Purgo

K223328 · Aeroclean Technologies, Inc. · FRA · Nov 30, 2022 · General Hospital

Device Facts

• Record ID: K223328
• Device Name: Purgo
• Applicant: Aeroclean Technologies, Inc.
• Product Code: FRA · General Hospital
• Decision Date: Nov 30, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6500
• Device Class: Class 2

Indications for Use

Pūrgo™ is a combination UV and air filtration device, equipped with UV-C LEDs and a True HEPA filter intended for the reduction of bacteria, virus, fungal spores, and particles in air for use in medical facilities and other indoor spaces. Pūrgo™ is non-sterile.

Device Story

Pūrgo™ is a free-standing air disinfection system for medical and home use. It pulls ambient air through a multi-layer filter cartridge (pre-filter, activated carbon, HEPA) to remove particulates; remaining air passes through a proprietary SteriDuct chamber containing 265 nm UV-C LEDs. UV-C irradiation damages microbial RNA/DNA to neutralize pathogens. Device includes sensors for UV irradiance and airflow; touch panel interface for fan speed (sleep, normal, boost) and status monitoring. Safety features include interlock switches (door/filter presence) and diffuser panels to prevent UV exposure and fan contact. Output is purified air returned to the room. Device is designed for rooms up to 3000 ft³; does not disturb laminar airflow in surgical suites. Benefits include reduction of airborne pathogens like SARS-CoV-2, bacteria, and fungal spores.

Clinical Evidence

No clinical data. Bench testing only. Efficacy demonstrated via log reduction testing of aerosolized biologicals (Gram+ bacteria, Gram- bacteria, RNA/DNA viruses, fungal spores) including SARS-CoV-2. Fractional efficiency testing per IEST-RP-CC001.6 confirmed 99.995% filter efficiency at 0.1-0.2 µm. Electrical safety, EMC, ozone emissions, and laminar airflow impact verified per applicable standards (UL 507, IEC 60601-1, IEC 60601-1-2).

Technological Characteristics

Free-standing air purifier. Multi-layer filter (pre-filter, activated carbon, HEPA). UV-C LED source (265 nm, 110 mW total power, 0.24 mW/cm² irradiance). Centrifugal fan. 120V power. Dimensions: 25.8"H x 19.5"W x 10.6"D. Standards: UL 507, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEST-RP-CC001.6. Firmware-controlled operation.

Indications for Use

Indicated for reduction of bacteria, virus, fungal spores, and particles in air in medical facilities and indoor spaces (including home healthcare). Suitable for use by healthcare professionals and lay users.

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

• Pūrgo™ (K213753)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 30, 2022

AeroClean Technologies, Inc. % Rita King CEO MethodSense, Inc. 1 Copley Pkwy. Ste. 410 Morrisville, North Carolina 27560

Re: K223328

Trade/Device Name: Purgo™M Regulation Number: 21 CFR 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: Class II Product Code: FRA Dated: October 27, 2022 Received: October 31, 2022

Dear Rita King:

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); 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 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.

Christopher K. Dugard -S

for Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

#### Enclosure

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# Indications for Use

510(k) Number (if known) K223328

Device Name Pūrgo™

#### Indications for Use (Describe)

Purgo is a combination UV and air filtration device, equipped with UV-C LEDs and a True HEPA filter intended for the reduction of bacteria, virus, fungal spores, and particles in air for use in medical facilities and other indoor spaces. Purgo is non-sterile.

Purgo has been demonstrated to remove the following organisms under the following exposure conditions:

| Organism | Name | Avg. max log reduction / exposure<br>time (min) |
|-----------------|-----------------------------------------------------|-------------------------------------------------|
| Gram + Bacteria | Methicillin resistant Staphylococcus<br>epidermidis | 4.6 (45) at normal speed |
| Gram + Bacteria | Bacillus globigii endospore | 4.1 (60) at normal speed |
| Gram - Bacteria | Escherichia coli | 5.4 (45) at normal speed |
| RNA Virus | MS2 bacteriophage | 5.4 (60) at normal speed |
| RNA Virus | SARS-CoV-2 | 4.2 (60) at normal speed |
| DNA Virus | Phi-X174 bacteriophage | 4.4 (45) at normal speed |
| Fungal Spore | Aspergillus brasiliensis spore | 4.3 (90) at normal speed |

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for AeroClean. The logo is in blue and consists of the word "AeroClean" in a sans-serif font. Below the word "AeroClean" is the phrase "Pathogen Elimination Technologies" in a smaller, lighter blue font. To the left of the word "AeroClean" are three horizontal lines that appear to be moving from left to right.

