(121 days)
Not Found
No
The description mentions an "Auto Protect Mode, which controls fan speed based on particulate levels detected in the use environment." While this is an automated function based on sensor input, it does not explicitly describe the use of AI or ML algorithms for learning, adaptation, or complex pattern recognition beyond a simple threshold-based control. The document also explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is intended for medical purposes and is used to destroy bacteria, mold, and viruses, which constitutes a therapeutic effect by improving air quality and potentially reducing the spread or presence of harmful microorganisms in the environment.
No
This device is an air purifier intended for destruction of airborne bacteria, mold, and viruses, which is a therapeutic function, not a diagnostic one. It does not identify or diagnose any medical condition.
No
The device description clearly outlines a physical air purifier with a fan, PECO filter, UV-A light, LCD display, touchscreen, and sensors. While it has software for control (including a mobile app), the primary medical function is performed by the hardware components (filtration and UV destruction).
Based on the provided information, the Molekule Air Pro air purifier is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Molekule Air Pro Function: The Molekule Air Pro is an air purifier. Its function is to clean the air in a room by capturing and destroying airborne contaminants. It does not interact with or analyze human specimens.
- Intended Use: The intended use clearly states it's for capturing particulate matter and destroying bacteria, mold, and viruses in the air. This is an environmental control function, not a diagnostic one.
- Device Description: The description details how it purifies air using filtration and UV light. There is no mention of analyzing biological samples.
- Performance Studies: The performance studies focus on the device's ability to reduce airborne microorganisms and filter particles from the air. These are tests of air purification efficacy, not diagnostic accuracy.
Therefore, the Molekule Air Pro air purifier falls under the category of an air purification device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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 +/- 0.11 / 90 minutes |
| Bacteria Endospores Bacillus Subtilis | 4.02 +/- 0.23 / 30 minutes |
| Mold Spores Aspergillus Brasiliensis | 4.15 +/- 0.06 / 60 minutes |
| Virus MS2 bacteriophage | 4.38 +/- 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 |
Product codes (comma separated list FDA assigned to the subject device)
FRA
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.
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 specified
Intended User / Care Setting
Healthcare Professional, Lay User
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing:
-
Test Methodology: MS2 bacteriophage, Aspergillus Brasiliensis Mold Spores, Bacillus Subtilis Endospores, and Escherichia Coli Bacteria were aerosolized into a sealed environmental bioaerosol chamber containing Molekule Air Pro device.
-
Purpose: To evaluate the efficacy of the Molekule Air Pro air purification device at reducing aerosolized MS2 bacteriophage, Aspergillus Brasiliensis Mold Spores, Bacillus Subtilis Endospores, and Escherichia Coli Bacteria by a combination of entrainment and destruction.
-
Key Results: Average net log reduction / time - MS2 Bacteriophage, 4.38 +/- 0.15 / 30 mins; Aspergillus Brasiliensis, 4.15 +/- 0.06 / 60 mins; Bacillus Subtilis, 4.02 +/- 0.23 / 30 mins; Escherichia Coli, 4.20 +/- 0.11 / 90 mins.
-
Test Methodology: MS2 bacteriophage was aerosolized into a sealed environmental bioaerosol chamber containing Molekule Air Pro device running at different fan speeds.
-
Purpose: To demonstrate performance at different fan speeds using MS2 bacteriophage as a challenge pollutant.
-
Key Results: Average net log reduction / time - Speed 2, 4.54 +/- 0.07 120 mins; Speed 3, 4.58 +/- 0.23 60 mins; Speed 6, 4.38 +/- 0.15 30 mins.
-
Test Methodology: 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.
-
Purpose: To ensure Air Pro meets Filtration Efficiency Requirements (95% or greater on 0.3 to 1.0 micron size particles) and device flow requirements.
-
Key Results: Required filtration efficiency 95% or greater on 0.3 to 1.0 micron size particles was achieved.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Average Net Log Reduction / Time:
- Escherichia Coli: 4.20 +/- 0.11 / 90 minutes
- Bacillus Subtilis: 4.02 +/- 0.23 / 30 minutes
- Aspergillus Brasiliensis: 4.15 +/- 0.06 / 60 minutes
- MS2 bacteriophage: 4.38 +/- 0.15 / 30 minutes (at fan speed 6)
- MS2 bacteriophage: 4.54 +/- 0.07 / 120 mins (at speed 2)
- MS2 bacteriophage: 4.58 +/- 0.23 / 60 mins (at speed 3)
Single Pass Mechanical Filtration Efficiency:
- Particulate Matter 0.3 to 1.0 micron size particles: 95% or greater according to ASHRAE 52.2
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Molekule Air Mini + Air Purifier, K202339
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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
1
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
2
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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3
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.
