(224 days)
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 |
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.
The provided text describes the acceptance criteria and the study that proves the CUBE Air Purifier meets those criteria. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| Performance study for removal efficiency by particle size using dust collecting filter materials | 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. |
| Efficacy against MS2 bacteriophage, Phi-X174 bacteriophage, Staphylococcus epidermidis, Escherichia coli (initial) | 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 (of PCO and UV-A) | 4 log reduction (99.99 %) | 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 | 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 %) | MS2 Bacteriophage: 5.35 ± 0.26 / 60 mins |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical performance testing conducted in a controlled laboratory environment. The "sample size" here refers to the number of tests performed on the device itself, rather than human subjects or a dataset of medical images.
- Sample Size for performance testing: The document does not explicitly state the number of repetitions for each performance test (e.g., how many times the aerosolized bacteria/virus reduction was measured). It typically presents average results with standard deviations, implying multiple runs were conducted.
- Data Provenance: The studies were conducted as part of the device's premarket notification (510(k)) submission to the FDA. This indicates that the data was generated specifically for regulatory purposes in a controlled laboratory setting (e.g., environmental bioaerosol chamber). The country of origin for the studies is not explicitly stated, but the submitter (Samsung Electronics Co., Ltd.) is based in South Korea. The studies are prospective in nature, as they involve actively testing the device's performance under specified conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable (N/A) to this type of device (air purifier). The "ground truth" for air purifiers is established through direct laboratory measurements of microbial reduction and filter efficiency, not through human expert interpretation of data like in medical imaging.
4. Adjudication Method for the Test Set
This is not applicable (N/A). Adjudication methods (e.g., 2+1, 3+1 consensus) are typically used in studies involving human interpretation (like in diagnostic imaging studies) to resolve disagreements among readers. For an air purifier, the "ground truth" is determined by objective scientific measurements in a lab.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable (N/A). MRMC studies are relevant for diagnostic devices where human readers (e.g., radiologists) interpret cases (e.g., medical images), often with or without AI assistance. This document describes the performance of an air purifier in reducing airborne pathogens, not a diagnostic tool requiring human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable in the context of an air purifier. The "device performance" is the standalone performance. The machine itself is performing the intended function (destroying bacteria and viruses). There isn't an "algorithm only" that then needs to be compared to a human-in-the-loop performance, as the device's function is purely mechanical and chemical (UV-A and photocatalytic oxidation). The tests performed (e.g., log reduction of microbes in a chamber) are measures of its standalone efficacy.
7. The Type of Ground Truth Used
The ground truth used in these studies is based on direct laboratory measurements of microbial viability and particle count reduction.
- For microbial reduction: The ground truth is the measured decrease in the concentration of specific bacteria and viruses (MS2 bacteriophage, Phi-X174 bacteriophage, Staphylococcus epidermidis, Escherichia coli) in a sealed chamber after exposure to the CUBE Air Purifier. This is a quantitative outcome data obtained through standard microbiological assay techniques.
- For filter efficiency: The ground truth is the measured percentage of particles (0.3 to 1.0 micron size) removed by the filter, according to ASHRAE 52.2 standards, which is a performance standard/outcome data.
8. The Sample Size for the Training Set
This is not applicable (N/A). The CUBE Air Purifier is a physical device employing UV and photocatalytic oxidation for air purification. It is not an AI/ML-based device that requires a "training set" of data to learn or develop an algorithm. Its performance is based on established physical and chemical principles.
9. How the Ground Truth for the Training Set Was Established
This is not applicable (N/A), as there is no "training set" described for this device.
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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
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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
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Indications for Use
510(k) Number (if known)
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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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
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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:
-
- 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.
