(183 days)
Pūrgo is a combination UV and air filtration device, equipped with UV-C LEDs and a True HEPA filter intended for the reduction of bacteria, virus, fungal spores, and particles in air for use in medical facilities and other indoor spaces. Pūrgo is non-sterile.
Pūrgo has been demonstrated to remove the following organisms under the following exposure conditions:
| Organism | Name | Avg. max log reduction / exposure time (min) |
|---|---|---|
| Gram + Bacteria | Methicillin resistant Staphylococcusepidermidis | 4.6 (45) at normal speed |
| Gram + Bacteria | Bacillus globigii endospore | 4.1 (60) at normal speed |
| Gram - Bacteria | Escherichia coli | 5.4 (45) at normal speed |
| RNA Virus | MS2 bacteriophage | 5.4 (60) at normal speed |
| DNA Virus | Phi-X174 bacteriophage | 4.4 (45) at normal speed |
| Fungal Spore | Aspergillus brasiliensis spore | 4.3 (90) at normal speed |
Pūrgo is a free-standing air disinfection system employing two technologies for purifying air: HEPA filtration and UV-C light irradiation, removing or destroying bacteria and viruses in air. Pūrgo may be used in medical facilities and commercial home healthcare environments. Pūrgo's main components consist of
- . LED UV-C lamps that generate irradiation to destroy microorganisms that are not filtered:
- . a proprietary SteriDuct chamber that intensifies the UV-C light to destroy microbiological material:
- . a filtration system with pre-filter, activated carbon filter, and HEPA filter;
- . a motor/impeller to move air through the filtration system:
- . sensors to monitor UV irradiance and airflow;
- . an electronic control system to power and control the device; and
- . a touch panel interface equipped with LEDs to indicate the working status of the device.
Pūrgo has several built-in safety features that will prevent operation of the filter cartridge is not in place or if the filter door is not closed. The unit also incorporates UV and airflow sensors that provide warnings to the user if the device is not performing as designed to purify air.
Pūrgo pulls air through a filter cartridge and then passes the filtered air through a chamber containing UV-C light to neutralize remaining airborne microorganisms (such as bacteria, viruses, and 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.
The document describes the acceptance criteria and the studies conducted for the Pūrgo device, a combination UV and air filtration system.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Microorganism Performance | 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 | Per Standard (IEST-RP-CC001.6) | - 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 | Per Standard (ACGIH 2019 TLVs, ANSI/IENSA RP-27.3-07) | - Meets daily exposure limits (<0.1 µW/cm² for an 8-hour duration) when operating normally. |
| - Considered part of the ANSI/IENSA RP-27.3-07 Exempt Risk Group. | ||
| Ozone | Per Standard (UL 867, UL ECVP 2998) | - Operates at less than 0.005 ppm at its highest and lowest fan speeds. |
| Airflow Performance | - Sleep: min. 125 CFM- Normal: min. 200 CFM- Boost: min. 315 CFM | Pass |
| Laminar Airflow Evaluation | Pūrgo does not disturb laminar flow | - Optimal placement determined to be near the outer wall of room (8' from surgery table) for Pūrgo flow rates of 230 to 315 CFM, regardless of HVAC return duct location. |
| Home Healthcare Environments | Per Standards (FDA Guidance "Design Considerations for Devices Intended for Home Use", IEC 60601-1, IEC 60601-1-11) | Pass |
| Electrical Safety | Per Standard (UL 507, IEC 60601-1) | Pass |
| Electromagnetic Compatibility | Per Standard (IEC 60601-1-2) | Pass |
| Software Validation | Meet defined specifications | Pass |
2. Sample Size Used for the Test Set and Data Provenance
For the Microorganism Performance testing:
- The device was tested with six different aerosolized biologicals at "normal speed."
- Two of these biologicals (MS2 and Bacillus globigii) were also tested at "sleep" and "boost" fan speeds.
- The document does not specify a numerical sample size (e.g., number of runs, number of devices) for the individual tests, only the types of organisms and conditions.
