(183 days)
Not Found
No
The description focuses on physical filtration and UV-C irradiation, with sensors and an electronic control system for basic monitoring and operation. There is no mention of AI, ML, or any learning or adaptive capabilities.
No.
The device is an air filtration and disinfection system, not a therapeutic device intended to diagnose, treat, or prevent disease in a human.
No
No
The device is a combination UV and air filtration device with significant hardware components including UV-C LEDs, filters, a motor, sensors, and an electronic control system. While it includes software, it is not solely software.
Based on the provided information, Pūrgo is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is defined as a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Pūrgo's Function: Pūrgo is an air purification system. Its intended use is to reduce bacteria, viruses, fungal spores, and particles in the air within indoor spaces, including medical facilities. It operates by filtering and using UV-C light to neutralize airborne microorganisms.
- Lack of Specimen Examination: Pūrgo does not examine specimens derived from the human body. It acts on the air in the environment.
- Purpose: Its purpose is to improve air quality and reduce the presence of airborne pathogens, not to provide diagnostic information about a person's health or disease state based on bodily specimens.
Therefore, Pūrgo falls under the category of an air purification or disinfection device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 |
| DNA Virus | Phi-X174 bacteriophage | 4.4 (45) at normal speed |
| Fungal Spore | Aspergillus brasiliensis spore | 4.3 (90) at normal speed |
Product codes
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 fungi). 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 (high-efficiency 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)
The Pirgo was verified and validated in accordance with documented Verification & Validation plans and protocols to ensure conformance with established performance criteria.
| Test Name | Applicable Standards | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| Microorganism Performance | 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 six (6) 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. | 4 log reduction (99.99%) | Average net log reduction / time |
| Methicillin resistant Staphylococcus epidermidis, 4.6 / 45 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 | ||||
| Phi-X174 bacteriophage, 4.4 / 45 mins at normal | ||||
| Aspergillus brasiliensis spore, 4.3 / 90 mins at normal | ||||
| Fractional Efficiency | IEST-RP-CC001.6 – HEPA and ULPA Filters | Fractional efficiency testing was performed on the Pūrgo filter and the Pūrgo 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 |
| Pūrgo Unit with Filter: fractional efficiency percentage of 99.990% at 0.1-0.2 µm | ||||
| UV Intensity | Not Applicable | The UV intensity performance of the Pūrgo units was verified to ensure the appropriate amount of UV irradiance is achieved in the SteriDuct. | ≥ 0.240 mW/cm² | Pass |
| UV Irradiance Exposure | 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 | 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 Pūrgo unit is able to operate at less than 0.005 ppm at its highest and lowest fan speed. | |
| Airflow Performance Evaluation | 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 | 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. |
| Home Healthcare Environments | 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 | 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 60601-1. | Per Standard | Pass | |
| Electromagnetic Compatibility | 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 | 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 | Pass |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Microorganism Performance:
- Methicillin resistant Staphylococcus epidermidis: 4.6 log reduction in 45 mins at normal speed
- Bacillus globigii endospore: 4.1 log reduction in 60 mins at normal speed, 4.4 log reduction in 60 mins at sleep speed, 4.2 log reduction in 45 mins at boost speed
- Escherichia coli: 5.4 log reduction in 45 mins at normal speed
- MS2 bacteriophage: 5.4 log reduction in 60 mins at normal speed, 4.3 log reduction in 60 mins at sleep speed, 4.5 log reduction in 45 mins at boost speed
- Phi-X174 bacteriophage: 4.4 log reduction in 45 mins at normal speed
- Aspergillus brasiliensis spore: 4.3 log reduction in 90 mins at normal speed
Fractional Efficiency:
- Filter: 99.995% at 0.1-0.2 µm
- Pūrgo Unit with Filter: 99.990% at 0.1-0.2 µm
UV Intensity: ≥ 0.240 mW/cm² (Pass)
UV Irradiance Exposure: 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: less than 0.005 ppm at its highest and lowest fan speed.
Airflow Performance Evaluation:
- Sleep: min. 125 CFM
- Normal: min. 200 CFM
- Boost: min. 315 CFM
Laminar Airflow Evaluation: Pūrgo does not disturb laminar flow
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
June 1, 2022
AeroClean Technologies, LLC % Rita King CEO MethodSense, Inc. One Copley Pkwy, Ste. 410 Morrisville, North Carolina 27560
Re: K213753
Trade/Device Name: Purgo Regulation Number: 21 CFR 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: Class II Product Code: FRA Dated: April 29, 2022 Received: May 2, 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.
