(30 days)
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 / exposuretime (min) |
|---|---|---|
| Gram + Bacteria | Methicillin resistant Staphylococcusepidermidis | 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 |
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.
This document describes the acceptance criteria and the study proving the device meets these criteria for the Purgo™ UV and air filtration device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance | Device Meets Criteria? |
|---|---|---|---|
| Microorganism Performance | |||
| RNA Virus: SARS-CoV-2 | ≥ 4 log reduction (99.99%) | Average net log reduction / time:SARS-CoV-2: 4.2 log reduction / 60 mins at normal speed | Yes |
| Gram + Bacteria: Methicillin resistant Staphylococcus epidermidis | ≥ 4 log reduction (99.99%) | 4.6 log reduction / 45 mins at normal speed | Yes |
| Gram + Bacteria: Bacillus globigii endospore | ≥ 4 log reduction (99.99%) (Normal, Sleep, Boost speeds) | 4.1 log reduction / 60 mins at normal speed4.4 log reduction / 60 mins at sleep speed4.2 log reduction / 45 mins at boost speed | Yes |
| Gram - Bacteria: Escherichia coli | ≥ 4 log reduction (99.99%) | 5.4 log reduction / 45 mins at normal speed | Yes |
| RNA Virus: MS2 bacteriophage | ≥ 4 log reduction (99.99%) (Normal, Sleep, Boost speeds) | 5.4 log reduction / 60 mins at normal speed4.3 log reduction / 60 mins at sleep speed4.5 log reduction / 45 mins at boost speed | Yes |
| DNA Virus: Phi-X174 bacteriophage | ≥ 4 log reduction (99.99%) | 4.4 log reduction / 45 mins at normal speed | Yes |
| Fungal Spore: Aspergillus brasiliensis spore | ≥ 4 log reduction (99.99%) | 4.3 log reduction / 90 mins at normal speed | Yes |
| Fractional Efficiency (Filter) | Per IEST-RP-CC001.6 Type H test | Filter: fractional efficiency percentage of 99.995% at 0.1-0.2 µm | Yes |
| Fractional Efficiency (Unit with Filter) | Per IEST-RP-CC001.6 Type H test | Pūrgo™ Unit with Filter: fractional efficiency percentage of 99.990% at 0.1-0.2 µm | Yes |
| UV Intensity | ≥ 0.240 mW/cm² | Pass (achieved appropriate amount of UV irradiance in the SteriDuct) | Yes |
| UV Irradiance Exposure | Per ACGIH 2019 TLVs for Chemical Substances and Physical Agents and Biological Exposure Indices (BEIs) | Meets daily exposure limits (less than 0.1 µW/cm² for an 8 hour duration) and is considered part of the ANSI/IENSA RP-27.3-07 Exempt Risk Group | Yes |
| Ozone Emissions | Per UL 867 and UL ECVP 2998 | Operates at less than 0.005 ppm at its highest and lowest fan speed | Yes |
| Airflow Performance (Sleep) | min. 125 CFM | Pass (meets minimum 125 CFM) | Yes |
| Airflow Performance (Normal) | min. 200 CFM | Pass (meets minimum 200 CFM) | Yes |
| Airflow Performance (Boost) | min. 315 CFM | Pass (meets minimum 315 CFM) | Yes |
| Laminar Airflow Evaluation | Pūrgo™ does not disturb laminar flow | Optimal placement near the outer wall of room (8' from the surgery table) for Pūrgo™ flow rates of 230 to 315 CFM, regardless of HVAC return duct location. | Yes |
| Home Healthcare Environments | Per FDA Guidance "Design Considerations for Devices Intended for Home Use" (Nov 24, 2014) and IEC 60601-1-11 | Pass (design and development followed guidance and complies with applicable standards) | Yes |
| Electrical Safety | Per UL 507 and IEC 60601-1 | Pass | Yes |
| Electromagnetic Compatibility | Per IEC 60601-1-2 | Pass | Yes |
| Software Validation | Meet defined specifications | Pass (software verification and validation testing performed for the Pūrgo™ device firmware) | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The provided text details the performance testing for the Purgo™ device, specifically for its aerosolized biological reduction capabilities, filtration efficiency, UV intensity, and other safety/performance metrics.
-
Microorganism Performance Testing: The testing was performed on the Purgo™ device. For each microorganism, the "Avg. max log reduction / exposure time" is reported, implying multiple runs or sufficient measures to establish an "average maximum log reduction." The exact sample size (number of devices tested or number of repetitions per test) is not explicitly stated as a numerical count (e.g., "n=X devices"). The data provenance is internal testing ("Internal Standards"). The document does not specify the country of origin of the data, nor whether it was retrospective or prospective. It is implied to be a prospective laboratory study for device validation.
