(121 days)
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:
| Test Item | Average Net Log Reduction / Time @ Fan Speed 6. Room Temperature Test | |
|---|---|---|
| Bacteria | Escherichia Coli | $4.20 \pm 0.11$ / 90 minutes |
| Bacteria Endospores | Bacillus Subtilis | $4.02 \pm 0.23$ / 30 minutes |
| Mold Spores | Aspergillus Brasiliensis | $4.15 \pm 0.06$ / 60 minutes |
| Virus | MS2 bacteriophage | $4.38 \pm 0.15$ / 30 minutes |
| Test Item | Single Pass Mechanical Filtration Efficiency | |
| Particulate Matter | 0.3 to 1.0 micron size particles | 95% or greater according to ASHRAE 52.2 |
The Molekule Air Pro air purifier is an ultraviolet air purifier that employs a photo electrochemical oxidation (PECO) ultraviolet air purification technology that destroys bacteria and viruses in air. The Molekule Air Pro may be used in medical facilities and in the home. A fan within the unit draws air up from vents in the bottom of the unit, up through the PECO filter (where it is exposed to low energy UV-A 320 - 400 nm light) and out through the vents on the top of the unit. PECO is an air purification technology that oxidizes microorganisms, including bacteria, molds and viruses. PECO works by shining UV-A light on the surface of the catalytic filter to initiate a chemical reaction that generates hydroxyl radicals. These radicals combine with microbiological contaminants that are captured on the filter. Once combined, a chemical reaction takes place destroying the contaminants.
The Molekule Air Pro is a freestanding device. It is a standalone device with an LCD display and a capacitive touchscreen user interface. Integrated WLAN provides a secondary means for controlling the device from the Molekule Android or iOS application.
Air Pro also includes a particulate matter sensor, particulate matter indicator, and Auto Protect Mode, which controls fan speed based on particulate levels detected in the use environment.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Molekule Air Pro:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria | Reported Device Performance (Average Net Log Reduction / Time @ Fan Speed 6. Room Temperature Test) |
|---|---|---|
| Bioaerosol Destruction | ||
| Bacteria (Escherichia Coli) | 4 log reduction (99.99%) | $4.20 \pm 0.11$ / 90 minutes |
| Bacteria Endospores (Bacillus Subtilis) | 4 log reduction (99.99%) | $4.02 \pm 0.23$ / 30 minutes |
| Mold Spores (Aspergillus Brasiliensis) | 4 log reduction (99.99%) | $4.15 \pm 0.06$ / 60 minutes |
| Virus (MS2 bacteriophage) | 4 log reduction (99.99%) | $4.38 \pm 0.15$ / 30 minutes |
| Particulate Matter Filtration | ||
| 0.3 to 1.0 micron size particles | 95% or greater according to ASHRAE 52.2 | Required filtration efficiency 95% or greater on 0.3 to 1.0 micron size particles was achieved. |
Performance at Different Fan Speeds (MS2 bacteriophage):
| Fan Speed | Acceptance Criteria (4 log reduction) | Reported Device Performance (Average net log reduction / time) |
|---|---|---|
| Speed 2 | 4 log reduction (99.99%) | $4.54 \pm 0.07$ / 120 mins |
| Speed 3 | 4 log reduction (99.99%) | $4.58 \pm 0.23$ / 60 mins |
| Speed 6 | 4 log reduction (99.99%) | $4.38 \pm 0.15$ / 30 mins |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes (number of units tested or number of replicates for each test) for the bioaerosol destruction and particulate filtration tests. It mentions "three PECO filters" were used for the fractional efficiency test.
The data provenance is not specified beyond being "nonclinical tests" conducted to support substantial equivalence. Information on the country of origin or whether the data was retrospective or prospective is not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided in the document. The "ground truth" for these performance tests is based on objective measurements of bioaerosol reduction and particle filtration efficiency, not on expert interpretation of observational data.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, which are not relevant for these specific engineering and microbiology performance tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The Molekule Air Pro is an air purification device, and its performance is evaluated through laboratory tests for bioaerosol destruction and particle filtration, not through human reader interpretation of medical images or data.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance evaluation was done. The performance testing described (bioaerosol destruction and particulate filtration) evaluated the device's capabilities without human intervention in its operation for the described tests. The device does operate in "Auto Mode Standard" or "manual mode," but the performance data presented is for the device operating independently to achieve purification.