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K211139
| Subject Device | Primary Predicate | Reference Device | |||||||
|---|---|---|---|---|---|---|---|---|---|
| K number | NA | K161468 | K200500 | ||||||
| Device Name | CUBE Air Purifier | Transformair Air Purifier | Molekule Air Pro RX | ||||||
| ClassificationName | 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 | ||||||
| PatientPopulation | General Hospital | General Hospital | General Hospital | ||||||
| User | Healthcare Professional | Healthcare Professional | Healthcare Professional | ||||||
| Indications forUse | The CUBE Air Purifier is a device intended formedical purposes that is used to destroy bacteriaand viruses in the air by exposure to ultravioletradiation.The CUBE Air Purifier has been demonstratedto destroy the following MS2 bacteriophage,Phi-X174 bacteriophage, Staphylococcusepidermidis, Escherichia coli entrained on thefilter of the subject device under the followingexposure conditions: | The Transformair Indoor Air Purifier, In DuctModel 16108 is a device intended for medicalpurposes that is used to destroy bacteria in theair by exposure to ultraviolet radiation.Transformair Indoor Air Purifier, In DuctModel 16108 has been demonstrated todestroy Staphylococcus epidermidis,Escherichia coli, MS2, Phi-X174, AspergillusNiger and Bacillus globigii entrained on thefilter of the subject device under the followingexposure conditions: | The Molekule Air Pro RX air purifier is adevice intended for medical purposes that isused to destroy bacteria and viruses in the airby exposure to ultraviolet radiation. The coretechnology components of the Molekule AirPro RX air purifier have been demonstrated todestroy the following MS2 bacteriophagebioaerosol entrained on the filter of the subjectdevice under the following exposureconditions: | ||||||
| Organisms | Name | AverageMaximum logreduction/exposure time(hours)Roomtemperaturetest | 45 °F | Average maximum log reduction/exposure time (hours)Test temperature72 °F | 110 °F | Organism | Name | AverageMaximumlog reduction/exposuretime (hours)Roomtemperaturetest | |
| Virus | MS2bacteriophage | 5.33±0.23/60 mins | 4.13/24hours | Virus, MS2 bacteriophage4.25/24hours | 5.51/24 hours | Virus | MS2bacteriophage | 5.21 /24 hours | |
| Virus | Phi-X174bacteriophage | 5.34±0.11/60 mins | Bacteria, Staphylococcus epidermidis | ||||||
| Bacteria | Staphylococcusepidermidis | 5.36±0.28/60 mins | 4.88/24hours | 4.02/24hoursBacteria, Escherichia coli | 4.20/0.33hours | ||||
| Bacteria | Escherichia coli | 5.17±0.05/60 mins |
The following table summarizes the similarities and differences between the subject and predicate devices.
Original 510(k) Submission File
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| Subject Device | Primary Predicate | Reference Device | |
|---|---|---|---|
| 4.31/24hours | |||
| 4.79/24hours | |||
| 4.40/0.33hours | |||
| Virus. Phi-X174 bacteriophage | |||
| 4.37/24hours | |||
| 4.37/24 hours | |||
| 4.37/24hours | |||
| Mold endospore, Aspergillus Niger | |||
| 3.91/72hours | |||
| 3.99/72hours | |||
| 4.22/72 hours | |||
| Bacterial endospore, Bacillus globigii | |||
| 4.11/72hours | |||
| 4.41/72hours | |||
| 4.41/72 hours | |||
| Environmentof 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 settingOne button turns the unit on and off. |
| Software | Basic Firmware and App, used to turn the uniton, off, and change fan speed. | None. The device is on whenever power isconnected. | Basic Firmware, used to turn the unit on, off,and change fan speed. |
| Mechanism ofAction | UV light of sufficient energy (UV-A) activatesphotocatalyst that destroys microorganismsentrained on the filter through a photochemicalreaction. | UV light of sufficient energy (UV-A) activatesphotocatalyst that destroys microorganismsentrained on the filter through a photochemicalreaction. | UV light of sufficient energy (UV-A) activatesphotocatalyst that destroys microorganismsentrained on the filter through a photochemicalreaction. |
| Installation | Free Standing | In-duct | Free Standing |
| Pre-Filter(s) | • Synthetic Media for mechanical filtrationupstream of the PCO filter.• DimensionsPre-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 filteronly)Total Filter surface area 3610 sq. in. | • Synthetic Media for mechanical filtrationupstream 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 filtrationupstream 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. |
| CatalyticFilter | • Proprietary filter media | • Proprietary filter media | • Proprietary filter media |
| Subject Device | Primary Predicate | Reference Device | |
| • Filter contains 4 mm spherical photocatalyticbeads | • Pleats per inch 1.25• Total Filter surface area 2800 sq. in.• Filter coated with the proprietaryphotocatalyst and a wire-mesh | • Pleats per inch 1.5• Total Filter surface area 4800 sq. in.• Filter coated with the proprietaryphotocatalyst 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 fluorescentbulbs• 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) provide300 - 800 CFM flow. |
