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.

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.

AI/ML Overview

The RGS / RGS mini is a medical ultraviolet air purifier intended to destroy bacteria in the air by exposure to ultraviolet radiation. The device was tested for its ability to eliminate specific bacteria and viruses.

Here's the detailed breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Type	Acceptance Criteria and Source	Reported Device Performance
Electrical Safety and Electromagnetic Compatibility	UL 507 Standard for Electrical Fans, IEC 60601-1-2 EMC for medical devices	Compliant / Pass
Bacteria Reduction Test (Gram-Negative - E. Coli)	Log 4 reduction of Gram-Negative Bacteria (21 CRF 880.6500)	Compliant / Pass: Log 4 Reduction of E. Coli
Bacteria Reduction Test (Gram-Positive - Staph. Epidermidis)	Log 4 reduction of Gram-Positive Bacteria (21 CRF 880.6500)	Compliant / Pass: Log 4 Reduction of Staphylococcus Epidermidis
Virus Inactivation Test (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 (Gram-Negative - E. Coli)	Log 4 reduction of Gram-Negative Bacteria (21 CRF 880.6500)	Compliant / Pass: Log 4 Reduction of E. Coli
Filtration Efficiency Testing (Gram-Positive - Staph. Epidermidis)	Log 4 reduction of Gram-Positive Bacteria (21 CRF 880.6500)	Compliant / Pass: Log 4 Reduction of Staphylococcus Epidermidis
UV Lamp Shelf Life	12,000 hrs. of continuous operation	Compliant / Pass: 12,000 hrs. of continuous operation
Pre-filter Shelf Life	3 months of continuous operation	Compliant / Pass: 3 months of continuous operation

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the specific sample sizes (number of tests) for each microbial reduction, filtration efficiency, or shelf-life test. However, the tests against bacteria and viruses were conducted by "LMS Technologies" to assess reduction capabilities in the air of a test chamber. The origin of the data is not specified beyond being generated by "LMS Technologies," implying a laboratory setting. These tests are inherently retrospective as they are conducted on a completed device to assess its performance against predefined criteria.

Specifically, for the RGS model:

Staphylococcus Epidermidis: Log reduction of 4.0 PFU/ft^3
Bacteriophage MS2: Log reduction of 4.02 PFU/ft^3
Escherichia Coli: Log reduction of 4.24 PFU/ft^3

For the RGS mini model:

Staphylococcus Epidermidis: Log reduction of 4.04 PFU/ft^3
Bacteriophage MS2: Log reduction of 4 PFU/ft^3
Escherichia Coli: Log reduction of 4.0 PFU/ft^3

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The "ground truth" for the performance tests relies on the results obtained by "LMS Technologies," which are standard microbiological and engineering testing methods. Expert consensus for determining the "ground truth" for microbial reduction or filtration efficiency is typically not applicable in this context; instead, it is based on quantitative laboratory measurements compared against defined log reduction targets.

4. Adjudication method for the test set:

Not applicable. The tests involve objective quantitative measurements (e.g., log reduction, hours of operation). There is no mention of an adjudication process for these test results, as they are typically direct measurements against predetermined performance targets.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI algorithms that involve human interpretation, which is not the case for an air purifier.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The device is an air purifier and does not involve an algorithm or human-in-the-loop performance in the conventional sense of a medical diagnostic or AI device. The performance tests are for the device's physical and functional capabilities in reducing airborne microbes and filtering particles.

7. The type of ground truth used:

The ground truth for the performance tests is derived from quantitative laboratory measurements of microbial reduction and filtration efficiency, and direct functional testing for electrical safety and shelf life. For example, for bacteria and virus reduction, the "ground truth" is the measured log reduction achieved in a controlled test chamber, compared against the acceptance criterion of a "Log 4 reduction."

8. The sample size for the training set:

Not applicable. This device is a physical air purifier, not an AI/ML-based device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this device.

Summary

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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.

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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

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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.

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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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

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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.

This device is not intended for use in areas with a sterile field or controlled air flow.

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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.