4
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 |
| Bacteria
Endospores | Bacillus Subtilis | $4.02 \pm 0.23$ / 30 minutes |
5
| Test Item | | Average Net Log Reduction / Time @
Fan Speed 6. Room Temperature Test |
|--------------------|-------------------------------------|--------------------------------------------------------------------------|
| 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 |
TECHNOLOGICAL CHARACTERISTIC COMPARISON:
The following table summarizes the similarities and differences between the subject and predicate devices.
6
| | Molekule Air Pro
air 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 |
| Classification
Regulation | 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 Professional
Lay User | Healthcare Professional
Lay User | Identical |
| | Molekule Air Pro | Molekule Air Mini+ | Discussion of Differences |
| | air purifier | air purifier (K202339) | |
| Indications for
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:
Average Net Log Reduction / Time @ Fan
Speed 6. Room Temperature Test
Escherichia Coli
4.20 +/- 0.11 / 90 mins
Bacillus Subtilis
4.02 +/- 0.23 / 30 mins
Aspergillus Brasiliensis
4.15 ± 0.06 / 60 mins
MS2 Bacteriophage
4.38 ± 0.15 / 30 mins
Single Pass Mechanical Filtration
Efficiency
Particulate Matter 0.3 to 1.0 micron size
particles 95% or greater according to
ASHRAE 52.2 | 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:
Average Maximum Log Reduction /
Entrainment Time @ Fan Speed 5. Room
Temperature Test
MS2 Bacteriophage
4.38 ± 0.15 / 30 mins
Single Pass Mechanical Filtration
Efficiency
Particulate Matter 0.3 to 1.0 micron size
particles 95% or greater according to
ASHRAE 52.2 | Based on additional testing, the indications
for use for the Air Pro were updated to
include molds, with specific results added
for bacteria and mold. Air Pro also has
additional testing to support a greater than
4-log reduction of MS2 bacteriophage at
fan speed 2, which is also the lowest
possible fan speed in Auto Mode
Standard. The indications were also
revised to clarify that the reductions
presented in the table are average net log
reductions from the combination of both
entrainment and destruction. These
differences in indications do not change
the intended use of the device. Both
devices are used to destroy
microorganisms in the air by the same
mechanism. |
| Environment of
Use | Hospital and other healthcare
setting.
Home healthcare. | Hospital and other healthcare
setting.
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, but
giving it space in a central location,
is recommended. Placement near
the patient is key. | Air Mini + will work in any room,
but giving it space in a central
location, and on a shelf, stand, or
table will help maximize air intake.
Placement near the patient is key. | The proposed device is designed
for larger rooms. They are not
placed on shelfs or tables due to the
different form factor. These
differences do not raise different
questions of safety or effectiveness.
Both devices meet applicable
standards for electrical safety, |
| | It should not be used in surgical
suites or in rooms with air
separation devices. | It should not be used in surgical
suites or in rooms with air
separation devices. | |
| | It is designed for rooms under 1000
ft². | It is designed for rooms under 250
ft². | including home levels, and have
been demonstrated to effectively
remove and destroy pathogens in
the air. |
| | | We recommend running it in the
room, closer to the bed. | |
| User Control | LCD screen with capacitive
touchscreen interface. User
Interface includes several dedicated
screens for fan speed control, PM
sensor readings in addition to other
administrative functions.
Application controls mimic device
touch panel | Touch panel with 5 manual fan
settings and one auto protect
setting,
Application controls mimic device
touch panel | The controls on the Air Pro and Air
Mini+ are simple and similar to
user controls on many other
devices that healthcare
professionals are accustomed to
using.
The app has the same functions as
the firmware and does not raise
different questions of safety or
effectiveness as demonstrated by
software verification and
validation. |
| | Molekule Air Pro
air purifier | Molekule Air Mini+
air purifier (K202339) | Discussion of Differences |
| 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. | Identical |
| 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. | 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 identical
in material, coated with the same
photocatalyst, and feature identical
layers. There are differences in the
dimensions related to the sizing
requirements for each device.
