictus" appearing larger than "Lighting LLC". Above the text is a stylized sunburst design in shades of yellow and orange, with rays emanating outwards. The overall design is clean and professional, conveying a sense of energy and illumination.
Image /page/7/Picture/2 description: The image shows a series of overlapping squares in different shades of yellow, orange, and brown. The squares are arranged in a descending order, creating a layered effect. The colors transition from light yellow at the top to dark brown at the bottom, suggesting a gradient or progression. The squares are positioned on the left side of the image, with the right side being mostly white space.
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Image /page/8/Picture/0 description: The image shows the logo for Invictus Lighting LLC. The logo features the company name in a serif font, with "Invictus Lighting" in a larger font size than "LLC". Above the company name is a stylized sunburst design with rays emanating upwards. The colors used in the logo are shades of yellow and brown.
Image /page/8/Picture/2 description: The image shows a series of overlapping rectangles in different shades of yellow, orange, and brown. The rectangles are arranged in a descending order, creating a layered effect. The colors transition from light yellow at the top to dark brown at the bottom, suggesting a gradient or progression. The overall composition is simple and abstract, with a focus on color and shape.
Image /page/8/Figure/4 description: The image shows a series of overlapping rectangles in different shades of yellow, orange, and brown. The rectangles are arranged in a step-like pattern, with each rectangle slightly offset from the one below it. The color palette creates a warm and inviting feel, and the overlapping design adds depth and dimension to the image. The background is white.
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Image /page/9/Picture/0 description: The image shows the logo for Invictus Lighting LLC. The logo features the company name in a serif font, with the word "Invictus" in a larger font size than "Lighting LLC". Above the company name is a stylized sunburst design with rays emanating outwards. The colors used in the logo are shades of yellow and brown.
Image /page/9/Picture/2 description: The image shows a series of overlapping rectangles in a descending order, creating a layered effect. The rectangles are arranged in a gradient of colors, starting with a light yellow at the top and transitioning to a dark brown at the bottom. The rectangles are stacked on top of each other, with each subsequent rectangle slightly offset to the right and lower than the one above it. The overall composition creates a sense of depth and dimension.
Image /page/9/Figure/4 description: The image shows a staircase-like design with overlapping rectangular shapes. The colors transition from brown at the bottom to shades of orange and yellow as they ascend. The design is set against a white background, with the shapes appearing to be layered on top of each other to create a three-dimensional effect.
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Image /page/10/Picture/0 description: The image shows the logo for Invictus Lighting LLC. The logo features a stylized sunburst design in shades of yellow and orange, with the company name written in a serif font below. The word "Invictus Lighting" is in a larger font size than "LLC", and the entire logo has a professional and modern look.
Image /page/10/Picture/2 description: The image shows a layered diagram with five levels. The levels are stacked on top of each other, with each level slightly offset to the right and decreasing in size from bottom to top. The colors of the levels vary from dark brown at the bottom to light yellow at the top. The bottom level is the largest and extends further to the right than the other levels.
Image /page/10/Figure/4 description: The image shows a series of overlapping rectangles that create a layered effect. The rectangles are arranged in a diagonal, stair-step pattern, with each rectangle slightly offset from the one below it. The colors of the rectangles transition from dark brown at the bottom to light yellow at the top, creating a gradient effect.
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Image /page/11/Picture/0 description: The image is a logo for Invictus Lighting LLC. The logo features the text "Invictus Lighting LLC" in a serif font, with the word "Invictus" in a larger font size than the rest of the text. Above the text is a stylized sunburst design with multiple rays emanating from a central point. The sunburst is colored in shades of yellow and orange, creating a warm and inviting feel.
Image /page/11/Picture/2 description: The image shows a series of overlapping rectangles in different shades of yellow, orange, and brown. The rectangles are arranged in a descending order, creating a layered effect. The colors transition from light yellow at the top to dark brown at the bottom, suggesting a gradient or progression.
Image /page/11/Figure/6 description: The image shows a layered design with a color gradient. The layers are arranged in a step-like fashion, starting from a dark brown at the bottom and transitioning to a light yellow at the top. The layers are stacked on top of each other, creating a three-dimensional effect. The left side of the image is white, providing a contrast to the colorful layers.
