CUBE Air Purifier

K211139 · Samsung Electronics Co., Ltd. · FRA · Nov 26, 2021 · General Hospital

Device Facts

• Record ID: K211139
• Device Name: CUBE Air Purifier
• Applicant: Samsung Electronics Co., Ltd.
• Product Code: FRA · General Hospital
• Decision Date: Nov 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The CUBE 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 CUBE Air Purifier has been demonstrated to destroy the following MS2 bacteriophage, Staphylococus epidermidis, Escherichia coli entrained on the filter of the under the following exposure conditions: [Table of organisms and log reduction data omitted for brevity].

Device Story

Freestanding medical air purifier for healthcare facilities; uses photocatalytic oxidation (PCO) to destroy airborne bacteria and viruses. Input: ambient air drawn through pre-filter and dust-collecting filter. Transformation: air passes over UV-A LED lights (320-400 nm) and TiO2-coated spherical beads; UV-A activates photocatalyst to induce photochemical reaction destroying microorganisms. Output: purified air. Operation: controlled via top-mounted buttons or optional SmartThings mobile app; integrated WLAN for connectivity. Healthcare providers use device to reduce bioaerosol load in clinical settings. Benefits: reduction of viable pathogens (MS2, Phi-X174, S. epidermidis, E. coli) in air, supporting infection control.

Clinical Evidence

No clinical data. Bench testing only. Efficacy demonstrated in sealed bioaerosol chamber; achieved >4 log reduction (99.99%) for MS2, Phi-X174, S. epidermidis, and E. coli within 60 minutes. Durability testing confirmed >50% photocatalytic activity after 10-year simulated use. Filtration efficiency >95% for 0.3-1.0 micron particles per ASHRAE 52.2.

Technological Characteristics

Freestanding air purifier; PCO technology using UV-A LED (320-400 nm) and TiO2 spherical beads. Synthetic media pre-filter and dust-collecting filter. Connectivity: WLAN for SmartThings app. Safety: UL 507 (fans), IEC 60601-1-2 (EMC). Power: 120V input, 24Vdc system. Dimensions: 15" x 16" x 17.3".

Indications for Use

Indicated for use in medical and healthcare facilities to destroy bacteria and viruses in the air via UV-A LED photocatalytic oxidation. Target population includes general hospital environments.

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

• Transformair Indoor Air Purifier (K161468)

Reference Devices

• Molekule Air Pro RX (K200500)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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".

November 26, 2021

Samsung Electronics Co., Ltd. % Kyoungju Kim Consultant MDLab Inc. Room 804, 161-17, Magokjungang-ro, Gangseo-gu Seoul. 07788 Korea, South

Re: K211139

Trade/Device Name: CUBE Air Purifier Regulation Number: 21 CFR 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: Class II Product Code: FRA Dated: October 14, 2021 Received: October 20, 2021

Dear Kyoungju Kim:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Clarence W. Murray, III, PhD 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)

K211139

Device Name CUBE Air Purifier

#### Indications for Use (Describe)

The CUBE 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 CUBE Air Purifier has been demonstrated to destroy the following MS2 bacteriophage, Staphylococus epidermidis, Escherichia coli entrained on the filter of the under the following exposure conditions:

| Organisms | Name | Average Maximum log reduction/<br>exposure time (hours) | |
|-----------|----------------------------|---------------------------------------------------------|--|
| | | Room temperature test | |
| Virus | MS2 bacteriophage | 5.33±0.23 /60 mins | |
| Virus | Phi-X174 bacteriophage | 5.34±0.11 /60 mins | |
| Bacteria | Staphylococcus epidermidis | 5.36±0.28 /60 mins | |
| Bacteria | Escherichia coli | 5.17±0.05 /60 mins | |

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|--|
| <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | |
| <label><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | |

### 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}------------------------------------------------

## 510(k) Summary

### Submitter

Samsung Electronics Co., Ltd. Hana Jung 129, Samsung-Ro, Yeongtong-Gu, Suwon-Si, Gyeonggido, 16677 South Korea Email: [e-mail] Phone: [phone] Fax: [phone]

### Device Information

- Trade Name: CUBE Air Purifier ●
- Common Name: Medical ultraviolet air purifier
- Classification Name: purifier, air, ultraviolet, medical ●
- Product Code: FRA
- . Panel: General Hospital
- . Regulation Number: 21 CFR §880.6500
- Device Class: Class II ●
- . Date prepared: 10/14/2021

### Predicate Device

Primary Predicate K161468, Transformair Indoor Air Purifier by Transformair, LLC.

