Molekule Air Pro

K211194 · Molekule, Inc. · FRA · Aug 20, 2021 · General Hospital

Device Facts

• Record ID: K211194
• Device Name: Molekule Air Pro
• Applicant: Molekule, Inc.
• Product Code: FRA · General Hospital
• Decision Date: Aug 20, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6500
• Device Class: Class 2
• Attributes: Therapeutic

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

Device Story

Molekule Air Pro is a freestanding ultraviolet air purifier for medical and home use. Device draws air via internal fan through a proprietary multi-layer PECO (photo electrochemical oxidation) filter. PECO technology uses UV-A light (320-400 nm) on a catalytic filter surface to generate hydroxyl radicals, which oxidize and destroy captured microorganisms (bacteria, mold, viruses). Device features an LCD capacitive touchscreen and integrated WLAN for mobile app control. Includes a particulate matter sensor and Auto Protect Mode to adjust fan speed based on detected air quality. Safety features include NFC-based filter authentication to prevent UV-A exposure and mechanical grates to prevent fan access. Output is purified air; clinical benefit is the reduction of airborne bioaerosols and particulate matter in the environment.

Clinical Evidence

No clinical data. Bench testing only. Efficacy demonstrated in sealed environmental bioaerosol chambers against E. coli, B. subtilis, A. brasiliensis, and MS2 bacteriophage, achieving >4-log reduction. Filtration efficiency verified per ASHRAE 52.2 (95% for 0.3-1.0 micron particles).

Technological Characteristics

Freestanding air purifier; PECO technology using UV-A (320-400 nm) LEDs (20 total, 16W) and proprietary multi-layer MERV16 catalytic filter. Centrifugal fan; 6 speed settings (25-260 CFM). Connectivity: WLAN (2.4 GHz), NFC. Standards: UL 507, IEC 60601-1-2, ASHRAE 52.2, AMCA 210, ANSI/AHAM AC-1.

Indications for Use

Indicated for use in medical facilities and home environments to capture 95% of particulate matter and destroy bacteria, mold, and viruses via UV-A exposure. Operates in Auto Mode Standard or manual mode at fan speed 2 or higher. Not for use in surgical suites or rooms with air separation devices.

Regulatory Classification

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.

Predicate Devices

• Molekule Air Mini + Air Purifier (K202339)

Submission Summary (Full Text)

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August 20, 2021

Molekule, Inc. % Adrienne Lenz Senior Medical Device Regulation Hymann, Phelps, & McNamara, P.C. 700 Thirteenth Street. N.W.. Suite 1200 Washington, District of Columbia 20005

Re: K211194

Trade/Device Name: Molekule Air Pro Regulation Number: 21 CFR 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: Class II Product Code: FRA Dated: July 16, 2021 Received: July 19, 2021

Dear Adrienne Lenz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K211194

#### Device Name Molekule Air Pro

#### Indications for Use (Describe)

The Molekule Air Pro air purifier is a device intended for medical purposes that is used to capture 95% of particulate matter and destroy bacteria, mold, and viruses by exposure to ultraviolet radiation when operated in Auto Mode Standard or manual mode at fan speed 2 or higher.

The Molekule Air Pro air purifier has been demonstrated to entrain and destroy the following bioaerosols under the following exposure/working conditions:

| Test Item | | Average Net Log Reduction / Time @ Fan Speed 6. Room Temperature Test |
|---------------------|----------------------------------|-----------------------------------------------------------------------|
| Bacteria | Escherichia Coli | $4.20 \u00b1 0.11$ / 90 minutes |
| Bacteria Endospores | Bacillus Subtilis | $4.02 \u00b1 0.23$ / 30 minutes |
| Mold Spores | Aspergillus Brasiliensis | $4.15 \u00b1 0.06$ / 60 minutes |
| Virus | MS2 bacteriophage | $4.38 \u00b1 0.15$ / 30 minutes |
| Test Item | | Single Pass Mechanical Filtration Efficiency |
| Particulate Matter | 0.3 to 1.0 micron size particles | 95% or greater according to ASHRAE 52.2 |

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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#### K211194 510(k) Summary

In accordance with 21 C.F.R. § 807.92 the following summary of information is provided:

DATE: July 16, 2021

#### SUBMITTER:

Molekule, Inc. 1301 Folsom St San Francisco, CA 94103 T 855-999-9069

#### PRIMARY CONTACT PERSON:

Adrienne R. Lenz Senior Medical Device Regulation Expert Hyman, Phelps, & McNamara, P.C. T 202-737-4292

### SECONDARY CONTACT PERSON:

Frank Bianco FDA Compliance Molekule, Inc. T 925-404-7724

### DEVICE:

TRADE NAME: Molekule Air Pro COMMON/USUAL NAME: Air Purifier CLASSIFICATION NAMES: Purifier, Air, Ultraviolet, Medical REVIEW PANEL: General Hospital PRODUCT CODE: FRA

### PREDICATE DEVICE(S):

Molekule Air Mini + Air Purifier, K202339

This predicate has not been subject to a design-related recall.

