(268 days)
No reference devices were used in this submission.
No
The description focuses on the physical components and their performance in reducing bacteria and viruses through UV radiation and filtration. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a medical ultraviolet air purifier that destroys bacteria and viruses in the air. Its purpose is to purify the air, not to directly treat or diagnose a medical condition in a patient.
No
The device is an air purifier that destroys bacteria and viruses in the air using UV radiation and filtration; it does not diagnose a medical condition.
No
The device description clearly outlines physical components such as a MERV 13 filter, TiO2 coated mesh, and UV lights, indicating it is a hardware device with a physical mechanism for air purification.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The RGS / RGS mini is an air purifier that destroys bacteria and viruses in the air using UV radiation and filtration. It acts on the environment (air) rather than on a human specimen.
- Intended Use: The intended use is to purify air in various settings, including medical ones, to reduce airborne pathogens. This is an environmental control function, not a diagnostic one.
- Performance Metrics: The performance metrics are based on the reduction of microorganisms in the air (log reduction), not on the analysis of biological samples.
Therefore, the RGS / RGS mini falls under the category of an air purification device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The RGS / RGS mini is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy bacteria in the air by exposure to ultraviolet radiation.
The RGS and RGS mini have demonstrated the ability to eliminate Staphylococcus Epidermidis, Bacteriophage MS2, and Escherichia Coli in the air of the test chamber in 60 minutes under the following conditions.
The device with model number RGS and a high fan speed of 600 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.0 PFU/ft^3. The device with model number RGS and a high fan speed of 600 CFM when tested against Bacteriophage MS2 had a log reduction of 4.02 PFU/ft^3.The device with model number RGS and a high fan speed of 600 CFM when tested against Escherichia Coli had a log reduction of 4.24 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.04 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Bacteriophage MS2 had a log reduction of 4 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Escherichia Coli had a log reduction of 4.0 PFU/ft^3.
This device is not intended for use in areas with a sterile field or controlled air flow.
Product codes (comma separated list FDA assigned to the subject device)
FRA
Device Description
The RGS / RGS mini is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy bacteria in the air by exposure to ultraviolet radiation.
The device uses a MERV 13 filter for particle filtration. Down upstream of the pre-filter is a PCO component. The PCO consists of a TiO2 coated mesh and UV lights. When the UV lights (UV-C) provide sufficient energy, the TiO2 coated photo catalyst is activated. This component will deactivate microorganisms and viruses through a chemical reaction.
The RGS / RGS mini model numbers RGS and RGS mini have demonstrated the ability to eliminate Staphylococcus Epidermidis, Bacteriophage MS2, and Escherichia Coli in the air of the test chamber in 60 minutes under the following conditions. The device with model number RGS and a high fan speed of 600 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.0 PFU/ft^3. The device with model number RGS and a high fan speed of 600 CFM when tested against Bacteriophage MS2 had a log reduction of 4.02 PFU/ft^3.The device with model number RGS and a high fan speed of 600 CFM when tested against Escherichia Coli had a log reduction of 4.24 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.04 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Bacteriophage MS2 had a log reduction of 4 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Escherichia Coli had a log reduction of 4.0 PFU/ft^3.
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
General Hospital, Public Schools, Hotels, Restaurants, Casinos
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 Performance Data:
- Electrical Safety and Electromagnetic Compatibility Testing:
- Purpose: General requirements for basic safety and essential performance including UV light leakage and intensity.
- Acceptance Criteria: UL 507 Standard for Electrical Fans, IEC 60601-1-2 EMC for medical devices.
- Results: Compliant / Pass
- Bacteria Reduction Test:
- Purpose: LMS Technologies reduction of Gram Negative (E. Coli) and Gram Positive (Staph. Epidermidis) bacteria.
- Acceptance Criteria: Log 4 reduction of Gram-Positive and Gram-Negative Bacteria, 21 CRF 880.6500.
- Results: Compliant / Pass, Log 4 Reduction of E. Coli and Staphylococcus Epidermidis.
- Virus Inactivation Test:
- Purpose: LMS Technologies Reduction of MS-2 Bacteriophage.
- Acceptance Criteria: Log 4 reduction of representative virus, 21 CRF 880.6500.
- Results: Compliant / Pass, Log 4 Reduction of MS-2 Bacteriophage.