7. Type of Ground Truth Used
The ground truth used for these studies is based on:
- Direct Measurement of Bioaerosol Reduction: This involves aerosolizing a known quantity of microorganisms and measuring the reduction in their concentration over time within a sealed chamber due to the device's operation.
- Standardized Filtration Efficiency Testing: This involves testing the filter's ability to remove particles of specific sizes according to the ASHRAE 52.2-2012 standard using specialized equipment.
8. Sample Size for the Training Set
This information is not applicable and not provided. The Molekule Air Pro is a physical device that performs air purification. It is not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for such a device would involve its engineering design, material selection, and optimization, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no "training set" for an AI/ML algorithm in the context of this device. The development of the device's technology (PECO) and its components (filters, UV LEDs, fan) would be based on scientific principles, engineering design, and iterative testing, not on establishing ground truth for a data-driven model.
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Image /page/0/Picture/0 description: The image shows 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. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 20, 2021
Molekule, Inc. % Adrienne Lenz Senior Medical Device Regulation Hymann, Phelps, & McNamara, P.C. 700 Thirteenth Street. N.W.. Suite 1200 Washington, District of Columbia 20005
Re: K211194
Trade/Device Name: Molekule Air Pro Regulation Number: 21 CFR 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: Class II Product Code: FRA Dated: July 16, 2021 Received: July 19, 2021
Dear Adrienne Lenz:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211194
Device Name Molekule Air Pro
Indications for Use (Describe)
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:
| Test Item | Average Net Log Reduction / Time @ Fan Speed 6. Room Temperature Test | |
|---|---|---|
| Bacteria | Escherichia Coli | $4.20 \u00b1 0.11$ / 90 minutes |
| Bacteria Endospores | Bacillus Subtilis | $4.02 \u00b1 0.23$ / 30 minutes |
| Mold Spores | Aspergillus Brasiliensis | $4.15 \u00b1 0.06$ / 60 minutes |
| Virus | MS2 bacteriophage | $4.38 \u00b1 0.15$ / 30 minutes |
| Test Item | Single Pass Mechanical Filtration Efficiency | |
| Particulate Matter | 0.3 to 1.0 micron size particles | 95% or greater according to ASHRAE 52.2 |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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K211194 510(k) Summary
In accordance with 21 C.F.R. § 807.92 the following summary of information is provided:
DATE: July 16, 2021
SUBMITTER:
Molekule, Inc. 1301 Folsom St San Francisco, CA 94103 T 855-999-9069
PRIMARY CONTACT PERSON:
Adrienne R. Lenz Senior Medical Device Regulation Expert Hyman, Phelps, & McNamara, P.C. T 202-737-4292
SECONDARY CONTACT PERSON:
Frank Bianco FDA Compliance Molekule, Inc. T 925-404-7724
DEVICE:
TRADE NAME: Molekule Air Pro COMMON/USUAL NAME: Air Purifier CLASSIFICATION NAMES: Purifier, Air, Ultraviolet, Medical REVIEW PANEL: General Hospital PRODUCT CODE: FRA
PREDICATE DEVICE(S):
Molekule Air Mini + Air Purifier, K202339
This predicate has not been subject to a design-related recall.
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DEVICE DESCRIPTION:
The Molekule Air Pro air purifier is an ultraviolet air purifier that employs a photo electrochemical oxidation (PECO) ultraviolet air purification technology that destroys bacteria and viruses in air. The Molekule Air Pro may be used in medical facilities and in the home. A fan within the unit draws air up from vents in the bottom of the unit, up through the PECO filter (where it is exposed to low energy UV-A 320 - 400 nm light) and out through the vents on the top of the unit. PECO is an air purification technology that oxidizes microorganisms, including bacteria, molds and viruses. PECO works by shining UV-A light on the surface of the catalytic filter to initiate a chemical reaction that generates hydroxyl radicals. These radicals combine with microbiological contaminants that are captured on the filter. Once combined, a chemical reaction takes place destroying the contaminants.