- The data provenance is from non-clinical testing, performed by AeroClean Technologies, LLC, as "Internal Standards." There is no indication of country of origin for the underlying data samples or whether it was retrospective or prospective, beyond the fact that it was laboratory testing.
For Fractional Efficiency testing:
- Performed on "the Pūrgo filter and the Pūrgo device itself."
- Sample size not explicitly stated for number of filters or devices tested.
For other tests (UV Intensity, UV Irradiance Exposure, Ozone, Airflow Performance Evaluation, Laminar Airflow Evaluation, Home Healthcare Environments, Electrical Safety, Electromagnetic Compatibility, Software Validation), sample sizes are not explicitly stated. The tests are generally described as "testing was performed" or "evaluation was performed."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not specify the number or qualifications of experts used to establish ground truth for any of the test sets.
- All tests are presented as laboratory-based performance evaluations against established standards or internal criteria, rather than expert-derived ground truth.
4. Adjudication Method for the Test Set
- No adjudication method is mentioned as these are performance verification tests against predefined acceptance criteria, not subjective evaluations requiring expert consensus or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No MRMC comparative effectiveness study was done or mentioned. The submission focuses on the standalone performance of the device against a predicate, not human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, standalone performance was done. All the reported testing, particularly the "Microorganism Performance" and "Fractional Efficiency" tests, represent the standalone performance of the Pūrgo device (algorithm/device only without human intervention in the purification process).
7. The Type of Ground Truth Used
- The ground truth used for performance validation is primarily based on laboratory measurements and adherence to recognized standards (e.g., IEST-RP-CC001.6 for fractional efficiency, ACGIH TLVs for UV exposure, UL 867 for ozone, UL 507 and IEC 60601-1 for electrical safety).
- For microorganism reduction, the "log reduction" figures are derived from measured concentrations of live microorganisms before and after exposure to the device in controlled laboratory settings.
8. The Sample Size for the Training Set
- The Pūrgo device is an air purification device, not an AI or machine learning model that typically requires a "training set." Therefore, this concept does not apply, and no training set sample size is mentioned.
9. How the Ground Truth for the Training Set Was Established
- Since the device is not an AI/ML system requiring a training set, this question is not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
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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
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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 Staphylococcusepidermidis | 4.6 (45) at normal speed |
| Gram + Bacteria | Bacillus globigii endospore | 4.1 (60) at normal speed |
| Gram - Bacteria | Escherichia coli | 5.4 (45) at normal speed |
| RNA Virus | MS2 bacteriophage | 5.4 (60) at normal speed |
| 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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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 100Palm Beach Gardens, FL 33410 |
|---|---|
| Primary Contact: | Rita King, CEOMethodSense, Inc.Email: ritaking@methodsense.comPhone: (919) 313-3961Fax: (919) 313-3979 |
| Company Contact: | Richard FosterTitle: Senior Director, Quality and Regulatory AffairsEmail: rfoster@aeroclean.comPhone: (773) 791-6198 |
| Date Prepared: | 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.
