(190 days)
The Molekule Air Mini air purifier is a device intended for medical purposes that is used to capture 95% of particulate matter and destroy bacteria and viruses by exposure to ultraviolet radiation.
The Molekule Air Mini air purifier has been demonstrated to destroy the following MS2 bacteriophage bioaerosol entrained on the filter of the subject device under the following exposure/working conditions:
Virus: MS2 bacteriophage - Average maximum log reduction / entrainment time (hours) at Fan Speed 5. Room temperature test. 5.09 ± 0.42 / 120 mins
Particulate matter: 0.3 to 1.0 micron size particles - Single Pass Mechanical Filtration Efficiency 95% or greater according to ASHRAE 52.2
The Molekule Air Mini + air purifier is a device intended for medical purposes that is used to capture 95% of particulate matter and destroy bacteria and viruses by exposure to ultraviolet radiation when operated in manual mode at fan speed 3 or higher.
The Molekule Air Mini + air purifier has been demonstrated to destroy the following MS2 bacteriophage bioaerosol entrained on the filter of the subject device under the following exposure/working conditions:
Virus: MS2 bacteriophage - Average maximum log reduction / entrainment time (hours) at Fan Speed 5. Room temperature test. 5.09 ± 0.42 / 120 mins
Particulate matter: 0.3 to 1.0 micron size particles - Single Pass Mechanical Filtration Efficiency 95% or greater according to ASHRAE 52.2
The Molekule Air Mini and Air Mini + air purifiers are ultraviolet air purifiers that employ a photo electrochemical oxidation (PECO) ultraviolet air purification technology that destroys bacteria and viruses in air. The Molekule Air Mini and Air Mini + may be used in medical facilities and in the home. The Molekule Air Mini and Air Mini + air purifiers includes a low energy ultraviolet light (UV-A 320 - 400 nm) and a catalytic filter. They are standalone devices that can be controlled via a button on the device and may also be controlled using the Molekule Android or iOS application.
PECO is an air purification technology that oxidizes bacteria 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, such as bacteria and viruses, that are captured on the filter. Once combined, a chemical reaction takes place destroying the contaminants.
The Molekule Air Mini and Air Mini + are freestanding devices. 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 UV-A light), and out through the vents on the top of the unit.
The Molekule Air Mini and Air Mini + user interface includes a capacitive touch button and LED indicators on the top of the device. Power (on/off) and fan speed are controlled via the capacitive touch button. Integrated WLAN provides a secondary means for controlling the device from the Molekule Android or iOS application.
Air Mini + additionally 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.
This document describes the Molekule Air Mini and Mini+ air purifiers, which are intended for medical purposes to capture particulate matter and destroy bacteria and viruses. The following information is extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Virus Destruction (MS2 bacteriophage) | 4 log reduction (99.99%) | 4.18 ± 0.56 net log reduction at 90 mins |
| 5.09 ± 0.42 net log reduction at 120 mins | ||
| Particulate Matter Capture (0.3 to 1.0 micron size particles) | 95% or greater according to ASHRAE 52.2 | Required filtration efficiency 95% or greater was achieved. |
2. Sample Size Used for the Test Set and Data Provenance
- Virus (MS2 bacteriophage) testing: Performed using a sealed environmental bioaerosol chamber containing the Molekule® Air Mini device. The sample size for the MS2 bacteriophage destruction efficacy testing is not explicitly stated as a number of devices or iterations in the provided text, beyond the mention of "aerosolized into a sealed environmental bioaerosol chamber containing Molekule® Air Mini device."
- Particulate Matter Filtration: Tested using "three PECO filters."
- Data Provenance: The document does not specify the country of origin of the data. The tests described are "Performance Testing" which are laboratory-based, non-clinical tests. They are retrospective in the sense that they were conducted for the purpose of the 510(k) submission, confirming the device's performance after its design.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for the performance tests (virus destruction and particulate filtration) was established by direct measurement using scientific methods and established standards (ASHRAE 52.2), not by expert consensus in an observational or diagnostic context.
4. Adjudication Method for the Test Set
Not applicable. The reported results are direct measurements from performance tests, not subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No clinical tests were required to demonstrate substantial equivalence." This means there was no human-in-the-loop study, and therefore no MRMC study to assess human reader improvement with or without AI assistance. The device is an air purifier, not an AI diagnostic tool that human readers would use in conjunction with.
