ViroZap Indoor Air Purifier, In Duct Model 1008

K241140 · Applied Photonix, LLC · FRA · Aug 1, 2024 · General Hospital

Device Facts

• Record ID: K241140
• Device Name: ViroZap Indoor Air Purifier, In Duct Model 1008
• Applicant: Applied Photonix, LLC
• Product Code: FRA · General Hospital
• Decision Date: Aug 1, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The ViroZap™ Indoor Air Purifier, In Duct Model 1008 is a device intended for medical purposes that is used to destroy microorganisms entrained on the filter through a photochemical reaction in the air by exposure to UV-A radiation.

Device Story

In-duct air purifier for medical facilities; utilizes photo-electrochemical (PEC) technology to destroy airborne microorganisms. System comprises pre-filter, UV-A LED lamps (320-400 nm), and catalytic filter coated with TiO2 and plasmonic nanoparticles. Installed in HVAC ducts; operates by drawing air through filter where UV-A light activates photocatalyst, inducing photochemical reaction to destroy entrained pathogens. Benefits patient/staff by reducing bioaerosol levels in clinical environments. No user-facing software or clinical decision-making output; device functions as passive infrastructure component.

Clinical Evidence

Bench testing only. Efficacy demonstrated via bioaerosol chamber studies using six microorganism species (bacteria, viruses, mold spores, endospores). Testing confirmed >4.0 log reduction in kill kinetics at various temperatures and effective reduction of airborne bioaerosols in a 9.1' x 9.1' x 7' chamber. Accelerated aging studies (equivalent to one year) confirmed performance stability.

Technological Characteristics

In-duct medical air purifier; metal housing; pre-filter; UV-A LED light source (320-400 nm); catalytic filter (TiO2 + plasmonic nanoparticles) on metal wire mesh. Power: 120/220V, up to 1.25A, 240W. Dimensions: 28.5"x12.25" or 24"x12.25". UL compliant electronics.

Indications for Use

Indicated for destruction of microorganisms (Staphylococcus epidermidis, Klebsiella aerogenes, MS2 virus, Phi-X174 virus, Aspergillus brasiliensis mold spores, and Bacillus subtilis endospores) entrained on the filter in medical facilities.

Regulatory Classification

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.

Predicate Devices

• Transformair Indoor Air Purifier (K161468)

Submission Summary (Full Text)

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August 1, 2024

Applied Photonix, LLC % Jeffrey Shapiro King & Spalding LLP 1700 Pennsylvania Avenue, NW Suite 900 Washington DC 20006

Re: K241140

Trade/Device Name: ViroZap™ Indoor Air Purifier, In Duct Model 1008 Regulation Number: 21 CFR 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: Class II Product Code: FRA Dated: May 16, 2024 Received: May 16, 2024

Dear Jeffrery Shapiro:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Katharine Segars -S

Katharine Segars, PhD Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

#### K241140

Device Name

ViroZap™ Indoor Air Purifier, In Duct Model 1008

Indications for Use (Describe)

The ViroZap™ Indoor Air Purifier, In Duct Model 1008 is a device intended for medical purposes that is used to destroy microorganisms entrained on the filter through a photochemical reaction in the air by exposure to UV-A radiation.

The ViroZap™ Indoor Air Purifier, In Duct Model 1008 has been demonstrated to destroy Staphylococcus epidermidis, Klebsiella aerogenes, MS2 - a non-enveloped ssRNA virus, Phi-X174 - a non-enveloped ssDNA virus, Aspergillus brasiliensis mold spores, and Bacillus subtilis endospores entrained on the filter under the following exposure conditions:

| Organism | Name | Average Maximum Log Reduction / Exposure Time<br>(hours) by Temperature | | |
|------------------------|-------------------------------|-------------------------------------------------------------------------|------------------|------------------|
| | | 45°F | 72°F | 110°F |
| Bacteria | Staphylococcus<br>epidermidis | 4.94 / 12 hours | 4.54 / 4 hours | 4.51 / 4 hours |
| Bacteria | Klebsiella aerogenes | 5.40 / 1 hour | 6.55 / 1 hour | 6.54 / 1 hour |
| Virus | MS2 bacteriophage | 4.32 / 12 hours | 4.51 / 4 hours | 4.58 / 4 hours |
| Virus | Phi-X174 bacteriophage | 4.39 / 12 hours | 5.24 / 4 hours | 5.14 / 4 hours |
| Mold endospore | Aspergillus brasiliensis | 4.52 / 168 hours | 5.61 / 168 hours | 5.61 / 168 hours |
| Bacterial<br>endospore | Bacillus Subtilis | 4.83 / 168 hours | 4.21 / 168 hours | 4.34 / 168 hours |