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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:
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| Organism | Name | Avg. max log reduction / exposure time (min) |
|---|---|---|
| Gram + Bacteria | Methicillin resistant Staphylococcusepidermidis | 4.6 (45) at normal speed |
| Gram + Bacteria | Bacillus globigii endospore | 4.1 (60) at normal speed |
| Gram - Bacteria | Escherichia coli | 5.4 (45) at normal speed |
| RNA Virus | MS2 bacteriophage | 5.4 (60) at normal speed |
| DNA Virus | Phi-X174 bacteriophage | 4.4 (45) at normal speed |
| Fungal Spore | Aspergillus brasiliensis spore | 4.3 (90) at normal speed |
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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, byexposure to UV radiation, bacteria and viruses in interior spaces. | To remove and destroy, byexposure 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: | SimilarThe 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 speedBacillus globigii endospore 4.1 (60) at normal speedEscherichia coli 5.4 (45) at normal speedMS2 bacteriophage | Average Net Log Reduction / Time @ FanSpeed 6. Room Temperature TestEscherichia Coli $4.20 +/- 0.11 / 90 mins$Bacillus Subtilis $4.02 +/- 0.23 / 30 mins$ | Average Maximum log reduction /exposure time (hours):Room TemperatureVirus, 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 speedPhi-X174 bacteriophage4.4 (45) at normal speedAspergillus brasiliensis spore4.3 (90) at normal speed | Aspergillus Brasiliensis$4.15 \pm 0.06$ / 60 minsMS2 Bacteriophage$4.38 \pm 0.15$ / 30 minsSingle Pass MechanicalFiltration EfficiencyParticulate Matter 0.3 to 1.0micron size particles 95% orgreater according toASHRAE 52.2 | |||
| User | Healthcare ProfessionalLay User | Healthcare ProfessionalLay User | Healthcare Professional | Identical |
| Environment of Use | Hospital and other healthcaresetting.General Surgery Setting.Home healthcare. | Hospital and otherhealthcare setting.Home healthcare. | Hospital and generalsurgery setting | SimilarThe Environment of Use ofthe Pūrgo is identical tothat of the primarypredicate as both can beused in a hospital andother healthcare settingand the home healthcareenvironments.The Environment of Use ofthe Pūrgo is identical tothat of the secondarypredicate device as bothcan be used in the hospitaland general surgerysetting. |
| 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 acentral location isrecommended. Placementnear the patient is key.Pūrgo may be used insurgical suites.Pūrgo is designed for roomsup to 3000 ft³. | Air pro will work in anyroom, but giving it a spacein a central location, isrecommended. Placementnear the patient is key.It should not be used insurgical suites or in roomswith air separation devices.It is designed for roomsunder 1000 ft². | Specific information onplacement not availableDevice can be used insurgical suites. | SimilarThe Placement of Pūrgo isequivalent to that of theprimary predicate in acentral location and that ofthe secondary predicatedevice 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 selectionsfor 3 fan speeds, powerbutton, timer, and UV andairflow indicators. | LCD screen with capacitivetouchscreen interface. UserInterface includes severaldedicated screens for fanspeed control, PM sensorreadings in addition to otheradministrative functions.Application controls mimicdevice touch panel. | One knob controls thefour speed fan settingOne button turns the uniton and off. | SimilarThe User Controls of thedevices are equivalent, asall provide a user interfaceallowing the user control ofmajor functions of thedevice.The devices differ as theprimary predicate uses anLCD screen with anassociated softwareapplication and thesecondary predicate deviceuses a knob and buttonwhile Pūrgo has a staticinterface on a touch panel.This difference does notaffect the intended use orsafety and effectiveness ofthe device. |
| Software | Basic Firmware; used to turnthe unit on, off, change fanspeed, and otheradministrative functions(timer, UV and airflow status). | Basic Firmware and App;used to turn the unit on, off,and change fan speed. | Basic Firmware; used toturn the unit on, off, andchange fan speed. | SimilarAll devices utilize firmwarewhich provides equivalentfunctionality. The primarypredicate has an additionalsoftware application inaddition to its devicefirmware. This differencedoes not affect theintended use or safety andeffectiveness of the device. |