Reference Device K200500, Molekule Air Pro RX by Molekule, Inc.

### Indications for use

The CUBE 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 CUBE Air Purifier has been demonstrated to destroy the following MS2 bacteriophage. Phi-X174 bacteriophage. Staphylococcus epidermidis. Escherichia coli entrained on the filter of the subject device under the following exposure conditions:

| Organisms | Name | Average Maximum log reduction/<br>exposure time (hours) |
|-----------|----------------------------|---------------------------------------------------------|
| | | Room temperature test |
| Virus | MS2 bacteriophage | 5.33±0.23 /60 mins |
| Virus | Phi-X174 bacteriophage | 5.34±0.11 /60 mins |
| Bacteria | Staphylococcus epidermidis | 5.36±0.28 /60 mins |
| Bacteria | Escherichia coli | 5.17±0.05 /60 mins |

## Official Correspondent

MDLab Inc. Kvoungju Kim. Ph.D. Room 804, 161-17, Magokjungang-ro, Gangseo-gu, Seoul South Korea, 07788 Email: [e-mail] Phone: [phone] Fax: [phone]

{4}------------------------------------------------

### Device Description

The CUBE Air Purifier employs a photocatalytic oxidation (PCO) ultraviolet air purification technology that destroys bacteria and viruses in air in medical facilities. The CUBE Air Purifier includes a pre-filter, a dust collecting filter, UV-A LED lights (320-400 nm), and a catalytic filter.

The device is intended to be placed in medical and healthcare facilities.

### Summary of Technological Characteristics

The subject and primary predicate device (K161468) are similar in indications, design, technology, functions, and principle of operation.

The major differences between the subject and primary predicate are as follows:

- 1) Differences of technical characteristics
- Unlike the Transformair Air Purifier, which is installed in a vent, the CUBE Air Purifier is a ● freestanding device.
- The CUBE Air Purifier, usually used indoor, is therefore deals with room temperature while the Transformair Air Purifier deals with the air of wide-ranged temperature, from 45 °F to 110 °F.
- The CUBE Air Purifier and the predicate Transformair air purifier use the action of UV light on a ● Titanium Oxide (TiO2) photocatalyst to destroy microbiological contaminates in the air. Both devices use conventional UV-light and TiO2 catalytic material but, unlike the predicate, the CUBE Air Purifier uses UV-A LED instead of UV-A lamps. Also, the CUBE Air Purifier uses TiO2 in a shape of spherical bead while the predicate device utilizes it as coating on a wire-mesh. Both devices are designed to operate in a medical facility.
- . Unlike the Transformair Air Purifier, the CUBE Air Purifier can be optionally controlled with a mobile application. The user interface CUBE Air Purifier includes buttons and LED indicators on the top of the device. Power supply (on/off) and fan speed can be controlled with the buttons. In addition, there is an integrated WLAN in the body of the device enabling the control of the device with the SmartThings application optionally.

To Support these differences, we added the Molekule Air Purifier (K200500), which is a freestanding device at the room temperature with UV-A LED.

### 2) Differences of Indications for Use

The primary predicate, Transformair air purifier (K161468) covers larger range of the indications than the subject device. However, since the indications of the subject device are included in the indications of the predicate device.

