(47 days)
No
The summary describes a device that uses UV radiation and filtration for air purification and destruction of microorganisms. There is no mention of AI, ML, or related technologies in the device description, intended use, or performance studies.
Yes
The device is intended for medical purposes, used to destroy bacteria and viruses, and functions in medical facilities, aligning with the definition of a therapeutic device.
No
The device is an air purifier intended to destroy bacteria and viruses in the air, not to diagnose a medical condition.
No
The device description explicitly states it includes hardware components such as a pre-filter, UV lights, and a catalytic filter, and the performance studies include testing of these physical components (electrical safety, UV light leakage, filtration performance).
Based on the provided information, the Molekule Air Pro RX air purifier is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "destroy bacteria and viruses in the air by exposure to ultraviolet radiation." This describes a device that acts on the air itself, not on biological samples taken from the human body.
- Device Description: The description details an air purification system with filters and UV lights, designed to treat air.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health
- Using reagents or assays to detect specific substances in samples
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Molekule Air Pro RX's function is to purify the air in a medical setting, which is a different purpose.
N/A
Intended Use / Indications for Use
The Molekule Air Pro RX air purifier is a device intended for medical purposes that is used to destrov 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:
| Organism | Name | Average Maximum log reduction
/exposure time (hours) |
|---|---|---|
| | | Room temperature test |
| Virus | MS2 bacteriophage | 5.21 / 24 hours |
Product codes
FRA
Device Description
The Molekule Air Pro RX air purifier employs a photo-electrochemical oxidation (PECO) ultraviolet air purification technology that destroys bacteria, viruses and mold in air in medical facilities. The Molekule Air Pro RX air purifier includes a pre-filter and low energy ultraviolet lights (UV-A 320-400 nm), and a catalytic filter.
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
The patient population is listed as "General Hospital". No specific age range is indicated.
Intended User / Care Setting
Healthcare Professional / Hospital and general surgery setting
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)
Summary of Non-Clinical Tests:
- 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 tests for UV light leakage and light intensity
- Fluid modeling to confirm the system does not impact laminar flow systems
- Testing to demonstrate filtration performance and destruction of bacteria
- Third party testing was performed to characterize the kill rate kinetics for MS2 bacteriophage deposited onto the surface of Air Pro RX's proprietary photocatalytic coated filter media after exposure to Air Pro RX's UV-A light. The Air Pro RX Catalytic media effectively kills viable MS2 bacteriophage at room temperature. After one hour of UV exposure, an average of 3.41 LOG reduction was observed. After 24 hours of exposure, a 5.21 LOG reduction was observed.
Summary of Clinical Tests: Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Average Maximum log reduction /exposure time (hours) of MS2 bacteriophage: 5.21 / 24 hours (Room temperature test)
- After one hour of UV exposure, an average of 3.41 LOG reduction was observed.
- After 24 hours of exposure, a 5.21 LOG reduction was observed.
Predicate Device(s)
Transformair Indoor Air Purifier, K161468
Reference Device(s)
ABRACAIR (K052732)
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".
April 15, 2020
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: K200500
Trade/Device Name: Molekule Air Pro RX Regulation Number: 21 CFR 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: Class II Product Code: FRA Dated: February 27, 2020 Received: February 28, 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.
1
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 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 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.
CAPT Elizabeth F. Claverie, MS 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)
K200500
Device Name Molekule Air Pro RX
Indications for Use (Describe)
The Molekule Air Pro RX air purifier is a device intended for medical purposes that is used to destrov 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:
| Organism | Name | Average Maximum log reduction
/exposure time (hours) |
|----------|-------------------|---------------------------------------------------------|
| | | Room temperature test |
| Virus | MS2 bacteriophage | 5.21 / 24 hours |
| 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
510(K) SUMMARY
MOLEKULE AIR PRO RX
4
510(k) Summary
In accordance with 21 C.F.R. § 807.92 the following summary of information is provided:
DATE: April 15, 2020
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 RX COMMON/USUAL NAME: Air Purifier CLASSIFICATION NAMES: Purifier, Air, Ultraviolet, Medical REVIEW PANEL: General Hospital PRODUCT CODE: FRA
PREDICATE DEVICE(S):
Transformair Indoor Air Purifier, K161468
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Molekule Inc. is the current holder of the Transformair 510(k). This predicate has not been subject to a design-related recall. The ABRACAIR (K052732) is used as a reference device as, like the Molekule Air Pro RX, it is a freestanding device.
