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 logreduction	Exposure Time
MS2 bacteriophage	Turbo MODE	5.6 log reduction	20 minutes
MS2 bacteriophage	Sleep MODE	4.9 log reduction	45 minutes
Bacillus subtilisendospores	Turbo MODE	4.4 log reduction	20 minutes
Bacillus subtilisendospores	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.

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Qorda QD1 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Name	Acceptance Criteria	Reported Device Performance
Ozone Emissions	Ozone emitted to be < 0.050 ppm	Pass with the device operating in normal operating conditions under both TURBO and SLEEP Modes. The QD1 units averaged under 1.0 ppb of ozone emission throughout the 24-hour testing, with a maximum generation level less than 2.07 ppb. (0.00207 ppm)
Filtration of Particles	The device produces a 4 log reduction in the concentration of µm sized the two organism types (the MS2 bacteriophage and Bacillus subtilis endospores) and poly-styrene latex (PSL) microspheres	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 chamber (internal dimensions are 9.1 ft x 9.1 ft x 7 ft, with a displacement volume of 579 ft³, or 16.4 m³).
Combined Operation	To produce a 4 log reduction in the specified microorganisms	The QD1 unit, set to 'Turbo', was effective at reduction of both organisms (the MS2 bacteriophage and Bacillus subtilis endospores) by the required net log reduction of 4.0 or greater (equivalent to 99.99% or greater reduction) within 20 minutes when operating in a chamber (internal dimensions are 9.1 ft x 9.1 ft x 7 ft, with a displacement volume of 579 ft³, or 16.4 m³).
Air Change Rate Test	The criteria of air change rate in each mode is higher than the following:- Sleep mode is 6,000 ft³/h- Level 1 mode is 11,400 ft³/h- Level 2 mode is 13,800 ft³/h- Level 3 mode is 16,200 ft³/h- Turbo mode is 27,900 ft³/h	Air change rate of the QD1 showed that all results were higher than the standard air change range required for each stage.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for biological reduction and particle filtration: The text mentions the tests were conducted in "a chamber (internal dimensions are 9.1 ft x 9.1 ft x 7 ft, with a displacement volume of 579 ft³, or 16.4 m³)." This suggests a single test environment or chamber was used for multiple tests (ozone, particle filtration, and biological reduction). The exact number of runs or repetitions within this chamber for each test is not specified, but the phrasing implies controlled laboratory conditions rather than a large-scale field study.
Data Provenance: The studies are non-clinical, controlled laboratory tests. There is no information regarding the country of origin of the data explicitly, but Winix Inc. is based in the Republic of Korea, and the correspondent is in the USA. The tests were likely performed in a controlled laboratory setting by a third-party testing facility. The nature of these tests is prospective as they were designed and executed to evaluate the device's performance against predefined criteria.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. The ground truth for these performance tests is established by objective measurements and scientific methodologies in a laboratory setting (e.g., measuring ozone concentration, particle counts, and biological log reduction) rather than expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. As these are objective performance tests measuring physical and biological parameters, there is no need for an adjudication method typically used for subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document describes non-clinical performance testing of an air cleaning device, not a diagnostic or clinical imaging device that would involve human readers or MRMC studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a sense. The tests described are for the standalone performance of the Qorda QD1 device in an automated manner (filtering and inactivating at different fan speeds) without human intervention during its operation or performance assessment.

7. The Type of Ground Truth Used

The ground truth used in these studies is based on:

Direct Measurement of Physical and Chemical Properties:
- Ozone concentration (ppb).
- Particle counts and sizes (µm).
- Air volume and air change rates (ft³/h or m³/h).
Direct Measurement of Biological Inactivation/Reduction:
- Log reduction of specified microorganisms (MS2 bacteriophage and Bacillus subtilis endospores).

These are objective, quantifiable measurements derived from controlled laboratory experiments.

8. The Sample Size for the Training Set

Not applicable. This device is an air cleaner, not an AI/machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no AI/machine learning component, there is no training set or associated ground truth establishment for a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for 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 acronym "FDA" followed by the words "U.S. Food & Drug Administration" in a larger font and "Administration" in a smaller font.

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

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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

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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 logreduction	Exposure Time
MS2 bacteriophage	Turbo MODE	5.6 log reduction	20 minutes
MS2 bacteriophage	Sleep MODE	4.9 log reduction	45 minutes
Bacillus subtilisendospores	Turbo MODE	4.4 log reduction	20 minutes
Bacillus subtilisendospores	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."

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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 logreduction	Exposure Time
MS2 bacteriophage	Turbo MODE	5.6 log reduction	20 minutes
MS2 bacteriophage	Sleep MODE	4.9 log reduction	45 minutes
Bacillus subtilisendospores	Turbo MODE	4.4 log reduction	20 minutes
Bacillus subtilisendospores	Sleep MODE	4.3 log reduction	60 minutes

Device Description

Official Correspondent Withus Group Inc April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: +1-909-274-9971

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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]

[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.