| Item | Pūrgo(K213753)Subject Device | Molekule Air Pro(K211194)Primary Predicate | Molekule Air Pro RX(K200500)Secondary Predicate | Comparison |
| Mechanism ofAction | Air is pulled through a multi-layer filter (pre-filter, activatedcarbon, HEPA) to removemicroorganisms and then intoa UV chamber (SteriDuct)containing UV-C light withsufficient energy to kill anyremaining microorganisms. | UV light of sufficient energy(UV-A) activatesphotocatalyst that destroysmicroorganisms entrainedon the filter through aphotochemical reaction. | UV light of sufficientenergy (UV-A) activatesphotocatalyst thatdestroys microorganismsentrained on the filterthrough a photochemicalreaction. | SimilarThe mechanisms of actionof the devices are similaras all devices utilizefiltration and UV irradiationto remove microorganismsfrom air.The devices differ as thePūrgo device first filters theair and then separatelyapplies UV-C light to anymicroorganisms which areable to pass through thefilter while the predicatesuse technology which firstcaptures microorganismson a catalytic filter andapplies UV-A light to thefilter to destroymicroorganisms via aphotochemical reaction.This difference does notaffect the intended use ofthe device and safety andeffectiveness has beenconfirmed via performancetesting. |
| 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 | SimilarAll 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 | DifferentPūrgo does not use aphotocatalyst as itsmechanism of action isachieved via filtration andUV-C irradiation, unlike thepredicate devices whichrely on a photo-catalyticreaction for microorganismdestruction. This differencedoes not affect theintended use of the deviceand safety andeffectiveness has beenconfirmed via performancetesting. |
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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 | SimilarAll 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 CFMflow. | SimilarAll devices allow for theuser to control flow byproviding an adjustablespeed setting. The Pūrgoairflow range reaches amax of 315 CFM comparedto the primary predicate'smax of 260 CFM. Thisdifference does not affectthe intended use of thedevice and safety andeffectiveness has beenconfirmed via performancetesting. |
| Device Air ChangesPer Hour (ACH) | 1.875 – 2.36 device airchanges per hour on Boost,250 - 315 CFM, in a 1000 ft²room. | 1.83 device air changes perhour on setting 6, roughly260 CFM, in a 1000 ft² room | 6-9 ACH when used inroom with volume of4000 cubic feet(a typical OperatingRoom Volume) withflowrates of 450-650CFM at settings 2 and 3. | SimilarBoth Pūrgo and the primarypredicate achieve around1.8 ACH on the maximumspeed setting. Pūrgoachieves slightly higherACH during optimalperformance. Thisdifference does not affectthe intended use of thedevice and safety andeffectiveness has beenconfirmed via performancetesting. |
| 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 SecondaryPredicateNeither Pūrgo nor thesecondary predicate deviceutilize a particulate sensorthat the primary predicatehas. This difference doesnot affect the intended useof the device or safety andeffectiveness. |
| Fan ExposureSafety Features | Diffuser panel on side ofdevice and SteriDuct coverbehind filter door to blockuser from accessing spinningfan without tools. Safetyfeature confirmed by UL 507. | Vanes at outlet andHoneycomb inlet of fan withsmall enough grating toblock user from accessingspinning fan without tools.Safety feature confirmed byUL 507. | Grill at outlet and inlet offan with small enoughgrating to block user fromaccessing spinning fanwithout tools. Safetyfeature confirmed byUL507. | SimilarAll devices provideprotection from thespinning fan for users. Thesafety features have beenconfirmed with UL 507testing. |
