Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a device that uses physical and chemical processes (filtration, UV radiation, photocatalytic oxidation) to purify air. There is no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

No.
The device's intended use is to destroy bacteria and viruses in the air. While this may contribute to a healthier environment, it does not directly treat a disease or condition in a patient, which is the primary characteristic of a therapeutic device. It acts on the environment, not directly on an individual.

Diagnostic

No
The device is an air purifier intended to destroy bacteria and viruses in the air, which is a treatment or mitigation function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly states it includes hardware components such as a pre-filter, dust collecting filter, UV-A LED lights, and a catalytic filter.

IVD (In Vitro Diagnostic)

Based on the provided information, the CUBE 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.
CUBE Air Purifier's Function: The CUBE Air Purifier's intended use is to destroy bacteria and viruses in the air within medical facilities. It does not analyze or process biological specimens from a patient.
Mechanism of Action: The device uses UV radiation and photocatalytic oxidation to directly inactivate microorganisms in the air. This is an environmental control function, not a diagnostic one.

Therefore, the CUBE Air Purifier falls under the category of an air purification device for medical purposes, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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:

Organisms	Name	Average Maximum log reduction/exposure time (hours)
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)
Over-The-Counter Use (21 CFR 801 Subpart C)

Product codes (comma separated list FDA assigned to the subject device)

FRA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Healthcare Professional / 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)

Non-clinical Testing:

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:
- Performance study for removal efficiency by particle size using dust collecting filter materials, DB63-04081A / DB63-04081D. Purpose: To ensure the CUBE Air Purifier meets filtration efficiency Requirements (95 % or greater on 0.3 to 1.0 micron size particles). Acceptance Criteria: The filter material shall achieve 95 % or greater on 0.3 to 1.0 micron size particles according to ASHRAE 52.2. Results: Required filtration efficiency 95 % or greater on 0.3 to 1.0 micron size particles was achieved.
- The estimate of the catalytic filter lifetime based on performance and stability evaluation. Purpose: To ensure the sustainability of photocatalytic activity and durability of the catalytic filter after 10 years of operation under constant UVA irradiation. Acceptance Criteria: The photocatalytic activity (CADR against toxic gas) shall maintain more than 50 % of initial activity after accelerating test simulating 10 years of operation. Results: Photocatalytic activity (CADR against toxic gas) after accelerating test was above 50 % compared to initial activity.
- Performance evaluation for the estimate of UVA LED Lifetime based on acceleration test. Purpose: To estimate the usable lifetime of UVA LED lamp. Acceptance Criteria: L50/B50. Results: 111,638 hours (12.7 years) to reach L50/B50.
- MS2 bacteriophage, Phi-X174 bacteriophage, Staphylococcus epidermidis, Escherichia coli were aerosolized into a sealed environmental bioaerosol chamber containing the CUBE Air Purifier. Purpose: To evaluate the efficacy of the CUBE Air Purifier at reducing viability of aerosolized MS2 bacteriophage, Phi-X174 bacteriophage, Staphylococcus epidermidis, Escherichia coli by a combination. Acceptance Criteria: 4 log reduction (99.99 %). Results: Average net log reduction / time MS2 bacteriophage, 5.33 ± 0.23 / 60 mins; Phi-X174 bacteriophage, 5.34 ± 0.11 / 60 mins; Staphylococcus epidermidis, 5.36 ± 0.28 / 60 mins; Escherichia coli, 5.17 ± 0.05 / 60 mins.
- Efficacy of the CUBE Air Purifier Device against MS2 Bacteriophage After 10 Years of Simulated Use. Purpose: To evaluate the efficacy of the CUBE Air Purifier after 10 years of simulated use at reducing viability of aerosolized MS2 bacteriophage. Acceptance Criteria: 4 log reduction (99.99 %). Results: Average net log reduction / time MS2 Bacteriophage, 5.35 ± 0.26 / 60 mins.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K161468

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.

K200500

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

Regulation Number and Section

§ 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).