{5}------------------------------------------------

# K211139

| | Subject Device | Primary Predicate | Reference Device | | | | | | |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|--------------------------------------------------------------------------------------|--------------------|----------|----------------------|-------------------------------------------------------------------------------------------------|
| K number | NA | K161468 | K200500 | | | | | | |
| Device Name | CUBE Air Purifier | Transformair Air Purifier | Molekule Air Pro RX | | | | | | |
| Classification<br>Name | Medical Ultraviolet Air purifier | Medical Ultraviolet Air purifier | Medical Ultraviolet Air purifier | | | | | | |
| Product Code | FRA | FRA | FRA | | | | | | |
| Regulation | 21 C.F.R. § 880.6500 | 21 C.F.R. § 880.6500 | 21 C.F.R. § 880.6500 | | | | | | |
| Class | II | II | II | | | | | | |
| Patient<br>Population | General Hospital | General Hospital | General Hospital | | | | | | |
| User | Healthcare Professional | Healthcare Professional | Healthcare Professional | | | | | | |
| Indications for<br>Use | The CUBE Air Purifier is a device intended for<br>medical purposes that is used to destroy bacteria<br>and viruses in the air by exposure to ultraviolet<br>radiation.<br><br>The CUBE Air Purifier has been demonstrated<br>to destroy the following MS2 bacteriophage,<br>Phi-X174 bacteriophage, Staphylococcus<br>epidermidis, Escherichia coli entrained on the<br>filter of the subject device under the following<br>exposure conditions: | The Transformair Indoor Air Purifier, In Duct<br>Model 16108 is a device intended for medical<br>purposes that is used to destroy bacteria in the<br>air by exposure to ultraviolet radiation.<br><br>Transformair Indoor Air Purifier, In Duct<br>Model 16108 has been demonstrated to<br>destroy Staphylococcus epidermidis,<br>Escherichia coli, MS2, Phi-X174, Aspergillus<br>Niger and Bacillus globigii entrained on the<br>filter of the subject device under the following<br>exposure conditions: | The Molekule Air Pro RX air purifier is a<br>device intended for medical purposes that is<br>used to destroy bacteria and viruses in the air<br>by exposure to ultraviolet radiation. The core<br>technology components of the Molekule Air<br>Pro RX air purifier have been demonstrated to<br>destroy the following MS2 bacteriophage<br>bioaerosol entrained on the filter of the subject<br>device under the following exposure<br>conditions: | | | | | | |
| | Organisms | Name | Average<br>Maximum log<br>reduction/<br>exposure time<br>(hours)<br>Room<br>temperature<br>test | 45 °F | Average maximum log reduction<br>/exposure time (hours)<br>Test temperature<br>72 °F | 110 °F | Organism | Name | Average<br>Maximum<br>log reduction/<br>exposure<br>time (hours)<br>Room<br>temperature<br>test |
| | Virus | MS2<br>bacteriophage | 5.33±0.23<br>/60 mins | 4.13/24<br>hours | Virus, MS2 bacteriophage<br>4.25/24<br>hours | 5.51/24 hours | Virus | MS2<br>bacteriophage | 5.21 /<br>24 hours |
| | Virus | Phi-X174<br>bacteriophage | 5.34±0.11<br>/60 mins | Bacteria, Staphylococcus epidermidis | | | | | |
| | Bacteria | Staphylococcus<br>epidermidis | 5.36±0.28<br>/60 mins | 4.88/24<br>hours | 4.02/24<br>hours<br>Bacteria, Escherichia coli | 4.20/0.33<br>hours | | | |
| | Bacteria | Escherichia coli | 5.17±0.05<br>/60 mins | | | | | | |

