(163 days)
Not Found
No
The description details standard air filtration and purification technologies with manual controls and basic timer/indicator functions. There is no mention of adaptive learning, predictive capabilities, or complex data analysis that would indicate AI/ML.
Yes
The device is described as filtering out and inactivating airborne particles "for medical purposes" and specifically demonstrated to reduce organisms like MS2 bacteriophage and Bacillus subtilis endospores, which are relevant in a medical context for improving air quality to prevent disease transmission or improve patient safety. It is also explicitly stated as a "medical recirculation air cleaner."
No
The device is an air cleaner designed to filter and inactivate airborne particles, not to diagnose a condition or disease.
No
The device description clearly outlines physical components such as filters, wheels, and a manual, indicating it is a hardware device with integrated software for control and additional functions.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is clearly stated as a "room recirculating air cleaner" for "filtering out and inactivating airborne particles from the air for medical purposes." This describes a device that acts on the air in a physical space, not on biological samples taken from the body (in vitro).
- Device Description: The description details the physical components and functions of an air purification system (filters, fan speeds, timers, etc.). It does not mention any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies focus on the device's ability to reduce airborne particles and biological agents in a chamber, as well as electrical safety and ozone emissions. These are relevant to an air cleaner, not an IVD.
- Key Metrics: The key metrics are log reductions of airborne organisms and particle filtration efficiency, which are measures of air purification performance. IVD metrics would typically involve sensitivity, specificity, accuracy, etc., related to detecting or measuring substances in biological samples.
- Predicate Device: The predicate device (K200321, Novaerus NV1050) is also described as an air purification system, further supporting the classification of the Qorda QD as an air cleaner, not an IVD.
In Vitro Diagnostics (IVDs) are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease. The Qorda QD does not perform any of these functions.
N/A
Intended Use / Indications for Use
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 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 endospores | Turbo MODE | 4.4 log reduction | 20 minutes |
| Bacillus subtilis endospores | Sleep MODE | 4.3 log reduction | 60 minutes |
Product codes (comma separated list FDA assigned to the subject device)
FRF
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.
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
Medical Facilities and Home
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:
-
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.
-
Performance data:
- Ozone emissions:
- Purpose: Confirm ozone emissions are below the maximum permitted levels
- Ozone emissions:
§ 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).
0
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
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
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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 log
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
endospores | Turbo MODE | 4.4 log reduction | 20 minutes |
| Bacillus subtilis
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
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
endospores | Turbo MODE | 4.4 log reduction | 20 minutes |
| Bacillus subtilis
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 | |
| 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 | |||
| Use/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 Novaerus NV1050 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. | Identical | ||
| Number of Filters | 6 | 3 | Difference |
| Air purifying | |||
| Mechanism | 4 steps (Pre-Filter, CD Carbon Filter, True HEPA Filter, Plasma | ||
| technology) | 4 steps (Pre-Filter, CD Carbon Filter, HEPA | ||
| 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 | ||
| airborne micro-organisms. A True HEPA Filter traps the | |||
| resulting debris and a CD Carbon Filter absorbs any ozone | |||
| generated as a byproduct of the plasma field. | Air from the room is passed through a plasma | ||
| field to inactivate airborne micro-organisms. A | |||
| HEPA filter traps the resulting debris and an | |||
| activated carbon filter absorbs any ozone | |||
| 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 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°C | ||
| Relative 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°C | ||
| Relative 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/A1:2012 | ||
| IEC 60601-1-2:2014 & IEC 60601-1-6:2013 | |||
| IEC 60601-1-11:2015 | IEC 60601-1:2005/A1:2012 | ||
| IEC 60601-1-2:2014 | Similar |
6
7
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 ozone | ||
| emissions are | |||
| below | |||
| the maximum | |||
| permitted levels |