The MDU/Rx™ medical model is an ultraviolet (UV) air purifying device intended for the reduction of bacteria and the MS2 and Phi-X174 virus in air in medical facilities. The MDU/Rx"" medical device is non sterile.

Device Description

The MDU/Rx" device purifies and sanitizes air by circulating ambient air through a filter into a chamber equipped with two ultraviolet (UV) lights (also called optics) with wavelengths in the range between ~100-285 nm, which encompasses the range of light called UV-C, as described in the general system design in Figure E-1.

AI/ML Overview

The provided text describes the Odorox® MDU/Rx™ medical device, an ultraviolet (UV) air purifier. While the document details the device's mechanism, safety testing, and some performance claims, it does not provide a clear table of acceptance criteria nor a comprehensive study demonstrating direct compliance. Instead, it relies on substantial equivalence to predicate devices and performance claims supported by a single test.

Based on the information provided, here's an attempt to answer your questions to the best of my ability, highlighting where information is missing or inferred:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a formal, quantifiable table. However, it claims intended performance. Based on the "Performance" and "MDU/Rx™ Device Effectiveness as an Air Sanitizer" sections, we can infer the claimed performance, though not formal acceptance criteria.

Performance Metric	Claimed Performance (Inferred)
Bacteria Reduction	High kill rates of 4-5 log reduction of airborne bacteria from initial concentrations of 6-8 log CFU/cu ft.
MS2 and Phi-X174 Virus Reduction	High kill rates of 4-5 log reduction of airborne virus from initial concentrations of 6-8 log CFU/cu ft.
Kill Rate Time	4 log or greater kill rate for all organisms tested within two hours.
Ozone Levels	Below 50 ppb in typical, normally ventilated treatment areas. Steady state of ~19 ppb (smaller chamber), ~14 ppb (larger chamber).
Carbon Monoxide Levels	Not detected above baseline levels.
Formaldehyde, Acetaldehyde, Other Aldehydes	Remained at or marginally above background concentrations.
Oxidized Volatile Organic Compounds (VOC)	No significant concentrations formed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: For the microbial efficacy testing, the document states: "Kill rates were measured in triplicate". This implies 3 replicates for each organism tested.
Data Provenance: The microbial efficacy testing was performed by "Aerosol Research and Engineering Laboratories (ARE, Overland Park, Kansas)," which is in the USA. The study was likely prospective as it involved aerosolizing microorganisms in a controlled chamber for testing.
Ozone and By-product Testing: Conducted by "Columbia Analytical Services (Simi Valley, CA)" in the USA, also likely prospective with hourly interval sampling. Additional ozone measurements were conducted by HGI (the manufacturer) in various treatment areas.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The concept of "experts establishing ground truth" as you'd find in diagnostic AI studies (e.g., radiologists) is not applicable here. This device performs a physical function (air purification). The "ground truth" for its performance is established through direct laboratory measurements of microbial count reduction and chemical concentrations. The experts involved would be the scientists and technicians at Aerosol Research and Engineering Laboratories and Columbia Analytical Services, who are presumed to be qualified in microbiology, aerosol science, and analytical chemistry, respectively. Their specific qualifications are not detailed in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This study does not involve human interpretation or subjective assessments that would require an adjudication method like 2+1 or 3+1. The results are quantitative measurements from laboratory tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not a diagnostic device involving human readers or AI assistance in interpretation. It's an air purification device. Therefore, no MRMC study was conducted.

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

Yes, effectively. The performance testing described (microbial kill rates, ozone, and by-product measurements) represents the standalone performance of the Odorox® MDU/Rx™ device without any human "in the loop" interaction beyond operating the device as intended. The efficacy is measured directly by its physical effect on the air.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used for this device's performance is direct laboratory measurement and quantification of:

Reduction in viable airborne microorganisms (bacteria and viruses) post-treatment.
Concentrations of chemical by-products (ozone, CO, aldehydes, VOCs) in the air post-treatment.

Essentially, it's empirical measurement of the device's physical effect on the air.