# 510(k) Summary

# K223328

## AeroClean Technologies, Inc.

This 510(k) Summary is in conformance with 21CFR 807.92

| Submitter: | AeroClean Technologies, Inc.<br>10455 Riverside Drive, Suite 100<br>Palm Beach Gardens, FL 33410 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King, CEO<br>MethodSense, Inc.<br>Email: [e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| Company Contact: | Richard Foster<br>Title: Senior Director Quality and Regulatory Affairs<br>Email: [e-mail]<br>Phone: [phone] |
| Date Prepared: | November 29, 2022 |
| Trade Name: | Pūrgo™ |
| Common Name: | Purifier, Air, Ultraviolet, Medical |
| Classification: | Class II |
| Regulation Number: | 21 CFR 880.6500 |
| Classification Panel: | General Hospital |
| Product Code: | FRA |

### Predicate Device:

| Trade Name | Primary Predicate |
|---------------------------|-------------------------------------|
| Trade Name | Pūrgo™ |
| Common Name | Purifier, Air, Ultraviolet, Medical |
| 510(k) Submitter / Holder | AeroClean Technologies, Inc. |
| 510(k) Number | K213753 |
| Regulation Number | 21 CFR 880.6500 |
| Classification Panel | General Hospital |
| Product Code | FRA |

The primary predicate device has not been subject to a design-related recall.

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Image /page/4/Picture/0 description: The image shows the logo for AeroClean. The logo is in blue and consists of the word "AeroClean" in a sans-serif font. Below the word "AeroClean" is the phrase "Pathogen Elimination Technologies" in a smaller, lighter blue font. To the left of the word "AeroClean" is a horizontal line that is slightly angled upwards.

### Device Description

Pūrgo™ is a free-standing air disinfection system employing two technologies for purifying air: HEPA filtration and UV-C light irradiation, removing or destroying bacteria and viruses in air. Pūrgo™ may be used in medical facilities and commercial home healthcare environments. Pūrgo™'s main components consist of:

- LED UV-C lamps that generate irradiation to destroy microorganisms that are not . filtered;
- . a proprietary SteriDuct chamber that intensifies the UV-C light to destroy microbiological material:
- a filtration system with pre-filter, activated carbon filter, and HEPA filter; .
- . a motor / impeller to move air through the filtration system;
- . sensors to monitor UV irradiance and airflow:
- . an electronic control system to power and control the device; and
- . a touch panel interface equipped with LEDs to indicate the working status of the device.

Pūrgo™ has several built-in safety features that will prevent operation of the filter cartridge is not in place or if the filter door is not closed. The unit also incorporates UV and airflow sensors that provide warnings to the user if the device is not performing as designed to purify air.

Pūrgo™ pulls air through a filter cartridge and then passes the filtered air through a chamber containing UV-C light to neutralize remaining airborne microorganisms (such as bacteria, viruses, and funqi). The filter cartridge contains a series of three filters, the first of which is a pre-filter that removes physically large particulate matter (such as dust) and protects the finer particle filters downstream. This is followed by an Activated Carbon filter. Finally, a HEPA (highefficiency particulate air) filter that removes 99.995% of the remaining airborne particles above a particle size of 0.1 µm.

Any microbes that still manage to make it through the filters, pass through the SteriDuct chamber where they are subjected to Ultraviolet Radiation at 265 nm (UV-C). UV radiation at this wavelength is particularly effective at destroying microbes. UV-C irradiation has been shown to damage the microbe's RNA and DNA genetic materials sufficiently to prevent the microbe's ability to reproduce.