- Filtration Efficiency Testing:
- Purpose: LMS Technologies reduction of Gram Negative (E. Coli) and Gram Positive (Staph. Epidermidis) bacteria.
- Acceptance Criteria: Log 4 reduction of Gram-Positive and Gram-Negative Bacteria, 21 CRF 880.6500.
- Results: Compliant / Pass, Log 4 Reduction of E. Coil and Staphylococcus Epidermidis.
- Shelf Life:
- Purpose: Identify the useful life of the UV lamps and pre-filter.
- Acceptance Criteria: UV lamp life of 12,000 hrs. of continuous operation. Pre-filter life of 3 months of continuous operation.
- Results: Compliant / Pass, UV lamp life of 12,000 hrs. of continuous operation. Pre-filter life of 3 months of continuous operation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
No reference devices were used in this submission.
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 2, 2023
Genesis Air, Inc. % Dan Briggs President www.genesisair.com 5202 Country Road 7350, Suite D Lubbock, Texas 79424 Phone Number: (806) 745-7000
Re: K222702
Trade/Device Name: RGS: RGS Mini Regulation Number: 21 CFR 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: Class II Product Code: FRA Dated: June 1, 2023 Received: May 5, 2023
Dear Dan Briggs:
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.
1
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 and Part 809); 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 (QS) 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Christopher K. Dugard -S
for Clarence W. Murray, III, Ph.D. Assistant Director THT4B1:Sterility Devices Team DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Center for Devices and Radiological Health U.S. Food and Drug Administration
Enclosure
2
Indications for Use
510(k) Number (if known) K222702
Device Name RGS / RGS mini
Indications for Use (Describe)
The RGS / RGS mini is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy bacteria in the air by exposure to ultraviolet radiation.
The RGS and RGS mini have demonstrated the ability to eliminate Staphylococcus Epidermidis, Bacteriophage MS2, and Escherichia Coli in the air of the test chamber in 60 minutes under the following conditions.
The device with model number RGS and a high fan speed of 600 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.0 PFU/ft^3. The device with model number RGS and a high fan speed of 600 CFM when tested against Bacteriophage MS2 had a log reduction of 4.02 PFU/ft^3.The device with model number RGS and a high fan speed of 600 CFM when tested against Escherichia Coli had a log reduction of 4.24 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.04 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Bacteriophage MS2 had a log reduction of 4 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Escherichia Coli had a log reduction of 4.0 PFU/ft^3.
This device is not intended for use in areas with a sterile field or controlled air flow.
| Type of Use ( Select one or both, as applicable ) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Genesis Air, Inc. Traditional 510(k) Premarket Submission RGS / RGS mini
510(k) Summary
RGS / RGS mini
K222702
1. Submission Sponsor
As required by 21CFR§807.92(c)
Genesis Air, Inc.
5202 Country Road 7350, Suite D
Lubbock, Texas 79424
United States of America
Phone Number: (806) 745-7000
Contact Person: Dan Briggs
Title: President
2. Submission Correspondent
Genesis Air, Inc.
5202 Country Road 7350, Suite D
Lubbock, Texas 79424
United States of America
Phone Number: (806) 745-7000
Contact Person: Connor Croak
Title: Engineer
Email: connor.croak@genesisair.com
3. Date Prepared
6/1/2023
4. Device Identification
| Trade/Proprietary Name: | RGS / RGS mini |
|---|---|
| Common/usual Name: | Air Purifier |
| Classification Name: | Medical ultraviolet air purifier |
| Regulation Number: | 21 CR §880.6500 |
| Product Code: | FRA |
| Device Class: | Class II |
| Classification Panel: | General Hospital |
4
5. Legally Marketed Predicate Device(s)
K212644, Aura Storm, Invictus Lighting
No reference devices were used in this submission.
6. Indication for Use Statement
The RGS / RGS mini is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy bacteria in the air by exposure to ultraviolet radiation.
The RGS / RGS mini have demonstrated the ability to eliminate Staphylococcus Epidermidis, Bacteriophage MS2, and Escherichia Coli in the air of the test chamber in 60 minutes under the following conditions.
The device with model number RGS and a high fan speed of 600 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.0 PFU/ft^3. The device with model number RGS and a high fan speed of 600 CFM when tested against Bacteriophage MS2 had a log reduction of 4.02 PFU/ft^3.The device with model number RGS and a high fan speed of 600 CFM when tested against Escherichia Coli had a log reduction of 4.24 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.04 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Bacteriophage MS2 had a log reduction of 4 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Escherichia Coli had a log reduction of 4.0 PFU/ft^3.