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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 FiltrationSystem	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
IntendedUse/Indications forUse	The Qorda QD1 is intended as a room recirculating air cleaner.The system is used for filtering out and inactivating airborneparticles from the air for medical purposes.	The Novaerus NV1050 is intended as a roomrecirculating air cleaner. The system is used forfiltering out and inactivating airborne particlesfrom the air for medical purposes.	Identical
Number of Filters	6	3	Difference
Air purifyingMechanism	4 steps (Pre-Filter, CD Carbon Filter, True HEPA Filter, Plasmatechnology)	4 steps (Pre-Filter, CD Carbon Filter, HEPAFilter, Plasma technology)	Identical
Use Location	Medical Facilities and Home	Medical Facilities	Difference
Technology	Air from the room is passed through a plasma field to inactivateairborne micro-organisms. A True HEPA Filter traps theresulting debris and a CD Carbon Filter absorbs any ozonegenerated as a byproduct of the plasma field.	Air from the room is passed through a plasmafield to inactivate airborne micro-organisms. AHEPA filter traps the resulting debris and anactivated carbon filter absorbs any ozonegenerated 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 Bacillus subtilis 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).	Bacillus Globigii 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°CRelative humidity: 15% ~ 90%	Temperature: 50°F to 95°F (10°C to 35 °C)Relative humidity: 10 to 75%RH	Similar
Storage range	Operating temperature: 5°C~40°CRelative humidity: 10% ~ 80%	Temperature: 13°F to 160°F (-10°C to + 71°C)Relative humidity: 10 to 93%RH	Similar
Standards used	IEC 60601-1:2005/A1:2012IEC 60601-1-2:2014 & IEC 60601-1-6:2013IEC 60601-1-11:2015	IEC 60601-1:2005/A1:2012IEC 60601-1-2:2014	Similar

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Non-clinical Testing

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/Methodology/Standard name	Purpose	Acceptance Criteria	Result
Ozone emissions	Confirm ozoneemissions arebelowthe maximumpermitted levels<0.050 ppm	Ozone emitted to be<0.050 ppm	Pass with the device operating in normaloperating conditions under both TURBOand SLEEP Modes. The QD1 unitsaveraged under 1.0 ppb of ozone emissionthroughout the 24-hour testing, with amaximum generation level less than 2.07ppb. Testing was conducted in a chamber(internal dimensions are 9.1 ft x 9.1 ft x 7ft, with a displacement volume of 579 ft³,or 16.4 m³.)
Filtration ofparticles	To demonstratethat the device canproduce a 4 logreduction inparticles	The deviceproduces a 4 logreduction in theconcentration of µmsized the two organismtypes(the MS2bacteriophage and Bacillussubtilis endospores) andpoly-styrene latex (PSL)microspheres	The QD1 produces a 3 log reduction in0.5 to 4.0 µm sized particles in 10minutes when operating at Turbo speed ina chamber (internal dimensions are 9.1 ftx 9.1 ft x 7 ft, with a displacementvolume of 579 ft³, or 16.4 m³
CombinedOperation	To demonstrate theperformance of theQorda QD1 atmaximum speed toinactivate and filterout specified micro-organisms	To produce a 4 logreduction in thespecified microorganisms	QD1 showed the following results in thethe MS2 bacteriophage and Bacillussubtilis endospores removal performancetest.The QD1 unit, set to 'Turbo', waseffective at reduction of bothorganisms by the required net logreduction of 4.0 or greater(equivalent to 99.99% or greaterreduction) within 20 minutes whenoperating in a chamber (internaldimensions are 9.1 ft x 9.1 ft x 7 ft,with a displacement volume of 579ft³, or 16.4 m³.)

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Air Change RateTest	To demonstrate theperformance from6,000 to 27,900ft3/h (170 to 790m3/h) in 5 steps.(Level 1, Level 2,Level 3, Turbo,Sleep)	The criteria of air changerate in each mode is higherthan the following:Sleep mode is 6,000 ft3/h.Level 1 mode is 11,400 ft3/h.Level 2 mode is 13,800 ft3/h.Level 3 mode is 16,200 ft3/h.Turbo mode is 27,900 ft3/h.	Air change rate of the QD1 showed thatall results were higher than the standardair change range required for each stage.
SoftwareValidationReport	Software verification and validation testing was conducted, and documentation was providedas recommended by FDA's Guidance for Industry and FDA Staff,"Guidance for the Content of Premarket Submissions for Software Contained inMedical Devices." The software for this device was considered as a "moderate(Class B)"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.

Regulation Number and Section

§ 880.5045 Medical recirculating air cleaner.

(a)
Identification. A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.(b)
Classification. Class II (performance standards).