6. Standalone Performance
Yes, a standalone performance study was done. The document details "Performance Testing" for both virus destruction and particulate matter capture, which evaluates the device's capabilities without human intervention or interpretation. The results in the table directly reflect the algorithm's (or device's) standalone performance against the specified criteria.
7. Type of Ground Truth Used
The ground truth used for these performance studies was:
- Quantitative Measurement/Laboratory Testing: For virus destruction, it was the measured "log reduction" of MS2 bacteriophage in a sealed chamber. For particulate matter capture, it was the "Single Pass Mechanical Filtration Efficiency" measured according to ASHRAE 52.2. These are direct, objective measurements of the device's physical performance.
8. Sample Size for the Training Set
Not applicable. The Molekule Air Mini and Air Mini+ are physical medical devices (air purifiers) that use a photo electrochemical oxidation (PECO) ultraviolet air purification technology. They do not appear to employ a machine learning algorithm that requires a "training set" in the conventional sense of AI/ML models. The "software" mentioned is for basic device control (on/off, fan speed) and authentication of filters, not for complex data processing requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of an AI/ML training set in the provided document.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
February 23, 2021
Molekule, Inc. % Adrienne Lenz Senior Medical Device Regulation Expert Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street, N.W., Suite 1200 Washington, District of Columbia 20005
Re: K202339
Trade/Device Name: Molekule Air Mini, Molekule Air Mini + Regulation Number: 21 CFR 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: Class II Product Code: FRA Dated: August 14, 2020 Received: August 17, 2020
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
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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,
for Clarence W. Murray, III, Ph.D. Acting 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)
Device Name
Molekule Air Mini
Indications for Use (Describe)
The Molekule Air Mini air purifier is a device intended for medical purposes that is used to capture 95% of particulate matter and destroy bacteria and viruses by exposure to ultraviolet radiation.
The Molekule Air Mini air purifier has been demonstrated to destroy the following MS2 bacteriophage bioaerosol entrained on the filter of the subject device under the following exposure/working conditions:
| Test Item | Test Result | |
|---|---|---|
| Virus | MS2bacteriophage | Average maximum log reduction /entrainment time (hours) at Fan Speed 5.Room temperature test.5.09 ± 0.42 / 120 mins |
| Particulate matter | 0.3 to 1.0 micronsize particles | Single Pass Mechanical Filtration Efficiency95% 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This 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."
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Indications for Use
510(k) Number (if known)
Device Name Molekule Air Mini +
Indications for Use (Describe)
The Molekule Air Mini + air purifier is a device intended for medical purposes that is used to capture 95% of particulate matter and destroy bacteria and viruses by exposure to ultraviolet radiation when operated in manual mode at fan speed 3 or higher.
The Molekule Air Mini + air purifier has been demonstrated to destroy the following MS2 bacteriophage bioaerosol entrained on the filter of the subject device under the following exposure/working conditions:
| Test Item | Test Result | |
|---|---|---|
| Virus | MS2 bacteriophage | Average maximum log reduction / entrainment time (hours) at Fan Speed 5. Room temperature test. |
| 5.09 ± 0.42 / 120 mins | ||
| Particulate matter | 0.3 to 1.0 micron size particles | Single Pass Mechanical Filtration Efficiency 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This 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."
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510(k) Summary
K202339
In accordance with 21 C.F.R. § 807.92 the following summary of information is provided:
DATE: February 22, 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 Mini, Molekule Air Mini + COMMON/USUAL NAME: Air Purifier CLASSIFICATION NAMES: Purifier, Air, Ultraviolet, Medical REVIEW PANEL: General Hospital PRODUCT CODE: FRA
PREDICATE DEVICE(S):
Molekule Air Pro RX Air Purifier, K200500
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This predicate has not been subject to a design-related recall.
DEVICE DESCRIPTION:
The Molekule Air Mini and Air Mini + air purifiers are ultraviolet air purifiers that employ a photo electrochemical oxidation (PECO) ultraviolet air purification technology that destroys bacteria and viruses in air. The Molekule Air Mini and Air Mini + may be used in medical facilities and in the home. The Molekule Air Mini and Air Mini + air purifiers includes a low energy ultraviolet light (UV-A 320 - 400 nm) and a catalytic filter. They are standalone devices that can be controlled via a button on the device and may also be controlled using the Molekule Android or iOS application.