These differences do not raise
differences in safety or
effectiveness. |
| Photocatalyst | Proprietary catalyst (same as
predicate) | Proprietary catalyst | Identical |
| | Molekule Air Pro
air 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 split
amongst 5 PCBs (4 LEDs per
PCB)
•
Total UV Power: 16 W
•
| 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 | The UV LEDs in the Molekule Air
Mini+ and Molekule Air Pro are
identical. Air Pro feature
significantly larger filter areas and
thus, more LEDs are used and
more UV power is needed to
achieve the minimum irradiance on
the 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 same
effect. See discussion of air
changes per hour in the next row
for additional discussion. |
| Device Air
Changes Per Hour
(ACH) | 1.83 device air changes per hour on
setting 6, roughly 260 CFM, in a
1000 ft² room | 2.43 device air changes per hour on
setting 5, roughly 86 CFM, in a
250 ft² room | Air Pro is designed for larger
rooms. The effective cleaning rate
can be roughly compared by
normalizing the device air change
for each product. This allows for a
quantification of purified air
relative to ventilation rate. We see
uniformity amongst the products. |
| | Molekule Air Pro
air 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 a
built-in particulate matter sensor
that can be used to evaluate the
environment the device is in and
provide an air quality level that the
device can use to ramp up or down
fan speed as appropriate. They use
different sensors, with Air Pro
featuring a sensor capable of
binning particles in different sizes,
providing additional information.
This difference does not raise
different quesitons of safety or
effectiveness. All devices meet
standards for electric fans/EMC
and have demonstrated appropriate
performance in testing. |
| | Molekule Air Pro
air purifier | Molekule Air Mini+
air purifier (K202339) | Discussion of Differences |
| 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-A 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-A light that would
occur without a genuine Molekule
Filter being present. | Identical |
| 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. | Identical |
| Input Voltage | 120 Volt | 120 Volt | Identical |
| | Molekule Air Pro
air 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 the
larger power consumption, given
that both units operate off 120V
AC. See power consumption row
below for more details. |
| Power
Consumption | Up to 152.8 Watts | Up to 55 Watts | Difference in power consumption
of the system is largely due to the
fan and LEDS. Air Pro utilizes a
larger fan and more LEDs than Air
Mini+ and thus will consume more
power.
This difference does not impact
safety or effectiveness as both
devices comply with applicable
safety standards. |
| Electronic Data
Interface | NFC
WLAN (2.4 GHZ) | NFC
WLAN (2.4 GHZ) | Identical |
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10
11
12
13
14
| | Molekule Air Pro
air 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 larger
housing to accomodate the larger
fan and filter.
This is due to the difference in
target Air Flow by the device. |
| | Molekule Air Pro
air purifier | Molekule Air Mini+
air purifier (K202339) | Discussion of Differences |
| Standards | FCC Part 15 C Radio Frequency
Devices
UL 507 Standard for Electrical
Fans
IEC 60601-1-2 EMC. EMC for
Medical Devices
ASHRAE 52.2-2012 Method of
Testing General Ventilation Air-
Cleaning Devices for Removal
Efficiency by Particle Size
AMCA 210-1999 Laboratory
Methods Of Testing Fans For
Rating
ANSI/AHAM AC-1-2019
Method for Measuring
Performance of Portable
Household Electric Room Air
Cleaners | FCC Part 15 C Radio Frequency
Devices
UL 507 Standard for Electrical
Fans
IEC 60601-1-2 EMC. EMC for
Medical Devices
ASHRAE 52.2-2012 Method of
Testing General Ventilation Air-
Cleaning Devices for Removal
Efficiency by Particle Size
AMCA 210-1999 Laboratory
Methods Of Testing Fans For
Rating
ANSI/AHAM AC-1-2019
Method for Measuring
Performance of Portable
Household Electric Room Air
Cleaners | Identical |
15
16
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
17
• Performance Testing:
| Test Methodology | Purpose | Acceptance
Criteria | Results |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MS2 bacteriophage, Aspergillus
Brasiliensis Mold Spores, Bacillus
Subtilis Endospores, and Escherichia
Coli Bacteria were aerosolized into a
sealed environmental bioaerosol
chamber containing Molekule® Air
Pro device. | To evaluate the efficacy of the
Molekule® Air Pro air purification
device at reducing aerosolized MS2
bacteriophage, Aspergillus
Brasiliensis Mold Spores, Bacillus
Subtilis Endospores, and
Escherichia Coli Bacteria by a
combination of entrainment and
destruction. | 4 log reduction
(99.99%) | Average net log reduction / time
MS2 Bacteriophage, $4.38 \pm 0.15$ / 30 mins
Aspergillus Brasiliensis, $4.15 +/- 0.06$ / 60
mins
Bacillus Subtilis, $4.02 +/- 0.23$ / 30 mins
Escherichia Coli, $4.20 +/- 0.11$ / 90 mins |
| MS2 bacteriophage was aerosolized
into a sealed environmental
bioaerosol chamber containing
Molekule® Air Pro device running at
different fan speeds. | To demonstrate performance at
different fan speeds using MS2
bacteriophage as a challenge
pollutant. | 4 log reduction
(99.99%) | Average net log reduction / time
Speed 2, $4.54 +/- 0.07$ 120 mins
Speed 3, $4.58 +/- 0.23$ 60 mins
Speed 6, $4.38 \pm 0.15$ 30 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 Pro 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. |
18
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.