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
1
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 medical devices and radiation-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,
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213753
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. Pürgo 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 |
| 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) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K213753 510(k) Summary
AeroClean Technologies, LLC.
This 510(k) Summary is in conformance with 21CFR 807.92
| Submitter: | AeroClean Technologies, LLC.
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: | June 1, 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(s):
| Primary Predicate | Secondary Predicate | |
|---|---|---|
| Trade Name | Molekule Air Pro | Molekule Air Pro RX |
| 510(k) Submitter / Holder | Molekule, Inc. | Molekule, Inc. |
| 510(k) Number | K211194 | K200500 |
| Regulation Number | 21 CFR 880.6500 | 21 CFR 880.6500 |
| Classification | Class II | Class II |
| Classification Panel | General Hospital | General Hospital |
| Product Code | FRA | FRA |
The primary predicate device and secondary predicate device have not been subject to a design-related recall.
4
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 fungi). 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.
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. Purgo is non-sterile.
Pūrgo has been demonstrated to remove the following organisms under the following exposure conditions:
5
| 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 |
| DNA Virus | Phi-X174 bacteriophage | 4.4 (45) at normal speed |
| Fungal Spore | Aspergillus brasiliensis spore | 4.3 (90) at normal speed |
6
Summary of Technological Characteristics compared to Predicate Device
| Item | Pūrgo
(K213753)
Subject Device | Molekule Air Pro
(K211194)
Primary Predicate | Molekule Air Pro RX
(K200500)
Secondary Predicate | 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. | 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. | The Molekule Air Pro air purifier is a device intended for medical purposes that is used to capture 95% of particulate matter and destroy bacteria, mold, and viruses by exposure to ultraviolet radiation when operated in Auto Mode Standard or manual mode at fan speed 2 or higher. The Molekule Air Pro air purifier has been demonstrated to entrain and destroy the following bioaerosols under the following exposure/working conditions: | The Molekule Air Pro RX air purifier is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation.
The core technology components of the Molekule Air Pro RX air purifier have been demonstrated to destroy the following MS2 bacteriophage bioaerosol entrained on the filter of the subject device under the following exposure conditions: | Similar
The indications for use of the devices are equivalent. The devices have different performance metrics for the chosen microorganisms. |
| | 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
Bacillus globigii endospore 4.1 (60) at normal speed
Escherichia coli 5.4 (45) at normal speed
MS2 bacteriophage | Average Net Log Reduction / Time @ Fan
Speed 6. Room Temperature Test
Escherichia Coli $4.20 +/- 0.11 / 90 mins$
Bacillus Subtilis $4.02 +/- 0.23 / 30 mins$ | Average Maximum log reduction /exposure time (hours):
Room Temperature
Virus, MS2 bacteriophage $5.21 / 24 hours$ | |
| Item | Pūrgo
(K213753)
Subject Device | Molekule Air Pro
(K211194) | Molekule Air Pro RX
(K200500) | Comparison |
| | | Primary Predicate | Secondary Predicate | |
| | 5.4 (60) at normal speed
Phi-X174 bacteriophage
4.4 (45) at normal speed
Aspergillus brasiliensis spore
4.3 (90) at normal speed | Aspergillus Brasiliensis
$4.15 \pm 0.06$ / 60 mins
MS2 Bacteriophage
$4.38 \pm 0.15$ / 30 mins
Single Pass Mechanical
Filtration Efficiency
Particulate Matter 0.3 to 1.0
micron size particles 95% or
greater according to
ASHRAE 52.2 | | |
| User | Healthcare Professional
Lay User | Healthcare Professional
Lay User | Healthcare Professional | Identical |
| Environment of Use | Hospital and other healthcare
setting.
General Surgery Setting.
Home healthcare. | Hospital and other
healthcare setting.
Home healthcare. | Hospital and general
surgery setting | Similar
The Environment of Use of
the Pūrgo is identical to
that of the primary
predicate as both can be
used in a hospital and
other healthcare setting
and the home healthcare
environments.
The Environment of Use of
the Pūrgo is identical to
that of the secondary
predicate device as both
can be used in the hospital
and general surgery
setting. |
| Item | Pūrgo
(K213753)
Subject Device | Molekule Air Pro
(K211194)
Primary Predicate | Molekule Air Pro RX
(K200500)
Secondary Predicate | Comparison |
| 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. | Air pro will work in any
room, but giving it a space
in a central location, is
recommended. Placement
near the patient is key.
It should not be used in
surgical suites or in rooms
with air separation devices.