-
Other Tests (Fractional Efficiency, UV Intensity, Ozone, Airflow, Electrical Safety, EMC, Software Validation): These tests were conducted on the Purgo™ device. Similar to microorganism performance, the exact sample size (number of devices/filters tested) is not explicitly stated. These also appear to be prospective laboratory studies conducted by the manufacturer or a contracted testing facility.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document describes performance testing of a physical device against biological agents and engineering standards. It does not involve interpretation of medical images or patient data that would typically require expert radiologists or other clinical experts for ground truth establishment.
- Microorganism Performance: The "ground truth" for the efficacy data points (log reduction) is established by quantitative laboratory measurements of aerosolized biologicals before and after exposure to the device. This is a direct measurement of the device's performance, not an expert consensus on a medical finding. The qualifications of the personnel conducting these highly specialized microbiological and engineering tests are not provided in this document.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring human adjudication of data points (e.g., radiological reads). The results are direct measurements from laboratory and engineering tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is typically relevant for AI/CADe systems that assist human readers in interpreting medical images. This document describes the performance of an air purification device, which does not involve human readers interpreting cases. Therefore, there is no mention of human readers improving with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in the sense that the device's performance (purification of air) is evaluated independently without human intervention during its operation. The performance metrics (log reduction, filtration efficiency, etc.) describe the device's inherent capabilities. This is a standalone device performance study, not a standalone algorithm study (as it's not an AI/software-only device).
7. The Type of Ground Truth Used
The ground truth for the performance testing is based on:
- Quantitative Laboratory Measurements: For microorganism reduction, validated laboratory methods were used to quantify the reduction in viable biological agents.
- Established Engineering Standards and Test Methods: For aspects like fractional efficiency, UV intensity, ozone emissions, electrical safety, EMC, and airflow performance, the device was tested against recognized industry and regulatory standards (e.g., IEST-RP-CC001.6, ACGIH, UL 867, UL ECVP 2998, IEC 60601 series). Compliance with these standards serves as the ground truth for these parameters.
- Computational Fluid Dynamics (CFD) Analysis: For laminar airflow evaluation, CFD was used to model and predict the device's impact on airflow, which is a form of simulated "ground truth" based on physics.
8. The Sample Size for the Training Set
Not applicable. This device is a physical air purification system and does not employ machine learning or AI algorithms that would require a "training set" of data in the typical sense (e.g., for image recognition, natural language processing). Its design and performance are based on established engineering principles of UV germicidal irradiation and HEPA filtration.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm. The device's efficacy is based on its physical and mechanical design and the known properties of UV-C light and HEPA filtration.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Christopher K. Dugard -S
for Clarence W. Murray, III, Ph.D. Assistant Director 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 / exposuretime (min) |
|---|---|---|
| Gram + Bacteria | Methicillin resistant Staphylococcusepidermidis | 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.10455 Riverside Drive, Suite 100Palm Beach Gardens, FL 33410 |
|---|---|
| Primary Contact: | Rita King, CEOMethodSense, Inc.Email: ritaking@methodsense.comPhone: 919-313-3961Fax: 919-313-3979 |
| Company Contact: | Richard FosterTitle: Senior Director Quality and Regulatory AffairsEmail: rfoster@aeroclean.comPhone: (773) 791-6198 |
| 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 /exposure time (min) |
|---|---|---|
| Gram + Bacteria | Methicillin resistant Staphylococcusepidermidis | 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 DevicePūrgo™ (K223328) | Primary Predicate DevicePūrgo™ (K213753) | Comparison |
|---|---|---|---|