Summary

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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/
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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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3

510(k) Summary

Submitter

Samsung Electronics Co., Ltd. Hana Jung 129, Samsung-Ro, Yeongtong-Gu, Suwon-Si, Gyeonggido, 16677 South Korea Email: hana822.jung@samsung.com Phone: +82-10-8307-0822 Fax: +82-31-8062-9327

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/
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: kj.kim@mdlab.co.kr Phone: +82-10-2264-5341 Fax: 82-2-3664-0830

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
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
Population	General Hospital	General Hospital	General Hospital
User	Healthcare Professional	Healthcare Professional	Healthcare Professional
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: | 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.

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
hours
		4.79/24
hours
		4.40/0.33
hours
		Virus. Phi-X174 bacteriophage
		4.37/24
hours
		4.37/24 hours
		4.37/24
hours
		Mold endospore, Aspergillus Niger
		3.91/72
hours
		3.99/72
hours
		4.22/72 hours
		Bacterial endospore, Bacillus globigii
		4.11/72
hours
		4.41/72
hours
		4.41/72 hours
Environment
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
(Adjusted fan speed by smart, high, wind-free,
sleep mode)	HVAC fan speed controls the air flow	One knob controls the four-speed fan setting
One button turns the unit on and off.
Software	Basic Firmware and App, used to turn the unit
on, off, and change fan speed.	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.	UV light of sufficient energy (UV-A) activates
photocatalyst that destroys microorganisms
entrained on the filter through a photochemical
reaction.
Installation	Free Standing	In-duct	Free Standing
Pre-Filter(s)	• Synthetic Media for mechanical filtration
upstream of the PCO filter.
• Dimensions
Pre-filter: 13 in. x 13.7 in. x 0.2 in.
Dust collecting filter: 12.6 in. x 13.4 in. x 1.6 in.
• Pleats per inch 0.16 (Dust collecting filter
only)
Total Filter surface area 3610 sq. in.	• 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.
Catalytic
Filter	• Proprietary filter media	• Proprietary filter media	• Proprietary filter media
	Subject Device	Primary Predicate	Reference Device
	• Filter contains 4 mm spherical photocatalytic
beads	• Pleats per inch 1.25
• Total Filter surface area 2800 sq. in.
• Filter coated with the proprietary
photocatalyst and a wire-mesh	• 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	Proprietary catalyst	Proprietary catalyst
Light Source	• UV-A Light Source, LED
• Wavelength, 320-400 nm
• Power per Lamp/String, 9.6 W
• Number of Lamps/String, 3
• Total UV Power, 28.8 W
• Filter Irradiance (Minimum), 1 W/m²	• UV Light Source, black light fluorescent
bulbs
• Wavelength, 320-400 nm
• Power per Lamp/String, 17 W
• Number of Lamps/String, 6
• Total UV Power, 102 W
• Filter Irradiance (Minimum), 25 W/m²	• UV Light Source, LED
• Wavelength, 320-400 nm
• Power per Lamp/String, 11.4 W
• Number of Lamps/String, 6
• Total UV Power, 68.4 W
• Filter Irradiance (Minimum), 30 W/m²
Air Source	Turbo Fan	HVAC fan	Centrifugal Fan
Flow Control	Four speeds (low, medium, high, wind-free)
provide 35.7-148 CFM flow.	Building HVAC system	our speeds (low, medium, high, boost) provide
300 - 800 CFM flow.
Air changes
per hour	0.5-2.2 ACH when used in room with volume of
4000 cubic feet (a typical operating room
volume) with flowrates of 35.7-148 CFM at
settings low and high.	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.
UV Light
Exposure
Safety
Features	Safety switches exist in the rear panel. If the
rear panel is removed, the unit will not operate.
The purpose of these switches is to protect the
users from any possibility of exposure to direct
contact with UV light. Safety feature confirmed
by UL 507.	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 UL 507.
Fan Exposure
Safety
Features	Safety switches exist in the rear panel. If the
rear panel is removed, the unit will not operate.
The purpose of these switches is to protect the
user from any possibility of exposure to direct
contact with spinning fan. Safety feature
confirmed by UL 507.	Installed in duct away from user, 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 UL 507.
Voltage	Input: 120 Volt (plugs into standard single
phase 120 Volt outlet)
Output: 24 Vdc
(System In 24 Vdc)	120 Volt (plugs into standard outlet: no
switch, always on)	120 Volt (plugs into standard single phase 120
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
Consumption	Up to 55 Watts	Up to 240 Watts	Up to 450 Watts
Dimensions	• Outer frame dimensions:
15 in. x 16 in. x 17.3 in.
• Pre-Filter: 13 in. x 13.7 in. x 0.2 in.
• Dust Collecting Filter:
12.6 in. x 13.4 in. x 1.6 in.	• 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 in. x 22 in. x 52 in.
• Filter dimensions:
Filter: 20 in. x 20 in. x 4 in.
• Pre-Filter:
20 in. x 20 in. x 4 in. or 20 in. x 20 in. x 2 in.
Mobile App
(Optional)	If the mobile App (SmartThings) is installed on
smartphone, the user can control the device with
a smartphone.	None	None
Standard	UL 507 Standard for Electrical Fans
IEC 60601-1-2 EMC. EMC for Medical
Devices.	ANSI/UL 1995-2011 & CANCSA 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.

