Qorda QD1

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September 14, 2022 Winix Inc. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620 Re: K220990 Trade/Device Name: Qorda QD1 Regulation Number: 21 CFR 880.5045 Regulation Name: Medical Recirculating Air Cleaner Regulatory Class: Class II Product Code: FRF Dated: August 22, 2022 Received: August 23, 2022 Dear April Lee: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (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}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K220990 Device Name Qorda QD1 Indications for Use (Describe) The Qorda QD is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical purposes. The Qorda QD1 has been demonstrated to remove the following organisms under the following exposure conditions: | Organism | Fan Speed | Average Maximum log<br>reduction | Exposure Time | |----------------------------------------|------------|----------------------------------|---------------| | MS2 bacteriophage | Turbo MODE | 5.6 log reduction | 20 minutes | | MS2 bacteriophage | Sleep MODE | 4.9 log reduction | 45 minutes | | <i>Bacillus subtilis</i><br>endospores | Turbo MODE | 4.4 log reduction | 20 minutes | | <i>Bacillus subtilis</i><br>endospores | Sleep MODE | 4.3 log reduction | 60 minutes | | 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) #### 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 tine to 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 WINIX INC. Daewoon Kang 80-13, Sujeong-ro, Jangan-myeon Hwaseong-si, Gyeonggi-do, 18583 Republic of Korea Email: kdw9478@winix.com Phone: +82-31-5180-7575 #### Device Information - Trade Name: Qorda QD1 - Classification Name: Medical recirculating air cleaner ● - Common Name: Air Filtration System, HEPA Air Filtration System - Product Code: FRF ● - Panel: General Hospital - Regulation Number: 21 CFR 880.5045 ● - Device Class: Class II ● - Date prepared: 08/22/2022 ## Primary Predicate Device - K200321, Novaerus NV1050 manufactured by Novaerus US Inc. - #### Indications for use The Qorda QD1 is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical purposes. The Qorda QD1 has been demonstrated to remove the following organisms under the following exposure conditions: | Organism | Fan Speed | Average Maximum log<br>reduction | Exposure Time | |---------------------------------|------------|----------------------------------|---------------| | MS2 bacteriophage | Turbo MODE | 5.6 log reduction | 20 minutes | | MS2 bacteriophage | Sleep MODE | 4.9 log reduction | 45 minutes | | Bacillus subtilis<br>endospores | Turbo MODE | 4.4 log reduction | 20 minutes | | Bacillus subtilis<br>endospores | Sleep MODE | 4.3 log reduction | 60 minutes | ## Device Description Oorda OD1 is a freestanding medical recirculation air cleaner that facilitates movement with wheels. The device includes two pre-filters, two deodorizing filters, two HEPA filters - 3 filters in the front panel and 3 filters in the rear panel), and a manual for users. The device can adjust the air volume in four stages through manual operation (Level 1, Level3, Turbo) and Sleep mode. When operating in sleep mode, the equipment LED and PlasmaWave are turned off and operated with low noise. ## Official Correspondent Withus Group Inc April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: +1-909-274-9971 {4}------------------------------------------------ The device contains the following additional functions. (1)Child lock: Button lock function that prevents children or pets from changing their current motion mode even if they accidentally operate device. (2)Filter Replacement Guide: The remaining filter life is displayed on the front display of the device and tells you when to replace the filter. (3)Adjustment of illuminance: You can adjust the illuminance in four stages (100%, 50%, 20%, OFF). (4)You can turn on or off the PlasmaWave. (5)The timer allows the equipment to turn off automatically after a certain period of time. Qorda QD1 inhales air in both directions on the front and rear of the device and purifies it through the four cleaning steps below: [Pre-Filter] The air is drawn in through the cover front, passes through the Pre-Filter then