This device is not intended for use in areas with a sterile field or controlled air flow.
5
7. Device Description
The RGS / RGS mini is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy bacteria in the air by exposure to ultraviolet radiation.
The device uses a MERV 13 filter for particle filtration. Down upstream of the pre-filter is a PCO component. The PCO consists of a TiO2 coated mesh and UV lights. When the UV lights (UV-C) provide sufficient energy, the TiO2 coated photo catalyst is activated. This component will deactivate microorganisms and viruses through a chemical reaction.
The RGS / RGS mini model numbers RGS and RGS mini have demonstrated the ability to eliminate Staphylococcus Epidermidis, Bacteriophage MS2, and Escherichia Coli in the air of the test chamber in 60 minutes under the following conditions. The device with model number RGS and a high fan speed of 600 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.0 PFU/ft^3. The device with model number RGS and a high fan speed of 600 CFM when tested against Bacteriophage MS2 had a log reduction of 4.02 PFU/ft^3.The device with model number RGS and a high fan speed of 600 CFM when tested against Escherichia Coli had a log reduction of 4.24 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.04 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Bacteriophage MS2 had a log reduction of 4 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Escherichia Coli had a log reduction of 4.0 PFU/ft^3.
8. Substantial Equivalence Discussion
The following table compares the RGS / RGS mini to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing.
Table 5A – Comparison of Characteristics
6
iraditional ५३०५) rremarket supmission
RGS / RGS mini
| Manufacturer | Genesis Air, Inc. | Invictus Lighting, LLC | Device Comparison |
|---|---|---|---|
| Trade Name | RGS / RGS mini | Invictus Aura Storm Air Purifier | |
| 510(k) Number | K222702 | K212644 | |
| Panel | General Hospital | General Hospital | |
| Product Code | FRA | FRA | |
| Regulation Number | 21 C.F.R. § 800.6500 | 21 C.F.R. § 800.6500 | |
| Regulation Name | Medical ultraviolet air purifier | Medical ultraviolet air purifier | |
| Class | II | II | |
| Rx/OTC | OTC | OTC | |
| User | Healthcare Professional | ||
| Lay User | Healthcare Professional | ||
| Lay User | Same | ||
| Environment of Use | General Hospital, | ||
| Public Schools, | |||
| Hotels, | |||
| Restaurants, | |||
| Casinos | Hospitals, medical | ||
| facilities, | |||
| medical clinics, nursing | |||
| facilities, and dental | |||
| facilities. | Same | ||
| User | Health Care | ||
| Professionals, | |||
| School Districts, | |||
| Hotels, | |||
| Restaurants, Casinos | Health Care | ||
| Professional, Lay User | Same | ||
| Installation | Free Standing and Wall Mount | Free Standing | |
| Indications for Use | The RGS / RGS mini is | ||
| a medical ultraviolet | |||
| air purifier that is | |||
| intended for medical | |||
| purposes. It is used | |||
| to destroy bacteria in | |||
| the air by exposure | |||
| to ultraviolet | |||
| radiation. | |||
| The RGS / RGS mini | |||
| have demonstrated | |||
| the ability to | |||
| eliminate | |||
| Staphylococcus | |||
| Epidermidis, | |||
| Bacteriophage MS2, | |||
| and Escherichia Coli | |||
| in the air of the test | |||
| chamber in 60 | |||
| minutes under the | |||
| following conditions. | 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 | Similar. The different | ||
| organisms for each | |||
| does not affect the | |||
| safety. | |||
| The device with model | |||
| number RGS and a high | |||
| fan speed of 600 CFM | |||
| when tested against | |||
| Staphylococcus | |||
| Epidermidis (gram | |||
| positive) had a log | |||
| reduction of 4.0 | |||
| PFU/ft^3. The device | |||
| with model number | |||
| RGS and a high fan | |||
| speed of 600 CFM | |||
| when tested against | |||
| Bacteriophage MS2 | |||
| had a log reduction of | |||
| 4.02 PFU/ft^3.The | |||
| device with model | |||
| number RGS and a high | |||
| fan speed of 600 CFM | |||