The ViroZap™ Indoor Air Purifier, In Duct Model 1008 has been demonstrated to destroy Staphylococcus epidermidis, Klebsiella aerogenes, MS2, Phi-X174, Aspergillus brasiliensis, and Bacillus subtilis in a large chamber (9.1 ft x 9.1 ft x 7 ft) at a flow rate of 500 cfm (cubic feet per minute):

| Organism | Name | Average Net Log Reduction<br>in 20 Minutes |
|---------------------|----------------------------|--------------------------------------------|
| Bacteria | Staphylococcus epidermidis | 5.17 |
| Bacteria | Klebsiella aerogenes | 5.56 |
| Virus | MS2 bacteriophage | 5.00 |
| Virus | Phi-X174 bacteriophage | 5.34 |
| Mold endospore | Aspergillus brasiliensis | 4.50 |
| Bacterial endospore | Bacillus Subtilis | 4.58 |

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Prescription Use (Part 21 CFR 801 Subpart D)

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Image /page/4/Picture/0 description: The image shows the logo for Applied Photonix. The logo consists of a row of five red squares above the words "APPLIED" and "PHOTONIX", which are stacked on top of each other. The words are in a serif font and are black.

# 510(k) SUMMARY

# ViroZap™ Indoor Air Purifier, In Duct Model 1008

# K241140

Submitter:

| Company Name: | Applied Photonix, LLC |
|-------------------------------------|-------------------------------------------------------------|
| Company Address: | 3802 Spectrum Blvd.<br>Suite 202-1<br>Tampa, FL 33612 |
| Contact Person:<br>Phone:<br>Email: | Dr. D. Yogi Goswami<br>352-871-3800<br>[e-mail] |
| Date Prepared: | August 1, 2024 |
| Device: | |
| Proprietary Name: | ViroZapTM Indoor Air Purifier, In Duct Model 1008 |
| Common or Usual Name: | Air purifier ultraviolet or ultraviolet air purifier |
| Classification Name: | Medical Ultraviolet Air Purifier |
| Regulation Number: | 21 C.F.R. § 880.6500 |
| Product Code: | FRA |
| Device Class: | Class 2 |
| Category: | General Hospital |

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Image /page/5/Picture/0 description: The image shows the logo for Applied Photonix. The logo consists of five red squares in a row above the words "APPLIED" and "PHOTONIX", which are stacked on top of each other. The words are in a simple, sans-serif font and are black in color.

Predicate Device: The predicate device is shown in the following table:

| Predicate Device | Transformair Indoor Air Purifier |
|---------------------|----------------------------------|
| Manufacturer | Transformair, Inc. |
| 510(k) Number | K161468 |
| Regulation Number | 21 C.F.R. § 880.6500 |
| Regulation Name | Medical Ultraviolet Air Purifier |
| Regulatory Class | II |
| Product Code | FRA |
| Review Panel | General Hospital |
| Combination Product | No |

## Intended Use / Indications for Use:

The ViroZap™ Indoor Air Purifier, In Duct Model 1008 is a device intended for medical purposes that is used to destroy microorganisms entrained on the filter through a photochemical reaction in the air by exposure to UV-A radiation.

The ViroZap™ Indoor Air Purifier, In Duct Model 1008 has been demonstrated to destroy Staphylococcus epidermidis, Klebsiella aerogenes, MS2 - a non-enveloped ssRNA virus, Phi-X174 - a non-enveloped ssDNA virus, Aspergillus brasiliensis mold spores, and Bacillus subtilis endospores entrained on the filter under the following exposure conditions:

| Organism | Name | Average Maximum Log Reduction / Exposure Time<br>(hours) by Temperature | | |
|------------------------|-------------------------------|-------------------------------------------------------------------------|------------------|------------------|
| | | 45°F | 72°F | 110°F |
| Bacteria | Staphylococcus<br>epidermidis | 4.94 / 12 hours | 4.54 / 4 hours | 4.51 / 4 hours |
| Bacteria | Klebsiella aerogenes | 5.40 / 1 hour | 6.55 / 1 hour | 6.54 / 1 hour |
| Virus | MS2 bacteriophage | 4.32 / 12 hours | 4.51 / 4 hours | 4.58 / 4 hours |
| Virus | Phi-X174 bacteriophage | 4.39 / 12 hours | 5.24 / 4 hours | 5.14 / 4 hours |
| Mold endospore | Aspergillus brasiliensis | 4.52 / 168 hours | 5.61 / 168 hours | 5.61 / 168 hours |
| Bacterial<br>endospore | Bacillus Subtilis | 4.83 / 168 hours | 4.21 / 168 hours | 4.34 / 168 hours |

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Image /page/6/Picture/0 description: The image shows the logo for Applied Photonix. The logo consists of a row of five red squares above the words "APPLIED" and "PHOTONIX", which are stacked on top of each other. There is a thin black line above the word "PHOTONIX".