| UV Light ExposureSafety Features | Safety interlock switch existsin filter door to ensure if thedoor is open or if a filter ismissing, the unit will notoperate. The purpose ofthese switches is to protectthe user from any possibilityof exposure to direct contactwith UV light. Safety featureconfirmed by UL 507. | If a validated, serialized,Molekule filter is missing,the unit will not operate. Theunit authenticates the filtervia NFC, before and duringoperation.The purpose of this systemis to protect the user fromany possibility of exposureto direct contact with UV-Alight that would occurwithout a genuine MolekuleFilter being present. | Safety switches exist inthe following locations:PECO filter door, prefilter door, PECO filtercompartment, and prefilter compartment. If anydoor is open or if a filteris missing, the unit willnot operate. The purposeof these switches is toprotect the user from anypossibility of exposure todirect contact with UVlight. Safety featureconfirmed by UL507. | SimilarAll devices provideprotection from theexposure to UV light. Thesafety features have beenconfirmed with UL 507testing. |
| 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 standardsingle phase 120 Voltoutlet) | Identical |
| Current | Up to 1.00 Amps | Up to 1.27 Amps | Up to 3.72 amps | DifferentThe Pūrgo and predicatesdiffer due to the technicalspecifications of thedevices (i.e. the Pūrgouses fewer LEDs, fanpower consumption maydiffer) which results inlower power and currentconsumption. Thisdifference does not affectthe intended use or safetyand effectiveness of thedevice. |
| Power Consumption | Up to 120 Watts | Up to 152.8 Watts | Up to 450 Watts | DifferentThe Pūrgo and predicatesdiffer due to the technicalspecifications of thedevices (i.e. the Pūrgouses fewer LEDs, fanpower consumption maydiffer) which results inlower power and currentconsumption. Thisdifference does not affectthe intended use or safetyand effectiveness of thedevice. |
| Item | Pūrgo (K213753)Subject Device | Molekule Air Pro (K211194)Primary Predicate | Molekule Air Pro RX (K200500)Secondary Predicate | Comparison |
| Electronic DataInterface | None | NFCWLAN (2.4 GHz) | None | Similar to SecondaryPredicateNeither 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) x19.5"W x 10.6"DFilter 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 inWidth: 22 inHeight: 52 inArea = 25,168Filter Dimensions:20in x 20in x 4in | SimilarAll 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 forElectrical FansIEC 60601-1 Basic Safetyand Essential PerformanceIEC 60601-1-2 EMC. EMC forMedical DevicesIEC 60601-1-11 HomeHealthcare EnvironmentIEST-RP-CC001.6 HEPA andULPA Filters | FCC Part 15 C RadioFrequency DevicesUL 507 Standard forElectrical FansIEC 60601-1-2 EMC. EMCfor Medical DevicesASHRAE 52.2-2012 Methodof Testing GeneralVentilation Air CleaningDevices for RemovalEfficiency by Particle SizeAMCA 210-1999 LaboratoryMethods Of Testing FansFor RatingANSI/AHAM AC-1-2019Method for MeasuringPerformance of PortableHousehold Electric RoomAir Cleaners | UL 507 Standard forElectrical FansIEC 60601-1-2 EMC.EMC for MedicalDevices. | SimilarAll devices were tested toUL 507 and IEC 60601-1-2for electrical and EMCsafety. Pūrgo was tested tothe more stringent IEST-RP-CC001.6 standardinstead of ASHRAE 52.2as the primary predicatewas since Pūrgo utilizes aHEPA filter. For otherperformance testing, Pūrgowas tested using validationprotocols to verify safetyand 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 | AcceptanceCriteria | Results |
|---|---|---|---|---|
| MicroorganismPerformance | Internal Standards | Testing was performed to evaluate thePūrgo's efficacy against aerosolizedbiologicals. Testing was performed withthe Pūrgo device in accordance with thenormal use of the system (i.e. both thefiltration and UV systems active at thenormal speed) with six (6) differentaerosolized biologicals. Testing wasperformed with two aerosolizedbiologicals (MS2 and Bacillus globigii asthey are representative of the moredifficult biologicals to filter and destroy) atthe sleep and boost fan speeds todemonstrate that the efficacy of thedevice isn't compromised by changes infan speed. | 4 log reduction(99.99%) | Average net log reduction / timeMethicillin resistantStaphylococcus epidermidis,4.6 / 45 mins at normalBacillus globigii endospore,4.1 / 60 mins at normal,4.4 / 60 mins at sleep,4.2 / 45 mins at boostEscherichia coli,5.4 / 45 mins at normalMS2 bacteriophage,5.4 / 60 mins at normal,4.3 / 60 mins at sleep,4.5 / 45 mins at boostPhi-X174 bacteriophage,4.4 / 45 mins at normalAspergillus brasiliensis spore,4.3 / 90 mins at normal |
| Test Name | Applicable Standards | Purpose | AcceptanceCriteria | Results |
| FractionalEfficiency | IEST-RP-CC001.6 –HEPA and ULPA Filters | Fractional efficiency testing wasperformed on the Pūrgo filter and thePūrgo device itself per IEST-RP-CC001.6TypeH test to determine the fractionalefficiency percentage of particles ofvarying size ranges. | Per Standard | Filter: fractional efficiencypercentage of 99.995% at 0.1-0.2 µm |