The Molekule Air Pro is a freestanding device. It is a standalone device with an LCD display and a capacitive touchscreen user interface. Integrated WLAN provides a secondary means for controlling the device from the Molekule Android or iOS application.
Air Pro also includes a particulate matter sensor, particulate matter indicator, and Auto Protect Mode, which controls fan speed based on particulate levels detected in the use environment.
INTENDED USE:
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:
| Test Item | Average Net Log Reduction / Time @Fan Speed 6. Room Temperature Test | |
|---|---|---|
| Bacteria | Escherichia Coli | $4.20 \pm 0.11$ / 90 minutes |
| BacteriaEndospores | Bacillus Subtilis | $4.02 \pm 0.23$ / 30 minutes |
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| Test Item | Average Net Log Reduction / Time @Fan Speed 6. Room Temperature Test | |
|---|---|---|
| Mold Spores | AspergillusBrasiliensis | $4.15 \pm 0.06$ / 60 minutes |
| Virus | MS2 bacteriophage | $4.38 \pm 0.15$ / 30 minutes |
| Test Item | Single Pass Mechanical FiltrationEfficiency | |
| Particulate Matter | 0.3 to 1.0 micron sizeparticles | 95% or greater according to ASHRAE52.2 |
TECHNOLOGICAL CHARACTERISTIC COMPARISON:
The following table summarizes the similarities and differences between the subject and predicate devices.
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| Molekule Air Proair purifier | Molekule Air Mini+air purifier (K202339) | Discussion of Differences | |
|---|---|---|---|
| 510(k) Holder | Molekule | Molekule | Identical |
| Device Type | Medical Ultraviolet Air purifier | Medical Ultraviolet Air purifier | Identical |
| Product Code | FRA | FRA | Identical |
| ClassificationRegulation | 21 C.F.R. § 880.6500 | 21 C.F.R. § 880.6500 | Identical |
| Class | II | II | Identical |
| Patient Population | Not specified | Not specified | Identical |
| Rx/OTC | OTC | OTC | Identical |
| User | Healthcare ProfessionalLay User | Healthcare ProfessionalLay User | Identical |
| Molekule Air Pro | Molekule Air Mini+ | Discussion of Differences | |
| air purifier | air purifier (K202339) | ||
| Indications forUse | The Molekule Air Pro air purifier is adevice intended for medical purposes thatis used to capture 95% of particulatematter and destroy bacteria, mold, andviruses by exposure to ultraviolet radiationwhen operated in Auto Mode Standard ormanual mode at fan speed 2 or higher.The Molekule Air Pro air purifier has beendemonstrated to entrain and destroy thefollowing bioaerosols under the followingexposure/working conditions:Average Net Log Reduction / Time @ FanSpeed 6. Room Temperature TestEscherichia Coli4.20 +/- 0.11 / 90 minsBacillus Subtilis4.02 +/- 0.23 / 30 minsAspergillus Brasiliensis4.15 ± 0.06 / 60 minsMS2 Bacteriophage4.38 ± 0.15 / 30 minsSingle Pass Mechanical FiltrationEfficiencyParticulate Matter 0.3 to 1.0 micron sizeparticles 95% or greater according toASHRAE 52.2 | The Molekule Air Mini + air purifier is adevice intended for medical purposes thatis used to capture 95% of particulatematter and destroy bacteria and viruses byexposure to ultraviolet radiation whenoperated in manual mode at fan speed 3 orhigher.The Molekule Air Mini + air purifier hasbeen demonstrated to destroy thefollowing MS2 bacteriophage bioaerosolentrained on the filter of the subject deviceunder the following exposure/workingconditions:Average Maximum Log Reduction /Entrainment Time @ Fan Speed 5. RoomTemperature TestMS2 Bacteriophage4.38 ± 0.15 / 30 minsSingle Pass Mechanical FiltrationEfficiencyParticulate Matter 0.3 to 1.0 micron sizeparticles 95% or greater according toASHRAE 52.2 | Based on additional testing, the indicationsfor use for the Air Pro were updated toinclude molds, with specific results addedfor bacteria and mold. Air Pro also hasadditional testing to support a greater than4-log reduction of MS2 bacteriophage atfan speed 2, which is also the lowestpossible fan speed in Auto ModeStandard. The indications were alsorevised to clarify that the reductionspresented in the table are average net logreductions from the combination of bothentrainment and destruction. Thesedifferences in indications do not changethe intended use of the device. Bothdevices are used to destroymicroorganisms in the air by the samemechanism. |