8. The sample size for the training set

Not applicable. This device is a physical air purifier, not a software algorithm that requires a training set (e.g., for machine learning). The document does not describe any machine learning component of the device.

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

Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth to establish for such a set.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and clean, and it is easily recognizable.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 19,2014

HGI INDUSTIRES Dr. Connie Araps Chairman of HGI Scientific Advisory Board. 2055 High Ridge Road Boynton Beach, FL 33426 US

Re: K133800

Trade/Device Name: ODOROX(R) MDU/RX (TM) Regulation Number: 21 CFR 880.6500 Regulation Name: Medical UV Air Purifiers Regulatory Class: II Product Code: FRA Dated: November 17, 2014 Received: November 19, 2014

Dear Dr. Araps:

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. 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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Page 2 - Dr. Araps

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, mA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number	K133800
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Device Name

Odorox® MDU/Rx™

Indications for Use (Describe)

The MDU/Rx"" medical model is an ultraviolet (UV) air purifying device intended for the reduction of bacteria and the MS2 and Phi-X174 virus in air in medical facilities. The MDU/Rx"" medical device is non sterile.

Type of Use:

Over-the-counter use (21CFR 807 Subpart C)

Please do not write below this line – Continue on a Separate Page if needed

For FDA Use Only

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the logo for HGI Industries, Inc. The logo features a globe with green continents and blue oceans, surrounded by a yellow orbital path. Below the globe are the letters "HGI" in blue, with the word "industries, inc." in green underneath. The "®" symbol is located to the right of the globe.

Green

Technology

Image /page/3/Picture/2 description: The image shows three different environmental certification logos. The first logo is the Rainforest Alliance Certified seal, which features a green frog. The second logo is the Carbon Standard Carbon Neutral Approved seal, which features a green leaf. The third logo is the recycling symbol with the text "100% Post Consumer" below it.

510(k) Summary

510(k) Owner:

HGI Industries, Inc. 2055 High Ridge Road Boynton Beach, FL 33426 561-735-3701 Phone: Fax: 561-347-3824

Contact Person:

Connie Araps, PhD 2055 High Ridge Road Boynton Beach, FL 33426 Phone: 561-735-3701 Fax: 561-347-3824

Date Prepared:

December 15, 2014

Odorox® MDU/Rx™ Proprietary Name(s):

Common Name:

Air purifier ultraviolet or ultraviolet air purifier (used interchangeably by substantially equivalent devices)

Trade Name:

Classification Name: 21 CFR 880-6500 Class II Medical Ultraviolet Air

Odorox® MDU/Rx™

Purifier.

Product Code:

Category:

General Hospital

FRA

E-1

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510(k) Summary

Intended Use

Product Description

Image /page/4/Figure/5 description: This image shows a diagram of an air purification system. The system consists of a filter, fan, oxidizing UV source, and reflector. Contaminated air enters the system through the filter, and purified air exits the system through the reflector. The diagram also shows the flow of air through the system.

Figure E-1 MDU/Rx™ Device General System Design

UV light in this range is commonly called germicidal. The radiation penetrates the cell walls of bacteria and virus and is absorbed by the organic structures within the cell, causing them to decompose and the cell to die.

General product information is provided below in Table E-1.

E_Odorox 510(k) Summary_20141218b.docx

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MDU/Rx™ Device Ultraviolet Air Purifier Product Information Table E-1

MODEL #	PRODUCT NAME	DESCRIPTION	# Of OPTICS	Optic Model #
MDURXMA00	MDU/Rx™	MOBILE Air DISINFECTION UNIT, 120VAC	2	OPT-XX-176

The Odorox® MDU/Rx™ system is judged to be a Class II device that falls within the FDA category:

Common name: ultraviolet air purifier or air purifier ultraviolet ●
General Hospital .
Purifier, air, ultraviolet, medical .
Regulation Number: 880.6500
Product Code: FRA ●

