Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)

K211507 · Beiang Air Tech , Ltd. · FRF · Nov 22, 2022 · General Hospital

Device Facts

• Record ID: K211507
• Device Name: Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)
• Applicant: Beiang Air Tech , Ltd.
• Product Code: FRF · General Hospital
• Decision Date: Nov 22, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5045
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Airdog is a mobile air cleaner intended to be used to remove particles from the air for medical purposes. The device is intended for indoor use only. The Airdog has been demonstrated to effectively inactivate H3N2 and reduce Staphylococcus albus by 4 log with L4 speed.

Device Story

Floor-standing recirculating air cleaner; operates by drawing indoor air through a pre-filter, ionization frame, and ionization field to neutralize airborne microorganisms; negative-charged dust collecting electrode traps debris; carbon layer absorbs ozone byproduct. User selects operation parameters (auto-mode, sleep mode, wind speed) via display panel. Device status indicators and air quality sensor provide feedback. Intended for indoor use; operated by general users. Output is filtered air; clinical benefit is reduction of airborne particles and biological agents (H3N2, Staphylococcus albus) to support medical air quality requirements.

Clinical Evidence

Bench testing only. No clinical data. Bench tests demonstrated 4-log reduction of PM2.5 particles in 120 minutes, 4-log reduction of Staphylococcus albus, and 99.99% inactivation of H3N2 Influenza virus at L4 speed. Ozone emissions verified to meet UL867 (<50ppb) and USA CRB requirements.

Technological Characteristics

Floor-standing unit; plasma ion field for neutralization; negative-charged dust collecting electrode; activated carbon filter for ozone absorption. Powered by 100-240V AC. Includes air quality sensor, PCB modules, and display panel. Reusable ionization wireframe and collecting plates. Standards: IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 14971.

Indications for Use

Indicated for indoor use as a mobile air cleaner to remove airborne particles for medical purposes. No specific patient population or contraindications defined.

Regulatory Classification

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.

Predicate Devices

• Novaerus NV1050 (K200321)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 22, 2022

Beiang Air Tech LTD. % Tyra Chiu Regulatory Specialist Medical Wizdom, LLC 12F .- 4, No. 81, Sec. 2, Chang'an E. Rd., Zhongshan Dist. Taipei, 10491 Taiwan

Re: K211507

Trade/Device Name: Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) Regulation Number: 21 CFR 880.5045 Regulation Name: Medical recirculating air cleaner Regulatory Class: Class II Product Code: FRF Dated: October 21, 2022 Received: October 21, 2022

Dear Tyra Chiu:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Clarence W. Murray III -S

Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K211507

Device Name

Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)

Indications for Use (Describe)

The Airdog is a mobile air cleaner intended to be used to remove particles from the air for medical purposes. The device is intended for indoor use only.

The Airdog has been demonstrated to effectively inactivate H3N2 and reduce Staphylococcus albus by 4 log with L4 speed.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

X 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 and 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

Date November 22, 2022

| Manufacturer/ | BeiAng Air Tech Ltd. |
|---------------------|--------------------------------------------------------------------------------|
| 510(k) Owner | 175#, SONGBEI ROAD, SUZHOU INDUSTRIAL PARK,<br>JIANGSU PROVINCE, 215000, CHINA |
| Contact Person | Yan Zhang<br>Phone: [phone]<br>E-mail: [e-mail] |
| Device Trade Name | Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) |
| Common Name | Medical Recirculating Air Cleaner |
| Classification Name | Cleaner, Air, Medical Recirculating |
| Device Class | II |
| Review Panel | General Hospital |
| Regulation Number | 880.5045 |
| Product Code | FRF |

| Device Description<br>and Technology<br>Characteristics | The Airdog X5 Recirculating Air Cleaner is a floor-standing<br>air cleaner with an air quality sensor. The air from the<br>room enters the X5 and passes a pre-filter, ionization<br>frame, ionization field, collecting plates and carbon layer<br>that captures particular matter and virus from the air. The<br>X5 contains multiple PCB modules, air quality sensor,<br>device status indicators, power switch and a display panel<br>it allows user to select between different operation<br>parameter, including auto-mode, sleep mode and wind<br>speed. The lonization Wireframe and the Collecting Plate<br>can be cleaned routinely and are reusable. X5 is powered<br>from an AC wall outlet. It is intended to be used indoors<br>only. |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

{4}------------------------------------------------

#### Models KJ300F-X5

Indications for Use The Airdog is a mobile air cleaner intended to be used to remove particles from the air for medical purposes. The device is intended for indoor use only. The Airdog has been demonstrated to effectively inactivate H3N2 and reduce Staphylococcus albus by 4 log with L4 speed.