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

Original 510(k) Submission File

{6}------------------------------------------------

| | Subject Device | Primary Predicate | Reference Device |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | 4.31/24<br>hours | |
| | | 4.79/24<br>hours | |
| | | 4.40/0.33<br>hours | |
| | | Virus. Phi-X174 bacteriophage | |
| | | 4.37/24<br>hours | |
| | | 4.37/24 hours | |
| | | 4.37/24<br>hours | |
| | | Mold endospore, Aspergillus Niger | |
| | | 3.91/72<br>hours | |
| | | 3.99/72<br>hours | |
| | | 4.22/72 hours | |
| | | Bacterial endospore, Bacillus globigii | |
| | | 4.11/72<br>hours | |
| | | 4.41/72<br>hours | |
| | | 4.41/72 hours | |
| Environment<br>of Use | Hospital and general surgery setting | Hospital and general surgery setting | Hospital and general surgery setting |
| User Control | Two buttons for controlling power and modes<br>(Adjusted fan speed by smart, high, wind-free,<br>sleep mode) | HVAC fan speed controls the air flow | One knob controls the four-speed fan setting<br>One button turns the unit on and off. |
| Software | Basic Firmware and App, used to turn the unit<br>on, off, and change fan speed. | None. The device is on whenever power is<br>connected. | Basic Firmware, used to turn the unit on, off,<br>and change fan speed. |
| Mechanism of<br>Action | UV light of sufficient energy (UV-A) activates<br>photocatalyst that destroys microorganisms<br>entrained on the filter through a photochemical<br>reaction. | UV light of sufficient energy (UV-A) activates<br>photocatalyst that destroys microorganisms<br>entrained on the filter through a photochemical<br>reaction. | UV light of sufficient energy (UV-A) activates<br>photocatalyst that destroys microorganisms<br>entrained on the filter through a photochemical<br>reaction. |
| Installation | Free Standing | In-duct | Free Standing |
| Pre-Filter(s) | • Synthetic Media for mechanical filtration<br>upstream of the PCO filter.<br>• Dimensions<br>Pre-filter: 13 in. x 13.7 in. x 0.2 in.<br>Dust collecting filter: 12.6 in. x 13.4 in. x 1.6 in.<br>• Pleats per inch 0.16 (Dust collecting filter<br>only)<br>Total Filter surface area 3610 sq. in. | • Synthetic Media for mechanical filtration<br>upstream of the PECO filter.<br>• Dimensions 21.25 in. x 26 in. x 2 in.<br>• Pleats per inch 1.25<br>• Total Filter surface area 2800 sq. in. | • Synthetic Media for mechanical filtration<br>upstream of the PECO filter.<br>• Dimensions 20 in. x 20 in. x 4 in.<br>• Pleats per inch 1.5<br>• Total Filter surface area 4800 sq. in. |
| Catalytic<br>Filter | • Proprietary filter media | • Proprietary filter media | • Proprietary filter media |
| | Subject Device | Primary Predicate | Reference Device |
| | • Filter contains 4 mm spherical photocatalytic<br>beads | • Pleats per inch 1.25<br>• Total Filter surface area 2800 sq. in.<br>• Filter coated with the proprietary<br>photocatalyst and a wire-mesh | • Pleats per inch 1.5<br>• Total Filter surface area 4800 sq. in.<br>• Filter coated with the proprietary<br>photocatalyst and a wire-mesh |
| Photocatalyst | Proprietary catalyst | Proprietary catalyst | Proprietary catalyst |
| Light Source | • UV-A Light Source, LED<br>• Wavelength, 320-400 nm<br>• Power per Lamp/String, 9.6 W<br>• Number of Lamps/String, 3<br>• Total UV Power, 28.8 W<br>• Filter Irradiance (Minimum), 1 W/m² | • UV Light Source, black light fluorescent<br>bulbs<br>• Wavelength, 320-400 nm<br>• Power per Lamp/String, 17 W<br>• Number of Lamps/String, 6<br>• Total UV Power, 102 W<br>• Filter Irradiance (Minimum), 25 W/m² | • UV Light Source, LED<br>• Wavelength, 320-400 nm<br>• Power per Lamp/String, 11.4 W<br>• Number of Lamps/String, 6<br>• Total UV Power, 68.4 W<br>• Filter Irradiance (Minimum), 30 W/m² |
| Air Source | Turbo Fan | HVAC fan | Centrifugal Fan |
| Flow Control | Four speeds (low, medium, high, wind-free)<br>provide 35.7-148 CFM flow. | Building HVAC system | our speeds (low, medium, high, boost) provide<br>300 - 800 CFM flow. |