Substantial Equivalence

Based on the fact that the MDU/Rx " system uses UV light with wavelengths of 100 – 285 nm that includes the range commonly called germicidal (or UV-C) as the means by which it sanitizes, the company believes that the system is substantially equivalent to the following FDA approved, legally marketed systems:

ECO-Rx AIR PURIFIER WITH UV LIGHT MODEL RX-400 ●

o 510(k) Number: K062716
Regulation Number: 21 CFR 880.6500 o
- Regulation Name: Medical Ultraviolet Air Purifier
O Requlatory Class: O
- ll Product Code: FRA
- Decision: Substantially equivalent
O Date Approved: 10/27/2006 O
General Hospital o Classification:
Type: O
Traditional Combination Product: No o

RXAir 3000 ●

K951981
o 510(k) Number: Requlation Number: 21 CRF 880-6500 O
- Medical Ultraviolet Air Purifier Requlation Name:
Regulatory Class ll O
- Product Code: FRA
Decision: Substantially equivalent O
Date Approved: O
- 10/27/2006
Classification: General Hospital O Traditional
Type: O
Combination Product: No O

All three types of devices are self-contained systems with similar quartz UV-C optics and varying types of filters. The systems use integrated fans to circulate air through the filters to remove particulates and sanitize the air by exposure to UV-C radiation, which

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kills airborne microorqanisms. They have similar active components, design features and intended uses. They do not incorporate any other sanitizing components such as catalysts or electrical discharge. The use of filters in the MDU/Rx™ device is primarily for the purpose of keeping the optic surfaces clean and is not intended as a means of sanitizing air.

The MDU/Rx", RXAir 3000 and Eco RX-400 systems have the same intended use as described in Table E2. They are ultraviolet (UV) air purifying devices intended for the reduction of bacteria and specific virus in air in medical facilities. The devices are nonsterile. The construction of the devices is essentially the same in that they all circulate air through metal or plastic cases in which utilize UV-C lights (also called optics). As the air passes through the photolysis chamber and is exposed to the UV-C light, the microorganisms absorb the radiation and are killed. 1 They differ in the types of filters that are used, as described.

The RXAir 3000 uses a single "germicidal" UV-C lamp to sanitize and a five-stage filter to remove particulates, volatile organic compounds and bacteria. The ECO Rx 400 uses three UV-C lamps (also called optics) to sanitize and has a filter to remove particulates.

A comparison of the MDU/Rx"" device and available predicate product feature information is provided in Table E-2, below and compares:

Indications for use ●
Intended use ●
Materials of construction
Elements of design ●
Mechanism of action

Features	Odorox® Units	RXAir 3000	ECO RX-400
Indications forUse	UV Air sanitizer	UV Air Sanitizer	UV Air Sanitizer
	Intended Use	Kill bacteria, virusin air	Kill bacteria, virusin air	Kill bacteria, virusin air
Mechanisms ofaction	UV light killsmicroorganisms	UV light killsmicroorganisms	UV light killsmicroorganisms
	Elements ofdesign	Fan circulates airthrough shieldedchamber where UVlight irradiatesmicroorganisms	Fan circulates airthrough shieldedchamber where UVlight irradiatesmicroorganisms	Fan circulates airthrough shieldedchamber whereUV light irradiatesmicroorganisms
		Particulate filter	Yes	Yes
Internal Fan		Yes	Yes	Yes
Germicidal UV	Yes	Yes	Yes
UV Optic type	Quartz UV-C	Quartz UV-C	Quartz UV-C
Wavelengthrange of UVradiation	~100-285 nm	~100-285 nm	~100-285 nm

					Table E-2 Comparison of MDU/Rx™, RXAir 3000 and ECO RX-400 Features
--	--	--	--	--	----------------------------------------------------------------------

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Catalyst coatedsurfaces	No	No	No
Electric discharge	No	No	No
Chemicaladditives	No	No	No
Type andMaterials ofConstruction	Quartz UV optics,Metal or plasticstructural case andfan powered byelectric motor	Quartz UV optics,Metal or plasticstructural case andfan powered byelectric motor	Quartz UV optics,Metal or plasticstructural caseand fan poweredby electric motor