After passing through the filtration and SteriDuct UV-C chamber, the purified air then exits back into the room. The exit air does not destroy laminar air flow in a typical operating room environment.

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Image /page/5/Picture/0 description: The image shows the logo for AeroClean. The logo consists of the word "AeroClean" in a dark blue sans-serif font, with a light blue horizontal line extending from the left side of the "A". Below the word "AeroClean" is the phrase "Pathogen Elimination Technologies" in a smaller, light blue sans-serif font. The logo is simple and modern, and the colors are clean and professional.

## Indications for Use

Pūrgo™ is a combination UV and air filtration device, equipped with UV-C LEDs and a True HEPA filter intended for the reduction of bacteria, virus, fungal spores, and particles in air for use in medical facilities and other indoor spaces. Pūrgo™ is non-sterile.

Pūrgo™ has been demonstrated to remove the following organisms under the following exposure conditions:

| Organism | Name | Avg. max log reduction /<br>exposure time (min) |
|-----------------|-----------------------------------------------------|-------------------------------------------------|
| Gram + Bacteria | Methicillin resistant Staphylococcus<br>epidermidis | 4.6 (45) at normal speed |
| Gram + Bacteria | Bacillus globigii endospore | 4.1 (60) at normal speed |
| Gram - Bacteria | Escherichia coli | 5.4 (45) at normal speed |
| RNA Virus | MS2 bacteriophage | 5.4 (60) at normal speed |
| RNA Virus | SARS-CoV-2 | 4.2 (60) at normal speed |
| DNA Virus | Phi-X174 bacteriophage | 4.4 (45) at normal speed |
| Fungal Spore | Aspergillus brasiliensis spore | 4.3 (90) at normal speed |

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Image /page/6/Picture/0 description: The image contains the logo for AeroClean. The logo consists of the word "AeroClean" in a large, bold, sans-serif font, with the first letter "A" having a stylized horizontal line extending to the left. Below the main logo, in a smaller font size, is the text "Pathogen Elimination Technologies". The colors used are shades of blue and gray.

