Who is the manufacturer of Purgo?

Aeroclean Technologies, LLC filed the 510(k) submission for Purgo (K213753).

What is the FDA product code for Purgo?

FRA. It is classified under 21 CFR 880.6500 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Purgo?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Purgo?

Molekule Air Pro (K211194); Molekule Air Pro RX (K200500).

Who can help prepare an FDA 510(k) submission like Purgo?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Purgo

K213753 · Aeroclean Technologies, LLC · FRA · Jun 1, 2022 · General Hospital

Device Facts

Record ID	K213753
Device Name	Purgo
Applicant	Aeroclean Technologies, LLC
Product Code	FRA · General Hospital
Decision Date	Jun 1, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6500
Device Class	Class 2

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. Pürgo is non-sterile.

Device Story

Pūrgo is a free-standing air disinfection system for medical and home healthcare environments. It utilizes a multi-layer filter cartridge (pre-filter, activated carbon, HEPA) to capture airborne particles and microorganisms, followed by a proprietary SteriDuct chamber containing UV-C LEDs (265 nm) to neutralize remaining microbes by damaging RNA/DNA. The device includes a motor/impeller, airflow/UV sensors, and a touch panel interface. Safety features include interlock switches that prevent operation if the filter door is open or a filter is missing. Healthcare providers or patients operate the device via a touch panel to select fan speeds and monitor status. By reducing airborne bioaerosols and particles, the device aims to improve air quality in clinical and home settings.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including microorganism reduction efficacy (log reduction 4.1–5.4 for various bacteria, viruses, and spores), fractional efficiency testing (99.990% at 0.1-0.2 µm), ozone emission testing, airflow performance, and laminar airflow evaluation via CFD.

Technological Characteristics

Free-standing air purifier. Components: pre-filter, activated carbon filter, HEPA filter, SteriDuct chamber with 4 UV-C LEDs (265 nm). Connectivity: None. Power: 120V. Standards: UL 507, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEST-RP-CC001.6. Software: Basic firmware for fan control, timer, and status monitoring.

Indications for Use

Indicated for reduction of bacteria, viruses, fungal spores, and particles in air within medical facilities and indoor spaces. Suitable for use by healthcare professionals and lay users in home healthcare environments.

Regulatory Classification

Identification

A medical ultraviolet air purifier is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation.

Predicate Devices

Molekule Air Pro (K211194)
Molekule Air Pro RX (K200500)

Submission Summary (Full Text)

{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) | |-------------|----------------------------------------------| | <div></div> | Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDEDThis section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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. | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ {12}------------------------------------------------ | 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. | {13}------------------------------------------------ | 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…

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