It is designed for rooms
under 1000 ft². | Specific information on
placement not available
Device can be used in
surgical suites. | Similar
The Placement of Pūrgo is
equivalent to that of the
primary predicate in a
central location and that of
the secondary predicate
device in a surgical suite. |
| Item | Pūrgo
(K213753)
Subject Device | Molekule Air Pro
(K211194)
Primary Predicate | Molekule Air Pro RX
(K200500)
Secondary Predicate | Comparison |
| User Control | Touch panel with selections
for 3 fan speeds, power
button, timer, and UV and
airflow indicators. | LCD screen with capacitive
touchscreen interface. User
Interface includes several
dedicated screens for fan
speed control, PM sensor
readings in addition to other
administrative functions.
Application controls mimic
device touch panel. | One knob controls the
four speed fan setting
One button turns the unit
on and off. | Similar
The User Controls of the
devices are equivalent, as
all provide a user interface
allowing the user control of
major functions of the
device.
The devices differ as the
primary predicate uses an
LCD screen with an
associated software
application and the
secondary predicate device
uses a knob and button
while Pūrgo has a static
interface on a touch panel.
This difference does not
affect the intended use or
safety and effectiveness of
the device. |
| Software | Basic Firmware; used to turn
the unit on, off, change fan
speed, and other
administrative functions
(timer, UV and airflow status). | Basic Firmware and App;
used to turn the unit on, off,
and change fan speed. | Basic Firmware; used to
turn the unit on, off, and
change fan speed. | Similar
All devices utilize firmware
which provides equivalent
functionality. The primary
predicate has an additional
software application in
addition to its device
firmware. This difference
does not affect the
intended use or safety and
effectiveness of the device. |
| Item | Pūrgo
(K213753)
Subject Device | Molekule Air Pro
(K211194)
Primary Predicate | Molekule Air Pro RX
(K200500)
Secondary Predicate | Comparison |
| 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. | UV light of sufficient energy
(UV-A) activates
photocatalyst that destroys
microorganisms entrained
on the filter through a
photochemical reaction. | UV light of sufficient
energy (UV-A) activates
photocatalyst that
destroys microorganisms
entrained on the filter
through a photochemical
reaction. | Similar
The mechanisms of action
of the devices are similar
as all devices utilize
filtration and UV irradiation
to remove microorganisms
from air.
The devices differ as the
Pūrgo device first filters the
air and then separately
applies UV-C light to any
microorganisms which are
able to pass through the
filter while the predicates
use technology which first
captures microorganisms
on a catalytic filter and
applies UV-A light to the
filter to destroy
microorganisms via a
photochemical reaction.
This difference does not
affect the intended use of
the device and safety and
effectiveness has been
confirmed via performance
testing. |
| Installation | Free standing | Free standing | Free standing | Identical |
| Item | Pūrgo
(K213753)
Subject Device | Molekule Air Pro
(K211194)
Primary Predicate | Molekule Air Pro RX
(K200500)
Secondary Predicate | Comparison |
| 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 | Catalytic Filter:
Proprietary multi-layer filter media Dimensions: 6.18 in (diameter), 6.55 in Height. Pleats per inch: 3 pleats per inch of outer circumference Total Filter surface area: 616 in2 Filter coated with proprietary photocatalyst and a metal wire mesh MERV16 | Pre-Filter:
Synthetic Media for mechanical filtration upstream of the PECO filter Dimensions 20 in x 20 in x 4 in Pleats per inch 1.5 Total Filter surface area 4800 sq. in. Catalytic Filter: Proprietary filter media Dimensions 20 in x 20 in x 4 in Pleats per inch 1.5 Total Filter surface area 4800 sq in Filter coated with the proprietary photocatalyst and a wire-mesh | Similar
All devices utilize multi-layer filter(s). The devices differ as the Pūrgo filter utilizes HEPA and activated carbon filtration while the primary and secondary predicate devices utilize a proprietary multi-layer catalytic PECO filter. This difference does not affect the intended use of the device and safety and effectiveness has been confirmed via performance testing. |
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| Item | Pūrgo
(K213753)
Subject Device | Molekule Air Pro
(K211194)
Primary Predicate | Molekule Air Pro RX
(K200500)
Secondary Predicate | Comparison |
|---------------|--------------------------------------|----------------------------------------------------|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Photocatalyst | None | Proprietary catalyst | Proprietary catalyst | Different
Pūrgo does not use a
photocatalyst as its
mechanism of action is
achieved via filtration and
UV-C irradiation, unlike the
predicate devices which
rely on a photo-catalytic
reaction for microorganism
destruction. This difference
does not affect the
intended use of the device
and safety and
effectiveness has been
confirmed via performance
testing. |
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| Item | Pūrgo
(K213753)
Subject Device | Molekule Air Pro
(K211194)
Primary Predicate | Molekule Air Pro RX
(K200500)
Secondary Predicate | 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
(Minimum): 0.24 mW/cm² | UV Type: UV-A UV Light Source: LED Wavelength: 320-400 nm Total of 20 UV LEDs Total UV Power: 16 W Filter Irradiance
(Minimum): 20 W/m² | UV Type: UV-A UV Light Source: LED Wavelength: 320-400 nm Power per Lamp / String: 11.4W Number of Lamps / String: 6 Total UV Power: 68.4W Filter Irradiance
(Minimum): 30 W/m² | Similar
All devices utilize a UV light source for the purpose of destroying microorganisms.