moves to two filters stages(CD Carbon Filter, True HEPA Filter). The Pre-Filter protects CD Carbon Filter, True HEPA Filter inside the Pre-Filter. [CD Carbon Filter] Reduces any ozone generated as a byproduct of the plasma field. It also prolongs the True HEPA Filter lifespan. [True HEPA Filter] True HEPA Filter captures 99.99%* of airborne ultrafine particles as small as 0.003 microns. *Based on independent laboratory test conducted on particles as small as 0.003 microns in size. [PlasmaWave] PlasmaWave Technology has been tested by an independent third-party to remove particles from the air for medical purposes. {5}------------------------------------------------ # Summary of Technological Characteristics The subject and primary predicate device (K20032 ) are similar in indications, design, fundamental technology, functions, and principle of operation. A table to compare the technical characteristics is below. | | Subject Device | Primary Predicate | Discussion | |----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | K number | K220990 | K200321 | | | Product Name | Qorda QD1 | Novaerus NV 1050 | | | Common Name | Air Filtration System, HEPA Air Filtration System | Air Filtration System, HEPA Air Filtration<br>System | Identical | | Product Code | FRF | FRF | Identical | | Regulation Number | 21 CFR 880.5045 | 21 CFR 880.5045 | Identical | | Class | Class II | Class II | Identical | | Device Illustration | Image: Qorda QD1 device | Image: Novaerus NV 1050 device | Identical | | Intended<br>Use/Indications for<br>Use | The Qorda QD1 is intended as a room recirculating air cleaner.<br>The system is used for filtering out and inactivating airborne<br>particles from the air for medical purposes. | The Novaerus NV1050 is intended as a room<br>recirculating air cleaner. The system is used for<br>filtering out and inactivating airborne particles<br>from the air for medical purposes. | Identical | | Number of Filters | 6 | 3 | Difference | | Air purifying<br>Mechanism | 4 steps (Pre-Filter, CD Carbon Filter, True HEPA Filter, Plasma<br>technology) | 4 steps (Pre-Filter, CD Carbon Filter, HEPA<br>Filter, Plasma technology) | Identical | | Use Location | Medical Facilities and Home | Medical Facilities | Difference | | Technology | Air from the room is passed through a plasma field to inactivate<br>airborne micro-organisms. A True HEPA Filter traps the<br>resulting debris and a CD Carbon Filter absorbs any ozone<br>generated as a byproduct of the plasma field. | Air from the room is passed through a plasma<br>field to inactivate airborne micro-organisms. A<br>HEPA filter traps the resulting debris and an<br>activated carbon filter absorbs any ozone<br>generated as a byproduct of the plasma field. | Identical | | Device size (inches) | 14.6 in(W) x 14.6 in(D) x 32.6 in(H) | 19.0 (w) x 19.1 (D) x 36.5 (h) | Difference | | Device weight | 14.1 kg (30.9 lbs) | 112lb (51 kg) | Difference | | Power source | 120 VAC | 110V AC | Similar | | Air change rates | 6,000 to 27,900 ft3/h (170 to 790 m3/h) in 5 steps | 6,400 to 31,925 ft3/h (180 to 904 m3/h) in 5 steps | Difference | | Reduction of biological agents | The QD1 unit, set to 'Turbo', was effective at reducing both organisms(the MS2 bacteriophage and <i>Bacillus subtilis</i> endospores) by the FDA required net log reduction of 4.0 or greater (equivalent to 99.99% or greater reduction) within 20 minutes when operating in a room of 579 ft3 (16.4 m3). | <i>Bacillus Globigii</i> endospores and MS2 phage reduced by 3 log reduction in 10 minutes and 4 log reduction in 15 minutes when operating at full fan speed in a room of 580ft3 (16.4m3) | Difference | | Filtration of particles | The QD1 produces a 3 log reduction in 0.5 to 4.0 μm sized particles in 10 minutes when operating at Turbo speed in a room of 579 ft3 (16.4 m3). | NV1050 produces a 4 log reduction in 0.5 to 2.0 μm sized particles in 10 minutes in a 580ft3 (16.4m3) sealed room | Difference | | Ozone emitted | Ozone is being generated at a level of less than 2.07 ppb during the operation of the device. | Ozone emissions below 10 ppb (1/5th FDA limit for medical devices) | Similar | | Operational range | Operating temperature: 5°C~40°C<br>Relative humidity: 