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
Performance study for
removal efficiency by
particle size using dust
collecting filter
materials, DB63-04081A
/ DB63-04081D.	To ensure the CUBE Air
Purifier meets filtration
efficiency Requirements
(95 % or greater on 0.3
to 1.0 micron size
particles).	The filter material
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
The estimate of the
catalytic filter lifetime
based on performance
and stability evaluation.	To ensure the
sustainability of
photocatalytic activity
and durability of the
catalytic filter after 10
years of operation under
constant UVA
irradiation.	The photocatalytic
activity (CADR
against toxic gas) shall
maintain more than
50 % of initial activity
after accelerating test
simulating 10 years of
operation.	Photocatalytic activity
(CADR against toxic
gas) after accelerating
test was above 50 %
compared to initial
activity.
Performance evaluation
for the estimate of UVA
LED Lifetime based on
acceleration test.	To estimate the usable
lifetime of UVA LED
lamp	L50/B50	111,638 hours (12.7
years) to reach L50/B50.

10

| MS2 bacteriophage, Phi-
X174 bacteriophage,
Staphylococcus
epidermidis, Escherichia
coli were aerosolized
into a sealed
environmental bioaerosol
chamber containing the
CUBE Air Purifier. | To evaluate the efficacy
of the CUBE Air Purifier
at reducing viability of
aerosolized MS2
bacteriophage, Phi-X174
bacteriophage,
Staphylococcus
epidermidis, Escherichia
coli by a combination | 4 log reduction
(99.99 %) | Average net log
reduction / time
MS2 bacteriophage,
5.33 $\pm$ 0.23 / 60 mins
Phi-X174 bacteriophage,
5.34 $\pm$ 0.11 / 60 mins
Staphylococcus
epidermidis,
5.36 $\pm$ 0.28 / 60 mins
Escherichia coli,
5.17 $\pm$ 0.05 / 60 mins |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Efficacy of the CUBE
Air Purifier Device
against MS2
Bacteriophage After 10
Years of Simulated Use | To evaluate the efficacy
of the CUBE Air Purifier
after 10 years of
simulated use at reducing
viability of aerosolized
MS2 bacteriophage. | 4 log reduction
(99.99 %) | Average net log
reduction / time
MS2 Bacteriophage,
5.35 $\pm$ 0.26 / 60 mins |

Clinical Testing

Not applicable.

Conclusion

Based on intended uses, technological characteristics and non-clinical performance data, the CUBE Air Purifier is safe, as effective, and performs at least as well as the predicate, Transformair air purifier, cleared under K161468.