## Summary of Technological Characteristics compared to Predicate Device

| Characteristic | Subject Device<br>Pūrgo™ (K223328) | Primary Predicate Device<br>Pūrgo™ (K213753) | Comparison |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | To remove and destroy, by exposure to UV<br>radiation, bacteria and viruses in interior<br>spaces. | To remove and destroy, by exposure to UV<br>radiation, bacteria and viruses in interior<br>spaces. | Identical |
| Indications for<br>Use | Pūrgo™ is a combination UV and air filtration<br>device, equipped with UV-C LEDs and a True<br>HEPA filter intended for the reduction of<br>bacteria, virus, fungal spores, and particles in<br>air for use in medical facilities and other indoor<br>spaces. Pūrgo™ is non-sterile. | Pūrgo™ is a combination UV and air filtration<br>device, equipped with UV-C LEDs and a True<br>HEPA filter intended for the reduction of<br>bacteria, virus, fungal spores, and particles in<br>air for use in medical facilities and other indoor<br>spaces. Pūrgo™ is non-sterile. | Equivalent<br>The subject device<br>is also indicated for<br>use in removing<br>SARS-CoV-2.<br>The safety and<br>effectiveness of this<br>additional indication<br>for use has been<br>demonstrated<br>through<br>microorganism<br>performance testing. |
| | Pūrgo™ has been demonstrated to remove the<br>following organisms under the following<br>exposure conditions: | Pūrgo™ has been demonstrated to remove the<br>following organisms under the following<br>exposure conditions: | |
| | Avg. max log reduction / exposure time (min):<br>Methicillin resistant Staphylococcus epidermidis<br>4.6 (45) at normal speed | Avg. max log reduction / exposure time (min):<br>Methicillin resistant Staphylococcus epidermidis<br>4.6 (45) at normal speed | |
| | Bacillus globigii endospore 4.1 (60) at normal<br>speed | Bacillus globigii endospore 4.1 (60) at normal<br>speed | |
| | Escherichia coli 5.4 (45) at normal speed | Escherichia coli 5.4 (45) at normal speed | |
| | MS2 bacteriophage 5.4 (60) at normal speed | MS2 bacteriophage 5.4 (60) at normal speed | |
| | SARS-CoV-2 4.2 (60) at normal speed | | |
| | Phi-X174 bacteriophage 4.4 (45) at normal<br>speed | Phi-X174 bacteriophage 4.4 (45) at normal<br>speed | |
| | Aspergillus brasiliensis spore 4.3 (90) at normal<br>speed | Aspergillus brasiliensis spore 4.3 (90) at normal<br>speed | |
| User | Healthcare Professional<br>Lay User | Healthcare Professional<br>Lay User | Identical |
| Characteristic | Subject Device<br>Pūrgo™ (K223328) | Primary Predicate Device<br>Pūrgo™ (K213753) | Comparison |
| Environment of<br>Use | Hospital and other healthcare setting.<br>General Surgery Setting.<br>Home healthcare. | Hospital and other healthcare setting.<br>General Surgery Setting.<br>Home healthcare. | Identical |
| Placement | Pūrgo™ will work in any room, but giving it a<br>space in a central location is recommended.<br>Placement near the patient is key.<br>Pūrgo™ may be used in surgical suites.<br>Pūrgo™ is designed for rooms up to 3000 ft3. | Pūrgo™ will work in any room, but giving it a<br>space in a central location is recommended.<br>Placement near the patient is key.<br>Pūrgo™ may be used in surgical suites.<br>Pūrgo™ is designed for rooms up to 3000 ft3. | Identical |
| User Control | Touch panel with selections for 3 fan speeds,<br>power button, timer, and UV and airflow<br>indicators. | Touch panel with selections for 3 fan speeds,<br>power button, timer, and UV and airflow<br>indicators. | Identical |
| Software | Basic Firmware; used to turn the unit on, off,<br>change fan speed, and other administrative<br>functions (timer, UV and airflow status). | Basic Firmware; used to turn the unit on, off,<br>change fan speed, and other administrative<br>functions (timer, UV and airflow status). | Identical |
