(30 days)
Not Found
No
The device description and performance studies focus on physical filtration and UV-C irradiation, controlled by an electronic system and sensors. There is no mention of AI or ML algorithms for data analysis, decision-making, or adaptive control.
No
The device is an air filtration and disinfection system, which is intended for reducing airborne pathogens and particles, not for diagnosing, treating, or preventing disease in humans.
No
Explanation: The Pūrgo™ is an air purification device intended for the reduction of bacteria, viruses, fungal spores, and particles in the air. It does not diagnose any medical conditions or diseases.
No
The device description clearly outlines multiple hardware components including UV-C LEDs, a HEPA filter, a motor/impeller, sensors, and a touch panel interface. While it includes software validation, it is not solely software.
Based on the provided information, the Pūrgo™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use of Pūrgo™ is for the "reduction of bacteria, virus, fungal spores, and particles in air for use in medical facilities and other indoor spaces." This describes a device that acts on the environment (air) to reduce the presence of microorganisms and particles.
- Device Description: The device description details a system that filters and irradiates air to remove or destroy microorganisms. It describes physical processes (filtration and UV-C light) applied to the air itself.
- Lack of Diagnostic Function: An IVD is a device intended for use in vitro for the examination of specimens, including blood, tissues, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Pūrgo™ does not examine specimens from the human body or provide diagnostic information.
- Performance Studies: The performance studies focus on the device's ability to reduce microorganisms and particles in the air, as well as its physical and electrical safety. They do not involve testing on human specimens for diagnostic purposes.
In summary, Pūrgo™ is an air purification device, not a device used for in vitro diagnostic testing of human specimens.
N/A
Intended Use / Indications for Use
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 time (min) |
|---|---|---|
| Gram + Bacteria | Methicillin resistant Staphylococcus 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 |
Product codes (comma separated list FDA assigned to the subject device)
FRA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare Professional
Lay User
Hospital and other healthcare setting.
General Surgery Setting.
Home healthcare.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
- Microorganism Performance RNA Virus: SARS-CoV-2 testing performed:
- Purpose: Evaluate the Pūrgo™'s efficacy against aerosolized biologicals, specifically SARS-CoV-2, in addition to previously tested MS2 single strand RNA viral category. Testing was performed with the Pūrgo™ device with both filtration and UV systems active at normal speed, and for MS2 and Bacillus globigii at sleep and boost fan speeds.
- Acceptance Criteria: 4 log reduction (99.99%)
- Results: Average net log reduction / time: Methicillin resistant Staphylococcus epidermidis, 4.6 / 45 / 60 mins at normal; Bacillus globigii endospore, 4.1 / 60 mins at normal, 4.4 / 60 mins at sleep, 4.2 / 45 mins at boost; Escherichia coli, 5.4 / 45 mins at normal; MS2 bacteriophage, 5.4 / 60 mins at normal, 4.3 / 60 mins at sleep, 4.5 / 45 mins at boost; SARS-CoV-2, 4.2 / 60 mins at normal; Phi-X174 bacteriophage, 4.4 / 45 mins at normal; Aspergillus brasiliensis spore, 4.3 / 90 mins at normal.
- Fractional Efficiency:
- Purpose: Determine the fractional efficiency percentage of particles of varying size ranges for the Pūrgo™ filter and the Pūrgo™ device itself.
- Acceptance Criteria: Per Standard (presumably IEST-RP-CC001.6 - HEPA and ULPA Filters)
- Results: Filter: fractional efficiency percentage of 99.995% at 0.1-0.2 µm; Pūrgo™ Unit with Filter: fractional efficiency percentage of 99.990% at 0.1-0.2 µm.
- UV Intensity:
- Purpose: Verify the UV intensity performance of the Pūrgo™ units to ensure appropriate UV irradiance in the SteriDuct.
- Acceptance Criteria: ≥ 0.240 mW/cm²
- Results: Pass.
- UV Irradiance Exposure:
- Purpose: Measure irradiance values and determine effective irradiance to ensure UV exposure from the device is within safe limits.
- Acceptance Criteria: Per Standard (ACGIH 2019 Threshold Limit Values)
- Results: When operating in normal condition, the unit 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.
- Ozone:
- Purpose: Monitor ozone concentration at highest and lowest fan speeds.
- Acceptance Criteria: Per Standard (UL 867, UL ECVP 2998 Zero Ozone Emissions)
- Results: The Pūrgo™ unit is able to operate at less than 0.005 ppm at its highest and lowest fan speed.