In summary, the available information for the predicates and data from HGI indicate that all three devices generate UV-C radiation using quartz optics. The radiation is directly absorbed by the bacteria and virus in air as they pass through the photolysis chamber. The microorganisms die as a result of radiation damage to the DNA and other organic structures within the organisms' cell wall. UV-C radiation also reacts with oxygen and water vapor in air to generate very low concentrations of hydroxyl radicals in the range of 0.1 parts per trillion to one part per billion. Hydroxyl radicals can react with the lipids and proteins in the cell walls of microorganisms (including bacteria and virus) within the radiation chamber and kills them, contributing to the sanitization process. Both mechanisms occur concurrently.

Performance

The MDU/Rx™ model is designed to treat areas of approximately 130 to 500 square feet that would have 8 to 10 foot ceilings (~1300 to 5,000 cubic feet of space). The system is operated by the use of an on-off switch which activates both optics and the fan. The fan is set at a fixed speed of ~150 cubic feet per minute. When in use, an indicator light on the outside of the case is lit. The recommended mode of action is to have the unit running continuously. Larger spaces require the use of longer treatment times and/or multiple machines. The unit recirculates ambient air continuously through the UV-C photolysis chamber, where it is sanitized. Operational use guidelines are provided to users in the form of an Owner's Manual and advise that the MDU/Rx™ model is intended for use in ventilated spaces of four or more exchange rates per hour. The length of time required to reach optimal sanitization varies as a function of the volume of space being treated, and the dynamics of what occurs within the treatment space including:

Initial load of microorganisms
Degree of contamination being introduced by patient activities, treatment etc. ●
Movement of personnel/patients within the space
Rates of ventilation .

The device is intended to result in high kill rates of 4-5 log reduction of airborne bacteria and the MS2 and Phi-X174 virus of initial concentrations of 6 log 8 -10 CFU/cu ft. of air and is not intended to create a sterile environment.

The system uses commercially available 48 watt quartz optics as UV-C radiation sources. The 48 watt optic produces 10 watts of light at ~254 nm (at 100 hours of use). There is an indicator light to show that both optics are on and are functioning properly.

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The fan speed is not critical to the operation of the system. Generally, operating the fan at ~ 150 cfm results in slightly faster elimination of bacteria and virus than higher fan speeds as the ambient air has increased residence time within the photolysis chamber. The device uses a washable polyester filter to remove particulates greater than 8 microns. The purpose of the filter is primarily to keep the optics clean. Placement of the units is not critical to performance. In general the unit is best placed near a wall at an angle so as to create a vortex around the room to be treated.

Intertek tested the MDU™ model (identical to the proposed MDU/Rx™ model) for compliance with the safety Standards listed below:

Electrical safety fans, ventilators using Standards 1 and 2 ●
Safety for Luminaires using Standard 3 .
UV Safety using Standards 4 and 5 ●
1. Standard for Safety for Electric Fans, UL 507-9" Edition, Dated 12/13/1000, with revisions through And including September 27, 2007.
1. Standard for Fans and Ventilators, CSA C22.2 No. 113-10. General Instruction NO 1-7. Dated March 2. 2010.
1. Standard for Safety Luminaires UL 1598, 304 Edition, 9/17/2008 with revisions through and including 2/20/2009
1. UL Standard for Electrical Equipment for Measurement, Control and Laboratory use; Part 1: General requirements, UL 61010-1, 200 Edition, dated 07/12/04 with revisions through and including 07/22/05
1. Canadian Standards Association C22.2 No. 250, 0-04, 200 Edition, Dated 12/30/04 with revisions through and including 05/31/06

The Intertek report concluded that "…the MDU™ product covered by this report has been evaluated and found to comply with the applicable requirements" of the Standards referenced above." Based on the Intertek report, the MDU™ unit is ETL Listed (UL 507 and CSA C22.2).