The ViroZap™ Indoor Air Purifier, In Duct Model 1008 has been demonstrated to destroy Staphylococus epidermidis, Klebsiella aerogenes, MS2, Phi-X174, Aspergillus brasiliensis, and Bacillus subtilis in a large chamber (9.1 ft x 9.1 ft x 7 ft) at a flow rate of 500 cfm (cubic feet per minute):

| Organism | Name | Average Net Log Reduction<br>in 20 Minutes |
|------------------------|----------------------------|--------------------------------------------|
| Bacteria | Staphylococcus epidermidis | 5.17 |
| Bacteria | Klebsiella aerogenes | 5.56 |
| Virus | MS2 bacteriophage | 5.00 |
| Virus | Phi-X174 bacteriophage | 5.34 |
| Mold endospore | Aspergillus brasiliensis | 4.50 |
| Bacterial<br>endospore | Bacillus Subtilis | 4.58 |

# Device Description:

The ViroZap™ Indoor Air Purifier, In Duct Model 1008 is a medical ultraviolet air purifier, which incorporates patented photo-electrochemical or photo-electrocatalyst (PEC) ultraviolet air purification technology that destroys bacteria in air in medical facilities. It consists of a pre-fiter, UV-A lamps, and a catalytic filter coated with a photocatalyst. The ViroZap™ has metal housing with electronic controls, and it is installed in the ducts of a building's HVAC system.

It will be available in two sizes: one size with outer dimensions of 28.5 inches by 12.25 inches, and a second size with outer dimensions of 24 inches by 12.25 inches. The ViroZap 110 device has a pre-filter and a chamber equipped with 6 low energy ultraviolet LED lights (UV-A), which emit light with wavelengths between 320-400 nm, and a catalytic filter.

## Technological Characteristics Comparison:

Compared to the predicate device (K161468), the subject device has the same intended use but differs in the catalytic filter, light source, and the organisms demonstrated to be destroyed by the device (identified in the indications for use statement). The table below provides a comparison of the subject device and predicate device.

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Image /page/7/Picture/0 description: The image shows the logo for Applied Photonix. The logo consists of a row of five red squares above the words "APPLIED" and "PHOTONIX", which are stacked on top of each other. The text is in a simple, sans-serif font.

