(279 days)
No
The description focuses on physical filtration and UV-C sterilization, with no mention of AI or ML in the device's operation or control beyond a basic "Auto mode" which likely relies on the particulate matter sensor.
No
The device is an air purifier intended for medical purposes to capture and destroy bacteria and viruses in the air. While it has a medical purpose, it does not directly treat or prevent a disease or condition in a patient, which is characteristic of a therapeutic device. It operates on the environment, not directly on the patient.
No
The device is an air purifier designed to eliminate bacteria and viruses from the air, which is a therapeutic or environmental control function, not a diagnostic one. It does not identify or diagnose a disease or condition in a patient.
No
The device description clearly outlines a physical air purifier with multiple hardware components (filters, UV-C lamp, fan, sensors, buttons) and a multi-stage filtration system. It is a standalone physical unit, not a software application.
Based on the provided information, the Aura Storm air purifier 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.
- Aura Storm's Function: The Aura Storm air purifier operates on air within a room. It does not interact with or analyze any biological specimens from a human body. Its purpose is to purify the air by capturing and destroying airborne pathogens.
- Intended Use: The intended use clearly states it's for capturing and destroying bacteria and viruses in the air.
- Device Description: The description details a multi-stage filtration system and UV-C radiation applied to the air, not to biological samples.
- Performance Studies: The performance studies focus on the device's ability to reduce bacteria and viruses in the air and its filtration efficiency, not on analyzing biological specimens.
Therefore, the Aura Storm air purifier falls under the category of an air purification device intended for medical purposes, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
FRA
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.
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 were conducted. No clinical tests were required.
Bacteria Reduction test:
Purpose: To understand the log reduction rate for Staphylococcus albicans, Staphylococcus aureus, and Escherichia Coli
Results: 4-LOG reduction in 60 minutes at highest fan speed, 4-LOG reduction in 120 minutes at lowest fan speed.
Virus Inactivation test:
Purpose: To understand the log reduction rate for the A/PR8/34 H1N1 virus
Results: 4-LOG reduction in 60 minutes at highest fan speed, 4-LOG reduction in 120 minutes at lowest fan speed.
Filtration Efficiency Testing:
Purpose: To understand the filtration efficiency of the HEPA filter
Results: 99.98% filtration efficiency for particles greater than or equal to 0.3 microns.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial Elimination Rate (K (%)): 99.99% for Staphylococcus albicans, Staphylococcus aureus, and Escherichia Coli.
Bacterial Elimination Rate (Kt (%)): >= 99.99% for A/PR8/34 (H1N1).
Predicate Device(s)
Molekule Air Pro RX Air Purifier, K200500
Reference Device(s)
Molekule Air Mini Air Purifier, K202339
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains 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 in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
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
1
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
2
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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3
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.
4
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.
5
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 | Test | ||||||
| Number | Original | |||||||
| Bacteria | ||||||||
| Count | ||||||||
| $V_0$ (cfu/m3) | Original Bacteria | |||||||
| Count After | ||||||||
| Treatment | ||||||||
| $V_t$ (cfu/m3) | Natural | |||||||
| Decay Rate | ||||||||
| $N_t$ | Original | |||||||
| Bacteria | ||||||||
| Count | ||||||||
| $V_1$ (cfu/m3) | Original | |||||||
| Bacteria Count | ||||||||
| After Treatment | ||||||||
| $V_2$ (cfu/m3) | Bacterial | |||||||
| Elimination | ||||||||
| Rate | ||||||||
| $K$ (%) | ||||||||
| Staphylococcus | ||||||||
| albicans | 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% | |||||||
| Staphylococcus | ||||||||
| aureus | 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% | |||||||
| Escherichia | ||||||||
| Coli | 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 | Test
Number | Control Group | | | Test Group | | | |
|--------------------|-----------|----------------|---------------------------------------------|-------------------------------------------------------------|-----------------------------|---------------------------------------------|-------------------------------------------------------------|-------------------------------------------|--------|
| | | | Original
Bacteria
Count
V0(cfu/m3) | Original Bacteria
Count After
Treatment
Vt(cfu/m3) | Natural
Decay Rate
Nt | Original
Bacteria
Count
V1(cfu/m3) | Original
Bacteria Count
After Treatment
V2(cfu/m3) | Bacterial
Elimination
Rate
Kt(%) | |
| 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.