| Air changes<br>per hour | 0.5-2.2 ACH when used in room with volume of<br>4000 cubic feet (a typical operating room<br>volume) with flowrates of 35.7-148 CFM at<br>settings low and high. | Standard building HVAC of 2-3 ACH (air<br>changes per hour) when used in building<br>volume of 45600 cubic feet with flowrates of<br>1300-1950 CFM. | 6-9 ACH when used in room with volume of<br>4000 cubic feet (a typical Operating Room<br>Volume) with flowrates of 450-650 CFM at<br>settings 2 and 3. |
| UV Light<br>Exposure<br>Safety<br>Features | Safety switches exist in the rear panel. If the<br>rear panel is removed, the unit will not operate.<br>The purpose of these switches is to protect the<br>users from any possibility of exposure to direct<br>contact with UV light. Safety feature confirmed<br>by UL 507. | Installed in duct away from user, none<br>required. | Safety switches exist in the following<br>locations: PECO filter door, pre filter door,<br>PECO filter compartment, and pre filter<br>compartment. If any door is open or if a filter<br>is missing, the unit will not operate. The<br>purpose of these switches is to protect the user<br>from any possibility of exposure to direct<br>contact with UV light. Safety feature<br>confirmed by UL 507. |
| Fan Exposure<br>Safety<br>Features | Safety switches exist in the rear panel. If the<br>rear panel is removed, the unit will not operate.<br>The purpose of these switches is to protect the<br>user from any possibility of exposure to direct<br>contact with spinning fan. Safety feature<br>confirmed by UL 507. | Installed in duct away from user, none<br>required. | Grill at outlet and inlet of fan with small<br>enough grating to block user from accessing<br>spinning fan without tools. Safety feature<br>confirmed by UL 507. |
| Voltage | Input: 120 Volt (plugs into standard single<br>phase 120 Volt outlet)<br>Output: 24 Vdc<br>(System In 24 Vdc) | 120 Volt (plugs into standard outlet: no<br>switch, always on) | 120 Volt (plugs into standard single phase 120<br>Volt outlet) |
| | Subject Device | Primary Predicate | Reference Device |
| Current | Up to 2.3 amps | Up to 1.25 amps | Up to 3.72 amps |
| Power<br>Consumption | Up to 55 Watts | Up to 240 Watts | Up to 450 Watts |
| Dimensions | • Outer frame dimensions:<br>15 in. x 16 in. x 17.3 in.<br>• Pre-Filter: 13 in. x 13.7 in. x 0.2 in.<br>• Dust Collecting Filter:<br>12.6 in. x 13.4 in. x 1.6 in. | • Outer frame dimensions: 28.5" x 21" x<br>12.25"<br>• Filter dimensions: Filter: 7-20" x 7-26" x 5"<br>• Pre-Filter: 7-20" x 7-26" x 2" | • Outer frame dimensions:<br>22 in. x 22 in. x 52 in.<br>• Filter dimensions:<br>Filter: 20 in. x 20 in. x 4 in.<br>• Pre-Filter:<br>20 in. x 20 in. x 4 in. or 20 in. x 20 in. x 2 in. |
| Mobile App<br>(Optional) | If the mobile App (SmartThings) is installed on<br>smartphone, the user can control the device with<br>a smartphone. | None | None |
| Standard | UL 507 Standard for Electrical Fans<br>IEC 60601-1-2 EMC. EMC for Medical<br>Devices. | ANSI/UL 1995-2011 & CANCSA C22.2 No.<br>236-11, Heating and Cooling Equipment and<br>UL 2043, Heat and Visible Smoke Release<br>For Discrete Products and Their Accessories<br>Installed in Air-Handling Spaces. | UL 507 Standard for Electrical Fans<br>IEC 60601-1-2 EMC. EMC for Medical<br>Devices. |

{7}------------------------------------------------

Original 510(k) Submission File

{8}------------------------------------------------

{9}------------------------------------------------

## Non-clinical Testing

The CUBE Air Purifier complies with voluntary standards for electrical safety and electromagnetic compatibility.

The following were provided:

- . 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.
- . UV light exposure and UV irradiance testing according to UL 507:2017.
- Fluid modeling to confirm the system does not impact laminar flow systems. The CUBE Air Purifier ● does not provoke back flow and the pressure change in AII rooms.
- . Performance Testing:

| Test Methodology | Purpose | Acceptance Criteria | Results |
|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Performance study for<br>removal efficiency by<br>particle size using dust<br>collecting filter<br>materials, DB63-04081A<br>/ DB63-04081D. | To ensure the CUBE Air<br>Purifier meets filtration<br>efficiency Requirements<br>(95 % or greater on 0.3<br>to 1.0 micron size<br>particles). | The filter material<br>shall achieve 95 % or<br>greater on 0.3 to 1.0<br>micron size parti…