DEVICE DESCRIPTION:
The Molekule Air Pro RX air purifier employs a photo-electrochemical oxidation (PECO) ultraviolet air purification technology that destroys bacteria, viruses and mold in air in medical facilities. The Molekule Air Pro RX air purifier includes a pre-filter and low energy ultraviolet lights (UV-A 320-400 nm), and a catalytic filter.
INTENDED USE:
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:
| Organism | Name | Average Maximum log reduction
/exposure time (hours)
Room temperature test |
|----------|-------------------|----------------------------------------------------------------------------------|
| Virus | MS2 bacteriophage | 5.21 / 24 hours |
TECHNOLOGY:
The Molekule Air Pro RX air purifier employs a photo-electrochemical oxidation (PECO) ultraviolet air purification technology that destroys bacteria in air in medical facilities. It is designed using the technology platform from the Transformair Air Purifier. The Molekule Air Pro RX air purifier includes a pre-filter, low energy ultraviolet lights (UV-A 320-400 nm), and a catalytic filter.
PECO is an air purification technology that fully oxidizes bacteria, viruses, and mold. 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, viruses, and mold spores that are captured on the filter. Once combined, a chemical reaction takes place killing the contaminants.
6
Unlike the Transformair Air Purifier which is installed in a vent, the Molekule Air Pro RX air purifier is a freestanding device. The following table summarizes the similarities and differences between the subject and predicate devices.
| Transformair air purifier (K161468) | Molekule Air Pro RX air purifier (K200500) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Product Name | Transformair Air purifier | Molekule Air Pro RX Air purifier | |||||||||||
| Device Type | Medical Ultraviolet Air purifier | Medical Ultraviolet Air purifier | |||||||||||
| Product Code | FRA | FRA | |||||||||||
| Classification Regulation | 21 C.F.R. § 880.6500 | 21 C.F.R. § 880.6500 | |||||||||||
| Class | II | II | |||||||||||
| Patient Population | General Hospital | General Hospital | |||||||||||
| User | Healthcare Professional | Healthcare Professional | |||||||||||
| Indications for Use | The Transformair Indoor Air Purifier, In Duct Model 16108 is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation. |
Transformair Indoor Air Purifier, In Duct Model 16108 has been demonstrated to destroy Staphylococcus epidermidis, Escherichia coli, MS2, Phi-X174, Aspergillus Niger and Bacillus globigii entrained on the filter of the subject device under the following exposure conditions:
Average Maximum log reduction /exposure time (hours)
Test temperature
45 °F 72 °F 110 °F Virus, MS2 bacteriophage
4.13 / 24 hours 4.25 / 24 hours 5.51 / 24 hours Bacteria, Staphylococcus epidermidis
4.88 / 24 hours 4.02 / 0.33 hours 4.20 / 0.33 hours | | | | | | | | | | 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 | | |
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| | Transformair air purifier
(K161468) | Molekule Air Pro RX air
purifier (K200500) |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Bacteria, Escherichia coli
4.31 / 24 4.79 / 24 4.40 / 0.33
hours hours hours | |
| | Virus, Phi-X174 bacteriophage
4.37 / 24 4.37 / 24 4.37 / 24
hours hours hours | |
| | Mold endospore, Aspergillus Niger
3.91 / 72 3.99 / 72 4.22 / 72
hours hours hours | |
| | Bacterial endospore, Bacillus globigii
4.11 / 72 4.41 / 72 4.41 / 72
hours hours hours | |
| Environment of Use | Hospital and general surgery
setting | Hospital and general surgery
setting |
| User Control | HVAC fan speed controls the
air flow | One knob controls the four-
speed fan setting
One button turns the unit on
and off. |
| Software | None. The device is on
whenever power is connected. | 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. |
| Installation | In-duct | Free standing |
| Pre-Filter(s) | Synthetic Media for
mechanical filtration
upstream of the PECO
filter. Dimensions 21.25 in. x 26