6
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 Air
Purifier | Molekule Air Pro RX
(K200500) | Molecule Air Mini
(K202339) |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Holder | | Molekule | Molekule |
| Device Type | Medical Ultraviolet Air
Purifier | Medical Ultraviolet Air
Purifier | Medical Ultraviolet Air
Purifier |
| Product Code | FRA | FRA | FRA |
| Classification
Regulation | 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 Professional
Lay User | Healthcare Professional
Lay User | Healthcare Professional
Lay User |
| | Invictus Aura Storm Air
Purifier | Molekule Air Pro RX
(K200500) | Molecule Air Mini
(K202339) |
| Indications of Use | 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
reduction / entrainment
time (minutes) at Fan
Speed 1. Room
Temperature test: Log 4
(99.99%) / 120 minutes. | The Molekule Air Pro RX
air purifier is a device
intended for medical
purposes that is used to
destroy bacteria and
viruses in the air by
exposure to ultraviolet
radiation.
The core technology
components of the
Molekule Air Pro RX air
purifier have been
demonstrated to destroy
the following MS2
bacteriophage bioaerosol
entrained on the filter of
the subject device under
the following exposure
conditions:
Average Maximum log
reduction/exposure time
(hours)
Room temperature Virus,
MS2 bacteriophage
5.21/24 hours | The Molekule Air Mini
air purifier is a device
intended for medical
purposes that are used to
capture 95% of
particulate matter and
destroy bacteria and
viruses by exposure to
ultraviolet radiation.
The Molekule Air Mini
air purifier has been
demonstrated to destroy
the following MS2
bacteriophage bioaerosol
entrained on the filter of
the subject device under
the following exposure
conditions:
Average maximum log
reduction / entrainment
time (hours) at Fan
Speed 5. Room
temperature test for MS2
bacteriophage virus:
5.09 ± 0.42 120 mins
Single Pass Mechanical
Filtration Efficiency:
95% or greater according
to ASHRAE 52.2 |
| Environment of Use | Hospitals, medical
facilities, medical clinics,
nursing facilities, and
dental facilities. | Hospital, including
general, surgery, critical
care, and radiology.
Inpatient and general
nursing facilities,
diagnostic and radiology
rooms. | Hospital and other
healthcare setting.
Home healthcare. |
| | Invictus Aura Storm Air
Purifier | Molekule Air Pro RX
(K200500) | Molecule Air Mini
(K202339) |
| User Control | Touch panel with 4
manual fan settings, auto
mode, UV Lamp on/off,
Anion on/off, lock and
timer. | One knob controls the
four-speed fan setting
One button turns the unit
on and off. | Touch panel with 5
manual fan settings. |
| Software | Basic Firmware, used to
turn the unit on, off, and
change fan speed. | Basic Firmware, used to
turn the unit on, off, and
change fan speed. | Basic Firmware and
App, used to turn the unit
on, off, and change fan
speed. |
| 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 and HEPA
filter. | UV light of sufficient
energy (UV-A) activates
photocatalyst that
destroys
microorganisms
entrained
on the filter through a
photochemical reaction. | UV light of sufficient
energy (UV-A) activates
photocatalyst that
destroys microorganisms
entrained on the filter
through a photochemical
reaction. |
| Installation | Free Standing | Free Standing | Free Standing |
| 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 | • Synthetic Media for
mechanical filtration
upstream of the PECO
filter.
• Dimensions: 20 in x
20 in x 4 in
• Pleats per inch: 1.5
• Total Filter surface area:
4800 in2 | Not Applicable |
| HEPA Filter | • MERV 13
• Dimensions: 14 in x
15 in x 0.6875 in | Not Applicable | Not Applicable |
| | Invictus Aura Storm Air
Purifier | Molekule Air Pro RX
(K200500) | Molecule Air Mini
(K202339) |
| Catalytic Filter | • Patent Pending Hybrid
Oxydizer with proprietary
Dualaction Catalyst | • Proprietary multi-layer
filter media
• Dimensions: 20 in x
20 in x 4 in
• Pleats per inch: 1.5
• Total Filter surface
area: 4800 in2
• Filter coated with
proprietary
photocatalyst and a
metal wire mesh
• MERV16 | • Proprietary multilayer
filter media
• Dimensions: 6.18 in
(diameter), 6.55 in
Height.