| Air changesper hour | 0.5-2.2 ACH when used in room with volume of4000 cubic feet (a typical operating roomvolume) with flowrates of 35.7-148 CFM atsettings low and high. | Standard building HVAC of 2-3 ACH (airchanges per hour) when used in buildingvolume of 45600 cubic feet with flowrates of1300-1950 CFM. | 6-9 ACH when used in room with volume of4000 cubic feet (a typical Operating RoomVolume) with flowrates of 450-650 CFM atsettings 2 and 3. |
| UV LightExposureSafetyFeatures | Safety switches exist in the rear panel. If therear panel is removed, the unit will not operate.The purpose of these switches is to protect theusers from any possibility of exposure to directcontact with UV light. Safety feature confirmedby UL 507. | Installed in duct away from user, nonerequired. | Safety switches exist in the followinglocations: PECO filter door, pre filter door,PECO filter compartment, and pre filtercompartment. If any door is open or if a filteris missing, the unit will not operate. Thepurpose of these switches is to protect the userfrom any possibility of exposure to directcontact with UV light. Safety featureconfirmed by UL 507. |
| Fan ExposureSafetyFeatures | Safety switches exist in the rear panel. If therear panel is removed, the unit will not operate.The purpose of these switches is to protect theuser from any possibility of exposure to directcontact with spinning fan. Safety featureconfirmed by UL 507. | Installed in duct away from user, nonerequired. | Grill at outlet and inlet of fan with smallenough grating to block user from accessingspinning fan without tools. Safety featureconfirmed by UL 507. |
| Voltage | Input: 120 Volt (plugs into standard singlephase 120 Volt outlet)Output: 24 Vdc(System In 24 Vdc) | 120 Volt (plugs into standard outlet: noswitch, always on) | 120 Volt (plugs into standard single phase 120Volt outlet) |
| Subject Device | Primary Predicate | Reference Device | |
| Current | Up to 2.3 amps | Up to 1.25 amps | Up to 3.72 amps |
| PowerConsumption | 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" x12.25"• 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 onsmartphone, the user can control the device witha smartphone. | None | None |
| Standard | UL 507 Standard for Electrical FansIEC 60601-1-2 EMC. EMC for MedicalDevices. | ANSI/UL 1995-2011 & CANCSA C22.2 No.236-11, Heating and Cooling Equipment andUL 2043, Heat and Visible Smoke ReleaseFor Discrete Products and Their AccessoriesInstalled in Air-Handling Spaces. | UL 507 Standard for Electrical FansIEC 60601-1-2 EMC. EMC for MedicalDevices. |
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Original 510(k) Submission File
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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 forremoval efficiency byparticle size using dustcollecting filtermaterials, DB63-04081A/ DB63-04081D. | To ensure the CUBE AirPurifier meets filtrationefficiency Requirements(95 % or greater on 0.3to 1.0 micron sizeparticles). | The filter materialshall achieve 95 % orgreater on 0.3 to 1.0micron size particlesaccording to ASHRAE52.2. | Required filtrationefficiency 95 % orgreater on 0.3 to 1.0micron size particles wasachieved |
| The estimate of thecatalytic filter lifetimebased on performanceand stability evaluation. | To ensure thesustainability ofphotocatalytic activityand durability of thecatalytic filter after 10years of operation underconstant UVAirradiation. | The photocatalyticactivity (CADRagainst toxic gas) shallmaintain more than50 % of initial activityafter accelerating testsimulating 10 years ofoperation. | Photocatalytic activity(CADR against toxicgas) after acceleratingtest was above 50 %compared to initialactivity. |
| Performance evaluationfor the estimate of UVALED Lifetime based onacceleration test. | To estimate the usablelifetime of UVA LEDlamp | L50/B50 | 111,638 hours (12.7years) to reach L50/B50. |
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| MS2 bacteriophage, Phi-X174 bacteriophage,Staphylococcusepidermidis, Escherichiacoli were aerosolizedinto a sealedenvironmental bioaerosolchamber containing theCUBE Air Purifier. | To evaluate the efficacyof the CUBE Air Purifierat reducing viability ofaerosolized MS2bacteriophage, Phi-X174bacteriophage,Staphylococcusepidermidis, Escherichiacoli by a combination | 4 log reduction(99.99 %) | Average net logreduction / timeMS2 bacteriophage,5.33 $\pm$ 0.23 / 60 minsPhi-X174 bacteriophage,5.34 $\pm$ 0.11 / 60 minsStaphylococcusepidermidis,5.36 $\pm$ 0.28 / 60 minsEscherichia coli,5.17 $\pm$ 0.05 / 60 mins |
|---|---|---|---|
| Efficacy of the CUBEAir Purifier Deviceagainst MS2Bacteriophage After 10Years of Simulated Use | To evaluate the efficacyof the CUBE Air Purifierafter 10 years ofsimulated use at reducingviability of aerosolizedMS2 bacteriophage. | 4 log reduction(99.99 %) | Average net logreduction / timeMS2 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.
§ 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).