- Airflow Performance Evaluation:
- Purpose: Verify airflow performance at three fan speeds.
- Acceptance Criteria: Sleep: min. 125 CFM; Normal: min. 200 CFM; Boost: min. 315 CFM
- Results: Pass.
- Laminar Airflow Evaluation:
- Purpose: Evaluate airflow from the Pūrgo™ unit in a prototypical surgery room using Computational Fluid Dynamics (CFD) to determine combinations of unit positions and operating conditions that preserve a stable air curtain over the surgery table.
- Acceptance Criteria: Pūrgo™ does not disturb laminar flow.
- Results: Optimal placement determined 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.
- Home Healthcare Environments:
- Purpose: Ensure the home use device complies with applicable standards of safety and effectiveness and other regulatory requirements, following FDA Guidance "Design Considerations for Devices Intended for Home Use" (November 24, 2014) and IEC 60601-1-11.
- Acceptance Criteria: Per Standards
- Results: Pass.
- Electrical Safety:
- Purpose: Performed in accordance with UL 507 and IEC 60601-1.
- Acceptance Criteria: Per Standard
- Results: Pass.
- Electromagnetic Compatibility:
- Purpose: Performed in accordance with IEC 60601-1-2.
- Acceptance Criteria: Per Standard
- Results: Pass.
- Software Validation:
- Purpose: Software verification and validation testing performed for the Pūrgo™ device firmware.
- Acceptance Criteria: Meet defined specifications.
Clinical Testing:
- No clinical tests were required to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Log reduction for various microorganisms. For example, SARS-CoV-2 showed 4.2 log reduction in 60 minutes at normal speed.
Fractional efficiency percentage: Filter: 99.995% at 0.1-0.2 µm; Pūrgo™ Unit with Filter: 99.990% at 0.1-0.2 µm.
UV Irradiance: ≥ 0.240 mW/cm²
Ozone: less than 0.005 ppm at highest and lowest fan speed.
Airflow Performance: Sleep: min. 125 CFM; Normal: min. 200 CFM; Boost: min. 315 CFM.
UV exposure: less than 0.1 µW/cm² for an 8 hour duration.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
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
time (min) |
|-----------------|-----------------------------------------------------|-------------------------------------------------|
| Gram + Bacteria | Methicillin resistant Staphylococcus
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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3
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 100
Palm Beach Gardens, FL 33410 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King, CEO
MethodSense, Inc.
Email: ritaking@methodsense.com
Phone: 919-313-3961
Fax: 919-313-3979 |
| Company Contact: | Richard Foster
Title: Senior Director Quality and Regulatory Affairs
Email: rfoster@aeroclean.com
Phone: (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.
4
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.
5
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 Staphylococcus
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 |
6
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
Pūrgo™ (K223328) | Primary Predicate Device
Pūrgo™ (K213753) | Comparison |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | To remove and destroy, by exposure to UV
radiation, bacteria and viruses in interior
spaces. | To remove and destroy, by exposure to UV
radiation, bacteria and viruses in interior
spaces. | Identical |
| 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™ 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. | Equivalent
The subject device
is also indicated for
use in removing
SARS-CoV-2.