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Image /page/12/Picture/0 description: The image shows the logo for Invictus Lighting LLC. The logo features the company name in a serif font, with "Invictus" in a larger font size than "Lighting LLC". Above the text is a stylized sunburst design with several rays emanating upwards. The color scheme appears to be a gradient of yellow and orange.
SUMMARY OF NON-CLINICAL TESTS:
The Aura Storm air purifier complies with voluntary standards for electrical safety and electromagnetic compatibility. The following were provided in to demonstrate the subject device met the acceptance criteria or the testing specification :
- Biocompatibility Risk Analysis – No relevant concern
| Title of the Test | Purpose of the Test | Acceptance Criteria andthe Source of References | Results |
|---|---|---|---|
| Electrical safety andelectromagneticcompatibility testing | General requirements forbasic safety and essentialperformance includingUV light leakage andintensity | UL 507 Standard forElectrical FansIEC 60601-1-2 EMC.EMC for MedicalDevices. | Compliant / Pass |
| Bacteria Reductiontest | To understand the logreduction rate forStaphylococcus albicans,Staphylococcus aureus,and Escherichia Coli | 4 Log reduction of the testedbacteria3rd party testing at anaccredited laboratory | 4-LOG reduction in 60minutes at highest fanspeed4-LOG reduction in 120minutes at lowest fanspeed |
| Virus Inactivation test | To understand the logreduction rate for theA/PR8/34 H1N1 virus | 4 Log activation of thetested virus3rd party testing at anaccredited laboratory | 4-LOG reduction in 60minutes at highest fanspeed4-LOG reduction in 120minutes at lowest fanspeed |
| Filtration EfficiencyTesting | To understand thefiltration efficiency of theHEPA filter | ISO 29463 H13 ISO 35H≥ 99.975% filtration forparticles ≥ 0.3 microns3rd party testing at anaccredited laboratory | 99.98% filtrationefficiency for particlesgreater than or equal to0.3 microns |
| Shelf Life | Recommendedreplacement of filters andUV lamps | Manufacturer'sinformation | Filters should be replacedevery 6 months if beingrun continuouslyUV Lamps should bereplaced every 12 monthsif being run continuously |
Image /page/12/Picture/5 description: The image shows a series of overlapping rectangles in a descending staircase pattern. The colors of the rectangles transition from light yellow at the top to dark brown at the bottom, creating a gradient effect. The rectangles are arranged in a way that each subsequent rectangle is slightly offset and lower than the previous one, giving the impression of depth and layering. The background is white.
Image /page/12/Figure/9 description: The image shows a series of overlapping rectangles that create a layered, stepped effect. The rectangles are arranged in ascending order, with each subsequent rectangle slightly offset and positioned higher than the previous one. The color palette transitions from darker shades of brown and orange at the bottom to lighter shades of yellow at the top, creating a gradient effect. The background is white, which helps to emphasize the colorful rectangles.
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Image /page/13/Picture/0 description: The image shows the logo for Invictus Lighting LLC. The logo features the company name in a serif font, with the word "Invictus" in a larger font size than "Lighting LLC". Above the text is a stylized sunburst design in shades of yellow and orange. The sunburst has several rays emanating from a central point, creating a visual effect of light and energy.
SUMMARY OF CLINICAL TESTS:
No clinical tests were required to demonstrate substantial equivalence.
CONCLUSION:
The conclusions drawn from the nonclinical and clinical tests that the device is as safe, as effective, and performs as well as or better than the legally marketed device
Image /page/13/Picture/5 description: The image shows a series of overlapping rectangles in different shades of yellow, orange, and brown. The rectangles are arranged in a descending order, creating a layered effect. The colors transition from light yellow at the top to dark brown at the bottom. The rectangles are slightly offset from each other, revealing the edges of the layers beneath.
Invictus Lighting uc 1401 Main Ave SW, Hickory, NC 28602 (828) 855-9324 · invictuslighting.com
Image /page/13/Picture/7 description: The image shows a series of stacked rectangles that resemble steps. The colors of the rectangles range from dark brown at the bottom to light yellow at the top. The rectangles are arranged in a way that creates a visual sense of progression or growth.
§ 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).