Airdog X8 Air Purifier (KJ800F-X8)

K240696 · Suzhou Beiang Smart Technology Co., Ltd. · FRF · Jun 14, 2024 · General Hospital

Device Facts

• Record ID: K240696
• Device Name: Airdog X8 Air Purifier (KJ800F-X8)
• Applicant: Suzhou Beiang Smart Technology Co., Ltd.
• Product Code: FRF · General Hospital
• Decision Date: Jun 14, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5045
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Airdog X8 Air Purifier is a mobile air cleaner intended to remove particles from the air for medical purposes. The device is intended for indoor use only. The Airdog X8 has been demonstrated to effectively inactivate H3N2 and reduce Staphylococcus albus by 4 log with L5 speed.

Device Story

Airdog X8 is a mobile, indoor air cleaner; operates by drawing room air through a pre-filter, ionization frame, ionization field, collecting plates, and carbon filter. Plasma-ion field neutralizes airborne microorganisms; negatively charged collecting electrode traps debris; carbon stage absorbs ozone byproduct. Device features PCB modules, status indicators, power switch, and display panel for user-selectable operation parameters (auto-mode, sleep mode, wind speed). Powered by AC wall outlet. Intended for use by general public in indoor environments. Output consists of purified air; healthcare providers or patients use device to reduce airborne particles and biological agents, potentially benefiting patients by improving air quality. Device is not intended for connection to other medical instruments.

Clinical Evidence

No clinical data. Bench testing only. Performance demonstrated via 4-log reduction of PM2.5 particles in 30m3 chamber, 4-log reduction of Staphylococcus albus, and 99.99% reduction of H3N2 Influenza virus at L5 speed. Ozone emissions confirmed to meet UL867 (<50ppb) and USA CRB requirements.

Technological Characteristics

Mobile air cleaner; plasma-ion field and collecting electrode technology. Materials include pre-filter, ionization wireframe, collecting plates, and carbon filter. Powered by 100-240V AC. Dimensions: 29.92" x 14.96" x 14.96". Standards: UL 867:2011 Ed.5, CSA C22.2#187:2020 Ed.5, IEC 60335-2-65, FCC Part 15 Subpart B, ICES-003 Issue 7: 2020, ANSI C.63.18: 2014, ISO 14971, IEC 62304 ed.1.1.

Indications for Use

Indicated for indoor use as a mobile air cleaner to remove particles from the air for medical purposes.

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

• Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) (K211507)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 14, 2024

Suzhou Beiang Smart Technology Co., Ltd. % Chung Lun Chen Regulatory Consultant Lexnovia Venture Studio Ltd. 1F, No. 10, Lane 10, Section 3, Zhongxiao E. Road Da'an District Taipei, 106083 Taiwan

Re: K240696

Trade/Device Name: Airdog X8 Air Purifier (KJ800F-X8) Regulation Number: 21 CFR 880.5045 Regulation Name: Medical Recirculating Air Cleaner Regulatory Class: Class II Product Code: FRF Dated: May 16, 2024 Received: May 16, 2024

Dear Chung Lun Chen:

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 (the 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 available 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.

{1}------------------------------------------------

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

# Christopher K. Dugard -S

Christopher K. Dugard, M.S. Assistant Director DHT4B: Division of Infection Control

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

and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

## Indications for Use

510(k) Number (if known) K240696

Device Name Airdog X8 Air Purifier (KJ800F-X8)

#### Indications for Use (Describe)

The Airdog X8 Air Purifier is a mobile air cleaner intended to remove particles from the air for medical purposes. The device is intended for indoor use only. The Airdog X8 has been demonstrated to effectively inactivate H3N2 and reduce Staphylococcus albus by 4 log with L5 speed.

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

| <span></span> ☐ Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> ☑ 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."

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

## K240696 510(k) Summary

| Date | Mar 14, 2024 |
|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/ 510(k)<br>Owner | Suzhou Beiang Smart Technology Co., Ltd.<br>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<br>Common Name<br>Classification Name<br>Device Class<br>Review Panel<br>Regelation Number<br>Product Code | Airdog X8 Air Purifier (KJ800F-X8)<br>Air Purifier/ Medical Recirculating Air Cleaner<br>Cleaner, Air, Medical Recirculating<br>II<br>General Hospital<br>880.5045<br>FRF |
| Device Description and<br>Technology Characteristics | The Airdog X8 Air Purifier (X8) is a mobile air cleaner. The<br>air from the room enters the X8 and passes a pre-filter,<br>ionization frame, ionization field, collecting plates and<br>carbon filter that captures particular matter and biological<br>agents from the air. The X8 contains multiple PCB modules,<br>device status indicators, power switch and a display panel, it<br>allows user to select between different operation<br>parameters, including auto-mode, sleep mode and wind<br>speed.<br>The lonization wireframe and the collecting plate can be<br>cleaned routinely and are reusable. X8 is powered from an<br>AC wall outlet. It is intended to be used indoors only. The<br>device is not intended to be connected to other instruments<br>or medical devices. |
| Models | KJ800F-X8 |
| Indications for Use | The Airdog X8 Air Purifier is a mobile air cleaner intended to<br>be used to remove particles from the air for medical |

510(k) Summary

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

purposes. The device is intended for indoor use only. The Airdog X8 Air Purifier has been demonstrated to effectively inactivate H3N2 and reduce Staphylococcus albus by 4 log with L5 speed.