PECO is an air purification technology that oxidizes bacteria 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, such as bacteria and viruses, that are captured on the filter. Once combined, a chemical reaction takes place destroying the contaminants.
The Molekule Air Mini and Air Mini + are freestanding devices. 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 UV-A light), and out through the vents on the top of the unit.
The Molekule Air Mini and Air Mini + user interface includes a capacitive touch button and LED indicators on the top of the device. Power (on/off) and fan speed are controlled via the capacitive touch button. Integrated WLAN provides a secondary means for controlling the device from the Molekule Android or iOS application.
Air Mini + additionally 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:
Molekule Air Mini
The Molekule Air Mini air purifier is a device intended for medical purposes that is used to capture 95% of particulate matter and destroy bacteria and viruses by exposure to ultraviolet radiation.
The Molekule Air Mini air purifier has been demonstrated to destroy the following MS2 bacteriophage bioaerosol entrained on the filter of the subject device under the following exposure/working conditions:
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| Test Item | Test Result |
|---|---|
| VirusMS2bacteriophage | Average maximum log reduction /entrainment time (hours) at Fan Speed 5.Room temperature test.$5.09 \pm 0.42$ / 120 mins |
| Particulate matter0.3 to 1.0 micronsize particles | Single Pass Mechanical Filtration Efficiency95% or greater according to ASHRAE 52.2 |
Molekule Air Mini +
The Molekule Air Mini + air purifier is a device intended for medical purposes that is used to capture 95% of particulate matter and destroy bacteria and viruses by exposure to ultraviolet radiation when operated in manual mode at fan speed 3 or higher.
The Molekule Air Mini + air purifier has been demonstrated to destroy the following MS2 bacteriophage bioaerosol entrained on the filter of the subject device under the following exposure/working conditions:
| Test Item | Test Result |
|---|---|
| Virus | Average maximum log reduction / entrainment time (hours) at Fan Speed 5. Room temperature test.5.09 ± 0.42 / 120 mins |
| Particulate matter | Single Pass Mechanical Filtration Efficiency0.3 to 1.0 micron size particles95% or greater according to ASHRAE 52.2 |
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CHARACTERISTIC COMPARISON:
The following table summarizes the similarities and differences between the subject and predicate devices.
| Molekule Air Miniair purifier(K202339) | Molekule Air Mini +air purifier(K202339) | Predicate DeviceMolekule Air Pro RXair purifier(K200500) | |
|---|---|---|---|
| 510(k) Holder | Molekule | Molekule | Molekule |
| Device Type | Medical Ultraviolet Airpurifier | Medical Ultraviolet Airpurifier | Medical Ultraviolet Airpurifier |
| Product Code | FRA | FRA | FRA |
| ClassificationRegulation | 21 C.F.R. § 880.6500 | 21 C.F.R. § 880.6500 | 21 C.F.R. § 880.6500 |
| Class | II | II | II |
| Rx/OTC | OTC | OTC | OTC |
| User | Healthcare ProfessionalLay User | Healthcare ProfessionalLay User | Healthcare Professional |
| Molekule Air Miniair purifier(K202339) | Molekule Air Mini +air purifier(K202339) | Predicate DeviceMolekule Air Pro RXair purifier(K200500) | |
| Indications forUse | The Molekule Air Miniair purifier is a deviceintended for medicalpurposes that are used tocapture 95% ofparticulate matter anddestroy bacteria andviruses by exposure toultraviolet radiation.The Molekule Air Miniair purifier has beendemonstrated to destroythe following MS2bacteriophage bioaerosolentrained on the filter ofthe subject device underthe following exposureconditions:Average maximum logreduction / entrainmenttime (hours) at FanSpeed 5. Roomtemperature test for MS2bacteriophage virus:5.09 ± 0.42 120 minsSingle Pass MechanicalFiltration Efficiency:95% or greater accordingto ASHRAE 52.2 | The Molekule Air Mini +air purifier is a deviceintended for