The safety and
effectiveness of this
additional indication
for use has been
demonstrated
through
microorganism
performance testing. |
| | Pūrgo™ has been demonstrated to remove the
following organisms under the following
exposure conditions: | Pūrgo™ has been demonstrated to remove the
following organisms under the following
exposure conditions: | |
| | Avg. max log reduction / exposure time (min):
Methicillin resistant Staphylococcus epidermidis
4.6 (45) at normal speed | Avg. max log reduction / exposure time (min):
Methicillin resistant Staphylococcus epidermidis
4.6 (45) at normal speed | |
| | Bacillus globigii endospore 4.1 (60) at normal
speed | Bacillus globigii endospore 4.1 (60) at normal
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
speed | Phi-X174 bacteriophage 4.4 (45) at normal
speed | |
| | Aspergillus brasiliensis spore 4.3 (90) at normal
speed | Aspergillus brasiliensis spore 4.3 (90) at normal
speed | |
| User | Healthcare Professional
Lay User | Healthcare Professional
Lay User | Identical |
| Characteristic | Subject Device
Pūrgo™ (K223328) | Primary Predicate Device
Pūrgo™ (K213753) | Comparison |
| Environment of
Use | 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 a
space 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 a
space 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 airflow
indicators. | Touch panel with selections for 3 fan speeds,
power button, timer, and UV and airflow
indicators. | Identical |
| Software | Basic Firmware; used to turn the unit on, off,
change fan speed, and other administrative
functions (timer, UV and airflow status). | Basic Firmware; used to turn the unit on, off,
change fan speed, and other administrative
functions (timer, UV and airflow status). | Identical |
| Mechanism of
Action | Air is pulled through a multi-layer filter (pre-
filter, activated carbon, HEPA) to remove
microorganisms and then into a UV chamber
(SteriDuct) containing UV-C light with sufficient
energy to kill any remaining microorganisms. | Air is pulled through a multi-layer filter (pre-
filter, activated carbon, HEPA) to remove
microorganisms and then into a UV chamber
(SteriDuct) containing UV-C light with sufficient
energy 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 filter
media
• 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 filter
media
• 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 Device
Pūrgo™ (K223328) | Primary Predicate Device
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
minimum 125-315 CFM flow. | Three speeds (sleep, normal, boost) provide
minimum 125-315 CFM flow. | Identical |
| Device Air
Changes Per
Hour (ACH) | 1.875 – 2.36 device air changes per hour on
Boost, 250 - 315 CFM, in a 1000 ft² room. | 1.875 – 2.36 device air changes per hour on
Boost, 250 - 315 CFM, in a 1000 ft² room. | Identical |
| Fan Exposure
Safety Features | Diffuser panel on side of device and SteriDuct
cover behind filter door to block user from
accessing spinning fan without tools. Safety
feature confirmed by UL 507. | Diffuser panel on side of device and SteriDuct
cover behind filter door to block user from
accessing spinning fan without tools. Safety
feature confirmed by UL 507. | Identical |
| UV Light
Exposure Safety
Features | Safety interlock switch exists in filter door to
ensure if the door is open or if a filter is missing,
the unit will not operate. The purpose of these
switches is to protect the user from any
possibility of exposure to direct contact with UV
light. Safety feature confirmed by UL 507. | Safety interlock switch exists in filter door to
ensure if the door is open or if a filter is missing,
the unit will not operate. The purpose of these
switches is to protect the user from any
possibility of exposure to direct contact with UV
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
Consumption | Up to 120 Watts | Up to 120 Watts | Identical |
| Characteristic | Subject Device
Pūrgo™ (K223328) | Primary Predicate Device
Pūrgo™ (K213753) | Comparison |
| Dimensions | Unit Dimensions:
25.8"H (27.5" with casters) x 19.5"W x 10.6"D
Filter 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"D
Filter Dimensions:
16.5" x 19.5" x 2.5" | Identical |
| Standards | UL 507 Standard for Electrical Fans
IEC 60601-1 Basic Safety and Essential
Performance
IEC 60601-1-2 EMC. EMC for Medical Devices
IEC 60601-1-11 Home Healthcare Environment
IEST-RP-CC001.6 HEPA and ULPA Filters | UL 507 Standard for Electrical Fans
IEC 60601-1 Basic Safety and Essential
Performance
IEC 60601-1-2 EMC. EMC for Medical Devices
IEC 60601-1-11 Home Healthcare Environment
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
Criteria | Results |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Microorganism
Performance
RNA Virus:
SARS-CoV-2
testing
performed | Internal Standards | Testing was performed to evaluate the
Pūrgo™'s efficacy against aerosolized
biologicals. Testing was performed with
the Pūrgo™ device in accordance with
the normal use of the system (i.e. both
the filtration and UV systems active at the
normal speed) with seven (7) different
aerosolized biologicals. Testing was
performed with two aerosolized
biologicals (MS2 and Bacillus globigii as
they are representative of the more
difficult biologicals to filter and destroy) at
the sleep and boost fan speeds to
demonstrate that the efficacy of the
device isn't compromised by changes in
fan speed.