| Environment ofUse | Hospital and other healthcaresetting.Home healthcare. | Hospital and other healthcaresetting.Home healthcare. | Identical |
| Molekule Air Pro | Molekule Air Mini+ | Discussion of Differences | |
| air purifier | air purifier (K202339) | ||
| Placement | Air Pro will work in any room, butgiving it space in a central location,is recommended. Placement nearthe patient is key. | Air Mini + will work in any room,but giving it space in a centrallocation, and on a shelf, stand, ortable will help maximize air intake.Placement near the patient is key. | The proposed device is designedfor larger rooms. They are notplaced on shelfs or tables due to thedifferent form factor. Thesedifferences do not raise differentquestions of safety or effectiveness.Both devices meet applicablestandards for electrical safety, |
| It should not be used in surgicalsuites or in rooms with airseparation devices. | It should not be used in surgicalsuites or in rooms with airseparation devices. | ||
| It is designed for rooms under 1000ft². | It is designed for rooms under 250ft². | including home levels, and havebeen demonstrated to effectivelyremove and destroy pathogens inthe air. | |
| We recommend running it in theroom, closer to the bed. | |||
| User Control | LCD screen with capacitivetouchscreen interface. UserInterface includes several dedicatedscreens for fan speed control, PMsensor readings in addition to otheradministrative functions.Application controls mimic devicetouch panel | Touch panel with 5 manual fansettings and one auto protectsetting,Application controls mimic devicetouch panel | The controls on the Air Pro and AirMini+ are simple and similar touser controls on many otherdevices that healthcareprofessionals are accustomed tousing.The app has the same functions asthe firmware and does not raisedifferent questions of safety oreffectiveness as demonstrated bysoftware verification andvalidation. |
| Molekule Air Proair purifier | Molekule Air Mini+air purifier (K202339) | Discussion of Differences | |
| Software | Basic Firmware and App, used toturn the unit on, off, and changefan speed. | Basic Firmware and App, used toturn the unit on, off, and changefan speed. | Identical |
| Mechanism ofAction | UV light of sufficient energy (UV-A) activates photocatalyst thatdestroys microorganisms entrainedon the filter through aphotochemical reaction. | UV light of sufficient energy (UV-A) activates photocatalyst thatdestroys microorganisms entrainedon the filter through aphotochemical reaction. | Identical |
| Installation | Free standing | Free standing | Identical |
| Catalytic Filter | Proprietary multi-layer filter media Dimensions: 8.1 in (diameter), 11.7 in Height. Pleats per inch: 2.6 pleats per inch of outer circumference Total Filter surface area: 1779 in2 Filter coated with proprietary photocatalyst and a metal wire mesh MERV16 | 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 | Filters of both devices are identicalin material, coated with the samephotocatalyst, and feature identicallayers. There are differences in thedimensions related to the sizingrequirements for each device.These differences do not raisedifferences in safety oreffectiveness. |
| Photocatalyst | Proprietary catalyst (same aspredicate) | Proprietary catalyst | Identical |
| Molekule Air Proair purifier | Molekule Air Mini+air purifier (K202339) | Discussion of Differences | |