| Per Standard | Pūrgo Unit with Filter: fractionalefficiency percentage of99.990% at 0.1-0.2 µm | |||
| UV Intensity | Not Applicable | The UV intensity performance of thePūrgo units was verified to ensure theappropriate amount of UV irradiance isachieved in the SteriDuct. | ≥ 0.240mW/cm² | Pass |
| UV IrradianceExposure | American Conference ofGovernmental IndustrialHygienists (ACGIH) 2019Threshold Limit Values(TLVs) for ChemicalSubstances and PhysicalAgents and BiologicalExposure Indices (BEIs) | UV radiation testing and evaluation wasperformed to measure the irradiancevalues at each wavelength between 200-400nm and determine the effectiveirradiance of the UV radiation to ensureUV exposure from the device is withinsafe limits. | Per Standard | Testing demonstrated that whenoperating in the normal condition(filter in place), the unit meetsdaily exposure limits (less than0.1 µW/cm² for an 8 hourduration) and is considered partof the ANSI/IENSA RP-27.3-07Exempt Risk Group |
| Ozone | UL 867 - Electrostatic AirCleanersUL ECVP 2998 ZeroOzone Emissions for AirCleaners, 3rd edition –2020 | Ozone testing was performed per UL 867by monitoring the ozone concentration ina test chamber at the highest fan speedand lowest fan speed. | Per Standard | Testing demonstrates the Pūrgounit is able to operate at lessthan 0.005 ppm at its highestand lowest fan speed. |
| AirflowPerformanceEvaluation | Not Applicable | The airflow performance of the Pūrgounits was verified at the three fan speedsavailable to the user. | Sleep: min. 125CFMNormal: min.200 CFMBoost: min. 315CFM | Pass |
| Test Name | Applicable Standards | Purpose | AcceptanceCriteria | Results |
| Laminar AirflowEvaluation | Internal Standards | Computational fluid dynamics (CFD) wasperformed to evaluate airflow from thePūrgo unit in a prototypical surgery roomwith the aim of determining combinationsof Pūrgo unit positions and operatingconditions that preserves the stable aircurtain over the surgery table (i.e. doesnot disturb laminar flow). Flow rate,placement, and HVAC return duct positionwere considered in the analysis and | Pūrgo does notdisturb laminarflow | Testing determined that optimalplacement was near the outerwall of room (8' from the surgerytable) for Pūrgo flow rates of 230to 315 CFM. This is trueregardless of whether HVACreturn ducts were located nearthe ceiling or floor of the room. |
| HomeHealthcareEnvironments | FDA Guidance "DesignConsiderations forDevices Intended forHome Use" (November24, 2014)IEC 60601-1: Medicalelectrical equipment - Part1: General requirementsfor basic safety andessential performance;2012IEC 60601-1-11: Medicalelectrical equipment - Part1-11: Generalrequirements for basicsafety and essentialperformance - CollateralStandard: Requirementsfor medical electricalequipment and medicalelectrical systems used inthe home healthcareenvironment: 2015 | FDA's Guidance "Design Considerationsfor Devices Intended for Home Use"(November 24, 2014) was followed for thedesign and development of Pūrgo toensure the home use device complieswith applicable standards of safety andeffectiveness and other regulatoryrequirements. | Per Standards | Pass |
| Test Name | Applicable Standards | Purpose | AcceptanceCriteria | Results |
| Electrical Safety | UL 507: Standard forElectric FansIEC 60601-1: Medicalelectrical equipment - Part1: General requirementsfor basic safety andessential performance;2012 | Electrical safety testing was performed inaccordance with UL 507 and IEC 60601-1. | Per Standard | Pass |
| ElectromagneticCompatibility | IEC 60601-1-2: Medicalelectrical equipment -Part 1-2: Generalrequirements for basicsafety and essentialperformance - Collateralstandard: Electromagneticcompatibility -Requirements and tests;Edition 4.0 | Electromagnetic Compatibility testing wasperformed in accordance with IEC 60601-1-2. | Per Standard | Pass |
| SoftwareValidation | FDA Guidance "Guidancefor the Content ofPremarket Submissionsfor Software Contained inMedical Devices" (May 11,2005) | Software verification and validation testingwas performed for the Pūrgo devicefirmware. | Meet definedspecifications | 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.
§ 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).