The Pūrgo differs from the predicates as the Pūrgo device uses UV-C light at 265 nm in order to destroy microorganisms while the primary and secondary predicate devices use UV-A light at 320 to 400 nm to destroy microorganisms.
This difference does not affect the intended use of the device and safety and effectiveness has been confirmed via performance testing. |
| Air Source | Centrifugal Fan | Centrifugal Fan | Centrifugal Fan | Identical |
| Item | Pūrgo
(K213753)
Subject Device | Molekule Air Pro
(K211194)
Primary Predicate | Molekule Air Pro RX
(K200500)
Secondary Predicate | Comparison |
| Flow Control | Three speeds (sleep, normal,
boost) provide minimum 125-
315 CFM flow. | 6 speeds (low-high)
Provide 25-260 CFM | Four speeds (low,
medium, high, boost)
provide 300 - 800 CFM
flow. | Similar
All devices allow for the
user to control flow by
providing an adjustable
speed setting. The Pūrgo
airflow range reaches a
max of 315 CFM compared
to the primary predicate's
max of 260 CFM. This
difference does not affect
the intended use of the
device and safety and
effectiveness has been
confirmed via performance
testing. |
| 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. | 1.83 device air changes per
hour on setting 6, roughly
260 CFM, in a 1000 ft² room | 6-9 ACH when used in
room with volume of
4000 cubic feet
(a typical Operating
Room Volume) with
flowrates of 450-650
CFM at settings 2 and 3. | Similar
Both Pūrgo and the primary
predicate achieve around
1.8 ACH on the maximum
speed setting. Pūrgo
achieves slightly higher
ACH during optimal
performance. This
difference does not affect
the intended use of the
device and safety and
effectiveness has been
confirmed via performance
testing. |
| Item | Pūrgo
(K213753)
Subject Device | Molekule Air Pro
(K211194)
Primary Predicate | Molekule Air Pro RX
(K200500)
Secondary Predicate | Comparison |
| Particulate Sensor | None | Optical Particle Sensor | None | Similar to Secondary
Predicate
Neither Pūrgo nor the
secondary predicate device
utilize a particulate sensor
that the primary predicate
has. This difference does
not affect the intended use
of the device or safety and
effectiveness. |
| 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. | Vanes at outlet and
Honeycomb inlet of fan with
small enough grating to
block user from accessing
spinning fan without tools.
Safety feature confirmed by
UL 507. | Grill at outlet and inlet of
fan with small enough
grating to block user from
accessing spinning fan
without tools. Safety
feature confirmed by
UL507. | Similar
All devices provide
protection from the
spinning fan for users. The
safety features have been
confirmed with UL 507
testing. |
| 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. | If a validated, serialized,
Molekule filter is missing,
the unit will not operate. The
unit authenticates the filter
via NFC, before and during
operation.