| Light Source | UV Light Source: LED•Wavelength: 320-400 nm•Total of 20 UV LEDs splitamongst 5 PCBs (4 LEDs perPCB)•Total UV Power: 16 W• | UV Light Source: LED•Wavelength: 320-400 nm•Total of 12 UV LEDs splitamongst 4 PCBs (3 LEDs perPCB)•Total UV Power: 6.8W•Filter Irradiance (Minimum):20 W/m² | The UV LEDs in the Molekule AirMini+ and Molekule Air Pro areidentical. Air Pro featuresignificantly larger filter areas andthus, more LEDs are used andmore UV power is needed toachieve the minimum irradiance onthe filter. |
| Air Source | Centrifugal Fan | Centrifugal Fan | Identical |
| Flow Control | 6 speeds (low-high)Provide 25-260 CFM | 5 speeds (low-high)Provide 9-86 CFM | All devices achieve the sameeffect. See discussion of airchanges per hour in the next rowfor additional discussion. |
| Device AirChanges Per Hour(ACH) | 1.83 device air changes per hour onsetting 6, roughly 260 CFM, in a1000 ft² room | 2.43 device air changes per hour onsetting 5, roughly 86 CFM, in a250 ft² room | Air Pro is designed for largerrooms. The effective cleaning ratecan be roughly compared bynormalizing the device air changefor each product. This allows for aquantification of purified airrelative to ventilation rate. We seeuniformity amongst the products. |
| Molekule Air Proair purifier | Molekule Air Mini+air purifier (K202339) | Discussion of Differences | |
| Particulate Sensor | Optical Particle Matter Sensor | Optical Particle Sensor | Air Pro and Air Mini+ both have abuilt-in particulate matter sensorthat can be used to evaluate theenvironment the device is in andprovide an air quality level that thedevice can use to ramp up or downfan speed as appropriate. They usedifferent sensors, with Air Profeaturing a sensor capable ofbinning particles in different sizes,providing additional information.This difference does not raisedifferent quesitons of safety oreffectiveness. All devices meetstandards for electric fans/EMCand have demonstrated appropriateperformance in testing. |
| Molekule Air Proair purifier | Molekule Air Mini+air purifier (K202339) | Discussion of Differences | |
| UV LightExposure SafetyFeatures | If a validated, serialized, Molekulefilter is missing, the unit will notoperate. The unit authenticates thefilter via NFC, before and duringoperation.The purpose of this system is toprotect the user from anypossibility of exposure to directcontact with UV-A light that wouldoccur without a genuine MolekuleFilter being present. | If a validated, serialized, Molekulefilter is missing, the unit will notoperate. The unit authenticates thefilter via NFC, before and duringoperation.The purpose of this system is toprotect the user from anypossibility of exposure to directcontact with UV-A light that wouldoccur without a genuine MolekuleFilter being present. | Identical |
| Fan ExposureSafety Features | Vanes at outlet and Honeycombinlet of fan with small enoughgrating to block user fromaccessing spinning fan withouttools. Safety feature confirmed byUL 507. | Vanes at outlet and Honeycombinlet of fan with small enoughgrating to block user fromaccessing spinning fan withouttools. Safety feature confirmed byUL 507. | Identical |
| Input Voltage | 120 Volt | 120 Volt | Identical |
| Molekule Air Proair purifier | Molekule Air Mini+air purifier (K202339) | Discussion of Differences | |
| Current | Up to 1.27 Amps | Up to 0.55 Amps | Increase in current is due to thelarger power consumption, giventhat both units operate off 120VAC. See power consumption rowbelow for more details. |
| PowerConsumption | Up to 152.8 Watts | Up to 55 Watts | Difference in power consumptionof the system is largely due to thefan and LEDS. Air Pro utilizes alarger fan and more LEDs than AirMini+ and thus will consume morepower.This difference does not impactsafety or effectiveness as bothdevices comply with applicablesafety standards. |
| Electronic DataInterface | NFCWLAN (2.4 GHZ) | NFCWLAN (2.4 GHZ) | Identical |
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| Molekule Air Proair purifier | Molekule Air Mini+air purifier (K202339) | Discussion of Differences | |
|---|---|---|---|