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## DEVICE DESCRIPTION:

The Molekule Air Pro air purifier is an ultraviolet air purifier that employs a photo electrochemical oxidation (PECO) ultraviolet air purification technology that destroys bacteria and viruses in air. The Molekule Air Pro may be used in medical facilities and in the home. A fan within the unit draws air up from vents in the bottom of the unit, up through the PECO filter (where it is exposed to low energy UV-A 320 - 400 nm light) and out through the vents on the top of the unit. PECO is an air purification technology that oxidizes microorganisms, including bacteria, molds and viruses. PECO works by shining UV-A light on the surface of the catalytic filter to initiate a chemical reaction that generates hydroxyl radicals. These radicals combine with microbiological contaminants that are captured on the filter. Once combined, a chemical reaction takes place destroying the contaminants.

The Molekule Air Pro is a freestanding device. It is a standalone device with an LCD display and a capacitive touchscreen user interface. Integrated WLAN provides a secondary means for controlling the device from the Molekule Android or iOS application.

Air Pro also includes a particulate matter sensor, particulate matter indicator, and Auto Protect Mode, which controls fan speed based on particulate levels detected in the use environment.

## INTENDED USE:

The Molekule Air Pro air purifier is a device intended for medical purposes that is used to capture 95% of particulate matter and destroy bacteria, mold, and viruses by exposure to ultraviolet radiation when operated in Auto Mode Standard or manual mode at fan speed 2 or higher.

The Molekule Air Pro air purifier has been demonstrated to entrain and destroy the following bioaerosols under the following exposure/working conditions:

| | Test Item | Average Net Log Reduction / Time @<br>Fan Speed 6. Room Temperature Test |
|------------------------|-------------------|--------------------------------------------------------------------------|
| Bacteria | Escherichia Coli | $4.20 \pm 0.11$ / 90 minutes |
| Bacteria<br>Endospores | Bacillus Subtilis | $4.02 \pm 0.23$ / 30 minutes |

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| Test Item | | Average Net Log Reduction / Time @<br>Fan Speed 6. Room Temperature Test |
|--------------------|-------------------------------------|--------------------------------------------------------------------------|
| Mold Spores | Aspergillus<br>Brasiliensis | $4.15 \pm 0.06$ / 60 minutes |
| Virus | MS2 bacteriophage | $4.38 \pm 0.15$ / 30 minutes |
| Test Item | | Single Pass Mechanical Filtration<br>Efficiency |
| Particulate Matter | 0.3 to 1.0 micron size<br>particles | 95% or greater according to ASHRAE<br>52.2 |

# TECHNOLOGICAL CHARACTERISTIC COMPARISON:

The following table summarizes the similarities and differences between the subject and predicate devices.