The purpose of this system
is to protect the user from
any possibility of exposure
to direct contact with UV-A
light that would occur
without a genuine Molekule
Filter being present. | Safety switches exist in
the following locations:
PECO filter door, pre
filter door, PECO filter
compartment, and pre
filter compartment. If any
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 UL507. | Similar
All devices provide
protection from the
exposure to UV light. The
safety features have been
confirmed with UL 507
testing. |
| Item | Pūrgo
(K213753)
Subject Device | Molekule Air Pro
(K211194)
Primary Predicate | Molekule Air Pro RX
(K200500)
Secondary Predicate | Comparison |
| Input Voltage | 120 Volt | 120 Volt | 120 Volt
(plugs into standard
single phase 120 Volt
outlet) | Identical |
| Current | Up to 1.00 Amps | Up to 1.27 Amps | Up to 3.72 amps | Different
The Pūrgo and predicates
differ due to the technical
specifications of the
devices (i.e. the Pūrgo
uses fewer LEDs, fan
power consumption may
differ) which results in
lower power and current
consumption. This
difference does not affect
the intended use or safety
and effectiveness of the
device. |
| Power Consumption | Up to 120 Watts | Up to 152.8 Watts | Up to 450 Watts | Different
The Pūrgo and predicates
differ due to the technical
specifications of the
devices (i.e. the Pūrgo
uses fewer LEDs, fan
power consumption may
differ) which results in
lower power and current
consumption. This
difference does not affect
the intended use or safety
and effectiveness of the
device. |
| Item | Pūrgo (K213753)
Subject Device | Molekule Air Pro (K211194)
Primary Predicate | Molekule Air Pro RX (K200500)
Secondary Predicate | Comparison |
| Electronic Data
Interface | None | NFC
WLAN (2.4 GHz) | None | Similar to Secondary
Predicate
Neither Pūrgo nor the secondary predicate device utilize an electronic interface that the primary predicate has. This difference does not affect the intended use of the device or safety and effectiveness. |
| 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:
Height: 23.11 in (587 mm)
Diameter: 10.83 in (275 mm)
Filter Dimensions:
Diameter: 8.1 in (206 mm)
Height: 11.7 in (296 mm) | Unit Dimensions:
Length: 22 in
Width: 22 in
Height: 52 in
Area = 25,168
Filter Dimensions:
20in x 20in x 4in | Similar
All devices are able to be moved to authorized locations without the need for door size accommodations and all filters are able to be replaced by the intended user without the need for special tools or accommodations related to size. The minor differences in dimensions do not affect the intended use or safety and effectiveness of the device. |
| Item | Pūrgo
(K213753)
Subject Device | Molekule Air Pro
(K211194)
Primary Predicate | Molekule Air Pro RX
(K200500)
Secondary Predicate | Comparison |
| 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 | FCC Part 15 C Radio
Frequency Devices
UL 507 Standard for
Electrical Fans
IEC 60601-1-2 EMC. EMC
for Medical Devices
ASHRAE 52.2-2012 Method
of Testing General
Ventilation Air Cleaning
Devices for Removal
Efficiency by Particle Size
AMCA 210-1999 Laboratory
Methods Of Testing Fans
For Rating
ANSI/AHAM AC-1-2019
Method for Measuring
Performance of Portable
Household Electric Room
Air Cleaners | UL 507 Standard for
Electrical Fans
IEC 60601-1-2 EMC.
EMC for Medical
Devices. | Similar
All devices were tested to
UL 507 and IEC 60601-1-2
for electrical and EMC
safety. Pūrgo was tested to
the more stringent IEST-
RP-CC001.6 standard
instead of ASHRAE 52.2
as the primary predicate
was since Pūrgo utilizes a
HEPA filter. For other
performance testing, Pūrgo
was tested using validation
protocols to verify safety
and effectiveness. |
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Summary of Non-Clinical Testing
The Pirgo was verified and validated in accordance with documented Verification & Validation plans and protocols to ensure conformance with established performance criteria. See below for the type of tests performed. AeroClean has completed the following testing:
| Test Name | Applicable Standards | Purpose | Acceptance
Criteria | Results |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Microorganism
Performance | 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 six (6) 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. | 4 log reduction
(99.99%) | Average net log reduction / time
Methicillin resistant
Staphylococcus epidermidis,
4.6 / 45 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
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 | IEST-RP-CC001.6 –
HEPA and ULPA Filters | Fractional efficiency testing was
performed on the Pūrgo filter and the
Pūrgo 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 |
| | | | Per Standard | Pūrgo Unit with Filter: fractional
efficiency percentage of
99.990% at 0.1-0.2 µm |
| UV Intensity | Not Applicable | The UV intensity performance of the
Pūrgo units was verified to ensure the
appropriate amount of UV irradiance is
achieved in the SteriDuct. | ≥ 0.240
mW/cm² | Pass |
| UV Irradiance
Exposure | 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 | 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 Pūrgo
unit is able to operate at less
than 0.005 ppm at its highest
and lowest fan speed. |
| Airflow
Performance
Evaluation | 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 |
| Test Name | Applicable Standards | Purpose | Acceptance
Criteria | Results |
| Laminar Airflow
Evaluation | 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. |
| Home
Healthcare
Environments | 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 |
| Test Name | Applicable Standards | Purpose | Acceptance
Criteria | Results |
| Electrical Safety | 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 |
| Electromagnetic
Compatibility | 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 | 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 | Pass |
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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, K211194 Class II (21 CFR 880.6500), product code FRA.