| Dimensions | 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:Height: 12.04 in (306 mm)Diameter: 8.27 in (210 mm)Filter Dimensions:Diameter: 6.03 in (153 mm)Height: 6.45 in (164 mm) | The Molekule Air Pro has a largerhousing to accomodate the largerfan and filter.This is due to the difference intarget Air Flow by the device. |
| Molekule Air Proair purifier | Molekule Air Mini+air purifier (K202339) | Discussion of Differences | |
| Standards | FCC Part 15 C Radio FrequencyDevicesUL 507 Standard for ElectricalFansIEC 60601-1-2 EMC. EMC forMedical DevicesASHRAE 52.2-2012 Method ofTesting General Ventilation Air-Cleaning Devices for RemovalEfficiency by Particle SizeAMCA 210-1999 LaboratoryMethods Of Testing Fans ForRatingANSI/AHAM AC-1-2019Method for MeasuringPerformance of PortableHousehold Electric Room AirCleaners | FCC Part 15 C Radio FrequencyDevicesUL 507 Standard for ElectricalFansIEC 60601-1-2 EMC. EMC forMedical DevicesASHRAE 52.2-2012 Method ofTesting General Ventilation Air-Cleaning Devices for RemovalEfficiency by Particle SizeAMCA 210-1999 LaboratoryMethods Of Testing Fans ForRatingANSI/AHAM AC-1-2019Method for MeasuringPerformance of PortableHousehold Electric Room AirCleaners | Identical |
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SUMMARY OF NON-CLINICAL TESTS:
The Molekule Air Pro complies with voluntary standards for electrical safety and electromagnetic compatibility. The following data were provided in support of the substantial equivalence determination:
- Risk Analysis ●
- Software verification and validation testing and software information . recommended by FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- Electrical safety and electromagnetic compatibility testing per UL 507:2017 ● Electric Fans and IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances - Requirements and tests, respectively
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• Performance Testing:
| Test Methodology | Purpose | AcceptanceCriteria | Results |
|---|---|---|---|
| MS2 bacteriophage, AspergillusBrasiliensis Mold Spores, BacillusSubtilis Endospores, and EscherichiaColi Bacteria were aerosolized into asealed environmental bioaerosolchamber containing Molekule® AirPro device. | To evaluate the efficacy of theMolekule® Air Pro air purificationdevice at reducing aerosolized MS2bacteriophage, AspergillusBrasiliensis Mold Spores, BacillusSubtilis Endospores, andEscherichia Coli Bacteria by acombination of entrainment anddestruction. | 4 log reduction(99.99%) | Average net log reduction / timeMS2 Bacteriophage, $4.38 \pm 0.15$ / 30 minsAspergillus Brasiliensis, $4.15 +/- 0.06$ / 60minsBacillus Subtilis, $4.02 +/- 0.23$ / 30 minsEscherichia Coli, $4.20 +/- 0.11$ / 90 mins |
| MS2 bacteriophage was aerosolizedinto a sealed environmentalbioaerosol chamber containingMolekule® Air Pro device running atdifferent fan speeds. | To demonstrate performance atdifferent fan speeds using MS2bacteriophage as a challengepollutant. | 4 log reduction(99.99%) | Average net log reduction / timeSpeed 2, $4.54 +/- 0.07$ 120 minsSpeed 3, $4.58 +/- 0.23$ 60 minsSpeed 6, $4.38 \pm 0.15$ 30 mins |
| Fractional efficiency per ASHRAE52.2-2012 Method of TestingGeneral Ventilation Air-CleaningDevices for Removal Efficiency byParticle Size using three PECOfilters.System flow with filter installedaccording to AMCA 210-1999Fig.12. | To ensure Air Pro meets FiltrationEfficiency Requirements (95% orgreater on 0.3 to 1.0 micron sizeparticles) and device flowrequirements. | The filter shallachieve 95% orgreater on 0.3 to 1.0micron size particlesaccording toASHRAE 52.2. | Required filtration efficiency 95% orgreater on 0.3 to 1.0 micron size particleswas achieved. |
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SUMMARY OF CLINICAL TESTS:
No clinical tests were required to demonstrate substantial equivalence.
CONCLUSION:
Molekule, Inc. concludes that the nonclinical tests demonstrate that the Molekule Air Pro air purifier is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
§ 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).