15% ~ 90% | Temperature: 50°F to 95°F (10°C to 35 °C)<br>Relative humidity: 10 to 75%RH | Similar | | Storage range | Operating temperature: 5°C~40°C<br>Relative humidity: 10% ~ 80% | Temperature: 13°F to 160°F (-10°C to + 71°C)<br>Relative humidity: 10 to 93%RH | Similar | | Standards used | IEC 60601-1:2005/A1:2012<br>IEC 60601-1-2:2014 & IEC 60601-1-6:2013<br>IEC 60601-1-11:2015 | IEC 60601-1:2005/A1:2012<br>IEC 60601-1-2:2014 | Similar | {6}------------------------------------------------ {7}------------------------------------------------ ## Non-clinical Testing 1) Electrical Safety and Electromagnetic Compatibility Electrical, mechanical, environmental safety and performance testing were conducted according to standard IEC 60601-1:2012, IEC 60601-1-11:2015 and EMC testing was conducted according to IEC 60601-1- 2:2014. All test results were satisfying with the standards. ## 2) Performance data The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria of the standards listed below: | Test name/<br>Methodology/<br>Standard name | Purpose | Acceptance Criteria | Result | |---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Ozone emissions | Confirm ozone<br>emissions are<br>below<br>the maximum<br>permitted levels<br><0.050 ppm | Ozone emitted to be<br><0.050 ppm | Pass with the device operating in normal<br>operating conditions under both TURBO<br>and SLEEP Modes. The QD1 units<br>averaged under 1.0 ppb of ozone emission<br>throughout the 24-hour testing, with a<br>maximum generation level less than 2.07<br>ppb. Testing was conducted in a chamber<br>(internal dimensions are 9.1 ft x 9.1 ft x 7<br>ft, with a displacement volume of 579 ft³,<br>or 16.4 m³.) | | Filtration of<br>particles | To demonstrate<br>that the device can<br>produce a 4 log<br>reduction in<br>particles | The device<br>produces a 4 log<br>reduction in the<br>concentration of µm<br>sized the two organism<br>types(the MS2<br>bacteriophage and Bacillus<br>subtilis endospores) and<br>poly-styrene latex (PSL)<br>microspheres | The QD1 produces a 3 log reduction in<br>0.5 to 4.0 µm sized particles in 10<br>minutes when operating at Turbo speed in<br>a chamber (internal dimensions are 9.1 ft<br>x 9.1 ft x 7 ft, with a displacement<br>volume of 579 ft³, or 16.4 m³ | | Combined<br>Operation | To demonstrate the<br>performance of the<br>Qorda QD1 at<br>maximum speed to<br>inactivate and filter<br>out specified micro-<br>organisms | To produce a 4 log<br>reduction in the<br>specified microorganisms | QD1 showed the following results in the<br>the MS2 bacteriophage and Bacillus<br>subtilis endospores removal performance<br>test.<br>The QD1 unit, set to 'Turbo', was<br>effective at reduction of both<br>organisms by the required net log<br>reduction of 4.0 or greater<br>(equivalent to 99.99% or greater<br>reduction) within 20 minutes when<br>operating in a chamber (internal<br>dimensions are 9.1 ft x 9.1 ft x 7 ft,<br>with a displacement volume of 579<br>ft³, or 16.4 m³.) | {8}------------------------------------------------ | Air Change Rate<br>Test | To demonstrate the<br>performance from<br>6,000 to 27,900<br>ft3/h (170 to 790<br>m3/h) in 5 steps.<br>(Level 1, Level 2,<br>Level 3, Turbo,<br>Sleep) | The criteria of air change<br>rate in each mode is higher<br>than the following:<br>Sleep mode is 6,000 ft3/h.<br>Level 1 mode is 11,400 ft3/h.<br>Level 2 mode is 13,800 ft3/h.<br>Level 3 mode is 16,200 ft3/h.<br>Turbo mode is 27,900 ft3/h. | Air change rate of the QD1 showed that<br>all results were higher than the standard<br>air change range required for each stage. | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------| | Software<br>Validation<br>Report | Software verification and validation testing was conducted, and documentation was provided<br>as recommended by FDA's Guidance for Industry and FDA Staff,<br>"Guidance for the Content of Premarket Submissions for Software Contained in<br>Medical Devices." The software for this device was considered as a "moderate(Class B)"<br>level of concern. | | | # Clinical Data Not applicable # Conclusion The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K220990, Qorda QD1, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K200321.