Predicate Device(s) K200321 Novaerus NV1050/ Novaerus US Inc

### Summary of Comparison and Technological Characteristics

| | Proposed Device | Predicate Device | Comparison |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Airdog X5 Recirculating Air<br>Cleaner(model KJ300F-X5) | Novaerus NV1050 | - |
| 510(k) # | K211507 | K200321 | - |
| Applicant | BeiAng Air Tech Ltd. | Novaerus US Inc | - |
| Product code | FRF (21 CFR 880.5045) | FRF (21 CFR 880.5045) | Same |
| Classification | II | II | Same |
| OTC use | YES | YES | Same |
| Intended Use | The Airdog is a mobile air<br>cleaner intended to be used<br>to remove particles from the<br>air for medical purposes. The<br>device is intended for indoor<br>use only.<br>The Airdog has been<br>demonstrated to effectively<br>inactivate H3N2 and<br>reduce Staphylococcus<br>albus by 4 log with L4 speed. | The Novaerus NV 1050 is<br>intended as a room<br>recirculating air cleaner. The<br>system is used for filtering<br>out and inactivating airborne<br>particles form the air for<br>medical purpose | Same.<br>Both devices are<br>room recirculating<br>air cleaners for<br>medical purpose. |
| Use Environment | Indoor | Indoor | Same |
| | | | |
| Technology | Air from the room is passed<br>through a plasma ion field to<br>neutralize airborne micro-<br>organisms. A negative<br>charged dust collecting<br>electrode traps the resulting<br>debris and a third carbon<br><br>stage absorbs any ozone<br>generated as a byproduct.<br>(ETL test results also show<br>that even if the carbon net is<br>removed, the ozone is lower<br>than the regulatory<br>requirements) | Air from the room is passed<br>through a plasma field to<br>inactivate airborne micro-<br>organisms. A HEPA filter<br>traps the resulting debris<br>and an activated carbon<br>filter absorbs any ozone<br><br>generated as a byproduct<br>of the plasma field | Similar. Both have<br>the plasma filed and<br>carbon filter. The<br>predicate device<br>use HEPA filter to<br>traps the resulting<br>debris while the<br><br>subject device uses<br>a negative charged<br>dust collecting<br>electrode. |
| Power Source | 100-240V~50-60Hz | 110V AC | Different |
| Weight(kg) | 10.7 | 51 | Different |
| Dimension | 25.59 inch (H)* 12.04 inch<br>(W) *12.44 inch (L) | 36.5 inch (H) x 19.0 inch<br>(W) x 19.1inch (L) | Different |
| Reduction of<br>biological agents | H3N2 Influenza virus<br>inactivating by 99.99%<br>with operation with L4<br>speed Staphylococcus<br>albus reduced by<br>99.99% in 1 hour | Bacillus Globigii<br>endospores and MS2<br>phage reduced by 3 log<br>reduction in 10 minutes<br>and 4 log reduction in 15<br>minutes when operating at<br>full fan speed | Similar.<br>Both are capable of<br>reducing specified<br>biological agents by<br>4 log. |
| Filtration of particles | produces a 4 log<br>reduction in PM2.5 particles in<br>120 minutes in a 30 m3<br>chamber | 4 log reduction in 0.5 to 2.0<br>μm<br>sized particles in 10<br>minutes in a 580ft3<br>(16.4m3) sealed room | Similar.<br>Both are capable of<br>reducing particles<br>by 4 log |
| Ozone emitted | Meet the requirements<br>of ul867 (<50ppb) for<br>ozone and USA CRB | below 10 ppb | Similar.<br>Both <50ppb |
| Standards used | IEC 60601-1: 2005/A1:2012<br>IEC 60601-1-2: 2014<br>IEC 62304 ed.1.1<br>ISO 14971 | IEC 60601-1: 2005/A1:2012 | Different. |

{5}------------------------------------------------

{6}------------------------------------------------

Discussion on Bench tests show that the X5 produces 4-log reduction of Performance Data particles, 4-log elimination ratio of total bacteria counts, a 4-log Non-Clinical Tests inactivation in H3N2 Influenza virus and produce ozone emission which meets the requirements of ul867 for ozone and USA CRB.

> Software verification and validation was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

# Discussion on Clinical

#### Test Performed Not applicable

Conclusion The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.