| Intended Use | To remove and destroy, by exposure to UVradiation, bacteria and viruses in interiorspaces. | To remove and destroy, by exposure to UVradiation, bacteria and viruses in interiorspaces. | Identical |
| Indications forUse | Pūrgo™ is a combination UV and air filtrationdevice, equipped with UV-C LEDs and a TrueHEPA filter intended for the reduction ofbacteria, virus, fungal spores, and particles inair for use in medical facilities and other indoorspaces. Pūrgo™ is non-sterile. | Pūrgo™ is a combination UV and air filtrationdevice, equipped with UV-C LEDs and a TrueHEPA filter intended for the reduction ofbacteria, virus, fungal spores, and particles inair for use in medical facilities and other indoorspaces. Pūrgo™ is non-sterile. | EquivalentThe subject deviceis also indicated foruse in removingSARS-CoV-2.The safety andeffectiveness of thisadditional indicationfor use has beendemonstratedthroughmicroorganismperformance testing. |
| Pūrgo™ has been demonstrated to remove thefollowing organisms under the followingexposure conditions: | Pūrgo™ has been demonstrated to remove thefollowing organisms under the followingexposure conditions: | ||
| Avg. max log reduction / exposure time (min):Methicillin resistant Staphylococcus epidermidis4.6 (45) at normal speed | Avg. max log reduction / exposure time (min):Methicillin resistant Staphylococcus epidermidis4.6 (45) at normal speed | ||
| Bacillus globigii endospore 4.1 (60) at normalspeed | Bacillus globigii endospore 4.1 (60) at normalspeed | ||
| 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 normalspeed | Phi-X174 bacteriophage 4.4 (45) at normalspeed | ||
| Aspergillus brasiliensis spore 4.3 (90) at normalspeed | Aspergillus brasiliensis spore 4.3 (90) at normalspeed | ||
| User | Healthcare ProfessionalLay User | Healthcare ProfessionalLay User | Identical |
| Characteristic | Subject DevicePūrgo™ (K223328) | Primary Predicate DevicePūrgo™ (K213753) | Comparison |
| Environment ofUse | Hospital and other healthcare setting.General Surgery Setting.Home healthcare. | Hospital and other healthcare setting.General Surgery Setting.Home healthcare. | Identical |
| Placement | Pūrgo™ will work in any room, but giving it aspace in a central location is recommended.Placement near the patient is key.Pūrgo™ may be used in surgical suites.Pūrgo™ is designed for rooms up to 3000 ft3. | Pūrgo™ will work in any room, but giving it aspace in a central location is recommended.Placement near the patient is key.Pūrgo™ may be used in surgical suites.Pūrgo™ is designed for rooms up to 3000 ft3. | Identical |
| User Control | Touch panel with selections for 3 fan speeds,power button, timer, and UV and airflowindicators. | Touch panel with selections for 3 fan speeds,power button, timer, and UV and airflowindicators. | Identical |
| Software | Basic Firmware; used to turn the unit on, off,change fan speed, and other administrativefunctions (timer, UV and airflow status). | Basic Firmware; used to turn the unit on, off,change fan speed, and other administrativefunctions (timer, UV and airflow status). | Identical |
| Mechanism ofAction | Air is pulled through a multi-layer filter (pre-filter, activated carbon, HEPA) to removemicroorganisms and then into a UV chamber(SteriDuct) containing UV-C light with sufficientenergy to kill any remaining microorganisms. | Air is pulled through a multi-layer filter (pre-filter, activated carbon, HEPA) to removemicroorganisms and then into a UV chamber(SteriDuct) containing UV-C light with sufficientenergy to kill any remaining microorganisms. | Identical |
| Installation | Free standing | Free standing | Identical |
| Filter | Pūrgo™ Filter:• Multi-layer filter with 1/8" thick pre-filter, 1/8"thick activated carbon filter, and HEPA filtermedia• Dimensions: 16.5" x 19.5" x 2.5"HEPA filter:• Number of pleats: 140◦ Depth of pleats: 42mm◦ Minimum filter media area: 61 sq ft | Pūrgo™ Filter:• Multi-layer filter with 1/8" thick pre-filter, 1/8"thick activated carbon filter, and HEPA filtermedia• Dimensions: 16.5" x 19.5" x 2.5"HEPA filter:• Number of pleats: 140◦ Depth of pleats: 42mm◦ Minimum filter media area: 61 sq ft | Identical |
| Characteristic | Subject DevicePūrgo™ (K223328) | Primary Predicate DevicePūrgo™ (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) provideminimum 125-315 CFM flow. | Three speeds (sleep, normal, boost) provideminimum 125-315 CFM flow. | Identical |
| Device AirChanges PerHour (ACH) | 1.875 – 2.36 device air changes per hour onBoost, 250 - 315 CFM, in a 1000 ft² room. | 1.875 – 2.36 device air changes per hour onBoost, 250 - 315 CFM, in a 1000 ft² room. | Identical |