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| | Molekule Air Pro<br>air purifier | Molekule Air Mini+<br>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<br>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<br>Lay User | Healthcare Professional<br>Lay User | Identical |
| | Molekule Air Pro | Molekule Air Mini+ | Discussion of Differences |
| | air purifier | air purifier (K202339) | |
| Indications for<br>Use | The Molekule Air Pro air purifier is a<br>device intended for medical purposes that<br>is used to capture 95% of particulate<br>matter and destroy bacteria, mold, and<br>viruses by exposure to ultraviolet radiation<br>when operated in Auto Mode Standard or<br>manual mode at fan speed 2 or higher.<br>The Molekule Air Pro air purifier has been<br>demonstrated to entrain and destroy the<br>following bioaerosols under the following<br>exposure/working conditions:<br>Average Net Log Reduction / Time @ Fan<br>Speed 6. Room Temperature Test<br>Escherichia Coli<br>4.20 +/- 0.11 / 90 mins<br>Bacillus Subtilis<br>4.02 +/- 0.23 / 30 mins<br>Aspergillus Brasiliensis<br>4.15 ± 0.06 / 60 mins<br>MS2 Bacteriophage<br>4.38 ± 0.15 / 30 mins<br>Single Pass Mechanical Filtration<br>Efficiency<br>Particulate Matter 0.3 to 1.0 micron size<br>particles 95% or greater according to<br>ASHRAE 52.2 | The Molekule Air Mini + air purifier is a<br>device intended for medical purposes that<br>is used to capture 95% of particulate<br>matter and destroy bacteria and viruses by<br>exposure to ultraviolet radiation when<br>operated in manual mode at fan speed 3 or<br>higher.<br>The Molekule Air Mini + air purifier has<br>been demonstrated to destroy the<br>following MS2 bacteriophage bioaerosol<br>entrained on the filter of the subject device<br>under the following exposure/working<br>conditions:<br>Average Maximum Log Reduction /<br>Entrainment Time @ Fan Speed 5. Room<br>Temperature Test<br>MS2 Bacteriophage<br>4.38 ± 0.15 / 30 mins<br>Single Pass Mechanical Filtration<br>Efficiency<br>Particulate Matter 0.3 to 1.0 micron size<br>particles 95% or greater according to<br>ASHRAE 52.2 | Based on additional testing, the indications<br>for use for the Air Pro were updated to<br>include molds, with specific results added<br>for bacteria and mold. Air Pro also has<br>additional testing to support a greater than<br>4-log reduction of MS2 bacteriophage at<br>fan speed 2, which is also the lowest<br>possible fan speed in Auto Mode<br>Standard. The indications were also<br>revised to clarify that the reductions<br>presented in the table are average net log<br>reductions from the combination of both<br>entrainment and destruction. These<br>differences in indications do not change<br>the intended use of the device. Both<br>devices are used to destroy<br>microorganisms in the air by the same<br>mechanism. |
| Environment of<br>Use | Hospital and other healthcare<br>setting.<br>Home healthcare. | Hospital and other healthcare<br>setting.<br>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<br>giving it space in a central location,<br>is recommended. Placement near<br>the patient is key. | Air Mini + will work in any room,<br>but giving it space in a central<br>location, and on a shelf, stand, or<br>table will help maximize air intake.<br>Placement near the patient is key. | The proposed device is designed<br>for larger rooms. They are not<br>placed on shelfs or tables due to the<br>different form factor. These<br>differences do not raise different<br>questions of safety or effectiveness.<br>Both devices meet applicable<br>standards for electrical safety, |
| | It should not be used in surgical<br>suites or in rooms with air<br>separation devices. | It should not be used in surgical<br>suites or in rooms with air<br>separation devices. | |
| | It is designed for rooms under 1000<br>ft². | It is designed for rooms under 250<br>ft². | including home levels, and have<br>been demonstrated to effectively<br>remove and destroy pathogens in<br>the air. |
| | | We recommend running it in the<br>room, closer to the bed. | |
| User Control | LCD screen with capacitive<br>touchscreen interface. User<br>Interface includes several dedicated<br>screens for fan speed control, PM<br>sensor readings in addition to other<br>administrative functions.<br>Application controls mimic device<br>touch panel | Touch panel with 5 manual fan<br>settings and one auto protect<br>setting,<br>Application controls mimic device<br>touch panel | The controls on the Air Pro and Air<br>Mini+ are simple and similar to<br>user controls on many other<br>devices that healthcare<br>professionals are accustomed to<br>using.<br>The app has the same functions as<br>the firmware and does not raise<br>different questions of safety or<br>effectiveness as demonstrated by<br>software verification and<br>validation. |
| | Molekule Air Pro<br>air purifier | Molekule Air Mini+<br>air purifier (K202339) | Discussion of Differences |
| Software | Basic Firmware and App, used to<br>turn the unit on, off, and change<br>fan speed. | Basic Firmware and App, used to<br>turn the unit on, off, and change<br>fan speed. | Identical |
| Mechanism of<br>Action | UV light of sufficient energy (UV-<br>A) activates photocatalyst that<br>destroys microorganisms entrained<br>on the filter through a<br>photochemical reaction. | UV light of sufficient energy (UV-<br>A) activates photocatalyst that<br>destroys microorganisms entrained<br>on the filter through a<br>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<br>in material, coated with the same<br>photocatalyst, and feature identical<br>layers. There are differences in the<br>dimensions related to the sizing<br>requirements for each device.<br>These differences do not raise<br>differences in safety or<br>effectiveness. |
| Photocatalyst | Proprietary catalyst (same as<br>predicate) | Proprietary catalyst | Identical |
| | Molekule Air Pro<br>air purifier | Molekule Air Mini+<br>air purifier (K202339) |…