Office: (813) 825 - 1790

| Element for<br>Comparison | Predicate:<br>Transformair Indoor<br>Air Purifier; Model<br>16108<br>(K161468) | Subject Device:<br>ViroZapTM; Indoor Air<br>Purifier, In Duct Model<br>1008<br>(K241140) | Comparison |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product type | Medical Ultraviolet Air<br>Purifier | Medical Ultraviolet Air<br>Purifier | Identical |
| Regulation<br>Number | 21 C.F.R. § 880.6500 | 21 C.F.R. § 880.6500 | Identical |
| Indications<br>for Use | The Transformair Indoor<br>Air Purifier, In Duct<br>Model 16108 is a device<br>intended for medical<br>purposes that is used to<br>destroy microorganisms<br>entrained on the filter<br>through a photochemical<br>reaction in the air by<br>exposure to UV-A<br>radiation.<br><br>Transformair Indoor Air<br>Purifier, In Duct Model<br>16108 has been<br>demonstrated to destroy<br>Staphylococcus<br>epidermidis - a Gram<br>positive bacterium,<br>Escherichia coli – a Gram<br>negative bacterium, MS2,<br>Phi-X174, Aspergillus<br>Niger mold spores and<br>Bacillus globigii<br>endospores entrained on<br>the filter of the subject<br>device under the exposure<br>conditions described<br>above. | The ViroZapTM Indoor Air<br>Purifier, In Duct Model<br>1008 is a device intended<br>for medical purposes that<br>is used to destroy<br>microorganisms entrained<br>on the filter through<br>photochemical reaction in<br>the air by exposure to UV-<br>A radiation.<br><br>The ViroZapTM Indoor Air<br>Purifier, In Duct Model<br>1008 has been<br>demonstrated to destroy<br>Staphylococcus<br>epidermidis - a Gram<br>positive bacterium,<br>Klebsiella Aerogenes – a<br>Gram negative bacterium,<br>MS2 – a non-enveloped<br>ssRNA virus, Phi-X174 –<br>a non-enveloped ssDNA<br>virus, Bacillus subtilis<br>endospores, and<br>Aspergillus brasiliensis<br>mold spores under the<br>exposure conditions<br>described above. | Similar: The proposed<br>device and the predicate<br>device have the same<br>indications for use, except<br>there are minor differences<br>in the microorganisms<br>demonstrated to be<br>destroyed by the devices.<br>Both devices are<br>demonstrated to destroy a<br>Gram positive bacterium, a<br>Gram negative bacterium,<br>a non-enveloped ssRNA<br>virus, a non-enveloped<br>ssDNA virus, mold spores,<br>and endospores. |
| Element for<br>Comparison | Predicate:<br>Transformair Indoor<br>Air Purifier; Model<br>16108<br>(K161468) | Subject Device:<br>ViroZap™; Indoor Air<br>Purifier, In Duct Model<br>1008<br>(K241140) | Comparison |
| Mechanism<br>of Action | UV light of sufficient<br>energy (UV-A) activates<br>photocatalyst that destroys<br>microorganisms entrained<br>on the filter through a<br>photochemical reaction<br>that is enhanced by a metal<br>wire mesh. | UV light of sufficient<br>energy (UV-A LED)<br>activates photocatalyst that<br>destroys microorganisms<br>entrained on the filter<br>through a photochemical<br>reaction that is enhanced<br>by a metal wire mesh. | Identical |
| Use Location | Medical Facilities | Medical Facilities | Identical |
| Installation | In-Duct | In-Duct | Identical |
| Pre-Filter | Standard UL listed air<br>filter | Standard UL listed air<br>filter | Identical |
| Photocatalyst | Catalytic filter coated with<br>TiO2 and held in a metal<br>wire mesh | Catalytic filter coated with<br>TiO2 and plasmonic<br>nanoparticles, and held in<br>a metal wire mesh | Similar: Both the<br>proposed and predicate<br>device use a catalytic filter<br>coated with TiO2. The<br>plasmonic nanoparticle<br>coating was added to the<br>catalytic filter in the<br>proposed device to<br>enhance light capture. |
| Disinfecting | Catalytic filter | Catalytic filter | Similar: Both the<br>proposed and predicate<br>device use a catalytic filter<br>coated with TiO2. The<br>plasmonic nanoparticle<br>coating was added to the<br>catalytic filter in the<br>proposed device to<br>enhance light capture. |
| Element for<br>Comparison | Predicate:<br>Transformair Indoor<br>Air Purifier; Model<br>16108<br>(K161468) | Subject Device:<br>ViroZap™; Indoor Air<br>Purifier, In Duct Model<br>1008<br>(K241140) | Comparison |
| Light source | UV-A fluorescent tube<br>(~320-400 nm) | UV-A LED tube (~320-<br>400 nm) | Similar: The predicate<br>device uses a UV-A<br>fluorescent tube, and the<br>proposed device uses a<br>UV-A LED tube with the<br>same UV-A wavelength<br>and intensity. |
| Voltage | Up to 120/220 Volt (Plugs<br>into standard outlet) | Up to 120/220 Volt (Plugs<br>into standard outlet) | Identical |
| Current | Up to 1.25 amps | Up to 1.25 amps | Identical |
| Power<br>Consumption | Up to 240 Watts | Up to 240 Watts | Identical |
| Air cleaning<br>chamber | Particulate pre-filter, UV-<br>A lamps and a catalytic<br>filter | Particulate pre-filter, UV-<br>A lamps and a catalytic<br>filter | Identical |
| Electronics | UL compliant | UL compliant | Identical |
| Outer<br>Dimensions | 28.5 inches by 21 inches<br>by 12.25 inches | 28.5 inches by 21 inches<br>by 12.25 inches, and 24<br>inches by 24 inches by<br>12.25 inches | Identical and Additional<br>Size:<br>An additional size will be<br>offered for the proposed<br>device to fit inside<br>additional building ducts. |

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Image /page/8/Picture/0 description: The image shows the logo for Applied Photonix. The logo consists of five red squares arranged horizontally above the company name. The words "APPLIED" and "PHOTONIX" are stacked vertically, with "APPLIED" on top and "PHOTONIX" below.