medicalpurposes that are used tocapture 95% ofparticulate matter anddestroy bacteria andviruses in the air byexposure to ultravioletradiation when operatedin manual mode at fanspeed 3 or higher.The Molekule Air Mini +air purifier has beendemonstrated to destroythe following MS2bacteriophage bioaerosolentrained on the filter ofthe subject device underthe following exposureconditions:Average maximum logreduction / entrainmenttime (hours) at FanSpeed 5. Roomtemperature test for MS2bacteriophage virus:5.09 ± 0.42 120 minsSingle Pass MechanicalFiltration Efficiency:95% or greater accordingto ASHRAE 52.2 | The Molekule Air Pro RXair purifier is a deviceintended for medicalpurposes that is used todestroy bacteria andviruses in the air byexposure to ultravioletradiation.The core technologycomponents of theMolekule Air Pro RX airpurifier have beendemonstrated to destroythe following MS2bacteriophage bioaerosolentrained on the filter ofthe subject device underthe following exposureconditions:Average Maximum logreduction/exposure time(hours)Room temperature Virus,MS2 bacteriophage5.21/24 hours |
| Molekule Air Miniair purifier(K202339) | Molekule Air Mini +air purifier(K202339) | Predicate DeviceMolekule Air Pro RXair purifier(K200500) | |
| Environmentof Use | Hospital and otherhealthcare setting.Home healthcare. | Hospital and otherhealthcare setting.Home healthcare. | Hospital, includinggeneral, surgery, criticalcare, and radiology.Inpatient and generalnursing facilities,diagnostic and radiologyrooms. |
| User Control | Touch panel with 5manual fan settings.Application controlsmimic device touchpanel | Touch panel with 5manual fan settings andone auto protect setting.Application controlsmimic device touch panel | One knob controls thefour-speed fan settingOne button turns the uniton and off. |
| Software | Basic Firmware andApp, used to turn the uniton, off, and change fanspeed. | Basic Firmware and App,used to turn the unit on,off, and change fanspeed. | Basic Firmware, used toturn the unit on, off, andchange fan speed. |
| Mechanism ofAction | UV light of sufficientenergy (UV-A) activatesphotocatalyst thatdestroys microorganismsentrained on the filterthrough a photochemicalreaction. | UV light of sufficientenergy (UV-A) activatesphotocatalyst thatdestroys microorganismsentrained on the filterthrough a photochemicalreaction. | UV light of sufficientenergy (UV-A) activatesphotocatalyst that destroysmicroorganisms entrainedon the filter through aphotochemical reaction. |
| Installation | Free standing | Free standing | Free standing |
| Pre-Filter(s) | ● Not applicable | ● Not applicable | ● Synthetic Media formechanical filtrationupstream of the PECOfilter.● Dimensions: 20 in x20 in x 4 in● Pleats per inch: 1.5● Total Filter surfacearea: 4800 in² |
| Molekule Air Miniair purifier(K202339) | Molekule Air Mini +air purifier(K202339) | Predicate DeviceMolekule Air Pro RXair purifier(K200500) | |
| 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 | 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 | Proprietary multi-layer filter media Dimensions: 20 in x 20 in x 4 in Pleats per inch: 1.5 Total Filter surface area: 4800 in2 Filter coated with proprietary photocatalyst and a metal wire mesh MERV16 |
| Photocatalyst | Proprietary catalyst (same as predicate) | Proprietary catalyst (same as predicate) | Proprietary catalyst |
| Molekule Air Miniair purifier(K202339) | Molekule Air Mini +air purifier(K202339) | Predicate DeviceMolekule Air Pro RXair purifier(K200500) | |
| Light Source | UV Light Source: LED Wavelength: 320-400 nm Total of 12 UV LEDs split amongst 4 PCBs (3 LEDs per PCB) Total UV Power: 6.8 W Filter Irradiance (Minimum): 20 W/m² | UV Light Source: LED Wavelength: 320-400 nm Total of 12 UV LEDs split amongst 4 PCBs (3 LEDs per PCB) Total UV Power: 6.8W Filter Irradiance (Minimum): 20 W/m² | UV Light Source: LED Wavelength: 320-400 nm Power per Lamp/String: 11.4 W Number of Lamps/String: 6 Total UV Power: 68.4 W Filter Irradiance (Minimum): 30 W/m² |
| Air Source | Centrifugal Fan | Centrifugal Fan | Centrifugal Fan |