Ozone and organic oxidation by-products are formed as a result of the irradiation of ambient water vapor and oxygen in air by UV-C radiation with a range of wavelengths between ~100-285 nm. Columbia Analytical Services (Simi Valley, CA) evaluated the MDU™ device (identical to the proposed MDU/Rx™ device) for the purpose of measuring the types and concentrations of orqanic oxidation by-products and ozone in a 1296 cubic foot test space and a 3656 cubic foot test space. Air samples were taken in hourly intervals for up to fifteen hours. In summary, the data indicated that:

No carbon monoxide was detected above baseline levels
Formaldehyde, acetaldehyde and other target aldehydes remained at or ● marqinally above background concentrations
. No significant concentrations of oxidized volatile organic compounds (VOC) were formed
. Ozone reached a steady state concentration of ~19 ppb in the smaller chamber and ~14 ppb in the larger chamber. The highest oxidant levels resulted from

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using both optics with the fan at the low setting. These are the settings used by the MDU/Rx™ device.

Additional ozone measurement were conducted by HGI in a range of typical, normally ventilated treatment areas (3-6 exchange rates per hour) representative of those found in medical facilities. Measurements were also made without ventilation. The spaces ranged from ~1190 to 4102 cubic feet (~130 sf to ~450 sf with 8-9 foot ceilings). Testing times varied from 3 to 24 hours. Ozone (total oxidant) levels remained below 50 ppb for all tests.

Mode of Action

The primary mode of action for the MDU/Rx™ unit and its predicates is to sanitize air as it passes through the photolysis chamber by direct exposure to UV radiation with wavelengths between ~100-285 nm. The primary bactericidal mode of action of UV-C radiation results from the penetration of radiation into the interior of the cell where it is absorbed by key biochemicals. The UV radiation damages the RNA, DNA and other organic moieties within the cell preventing cell replication and causing cell death.

A secondary mode of action results from the formation of hydroxyl radicals within the photolysis chamber by the action of UV-C radiation with oxygen and water vapor in ambient air. The hydroxyl radicals react rapidly (within a second) with the lipids and proteins on the surface of the cells, causing the contents of the cell to leak and the cell to die.

MDU/Rx™ Device Effectiveness as an Air Sanitizer

The efficacy of the MDU/Rx™ device as an air sanitizer was determined by measuring the kill rates of selected aerosolized bacteria and virus. Studies of the kill rates of the following aerosolized microorganisms by the MDU/Rx™ unit were done for HGI by Aerosol Research and Engineering Laboratories (ARE, Overland Park, Kansas). The testing was conducted in a 563 cubic foot sterile stainless steel test clean-room chamber into which specified concentrations of aerosolized bacteria and virus were introduced.

. Staphylococcus epidermidis – a gram positive bacterium used as an index orqanism for Staphylococcus aureus: considered as representative of its class
. Erwinia herbicola – a gram neqative bacterium used as an index organism for Escherichia coli: considered as representative of its class

(Note: E. coli was tried but it proved too fragile to remain viable in an aerosol long enough to establish a stable baseline.)

. MS2 virus – a bacteriophage that infects E.coli that is used as a surrogate for mammalian influenza
. Phi-X174 virus – a DNA based bacteriophage that infects E.coli that is used as a surrogate model for HIV. HCV

Controls were run to establish a stable baseline of aerosolized microorganisms. Kill rates were measured in triplicate at regular intervals by sampling air from the chamber

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until a 4-5 log reduction in viable organism was measured. The MDU/Rx™ resulted in a 4 log or greater kill rate for all organisms tested within two hours.

Conclusion:

The performance testing demonstrates that the MDU/Rx™ medical device is substantially equivalent to the FDA approved claimed predicate devices, the RxAir 3000 and the ECO RX-400.

Footnotes

1. "The History of Ultraviolet Germicidal Irradiation for Air Disinfection", Nicholas G. Reed, Public Health Rep. 2010 Jan-Feb; 125(1): 15-27.

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).