| when tested against | |||
| Escherichia Coli had a | |||
| log reduction of 4.24 | |||
| PFU/ft^3. The device | |||
| with model number | |||
| RGS mini and a high | |||
| fan speed of | |||
| 500 CFM when tested | |||
| against Staphylococcus | |||
| Epidermidis. This | |||
| device is not intended | |||
| for use in areas with a | |||
| sterile field or | |||
| controlled air flow. | 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 | |||
| System Components | - Pre-filter |
- 6" TiO2 Coated
Photocatalyst
UV-C Lamp
(Approximately 254
nm) | - Pre-filter - HEPA H13+ Filter
- TiO2 Photo Catalyst
Filter
UV-C Sterilization Lamp
(253.7 nm) | Similar. Does not
affect Safety |
| Mechanism of Action | UV light (UV-C) of
sufficient energy
activates the TiO2
coated photocatalyst
that deactivates
microorganisms and | UV light of sufficient
energy (UV-C)
activates a TiO2
lined photocatalyst
that destroys
microorganisms | Same |
| | chemical reaction. | entrained on the
filter through a
photochemical
reaction, plus the
addition of a pre-
filter and
HEPA filter. | |
| Material | Frame: Galvanized
Steel Catalyst Panel:
Fiberglass and
titanium enriched
coating. | N/A | |
| Temperature Control | N/A | N/A | |
| Shelf Life | 1 year warranty
Pre-filter changes
every 3 months.
UV lamp changes every
12,000 hrs. | Recommended
replacement of filers
and UV lamps | Same |
| Light Sources | UV-C Light Source:
Mercury Vapor
lamps
Wavelength: 254nm
RGS: (2) 20" UVC Lamps
RGS total UV Power: 36
watts RGS mini: (2) 12"
UVC lamps RGS mini
totals UV power: 14
watts | UV-C Light
Source: LED
Wavelength:
253.7nm
Total of (2)
UV-C tubes
Lamps: (1 per
side)
Total UV Power: 8.0
watts | Similar, testing
showed no safety or
efficacy concerns |
| User Control | One knob turns the
unit on and controls
the infinitely variable
fans speed. | 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, Filter
reset. One button turns
the unit on and off. | Same |
| Software
Microprocessor | Analog Controls are
used to control the fan
speed. Analog safety
switches are used to
protect the user from
UV radiation and
impeller blade. | Basic Firmware, used to
turn the unit on, off, and
change fan speed. | NA |
| Battery Operated | Not applicable | Not applicable | |
| AC Powered | RGS: 120 VAC, up to | 120 VAC, 0.55 amps, Up | Same |
| | 3.40 amps and 408
watts
RGS mini: 120 VAC, up
to 3.02 amps and 363
watts. | to 65 watts | |
| | | | |
| Pre-Filter(s) | MERV 13 Filter is
used for particle
filtration upstream of
the PCO.
Dust Spot Efficiency:
89-90% Filter
Dimensions:
RGS: 12" x 24" x 4"
RGS mini : 12" x 12" x
2" | 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 | Same except for
proprietary
components. |
| HEPA Filer | HEPA Filter (Optional)
12" x 24"
x 6" | MERV 13
Dimensions: 14" x 15" x
0.125" | Similar, No Safety
Concerns. |
| Catalyst Mesh | Proprietary
Catalyst Media
Nominal
Dimensions:
RGS: 12" x 21" x 6"
RGS mini: 12" x 12" x
6" Photocatalyst
coated with
proprietary titanium
dioxide coating and
wire mesh. | Patent Pending Hybrid
Oxidizer with
proprietary Dual
action Catalyst.
Dimensions: N/A | |
| Photocatalyst | Proprietary Catalyst | Proprietary Catalyst | Same |
| Air Source | Centrifugal Fan | Centrifugal Fan | Same |
| Flow Source | Variable Fan
Speeds
RGS: 275 -
825 CFM
RGS mini: 300-500
CFM | 4 Speeds (low, medium
high, boost) and auto
mode provide up to 370
CFM | Same |
| Air Changes Per Hour
(ACH) | RGS: 3 ACH in a 16,000
ft³ Room RGS mini: 3
ACH in a 10,000 ft³
room. | 5.5 ACH on high fan
speed (Speed 4), in a
4,000 ft³ room. | Similar, no safety
concerns |
| Particulate Sensor | Not applicable | Not applicable | Same |
| UV Light Exposure
Safety Features | The Safety Switch is
located on the particle
filter door. If the
particle filter door is | There are two sets of
safety switches on the
Aura Storm. The first is
on both outer doors | Same |
| | | | |
| | open, then the device
will not operate. This
switch is in place to
protect the user from
UV light exposure and
exposure to the
moving fan wheel.