| Fan ExposureSafety Features | Diffuser panel on side of device and SteriDuctcover behind filter door to block user fromaccessing spinning fan without tools. Safetyfeature confirmed by UL 507. | Diffuser panel on side of device and SteriDuctcover behind filter door to block user fromaccessing spinning fan without tools. Safetyfeature confirmed by UL 507. | Identical |
| UV LightExposure SafetyFeatures | Safety interlock switch exists in filter door toensure if the door is open or if a filter is missing,the unit will not operate. The purpose of theseswitches is to protect the user from anypossibility of exposure to direct contact with UVlight. Safety feature confirmed by UL 507. | Safety interlock switch exists in filter door toensure if the door is open or if a filter is missing,the unit will not operate. The purpose of theseswitches is to protect the user from anypossibility of exposure to direct contact with UVlight. 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 |
| PowerConsumption | Up to 120 Watts | Up to 120 Watts | Identical |
| Characteristic | Subject DevicePūrgo™ (K223328) | Primary Predicate DevicePūrgo™ (K213753) | Comparison |
| Dimensions | Unit Dimensions:25.8"H (27.5" with casters) x 19.5"W x 10.6"DFilter Dimensions:16.5" x 19.5" x 2.5" | Unit Dimensions:25.8"H (27.5" with casters) x 19.5"W x 10.6"DFilter Dimensions:16.5" x 19.5" x 2.5" | Identical |
| Standards | UL 507 Standard for Electrical FansIEC 60601-1 Basic Safety and EssentialPerformanceIEC 60601-1-2 EMC. EMC for Medical DevicesIEC 60601-1-11 Home Healthcare EnvironmentIEST-RP-CC001.6 HEPA and ULPA Filters | UL 507 Standard for Electrical FansIEC 60601-1 Basic Safety and EssentialPerformanceIEC 60601-1-2 EMC. EMC for Medical DevicesIEC 60601-1-11 Home Healthcare EnvironmentIEST-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 | AcceptanceCriteria | Results |
|---|---|---|---|---|
| MicroorganismPerformanceRNA Virus:SARS-CoV-2testingperformed | Internal Standards | Testing was performed to evaluate thePūrgo™'s efficacy against aerosolizedbiologicals. Testing was performed withthe Pūrgo™ device in accordance withthe normal use of the system (i.e. boththe filtration and UV systems active at thenormal speed) with seven (7) differentaerosolized biologicals. Testing wasperformed with two aerosolizedbiologicals (MS2 and Bacillus globigii asthey are representative of the moredifficult biologicals to filter and destroy) atthe sleep and boost fan speeds todemonstrate that the efficacy of thedevice isn't compromised by changes infan speed.Additional testing was conducted usingSARS-CoV-2 virus to confirm the testingfor the previously tested MS2 singlestrand RNA viral category. | 4 logreduction(99.99%) | Average net log reduction / timeMethicillin resistantStaphylococcus epidermidis ,4.6 / 45 / 60 mins at normalBacillus globigii endospore,4.1 / 60 mins at normal,4.4 / 60 mins at sleep,4.2 / 45 mins at boostEscherichia coli ,5.4 / 45 mins at normalMS2 bacteriophage,5.4 / 60 mins at normal,4.3 / 60 mins at sleep,4.5 / 45 mins at boostSARS-CoV-2,4.2 / 60 mins at normalPhi-X174 bacteriophage,4.4 / 45 mins at normalAspergillus brasiliensis spore,4.3 / 90 mins at normal |
| Test Name | Applicable Standards | Purpose | AcceptanceCriteria | Results |
| FractionalEfficiencyNo additionaltesting necessary | IEST-RP-CC001.6 -HEPA and ULPA Filters | Fractional efficiency testing wasperformed on the PūrgoTM filter and thePūrgoTM device itself per IEST-RP-CC001.6 TypeH test to determine thefractional efficiency percentage ofparticles of varying size ranges. | Per Standard | Filter: fractional efficiencypercentage of 99.995% at 0.1-0.2μmPūrgoTM Unit with Filter: fractionalefficiency percentage of 99.990%at 0.1-0.2 µm |
| UV IntensityNo additionaltesting necessary | Not Applicable | The UV intensity performance of thePūrgoTM units was verified to ensure theappropriate amount of UV irradiance isachieved in the SteriDuct. | ≥ 0.240mW/cm² | Pass |
| UV IrradianceExposureNo additionaltesting necessary | American Conference ofGovernmental IndustrialHygienists (ACGIH) 2019Threshold Limit Values(TLVs) for ChemicalSubstances and PhysicalAgents and BiologicalExposure Indices (BEIs) | UV radiation testing and evaluation wasperformed to measure the irradiancevalues at each wavelength between 200-400nm and determine the effectiveirradiance of the UV radiation to ensureUV exposure from the device is withinsafe limits. | Per Standard | Testing demonstrated that whenoperating in the normal condition(filter in place), the unit meetsdaily exposure limits (less than 0.1µW/cm² for an 8 hour duration)and is considered part of theANSI/IENSA RP-27.3-07 ExemptRisk Group |