| Mechanism of<br>Action | Air is pulled through a multi-layer filter (pre-<br>filter, activated carbon, HEPA) to remove<br>microorganisms and then into a UV chamber<br>(SteriDuct) containing UV-C light with sufficient<br>energy to kill any remaining microorganisms. | Air is pulled through a multi-layer filter (pre-<br>filter, activated carbon, HEPA) to remove<br>microorganisms and then into a UV chamber<br>(SteriDuct) containing UV-C light with sufficient<br>energy to kill any remaining microorganisms. | Identical |
| Installation | Free standing | Free standing | Identical |
| Filter | Pūrgo™ Filter:<br>• Multi-layer filter with 1/8" thick pre-filter, 1/8"<br>thick activated carbon filter, and HEPA filter<br>media<br>• Dimensions: 16.5" x 19.5" x 2.5"<br>HEPA filter:<br>• Number of pleats: 140<br>◦ Depth of pleats: 42mm<br>◦ Minimum filter media area: 61 sq ft | Pūrgo™ Filter:<br>• Multi-layer filter with 1/8" thick pre-filter, 1/8"<br>thick activated carbon filter, and HEPA filter<br>media<br>• Dimensions: 16.5" x 19.5" x 2.5"<br>HEPA filter:<br>• Number of pleats: 140<br>◦ Depth of pleats: 42mm<br>◦ Minimum filter media area: 61 sq ft | Identical |
| Characteristic | Subject Device<br>Pūrgo™ (K223328) | Primary Predicate Device<br>Pūrgo™ (K213753) | Comparison |
| Light Source | UV Type: UV-C UV Light Source: LED Wavelength: 265 nm Total of 4 UV LEDs Total UV Power: 110 mW SteriDuct Irradiance: 0.24 mW/cm² | UV Type: UV-C UV Light Source: LED Wavelength: 265 nm Total of 4 UV LEDs Total UV Power: 110 mW SteriDuct Irradiance (Minimum): 0.24 mW/cm² | Identical |
| Air Source | Centrifugal Fan | Centrifugal Fan | Identical |
| Flow Control | Three speeds (sleep, normal, boost) provide<br>minimum 125-315 CFM flow. | Three speeds (sleep, normal, boost) provide<br>minimum 125-315 CFM flow. | Identical |
| Device Air<br>Changes Per<br>Hour (ACH) | 1.875 – 2.36 device air changes per hour on<br>Boost, 250 - 315 CFM, in a 1000 ft² room. | 1.875 – 2.36 device air changes per hour on<br>Boost, 250 - 315 CFM, in a 1000 ft² room. | Identical |
| Fan Exposure<br>Safety Features | Diffuser panel on side of device and SteriDuct<br>cover behind filter door to block user from<br>accessing spinning fan without tools. Safety<br>feature confirmed by UL 507. | Diffuser panel on side of device and SteriDuct<br>cover behind filter door to block user from<br>accessing spinning fan without tools. Safety<br>feature confirmed by UL 507. | Identical |
| UV Light<br>Exposure Safety<br>Features | Safety interlock switch exists in filter door to<br>ensure if the door is open or if a filter is missing,<br>the unit will not operate. The purpose of these<br>switches is to protect the user from any<br>possibility of exposure to direct contact with UV<br>light. Safety feature confirmed by UL 507. | Safety interlock switch exists in filter door to<br>ensure if the door is open or if a filter is missing,<br>the unit will not operate. The purpose of these<br>switches is to protect the user from any<br>possibility of exposure to direct contact with UV<br>light. Safety feature confirmed by UL 507. | Identical |
| Input Voltage | 120 Volt | 120 Volt | Identical |
| Current | Up to 1.00 Amps | Up to 1.00 Amps | Identical |
| Power<br>Consumption | Up to 120 Watts | Up to 120 Watts | Identical |
| Characteristic | Subject Device<br>Pūrgo™ (K223328) | Primary Predicate Device<br>Pūrgo™ (K213753) | Comparison |
| Dimensions | Unit Dimensions:<br>25.8"H (27.5" with casters) x 19.5"W x 10.6"D<br><br>Filter Dimensions:<br>16.5" x 19.5" x 2.5" | Unit Dimensions:<br>25.8"H (27.5" with casters) x 19.5"W x 10.6"D<br><br>Filter Dimensions:<br>16.5" x 19.5" x 2.5" | Identical |
| Standards | UL 507 Standard for Electrical Fans<br><br>IEC 60601-1 Basic Safety and Essential<br>Performance<br><br>IEC 60601-1-2 EMC. EMC for Medical Devices<br><br>IEC 60601-1-11 Home Healthcare Environment<br><br>IEST-RP-CC001.6 HEPA and ULPA Filters | UL 507 Standard for Electrical Fans<br><br>IEC 60601-1 Basic Safety and Essential<br>Performance<br><br>IEC 60601-1-2 EMC. EMC for Medical Devices<br><br>IEC 60601-1-11 Home Healthcare Environment<br><br>IEST-RP-CC001.6 HEPA and ULPA Filters | Identical |