- Predicate Device(s) K211507 Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)/ BeiAng Air Tech Ltd.
### Summary of Comparison and Technological Characteristics

| | Proposed Device | Predicate Device | Comparison |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Device Name | Airdog X8 Air Purifier | Airdog X5 Recirculating<br>Air Cleaner (model<br>KJ300F-X5) | - |
| 510(k) # | K240696 | K211507 | |
| Applicant | Suzhou Beiang Smart<br>Technology Co., Ltd. | BeiAng Air Tech Ltd. | Same |
| 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 X8 Air Purifier is a<br>mobile air cleaner intended to<br>be used to remove particles<br>from the air for medical<br>purposes. The device is<br>intended for indoor use only.<br>The Airdog X8 has been<br>demonstrated to effectively<br>inactivate H3N2 and reduce<br>Staphylococcus albus by 4<br>log with L5 speed. | The Airdog is a mobile air<br>cleaner intended to be used<br>to remove particles from the<br>air for medical purposes.<br>The device is intended for<br>indoor use only.<br>The Airdog has been<br>demonstrated to effectively<br>inactivate H3N2 and reduce<br>Staphylococcus albus by 4<br>log with L4 speed. | Same.<br>Both devices are<br>room<br>recirculating air<br>cleaners for<br>medical purpose. |
| Use<br>Environment | indoor | indoor | Same |
| Technology | Air from the room is passed<br>through a plasma-ion field to<br>neutralize airborne micro-<br>organisms.<br>negative<br>a<br>charged<br>dust<br>collecting<br>electrode traps the resulting<br>debris and a third carbon<br>absorbs any ozone<br>stage<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>regulatory<br>than<br>the<br>requirements) | Air from the room is passed<br>through a plasma-ion field to<br>neutralize airborne micro-<br>organisms.<br>negative<br>a<br>charged dust collecting<br>electrode traps the resulting<br>debris and a third carbon<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>regulatory<br>than<br>the<br>requirements) | Same |
| Power Source | 100-240V~50-60Hz | 100-240V~50-60Hz | Same |
| Weight(kg) | 19.7 | 10.7 | Different |
| Dimension | 29.92 inch (H) x 14.96 inch<br>(W) x 14.96 inch (L) | 25.59 inch (H) x 12.04<br>inch (W) x 12.44 inch (L) | Different |
| Reduction of<br>biological<br>agents | H3N2 Influenza virus<br>reduced by 99.99%<br>with operation with L5 speed | H3N2 Influenza virus<br>reduced by 99.99%<br>with operation with L4<br>speed | Similar |
| Filtration of<br>particles | Produces a 4-log reduction in<br>PM2.5 particles<br>in 120 minutes in a 30m3<br>chamber | Produces a 4-log reduction<br>in PM2.5 particles<br>in 120 minutes in a 30m3<br>chamber | Same |
| Ozone<br>emitted | Meet the requirements of<br>UL867(<50ppb)<br>for ozone and USA CRB | Meet the requirements of<br>UL 867(<50ppb)<br>for ozone and USA CRB | Same |
| Standards<br>used | ANSI C.63.18: 2014<br>IEC 62304 ed.1.1<br>ISO 14971<br>UL 867:2011 Ed.5<br>CSA C22.2#187:2020 Ed.5<br>FCC Part 15 Subpart B<br>ICES-003 Issue 7: 2020<br>IEC 60335-2-65 | IEC 60601-1: 2005/A1:2012<br>ANSI C.63.18: 2014<br>IEC 62304 ed.1.1<br>ISO 14971 | Different |

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

{7}------------------------------------------------

| Discussion on<br>Performance Data Non-<br>Clinical Tests | Bench tests show that the X8 produces 4-log reduction of particles, 4-log elimination ratio of total bacteria counts, a 4-log reduction in H3N2 Influenza virus and produce ozone emission which meets the requirements of UL867 for ozone and USA CRB.<br><br>Software verification and validation testing were conducted as recommended by FDA's Guidance for Industry and FDA Staff, “Guidance for the Content of Pre-market Submission for Software Contained in Medical Devices.” |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Discussion on Clinical<br>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 the legally marketed predicate device(s).