(190 days)
Not Found
No
The document describes a device that uses UV-A light and a catalytic filter for air purification. While the Air Mini + has an "Auto Protect Mode" that adjusts fan speed based on particulate levels, this is a rule-based or sensor-driven function, not indicative of AI/ML. There is no mention of learning, adaptation, or complex pattern recognition typically associated with AI/ML.
Yes
The device's intended use explicitly states it is used to "destroy bacteria and viruses" by exposure to ultraviolet radiation, which is a therapeutic action.
No
Explanation: The device is an air purifier designed to destroy bacteria and viruses and capture particulate matter, not to diagnose medical conditions.
No
The device description clearly states it is a physical air purifier with hardware components including a fan, UV light, catalytic filter, and a capacitive touch button. While it can be controlled by a software application, the core medical function (air purification) is performed by the hardware.
Based on the provided information, the Molekule Air Mini and Air Mini + air purifiers are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Molekule Air Mini and Air Mini + air purifiers operate on air within a room. They capture and destroy airborne particles, bacteria, and viruses. They do not analyze or interact with specimens taken from the human body.
- Intended Use: The intended use is to purify air for medical purposes by capturing particulate matter and destroying microorganisms in the air. This is an environmental control function, not a diagnostic function performed on biological samples.
- Performance Studies: The performance studies described evaluate the device's ability to reduce airborne MS2 bacteriophage and filter particulate matter from the air. These are tests of the device's air purification capabilities, not diagnostic performance on biological specimens.
Therefore, while these devices are intended for medical purposes and used in medical settings, their function and intended use do not align with the definition of an In Vitro Diagnostic device. They are air purification devices.
N/A
Intended Use / Indications for Use
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 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 Efficiency 0.3 to 1.0 micron size particles 95% or greater according to ASHRAE 52.2.
Product codes
FRA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare Professional Lay User. Hospital and other healthcare setting. Home healthcare.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical tests were conducted. These included:
- 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
- Performance Testing for MS2 bacteriophage: Evaluated efficacy of the Molekule® Air Mini air purification device at reducing aerosolized MS2 bacteriophage by a combination of entrainment and destruction. The test showed a 4.18 ± 0.56 net log reduction at 90 mins and 5.09 ± 0.42 net log reduction at 120 mins, meeting the 4 log reduction (99.99%) acceptance criteria.
- Performance Testing for Fractional efficiency per ASHRAE 52.2-2012 Method: Ensured Air Mini meets Filtration Efficiency Requirements (95% or greater on 0.3 to 1.0 micron size particles) and device flow requirements. Required filtration efficiency 95% or greater on 0.3 to 1.0 micron size particles was achieved.
No clinical tests were required.
Key Metrics
- MS2 bacteriophage reduction: 5.09 ± 0.42 net log reduction at 120 mins
- Particulate matter (0.3 to 1.0 micron size particles) Single Pass Mechanical Filtration Efficiency: 95% or greater
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6500 Medical ultraviolet air purifier.
(a)
Identification. A medical ultraviolet air purifier is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). 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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
2
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 | 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."
3
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."
4
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
5
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:
6
| Test Item | Test Result |
|---|---|
| Virus | |
| MS2 | |
| bacteriophage | Average maximum log reduction / |
| entrainment time (hours) at Fan Speed 5. | |
| Room temperature test. | |
| $5.09 \pm 0.42$ / 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 |
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 Efficiency |
| 0.3 to 1.0 micron size particles | |
| 95% or greater according to ASHRAE 52.2 |
7
CHARACTERISTIC COMPARISON:
The following table summarizes the similarities and differences between the subject and predicate devices.
| | Molekule Air Mini
air purifier
(K202339) | Molekule Air Mini +
air purifier
(K202339) | Predicate Device
Molekule Air Pro RX
air purifier
(K200500) |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Holder | Molekule | Molekule | Molekule |
| Device Type | Medical Ultraviolet Air
purifier | Medical Ultraviolet Air
purifier | Medical Ultraviolet Air
purifier |
| Product Code | FRA | FRA | FRA |
| Classification
Regulation | 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 Professional
Lay User | Healthcare Professional
Lay User | Healthcare Professional |
| | Molekule Air Mini
air purifier
(K202339) | Molekule Air Mini +
air purifier
(K202339) | Predicate Device
Molekule Air Pro RX
air purifier
(K200500) |
| Indications for
Use | The Molekule Air Mini
air purifier is a device
intended for medical
purposes that are 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
conditions:
Average maximum log
reduction / entrainment
time (hours) at Fan
Speed 5. Room
temperature test for MS2
bacteriophage virus:
5.09 ± 0.42 120 mins
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 are used to
capture 95% of
particulate matter and
destroy bacteria and
viruses in the air 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
conditions:
Average maximum log
reduction / entrainment
time (hours) at Fan
Speed 5. Room
temperature test for MS2
bacteriophage virus:
5.09 ± 0.42 120 mins
Single Pass Mechanical
Filtration Efficiency:
95% or greater according
to ASHRAE 52.2 | 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:
Average Maximum log
reduction/exposure time
(hours)
Room temperature Virus,
MS2 bacteriophage
5.21/24 hours |
| | Molekule Air Mini
air purifier
(K202339) | Molekule Air Mini +
air purifier
(K202339) | Predicate Device
Molekule Air Pro RX
air purifier
(K200500) |
| Environment
of Use | Hospital and other
healthcare setting.
Home healthcare. | Hospital and other
healthcare setting.