• Pleats per inch: 3
pleats per inch of
outer circumference
• Total Filter surface
area: 616 in2
• Filter coated with
proprietary
photocatalyst and a
metal wire mesh
• MERV16 |
| Carbon/Cold Catalyst
Oxidier Filter | • Dimensions: 14' x 15" x
0.625" | 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 tube
lamps (1 per side)
• Total UV Power: 8.0 W | • UV Light Source:
LED
• Wavelength: 320-400
nm
• Total of 12 UV LEDs
split amongst 4 PCBs
(3 LEDs per PCB)
• Total UV Power: 6.8
W
• Filter Irradiance
(Minimum): 20
W/m2 | • UV Light Source:
LED
• Wavelength: 320-400
nm
• Total of 12 UV LEDs
split amongst 4 PCBs
(3 LEDs per PCB)
• Total UV Power: 6.8
W
• Filter Irradiance
(Minimum): 20
W/m2 |
| Air Source | Centrifugal Fan | Centrifugal Fan | Centrifugal Fan |
| Flow Control | 4 speeds (low, medium,
high, boost) and auto
mode provide up to 370
CFM | Four speeds (low,
medium, high, boost)
provide 300-800 CFM
flow. | 5 speeds (low-high)
Provide 9-86 CFM |
| | Invictus Aura Storm Air
Purifier | Molekule Air Pro RX
(K200500) | Molecule Air Mini
(K202339) |
| Air Changes Per Hour
(ACH) | 5.5 ACH
on high fan speed (speed
4),
in a 4000 ft³ room | 6-9 ACH when used in
room with volume of
4000
cubic feet (a typical
Operating Room Volume)
with flowrates of 450-650
CFM at settings 2 and 3. | 2.43 device air changes
per hour on setting 5,
roughly 86 CFM, in a
250 ft² room |
| Particulate Sensor | Not applicable | Not Applicable | Not Applicable |
| UV Light Exposure
Safety Features | 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. | Safety switches exist in
the following locations:
PECO filter door, pre
filter door, PECO filter
compartment, and pre
filter compartment. Ifany
door is open or if a filter is
missing, the unit will not
operate. The purpose of
these switches is to
protect
the user from any
possibility of exposure to
direct contact with UV
light. Safety feature
confirmed by UL 507. | If a validated, serialized,
Molekule filter is
missing, the unit will not
operate. The unit
authenticates the filter
via NFC, before and
during operation.
The purpose of this
system is to protect the
user from any possibility
of exposure to direct
contact with UV light
that would occur without
a genuine Molekule
Filter being present. |
| | Invictus Aura Storm Air
Purifier | Molekule Air Pro RX
(K200500) | Molecule Air Mini
(K202339) |
| Fan Exposure Safety
Features | 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. | Grill at outlet and inlet of
fan with small enough
grating to block user from
accessing spinning fan
without tools. Safety
feature confirmed by UL
507. | Vanes at outlet and
Honeycomb inlet of fan
with small enough
grating to block user
from accessing spinning
fan without tools. Safety
feature confirmed by UL
507. |
| 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 Data
Interface | Not Applicable | Not Applicable | NFC
WLAN (2.4 GHZ) |
| Dimensions | Outer frame dimensions:
23 in (H) x 18.2 in (W) x
10.6 in (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 | Outer frame dimensions:
22 in x 22 in x 52 in
Filter dimensions:
Filter: 20 in x 20 in x 4 in
Pre-Filter: 20 in x 20 in x
4 in or 20 in x 20 in x 2 in | Unit Dimensions:
Height: 12.04 in
Diameter: 8.27 in
Filter Dimensions:
Diameter: 6.03 in
Height: 6.45 in |
| Standards | UL 507 Standard for
Electrical Fans
IEC 60601-1-2 EMC.
EMC for Medical
Devices. | UL 507 Standard for
Electrical Fans
IEC 60601-1-2 EMC.
EMC for Medical
Devices. | FCC Part 15 C Radio
Frequency Devices
UL 507 Standard for
Electrical Fans
IEC 60601-1-2 EMC.
EMC for Medical
Devices. |
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.
7
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.
8
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.
9
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.
10
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.
11
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.
12
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 and
the Source of References | Results |
|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical safety and
electromagnetic
compatibility testing | General requirements for
basic safety and essential
performance including
UV light leakage and
intensity | UL 507 Standard for
Electrical Fans
IEC 60601-1-2 EMC.
EMC for Medical
Devices. | Compliant / Pass |
| 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 | 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 | 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 |
| Shelf Life | Recommended
replacement of filters and
UV lamps | Manufacturer's
information | Filters should be replaced
every 6 months if being
run continuously
UV Lamps should be
replaced every 12 months
if 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.
13
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.