in. x 2 in. Pleats per inch 1.25 Total Filter surface area
2800 sq. in. | 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 sq. in. |
| | Transformair air purifier
(K161468) | Molekule Air Pro RX air
purifier (K200500) |
| Catalytic Filter | Proprietary filter media Dimensions 21.25 in. x 26 in. x 2 in. Pleats per inch 1.25 Total Filter surface area 2800 sq. in. Filter coated with proprietary photocatalyst and a wire-mesh | Proprietary filter media Dimensions 20 in. x 20 in. x 4 in. Pleats per inch 1.5 Total Filter surface area 4800 sq. in. Filter coated with the proprietary photocatalyst and a wire-mesh |
| Photocatalyst | Proprietary catalyst | Same proprietary catalyst |
| Light Source | UV Light Source, black light fluorescent bulbs Wavelength, 320-400nm (See Figure 13.3) Power per Lamp/ String, 17W Number of Lamps/ String, 6 Total UV Power, 102W Filter Irradiance (Minimum), 25W/m² | UV Light Source, LED Wavelength, 320-400nm Power per Lamp/ String, 11.4W Number of Lamps/ String, 6 Total UV Power, 68.4W Filter Irradiance (Minimum), 30W/m² |
| Air Source | HVAC fan | Centrifugal Fan |
| Flow Control | Building HVAC system | Four speeds (low, medium, high, boost) provide 300 - 800 CFM flow. |
| Air Changes Per
Hour | Standard building HVAC of 2-3 ACH (air changes per hour) when used in building volume of 45600 cubic feet with flowrates of 1300-1950 CFM. | 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. |
| | Transformair air purifier
(K161468) | Molekule Air Pro RX air
purifier (K200500) |
| UV Light Exposure
Safety Features | Installed in duct away from
user, none required. | 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 UL507. |
| Fan Exposure Safety
Features | Installed in duct without fan,
none required. | Grill at outlet and inlet of fan
with small enough grating to
block user from accessing
spinning fan without tools.
Safety feature confirmed by
UL507. |
| Voltage | 120 Volt
(plugs into standard outlet: no
switch, always on) | 120 Volt
(plugs into standard single
phase 120 Volt outlet) |
| Current | Up to 1.25 amps | Up to 3.72 amps |
| Power Consumption | Up to 240 Watts | Up to 450 Watts |
| Dimensions | Outer frame dimensions:
28.5" x 21" x 12.25"
Filter dimensions :
Filter: 7-20" x 7-26" x 5"
Pre-Filter: 7-20" x 7-26" x 2" | Outer frame dimensions:
22" x 22" x 52"
Filter dimensions:
Filter: 20" x 20" x 4"
Pre-Filter: 20" x 20" x 4" or
20″ x 20″ x 2″ |
| | Transformair air purifier
(K161468) | Molekule Air Pro RX air
purifier (K200500) |
| Standards | ANSI/UL 1995-2011 & CAN-
CSA C22.2 No. 236-11,
Heating and Cooling
Equipment and UL 2043, Heat
and Visible Smoke Release For
Discrete Products and Their
Accessories Installed in Air-
Handling Spaces. | UL 507 Standard for Electrical
Fans
IEC 60601-1-2 EMC. EMC for
Medical Devices. |
8
9
10
SUMMARY OF NON-CLINICAL TESTS:
The Molekule Air Pro RX air purifier complies with voluntary standards for electrical safety and electromagnetic compatibility. The following 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
- Performance tests for UV light leakage and light intensity ●
- Fluid modeling to confirm the system does not impact laminar flow systems ●
- Testing to demonstrate filtration performance and destruction of bacteria ●
- Third party testing was performed to characterize the kill rate kinetics for MS2 ● bacteriophage deposited onto the surface of Air Pro RX's proprietary photocatalytic coated filter media after exposure to Air Pro RX's UV-A light. The Air Pro RX Catalytic media effectively kills viable MS2 bacteriophage at room temperature. After one hour of UV exposure, an average of 3.41 LOG reduction was observed. After 24 hours of exposure, a 5.21 LOG reduction was observed.
SUMMARY OF CLINICAL TESTS: Not applicable.
11
CONCLUSION:
Based on the intended uses, technological characteristics and non-clinical performance data, the Molekule Air Pro RX is as safe, as effective, and performs at least as well as the predicate,Transformair air purifier, cleared under K161468.