Home healthcare. | Hospital, including
general, surgery, critical
care, and radiology.
Inpatient and general
nursing facilities,
diagnostic and radiology
rooms. |
| User Control | Touch panel with 5
manual fan settings.
Application controls
mimic device touch
panel | Touch panel with 5
manual fan settings and
one auto protect setting.
Application controls
mimic device touch panel | One knob controls the
four-speed fan setting
One button turns the unit
on and off. |
| Software | Basic Firmware and
App, used to turn the unit
on, off, and change fan
speed. | Basic Firmware and App,
used to turn the unit on,
off, and change fan
speed. | Basic Firmware, used to
turn the unit on, off, and
change fan speed. |
| Mechanism of
Action | UV light of sufficient
energy (UV-A) activates
photocatalyst that
destroys microorganisms
entrained on the filter
through a photochemical
reaction. | UV light of sufficient
energy (UV-A) activates
photocatalyst that
destroys microorganisms
entrained on the filter
through a photochemical
reaction. | UV light of sufficient
energy (UV-A) activates
photocatalyst that destroys
microorganisms entrained
on the filter through a
photochemical reaction. |
| Installation | Free standing | Free standing | Free standing |
| Pre-Filter(s) | ● Not applicable | ● Not applicable | ● 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 in² |
| | Molekule Air Mini
air purifier
(K202339) | Molekule Air Mini +
air purifier
(K202339) | Predicate Device
Molekule Air Pro RX
air 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 Mini
air purifier
(K202339) | Molekule Air Mini +
air purifier
(K202339) | Predicate Device
Molekule Air Pro RX
air 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 Air
Changes Per
Hour (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. |
| Particulate
Sensor | Not applicable | Optical Particle Sensor | Not applicable |
| | Molekule Air Mini
air purifier
(K202339) | Molekule Air Mini +
air purifier
(K202339) | Predicate Device
Molekule Air Pro RX
air purifier
(K200500) |
| UV Light
Exposure
Safety Features | If a validated, serialized,
Molekule filter is
missing, the unit will not
operate. The unit
authenticates the filter
via NFC, before and
during operation.
The purpose of this
system is to protect the
user from any possibility
of exposure to direct
contact with UV light
that would occur without
a genuine Molekule
Filter being present. | If a validated, serialized,
Molekule filter is
missing, the unit will not
operate. The unit
authenticates the filter
via NFC, before and
during operation.
The purpose of this
system is to protect the
user from any possibility
of exposure to direct
contact with UV light
that would occur without
a genuine Molekule
Filter being present. | Safety switches exist in
the following locations:
PECO filter door, pre
filter door, PECO filter
compartment, and pre
filter compartment. If any
door is open or if a filter is
missing, the unit will not
operate. The purpose of
these switches is to protect
the user from any
possibility of exposure to
direct contact with UV
light. Safety feature
confirmed by UL 507. |
| Fan Exposure
Safety Features | Vanes at outlet and
Honeycomb inlet of fan
with small enough
grating to block user
from accessing spinning
fan without tools. Safety
feature confirmed by UL
507. | Vanes at outlet and
Honeycomb inlet of fan
with small enough
grating to block user
from accessing spinning
fan without tools. Safety
feature confirmed by UL
507. | Grill at outlet and inlet of
fan with small enough
grating to block user from
accessing spinning fan
without tools. Safety
feature confirmed by UL
507. |
| Input Voltage | 120 Volt | 120 Volt | 120 Volt |
| Current | 0.55 Amps | 0.55 Amps | Up to 3.72 Amps |
| Power
Consumption | Up to 55 Watts | Up to 55 Watts | Up to 450 Watts |
| Electronic
Data Interface | NFC
WLAN (2.4 GHz) | NFC
WLAN (2.4 GHz) | Not applicable |
| | Molekule Air Mini
air purifier
(K202339) | Molekule Air Mini +
air purifier
(K202339) | Predicate Device
Molekule Air Pro RX
air 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 in
Pre-Filter: 20 in x 20 in x
4 in or 20 in x 20 in x 2 in |
| Standards | FCC Part 15 C Radio
Frequency Devices
UL 507 Standard for
Electrical Fans
IEC 60601-1-2 EMC.
EMC for Medical
Devices. | FCC Part 15 C Radio
Frequency Devices
UL 507 Standard for
Electrical Fans
IEC 60601-1-2 EMC.
EMC for Medical
Devices. | FCC Part 15 C Radio
Frequency Devices
UL 507 Standard for
Electrical Fans
IEC 60601-1-2 EMC.
EMC for Medical
Devices. |
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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 | Acceptance
Criteria | Results |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| • MS2 bacteriophage was
aerosolized into a sealed
environmental bioaerosol chamber
containing Molekule® Air Mini
device.
● | To evaluate the efficacy of the
Molekule® Air Mini air purification
device at reducing aerosolized MS2
bacteriophage by a combination of
entrainment and destruction. | 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 |
| Fractional efficiency per ASHRAE
52.2-2012 Method of Testing
General Ventilation Air-Cleaning
Devices for Removal Efficiency by
Particle Size using three PECO
filters.
System flow with filter installed
according to AMCA 210-1999
Fig.12. | To ensure Air Mini meets Filtration
Efficiency Requirements (95% or
greater on 0.3 to 1.0 micron size
particles) and device flow
requirements. | The filter shall
achieve 95% or
greater on 0.3 to 1.0
micron size particles
according to
ASHRAE 52.2. | Required filtration efficiency 95% or
greater on 0.3 to 1.0 micron size particles
was 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.