| Flow Control | 5 speeds (low-high)Provide 9-86 CFM | 5 speeds (low-high)Provide 9-86 CFM | Four speeds (low, medium, high, boost) provide 300-800 CFM flow. |
| Device AirChanges PerHour (ACH) | 2.43 device air changes per hour on setting 5, roughly 86 CFM, in a 250 ft² room | 2.43 device air changes per hour on setting 5, roughly 86 CFM, in a 250 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. |
| ParticulateSensor | Not applicable | Optical Particle Sensor | Not applicable |
| Molekule Air Miniair purifier(K202339) | Molekule Air Mini +air purifier(K202339) | Predicate DeviceMolekule Air Pro RXair purifier(K200500) | |
| UV LightExposureSafety Features | If a validated, serialized,Molekule filter ismissing, the unit will notoperate. The unitauthenticates the filtervia NFC, before andduring operation.The purpose of thissystem is to protect theuser from any possibilityof exposure to directcontact with UV lightthat would occur withouta genuine MolekuleFilter being present. | If a validated, serialized,Molekule filter ismissing, the unit will notoperate. The unitauthenticates the filtervia NFC, before andduring operation.The purpose of thissystem is to protect theuser from any possibilityof exposure to directcontact with UV lightthat would occur withouta 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 filter ismissing, the unit will notoperate. The purpose ofthese switches is to protectthe user from anypossibility of exposure todirect contact with UVlight. Safety featureconfirmed by UL 507. |
| Fan ExposureSafety Features | Vanes at outlet andHoneycomb inlet of fanwith small enoughgrating to block userfrom accessing spinningfan without tools. Safetyfeature confirmed by UL507. | Vanes at outlet andHoneycomb inlet of fanwith small enoughgrating to block userfrom accessing spinningfan without tools. Safetyfeature confirmed by UL507. | Grill at outlet and inlet offan with small enoughgrating to block user fromaccessing spinning fanwithout tools. Safetyfeature confirmed by UL507. |
| Input Voltage | 120 Volt | 120 Volt | 120 Volt |
| Current | 0.55 Amps | 0.55 Amps | Up to 3.72 Amps |
| PowerConsumption | Up to 55 Watts | Up to 55 Watts | Up to 450 Watts |
| ElectronicData Interface | NFCWLAN (2.4 GHz) | NFCWLAN (2.4 GHz) | Not applicable |
| Molekule Air Miniair purifier(K202339) | Molekule Air Mini +air purifier(K202339) | Predicate DeviceMolekule Air Pro RXair purifier(K200500) | |
| Dimensions | Unit Dimensions:Height: 12.04 in (306 mm)Diameter: 8.27 in (210 mm) | Unit Dimensions:Height: 12.04 in (306 mm)Diameter: 8.27 in (210 mm) | Outer frame dimensions:22 in x 22 in x 52 in |
| Filter Dimensions:Diameter: 6.03 in (153 mm)Height: 6.45 in (164 mm) | Filter Dimensions:Diameter: 6.03 in (153 mm)Height: 6.45 in (164 mm) | Filter dimensions:Filter: 20 in x 20 in x 4 inPre-Filter: 20 in x 20 in x4 in or 20 in x 20 in x 2 in | |
| Standards | FCC Part 15 C RadioFrequency DevicesUL 507 Standard forElectrical FansIEC 60601-1-2 EMC.EMC for MedicalDevices. | FCC Part 15 C RadioFrequency DevicesUL 507 Standard forElectrical FansIEC 60601-1-2 EMC.EMC for MedicalDevices. | FCC Part 15 C RadioFrequency DevicesUL 507 Standard forElectrical FansIEC 60601-1-2 EMC.EMC for MedicalDevices. |
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SUMMARY OF NON-CLINICAL TESTS:
The Molekule Air Mini and Air Mini + 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 wasaerosolized into a sealedenvironmental bioaerosol chambercontaining Molekule® Air Minidevice.● | To evaluate the efficacy of theMolekule® Air Mini air purificationdevice at reducing aerosolized MS2bacteriophage by a combination ofentrainment and destruction. | 4 log reduction(99.99%) | 4.18 ±0.56 net log reduction at 90 mins5.09 ± 0.42 net log reduction at 120 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 Mini 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. considers the Molekule Air Mini and Air Mini + air purifiers to be substantially equivalent to the 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).