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Image /page/7/Picture/0 description: The image shows the logo for AeroClean. The logo is in a dark blue color and features the word "AeroClean" in a bold, sans-serif font. There are three horizontal lines to the left of the word "AeroClean". Below the word "AeroClean" is the phrase "Pathogen Elimination Technologies" in a smaller, lighter blue font.

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Image /page/8/Picture/0 description: The image shows the logo for AeroClean. The logo is in blue and consists of the word "AeroClean" in a sans-serif font. Below the word "AeroClean" is the phrase "Pathogen Elimination Technologies" in a smaller, lighter blue font. To the left of the word "AeroClean" is a horizontal line that is broken into three segments.

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Image /page/9/Picture/0 description: The image contains the logo for AeroClean. The logo consists of the word "AeroClean" in a bold, sans-serif font, with the "A" having a stylized swoosh to the left of it. Below the main logo, in a smaller font size, is the text "Pathogen Elimination Technologies". The colors used are primarily shades of blue.

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Image /page/10/Picture/0 description: The image shows the logo for AeroClean. The word "AeroClean" is written in a bold, sans-serif font, with the "Aero" part in a darker shade of blue than the "Clean" part. A light blue horizontal line extends from the left side of the "A" in "Aero". Below the main logo, in a smaller, lighter font, is the tagline "Pathogen Elimination Technologies".

#### Summary of Non-Clinical Testing

The Purgo™ was verified and validated previously for submission K213753. The documented Verification & Validation plans and protocols demonstrated conformance with established performance criteria. This submission includes testing that was not available for the Purgo™ device. See below for the type of tests performed. AeroClean has completed the following testing:

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Image /page/11/Picture/0 description: The image shows the logo for AeroClean. The logo consists of the word "AeroClean" in a dark blue sans-serif font. To the left of the word "AeroClean" is a light blue horizontal line. Below the word "AeroClean" is the phrase "Pathogen Elimination Technologies" in a light blue sans-serif font.