Additional testing was conducted using
SARS-CoV-2 virus to confirm the testing
for the previously tested MS2 single
strand RNA viral category. | 4 log
reduction
(99.99%) | Average net log reduction / time
Methicillin resistant
Staphylococcus epidermidis ,
4.6 / 45 / 60 mins at normal
Bacillus globigii endospore,
4.1 / 60 mins at normal,
4.4 / 60 mins at sleep,
4.2 / 45 mins at boost
Escherichia coli ,
5.4 / 45 mins at normal
MS2 bacteriophage,
5.4 / 60 mins at normal,
4.3 / 60 mins at sleep,
4.5 / 45 mins at boost
SARS-CoV-2,
4.2 / 60 mins at normal
Phi-X174 bacteriophage,
4.4 / 45 mins at normal
Aspergillus brasiliensis spore,
4.3 / 90 mins at normal |
| Test Name | Applicable Standards | Purpose | Acceptance
Criteria | Results |
| Fractional
Efficiency
No additional
testing necessary | IEST-RP-CC001.6 -
HEPA and ULPA Filters | Fractional efficiency testing was
performed on the PūrgoTM filter and the
PūrgoTM device itself per IEST-RP-
CC001.6 TypeH test to determine the
fractional efficiency percentage of
particles of varying size ranges. | Per Standard | Filter: fractional efficiency
percentage of 99.995% at 0.1-0.2
μm
PūrgoTM Unit with Filter: fractional
efficiency percentage of 99.990%
at 0.1-0.2 µm |
| UV Intensity
No additional
testing necessary | Not Applicable | The UV intensity performance of the
PūrgoTM units was verified to ensure the
appropriate amount of UV irradiance is
achieved in the SteriDuct. | ≥ 0.240
mW/cm² | Pass |
| UV Irradiance
Exposure
No additional
testing necessary | American Conference of
Governmental Industrial
Hygienists (ACGIH) 2019
Threshold Limit Values
(TLVs) for Chemical
Substances and Physical
Agents and Biological
Exposure Indices (BEIs) | UV radiation testing and evaluation was
performed to measure the irradiance
values at each wavelength between 200-
400nm and determine the effective
irradiance of the UV radiation to ensure
UV exposure from the device is within
safe limits. | Per Standard | Testing demonstrated that when
operating in the normal condition
(filter in place), the unit 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 |
| Ozone
No additional
testing necessary | UL 867 - Electrostatic Air
Cleaners
UL ECVP 2998 Zero
Ozone Emissions for Air
Cleaners, 3rd edition -
2020 | Ozone testing was performed per UL 867
by monitoring the ozone concentration in
a test chamber at the highest fan speed
and lowest fan speed. | Per Standard | Testing demonstrates the PūrgoTM
unit is able to operate at less than
0.005 ppm at its highest and
lowest fan speed. |
| Test Name | Applicable Standards | Purpose | Acceptance Criteria | Results |
| Airflow Performance Evaluation
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
Normal: min. 200 CFM
Boost: min. 315 CFM | Pass |
| Laminar Airflow Evaluation
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
Criteria | Results |
| Home
Healthcare
Environments
No additional
testing necessary | FDA Guidance "Design
Considerations for
Devices Intended for
Home Use" (November
24, 2014)
IEC 60601-1: Medical
electrical equipment -
Part 1: General
requirements for basic
safety and essential
performance; 2012
IEC 60601-1-11: Medical
electrical equipment -
Part 1-11: General
requirements for basic
safety and essential
performance - Collateral
Standard: Requirements
for medical electrical
equipment and medical
electrical systems used
in the home healthcare
environment; 2015 | FDA's Guidance "Design Considerations
for Devices Intended for Home Use"
(November 24, 2014) was followed for
the design and development of Pūrgo™
to ensure the home use device complies
with applicable standards of safety and
effectiveness and other regulatory
requirements. | Per Standards | Pass |
| Electrical Safety
No additional
testing necessary | UL 507: Standard for
Electric Fans
IEC 60601-1: Medical
electrical equipment -
Part 1: General
requirements for basic
safety and essential
performance; 2012 | Electrical safety testing was performed in
accordance with UL 507 and IEC 60601-
-
| Per Standard | Pass |
| Test Name | Applicable Standards | Purpose | Acceptance
Criteria | Results |
| Electromagnetic
Compatibility
No additional
testing necessary | IEC 60601-1-2: Medical
electrical equipment –
Part 1-2: General
requirements for basic
safety and essential
performance – Collateral
standard:
Electromagnetic
compatibility –
Requirements and tests;
Edition 4.0 | Electromagnetic Compatibility testing
was performed in accordance with IEC
60601-1-2. | Per Standard | Pass |
| | Software
Validation
No additional
testing necessary | FDA Guidance
"Guidance for the
Content of Premarket
Submissions for
Software Contained in
Medical Devices" (May
11, 2005) | Software verification and validation
testing was performed for the Pūrgo™
device firmware. | Meet defined
specifications |
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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.