| OzoneNo additionaltesting necessary | UL 867 - Electrostatic AirCleanersUL ECVP 2998 ZeroOzone Emissions for AirCleaners, 3rd edition -2020 | Ozone testing was performed per UL 867by monitoring the ozone concentration ina test chamber at the highest fan speedand lowest fan speed. | Per Standard | Testing demonstrates the PūrgoTMunit is able to operate at less than0.005 ppm at its highest andlowest fan speed. |
| Test Name | Applicable Standards | Purpose | Acceptance Criteria | Results |
| Airflow Performance EvaluationNo 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 CFMNormal: min. 200 CFMBoost: min. 315 CFM | Pass |
| Laminar Airflow EvaluationNo 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 | AcceptanceCriteria | Results |
| HomeHealthcareEnvironmentsNo additionaltesting necessary | FDA Guidance "DesignConsiderations forDevices Intended forHome Use" (November24, 2014)IEC 60601-1: Medicalelectrical equipment -Part 1: Generalrequirements for basicsafety and essentialperformance; 2012IEC 60601-1-11: Medicalelectrical equipment -Part 1-11: Generalrequirements for basicsafety and essentialperformance - CollateralStandard: Requirementsfor medical electricalequipment and medicalelectrical systems usedin the home healthcareenvironment; 2015 | FDA's Guidance "Design Considerationsfor Devices Intended for Home Use"(November 24, 2014) was followed forthe design and development of Pūrgo™to ensure the home use device complieswith applicable standards of safety andeffectiveness and other regulatoryrequirements. | Per Standards | Pass |
| Electrical SafetyNo additionaltesting necessary | UL 507: Standard forElectric FansIEC 60601-1: Medicalelectrical equipment -Part 1: Generalrequirements for basicsafety and essentialperformance; 2012 | Electrical safety testing was performed inaccordance with UL 507 and IEC 60601-1. | Per Standard | Pass |
| Test Name | Applicable Standards | Purpose | AcceptanceCriteria | Results |
| ElectromagneticCompatibilityNo additionaltesting necessary | IEC 60601-1-2: Medicalelectrical equipment –Part 1-2: Generalrequirements for basicsafety and essentialperformance – Collateralstandard:Electromagneticcompatibility –Requirements and tests;Edition 4.0 | Electromagnetic Compatibility testingwas performed in accordance with IEC60601-1-2. | Per Standard | Pass |
| SoftwareValidationNo additionaltesting necessary | FDA Guidance"Guidance for theContent of PremarketSubmissions forSoftware Contained inMedical Devices" (May11, 2005) | Software verification and validationtesting was performed for the Pūrgo™device firmware. | Meet definedspecifications |
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Image /page/12/Picture/0 description: The image shows the logo for AeroClean. The logo consists of the word "AeroClean" in a bold, sans-serif font, with a horizontal line extending from the left side of the "A". Below the word "AeroClean" is the phrase "Pathogen Elimination Technologies" in a smaller, lighter font.
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Image /page/13/Picture/0 description: The image shows the logo for AeroClean. The logo consists of the word "AeroClean" in a bold, sans-serif font, with a horizontal line extending from the left side of the "A". Below the word "AeroClean" is the phrase "Pathogen Elimination Technologies" in a smaller, lighter font.
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Image /page/14/Picture/0 description: The image shows the logo for AeroClean. The logo is in a dark blue color 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.
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Image /page/15/Picture/0 description: The image shows the logo for AeroClean. The logo is in a dark blue color 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.
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Image /page/16/Picture/0 description: The image shows the logo for AeroClean. The logo consists of the word "AeroClean" in a sans-serif font, with the first letter "A" in a slightly lighter shade of blue than the rest of the word. Below the word "AeroClean" is the phrase "Pathogen Elimination Technologies" in a smaller, lighter sans-serif font.
Summary Clinical Testing
No clinical tests were required to demonstrate substantial equivalence.
Conclusion
The conclusions drawn from the nonclinical testing demonstrate that the subject device, Pūrgo™ is as safe, as effective, and performs as well as or better than the legally marketed predicate, K213753 Class II (21 CFR 880.6500), product code FRA.
§ 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).