Safety features
confirmed by UL 507. | 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
improperly installed or
the filter is missing, the
unit will not operate.
The unit will not operate
with eh generic filter and
the Invictus filter must
be used for the system
to work. These witches
have been designed to
protect eh user
form any possibility of
exposure to direct
contact with UV light.
Safety features
confirmed by ETL to UL
507 safety standard. | |
| Fan Exposure Safety | The outlet grill protects
the user from being
able to access the
spinning fan wheel.
Inlet fan
grille protects user
from being able to
access the spinning fan
wheel. | 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
-
| |
| Input Voltage | 120-volt single phase
AC power
at 60 Hz | 120-volt | |
| Current | RGS mini: up to 3.02
amps
RGS: up to 3.40 amps | 0.55 amps | |
| Power Consumption | RGS mini: up to 362
watts
RGS: up to 408 watts | Up to 65 watts | |
| Dimensions | RGS mini outer casing
dimensions: 19" x 15" x
15" | Outer frame
dimensions: 23 in
(H) x 18.2 in (W) x 10.6
in (L) | |
| Standards | x 12" x
2" Carbon Filter: 12" x
12" x 2"
HEPA Filter: 12" x
12" x 6" RGS casing
dimensions: 15" x
16.25" x 33.25"
Filter dimensions:
Standard Pre-filter: 12"
x 24" x 4"
Alternative Pre-filter:
12" x 24" x 2"
Carbon Filter: 12" x 24"
x 2" HEPA Filter: 12" x
24" x 6" | 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 | |
| | 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 | |
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9. Non-Clinical Performance Data
Internal verification and validation testing confirms that product specifications are met which are equivalent in design and technological characteristics as the predicate device. The testing results support that the electrical safety testing, and functional testing of the product were met for the acceptance of the device.
| Test Type | Purpose for the Test | Acceptance Criteria
and the Source for
the Reference | 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 | LMS Technologies
reduction of Gram
Negative (E. Coli) and
Gram Positive (Staph.
Epidermidis) bacteria. | Log 4 reduction of
Gram-Positive and
Gram-Negative
Bacteria
21 CRF 880.6500 | Compliant / Pass
Log 4 Reduction of E.
Coil and
Staphylococcus
Epidermidis |
| Virus Inactivation Test | LMS Technologies
Reduction of MS-2
Bacteriophage | Log 4 reduction of
representative virus
21 CRF 880.6500 | Compliant / Pass
Log 4 Reduction of
MS-2 Bacteriophage |
| Filtration Efficiency
Testing | LMS Technologies
reduction of Gram
Negative (E. Coli) and
Gram Positive (Staph.
Epidermidis) bacteria. | Log 4 reduction of
Gram-Positive and
Gram-Negative
Bacteria
21 CRF 880.6500 | Compliant / Pass
Log 4 Reduction of E.
Coil and
Staphylococcus
Epidermidis |
| Shelf Life | Identify the useful life
of the UV lamps and
pre-filter. | UV lamp life of 12,000
hrs. of continuous
operation.
Pre-filter life of 3
months of continuous
operation. | Compliant / Pass
UV lamp life of 12,000
hrs. of continuous
operation.
Pre-filter life of 3
months of continuous
operation. |
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Biocompatibility testing
This device is not intended to be placed in or on the body. Not applicable.
Electrical safety and electromagnetic compatibility (EMC)
The RGS / RGS mini complies with the applicable voluntary standard which includes IEC 60601-1-2:2014. The overall mechanical, electronic, and safety features of the RGS / RGS mini complies with these voluntary standards including IEC 60601-1-2 for Electromagnetic Compatibility.
Software Verification and Validation Testing
The RGS / RGS mini does not contain any software. There is no software documentation to review.
10. Animal Performance Data
Not applicable
11. Clinical Performance Data
Not applicable
12. Conclusions
The conclusions drawn from the nonclinical tests demonstrate that the device is as sffective, and performs as well as or better than the legally marketed device K212644.