| Test Name | Applicable Standards | Purpose | Acceptance<br>Criteria | Results |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Microorganism<br>Performance<br>RNA Virus:<br>SARS-CoV-2<br>testing<br>performed | Internal Standards | Testing was performed to evaluate the<br>Pūrgo™'s efficacy against aerosolized<br>biologicals. Testing was performed with<br>the Pūrgo™ device in accordance with<br>the normal use of the system (i.e. both<br>the filtration and UV systems active at the<br>normal speed) with seven (7) different<br>aerosolized biologicals. Testing was<br>performed with two aerosolized<br>biologicals (MS2 and Bacillus globigii as<br>they are representative of the more<br>difficult biologicals to filter and destroy) at<br>the sleep and boost fan speeds to<br>demonstrate that the efficacy of the<br>device isn't compromised by changes in<br>fan speed.<br>Additional testing was conducted using<br>SARS-CoV-2 virus to confirm the testing<br>for the previously tested MS2 single<br>strand RNA viral category. | 4 log<br>reduction<br>(99.99%) | Average net log reduction / time<br>Methicillin resistant<br><i>Staphylococcus epidermidis</i> ,<br>4.6 / 45 / 60 mins at normal<br><i>Bacillus globigii</i> endospore,<br>4.1 / 60 mins at normal,<br>4.4 / 60 mins at sleep,<br>4.2 / 45 mins at boost<br><i>Escherichia coli</i> ,<br>5.4 / 45 mins at normal<br>MS2 bacteriophage,<br>5.4 / 60 mins at normal,<br>4.3 / 60 mins at sleep,<br>4.5 / 45 mins at boost<br>SARS-CoV-2,<br>4.2 / 60 mins at normal<br><i>Phi-X174</i> bacteriophage,<br>4.4 / 45 mins at normal<br><i>Aspergillus brasiliensis</i> spore,<br>4.3 / 90 mins at normal |
| Test Name | Applicable Standards | Purpose | Acceptance<br>Criteria | Results |
| Fractional<br>Efficiency<br>No additional<br>testing necessary | IEST-RP-CC001.6 -<br>HEPA and ULPA Filters | Fractional efficiency testing was<br>performed on the PūrgoTM filter and the<br>PūrgoTM device itself per IEST-RP-<br>CC001.6 TypeH test to determine the<br>fractional efficiency percentage of<br>particles of varying size ranges. | Per Standard | Filter: fractional efficiency<br>percentage of 99.995% at 0.1-0.2<br>μm<br>PūrgoTM Unit with Filter: fractional<br>efficiency percentage of 99.990%<br>at 0.1-0.2 µm |
| UV Intensity<br>No additional<br>testing necessary | Not Applicable | The UV intensity performance of the<br>PūrgoTM units was verified to ensure the<br>appropriate amount of UV irradiance is<br>achieved in the SteriDuct. | ≥ 0.240<br>mW/cm² | Pass |
| UV Irradiance<br>Exposure<br>No additional<br>testing necessary | American Conference of<br>Governmental Industrial<br>Hygienists (ACGIH) 2019<br>Threshold Limit Values<br>(TLVs) for Chemical<br>Substances and Physical<br>Agents and Biological<br>Exposure Indices (BEIs) | UV radiation testing and evaluation was<br>performed to measure the irradiance<br>values at each wavelength between 200-<br>400nm and determine the effective<br>irradiance of the UV radiation to ensure<br>UV exposure from the device is within<br>safe limits. | Per Standard | Testing demonstrated that when<br>operating in the normal condition<br>(filter in place), the unit meets<br>daily exposure limits (less than 0.1<br>µW/cm² for an 8 hour duration)<br>and is considered part of the<br>ANSI/IENSA RP-27.3-07 Exempt<br>Risk Group |
| Ozone<br>No additional<br>testing necessary | UL 867 - Electrostatic Air<br>Cleaners<br>UL ECVP 2998 Zero<br>Ozone Emissions for Air<br>Cleaners, 3rd edition -<br>2020 | Ozone testing was performed per UL 867<br>by monitoring the ozone concentration in<br>a test chamber at the highest fan speed<br>and lowest fan speed. | Per Standard | Testing demonstrates the PūrgoTM<br>unit is able to operate at less than<br>0.005 ppm at its highest and<br>lowest fan speed. |
| Test Name | Applicable Standards | Purpose | Acceptance Criteria | Results |
| Airflow Performance Evaluation<br>No additional testing necessary | Not Applicable | The airflow performance of the Pūrgo™ units was verified at the three fan speeds available to the user. | Sleep: min. 125 CFM<br>Normal: min. 200 CFM<br>Boost: min. 315 CFM | Pass |
| Laminar Airflow Evaluation<br>No additional testing necessary | Internal Standards | Computational fluid dynamics (CFD) was performed to evaluate airflow from the Pūrgo™ unit in a prototypical surgery room with the aim of determining combinations of Pūrgo™ unit positions and operating conditions that preserves the stable air curtain over the surgery table (i.e. does not disturb laminar flow). Flow rate, placement, and HVAC return duct position were considered in the analysis and | Pūrgo™ does not disturb laminar flow | Testing determined that optimal placement was near the outer wall of room (8' from the surgery table) for Pūrgo™ flow rates of 230 to 315 CFM. This is true regardless of whether HVAC return ducts were located near the ceiling or floor of the room. |
| Test Name | Applicable Standards | Purpose | Acceptance<br>Criteria | Results |
| Home<br>Healthcare<br>Environments<br>No additional<br>testing necessary | FDA Guidance "Design<br>Considerations for<br>Devices Intended for<br>Home Use" (November<br>24, 2014)<br>IEC 60601-1: Medical<br>electrical equipment -<br>Part 1: General<br>requirements for basic<br>safety and essential<br>performance; 2012<br>IEC 60601-1-11: Medical<br>electrical equipment -<br>Part 1-11: General<br>requirements for basic<br>safety and essential<br>performance - Collateral<br>Standard: Requirements<br>for medical electrical<br>equipment and medical<br>electrical systems used<br>in the home healthcare<br>environment; 2015 | FDA's Guidance "Design Considerations<br>for Devices Intended for Home Use"<br>(November 24, 2014) was followed for<br>the design and development of Pūrgo™<br>to ensure the home use device complies<br>with applicable standards of safety and<br>effectiveness and other regulatory<br>requirements. | Per Standards | Pass |
| Electrical Safety<br>No additional<br>testing necessary | UL 507: Standard for<br>Electric Fans<br>IEC 60601-1: Medical<br>electrical equipment -<br>Part 1: General<br>requirements for basic<br>safety and essential<br>performance; 2012 | Electrical safety testing was performed in<br>accordance with UL 507 and IEC 60601-<br>1. | Per Standard | Pass |
| Test Name | Applicable Standards | Purpose | Acceptance<br>Criteria…