Office: (813) 825 - 1790

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Image /page/9/Picture/0 description: The image shows the logo for Applied PhotoniX. The logo consists of five red squares arranged horizontally above the words "APPLIED" and "PHOTONIX", which are stacked vertically. The text is in a simple, sans-serif font.

Office: (813) 825 - 1790

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Image /page/10/Picture/0 description: The image shows the logo for Applied Photonix. The logo consists of a row of five red squares above the words "APPLIED" and "PHOTONIX", which are stacked on top of each other. The text is in a simple, sans-serif font.

# Summary of Non-Clinical Testing:

| Test | Brief Description | Acceptance Criteria | Results (Pass/Fail) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Study to characterize the<br>efficacy of the subject<br>device to reduce<br>respirable bioaerosol<br>levels for six broad-<br>ranged species of<br>microorganisms from<br>room air. | Six microorganism species<br>were aerosolized in a<br>sealed bioaerosol chamber<br>containing the subject<br>device.<br><br>Bioaerosol samples were<br>taken at multiple time<br>points throughout each<br>trial, in order to quantify<br>the reduction rate<br>capability of the device. | Confirmation that the<br>effectiveness of the<br>device against ssRNA<br>virus, ssDNA virus,<br>Gram negative<br>bacteria, Gram positive<br>bacteria, bacteria<br>endospores, and mold<br>spores was equivalent<br>or superior to the<br>predicate, Transformair<br>(Κ161468). | Pass<br><br>The subject device was<br>effective in reducing a<br>broad range of airborne<br>microorganisms within<br>a short period of time. |
| In vitro study to<br>characterize the<br>temperature variant kill<br>rate kinetics for six<br>different bioaerosols<br>deposited on the surface<br>of the subject device's<br>photocatalytic coated<br>filter media after<br>exposure to UV-A light. | Samples of the subject<br>device's photocatalytic<br>coated filter media were<br>tested against six<br>aerosolized<br>microorganisms.<br><br>The samples were tested at<br>three different<br>temperatures. The kill<br>kinetic testing was<br>assessed at multiple<br>sampling points to create a<br>reduction curve with each<br>species at each<br>temperature. The trials<br>were carried out to<br>quantify at least a 4.0 log<br>reduction | Confirmation that the<br>kill kinetics of the<br>modified catalytic filter<br>was equivalent or<br>superior to the<br>predicate device<br>catalytic filter. | Pass<br><br>As with the predicate<br>device, the filter media<br>achieved more than a<br>4.0 log reduction in<br>each species at each<br>temperature. |

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Image /page/11/Picture/0 description: The image shows the logo for Applied Photonix. The logo consists of six red squares arranged horizontally above the company name. The words "APPLIED" and "PHOTONIX" are stacked vertically, with a horizontal line separating them.

Office: (813) 825 - 1790

| Test | Brief Description | Acceptance Criteria | Results (Pass/Fail) |
|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test to evaluate the<br>efficacy of filter media<br>following accelerated<br>aging equivalent to one<br>year. | A microorganism was<br>aerosolized into a sealed<br>environment containing the<br>subject device. Bioaerosol<br>samples were taken at<br>multiple time points<br>throughout each trial to<br>quantify the reduction rate<br>capability of the device. | Confirmation that the<br>subject device had<br>equivalent performance<br>after accelerated aging<br>equivalent to one year. | Pass<br><br>The subject device was<br>effective at reducing<br>the microorganism<br>after undergoing<br>accelerated aging. The<br>results from the aged<br>device were equivalent<br>to trials run on the<br>unaged device. |

## Clinical Testing: N/A

### Substantial Equivalence Discussion:

The proposed device and the predicate device have the same indications for use, except there are minor differences in the microorganisms demonstrated to be destroyed by the devices. The minor differences do not constitute a new intended use because both devices are demonstrated to destroy a Gram positive bacterium, a Gram negative bacterium, a non-enveloped ssRNA virus, a nonenveloped ssDNA virus, mold spores, and endospores.

The subject device has a catalytic filter with a coating consisting of TiO2 mixed with plasmonic nanoparticles, whereas the prior cleared version has only a TiO2 coating. Plasmonic nanoparticles are added to improve light capture and thereby performance of the filter. This is demonstrated by testing the subject device using the same lab and test methods that were used for the predecessor. predicate. This change improves device performance and does not raise different questions of safety or effectiveness.

The change from fluorescent to LED UV-A bulbs does not raise different questions of safety or effectiveness since the identical UV-A light (at 365 nm wavelength) is still being delivered.

The subject device is therefore substantially equivalent to the predicate device.

#### Conclusion:

Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device (K161468), Class II (21 CFR 880.6500), product code FRA.