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

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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 ProfessionalLay User	Healthcare ProfessionalLay User	Same
Environment of Use	General Hospital,Public Schools,Hotels,Restaurants,Casinos	Hospitals, medicalfacilities,medical clinics, nursingfacilities, and dentalfacilities.	Same
User	Health CareProfessionals,School Districts,Hotels,Restaurants, Casinos	Health CareProfessional, Lay User	Same
Installation	Free Standing and Wall Mount	Free Standing
Indications for Use	The RGS / RGS mini isa medical ultravioletair purifier that isintended for medicalpurposes. It is usedto destroy bacteria inthe air by exposureto ultravioletradiation.The RGS / RGS minihave demonstratedthe ability toeliminateStaphylococcusEpidermidis,Bacteriophage MS2,and Escherichia Coliin the air of the testchamber in 60minutes under thefollowing conditions.	The Aura Storm airpurifier is a deviceintended for medicalpurposes that is used tocapture and destroybacteria and viruses inthe air through themulti-stage filtrationsystem and exposure toultraviolet radiation.The Aura Storm airpurifier has beendemonstrated todestroy the followingbacteria: Staphylococcusalbicans,Staphylococcus aureus,and Escherichia Coli;and virus: A/PR8/34H1N1 virus entrainedon the filter of thesubject device under	Similar. The differentorganisms for eachdoes not affect thesafety.
	The device with modelnumber RGS and a highfan speed of 600 CFMwhen tested againstStaphylococcusEpidermidis (grampositive) had a logreduction of 4.0PFU/ft^3. The devicewith model numberRGS and a high fanspeed of 600 CFMwhen tested againstBacteriophage MS2had a log reduction of4.02 PFU/ft^3.Thedevice with modelnumber RGS and a highfan speed of 600 CFMwhen tested againstEscherichia Coli had alog reduction of 4.24PFU/ft^3. The devicewith model numberRGS mini and a highfan speed of500 CFM when testedagainst StaphylococcusEpidermidis. Thisdevice is not intendedfor use in areas with asterile field orcontrolled air flow.	the following exposureconditions: AverageMaximum logreduction/entrainmenttime (minutes) at FanSpeed 4. RoomTemperature test:Log 4(99.99%) / 60minutes. AverageMaximum logreduction / entrainmenttime (minutes) at FanSpeed 1. RoomTemperature test: Log 4(99.99%) / 120 minutes
System Components	- Pre-filter- 6" TiO2 CoatedPhotocatalystUV-C Lamp(Approximately 254nm)	- Pre-filter- HEPA H13+ Filter- TiO2 Photo CatalystFilterUV-C Sterilization Lamp(253.7 nm)	Similar. Does notaffect Safety
Mechanism of Action	UV light (UV-C) ofsufficient energyactivates the TiO2coated photocatalystthat deactivatesmicroorganisms and	UV light of sufficientenergy (UV-C)activates a TiO2lined photocatalystthat destroysmicroorganisms	Same
	chemical reaction.	entrained on thefilter through aphotochemicalreaction, plus theaddition of a pre-filter andHEPA filter.
Material	Frame: GalvanizedSteel Catalyst Panel:Fiberglass andtitanium enrichedcoating.	N/A
Temperature Control	N/A	N/A
Shelf Life	1 year warrantyPre-filter changesevery 3 months.UV lamp changes every12,000 hrs.	Recommendedreplacement of filersand UV lamps	Same
Light Sources	UV-C Light Source:Mercury VaporlampsWavelength: 254nmRGS: (2) 20" UVC LampsRGS total UV Power: 36watts RGS mini: (2) 12"UVC lamps RGS minitotals UV power: 14watts	UV-C LightSource: LEDWavelength:253.7nmTotal of (2)UV-C tubesLamps: (1 perside)Total UV Power: 8.0watts	Similar, testingshowed no safety orefficacy concerns
User Control	One knob turns theunit on and controlsthe infinitely variablefans speed.	The unit features acapacitive touch button.Control to operate theOn/Off, Fan speed (4speeds), Auto mode, UVlamp, Anion generator,Child lock, Timer, Filterreset. One button turnsthe unit on and off.	Same
SoftwareMicroprocessor	Analog Controls areused to control the fanspeed. Analog safetyswitches are used toprotect the user fromUV radiation andimpeller blade.	Basic Firmware, used toturn the unit on, off, andchange 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 408wattsRGS mini: 120 VAC, upto 3.02 amps and 363watts.	to 65 watts

Pre-Filter(s)	MERV 13 Filter isused for particlefiltration upstream ofthe PCO.Dust Spot Efficiency:89-90% FilterDimensions:RGS: 12" x 24" x 4"RGS mini : 12" x 12" x2"	Synthetic screenmesh type addedprior to HEPA.Designed to trap largerparticles and keepthem out of the HEPA.Dimensions: 14 in x 15in x 0.125 in	Same except forproprietarycomponents.
HEPA Filer	HEPA Filter (Optional)12" x 24"x 6"	MERV 13Dimensions: 14" x 15" x0.125"	Similar, No SafetyConcerns.
Catalyst Mesh	ProprietaryCatalyst MediaNominalDimensions:RGS: 12" x 21" x 6"RGS mini: 12" x 12" x6" Photocatalystcoated withproprietary titaniumdioxide coating andwire mesh.	Patent Pending HybridOxidizer withproprietary Dualaction Catalyst.Dimensions: N/A
Photocatalyst	Proprietary Catalyst	Proprietary Catalyst	Same
Air Source	Centrifugal Fan	Centrifugal Fan	Same
Flow Source	Variable FanSpeedsRGS: 275 -825 CFMRGS mini: 300-500CFM	4 Speeds (low, mediumhigh, boost) and automode provide up to 370CFM	Same
Air Changes Per Hour(ACH)	RGS: 3 ACH in a 16,000ft³ Room RGS mini: 3ACH in a 10,000 ft³room.	5.5 ACH on high fanspeed (Speed 4), in a4,000 ft³ room.	Similar, no safetyconcerns
Particulate Sensor	Not applicable	Not applicable	Same
UV Light ExposureSafety Features	The Safety Switch islocated on the particlefilter door. If theparticle filter door is	There are two sets ofsafety switches on theAura Storm. The first ison both outer doors	Same

	open, then the devicewill not operate. Thisswitch is in place toprotect the user fromUV light exposure andexposure to themoving fan wheel.Safety featuresconfirmed by UL 507.	where the magneticswitch will disengage,and the unit will not turnon. A secondary switchin the Aura Storm filterand if the filter isimproperly installed orthe filter is missing, theunit will not operate.The unit will not operatewith eh generic filter andthe Invictus filter mustbe used for the systemto work. These witcheshave been designed toprotect eh userform any possibility ofexposure to directcontact with UV light.Safety featuresconfirmed by ETL to UL507 safety standard.
Fan Exposure Safety	The outlet grill protectsthe user from beingable to access thespinning fan wheel.Inlet fangrille protects userfrom being able toaccess the spinning fanwheel.	Non-removable grillat air output andthe switch safetyfeature at the inletprevent the userfrom accessingspinning fanwithout tools.Safety featureconfirmed by ETLtested to UL507.
Input Voltage	120-volt single phaseAC powerat 60 Hz	120-volt
Current	RGS mini: up to 3.02ampsRGS: up to 3.40 amps	0.55 amps
Power Consumption	RGS mini: up to 362wattsRGS: up to 408 watts	Up to 65 watts
Dimensions	RGS mini outer casingdimensions: 19" x 15" x15"	Outer framedimensions: 23 in(H) x 18.2 in (W) x 10.6in (L)
Standards	x 12" x2" Carbon Filter: 12" x12" x 2"HEPA Filter: 12" x12" x 6" RGS casingdimensions: 15" x16.25" 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" x24" x 6"	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/ColdCatalyst OxidizerFilter: 14 in x 15in x0.625 in
	UL 507 Standard forElectrical Fans IEC60601-1-2 EMCEMC for MedicalDevices	UL 507 Standard forElectrical Fans IEC60601-1-2 EMCEMC 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 Criteriaand the Source forthe Reference	Results
Electrical Safety andElectromagneticCompatibility Testing	General requirementsfor basic safety andessential performanceincluding UV lightleakage and intensity.	UL 507 Standard forElectrical FansIEC 60601-1-2 EMCEMC for medicaldevices.	Compliant / Pass
Bacteria ReductionTest	LMS Technologiesreduction of GramNegative (E. Coli) andGram Positive (Staph.Epidermidis) bacteria.	Log 4 reduction ofGram-Positive andGram-NegativeBacteria21 CRF 880.6500	Compliant / PassLog 4 Reduction of E.Coil andStaphylococcusEpidermidis
Virus Inactivation Test	LMS TechnologiesReduction of MS-2Bacteriophage	Log 4 reduction ofrepresentative virus21 CRF 880.6500	Compliant / PassLog 4 Reduction ofMS-2 Bacteriophage
Filtration EfficiencyTesting	LMS Technologiesreduction of GramNegative (E. Coli) andGram Positive (Staph.Epidermidis) bacteria.	Log 4 reduction ofGram-Positive andGram-NegativeBacteria21 CRF 880.6500	Compliant / PassLog 4 Reduction of E.Coil andStaphylococcusEpidermidis
Shelf Life	Identify the useful lifeof the UV lamps andpre-filter.	UV lamp life of 12,000hrs. of continuousoperation.Pre-filter life of 3months of continuousoperation.	Compliant / PassUV lamp life of 12,000hrs. of continuousoperation.Pre-filter life of 3months of continuousoperation.

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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.

Regulation Number and Section

§ 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).