K Number

Device Name

Airdog X8 Air Purifier (KJ800F-X8)

Manufacturer

Suzhou Beiang Smart Technology Co., Ltd.

Date Cleared

2024-06-14

(92 days)

Product Code

FRF

Regulation Number

880.5045

Intended 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 Description

The Airdog X8 Air Purifier (X8) is a mobile air cleaner. The air from the room enters the X8 and passes a pre-filter, ionization frame, ionization field, collecting plates and carbon filter that captures particular matter and biological agents from the air. The X8 contains multiple PCB modules, device status indicators, power switch and a display panel, it allows user to select between different operation parameters, including auto-mode, sleep mode and wind speed. The Ionization wireframe and the collecting plate can be cleaned routinely and are reusable. X8 is powered from an AC wall outlet. It is intended to be used indoors only. The device is not intended to be connected to other instruments or medical devices.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K211507

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on physical filtration and ionization processes, and explicitly states "Mentions AI, DNN, or ML: Not Found". The "auto-mode" mentioned is a common feature in many devices and doesn't necessarily imply AI/ML.

Therapeutic

Yes.
The "Intended Use / Indications for Use" section states: "The Airdog X8 Air Purifier is a mobile air cleaner intended to remove particles from the air for medical purposes." This explicitly indicates a therapeutic intent.

Diagnostic

The device is an air purifier intended to remove particles from the air, not to diagnose medical conditions or diseases.

SaMD (Software as a Medical Device)

The device description clearly outlines multiple hardware components including a pre-filter, ionization frame, ionization field, collecting plates, carbon filter, PCB modules, device status indicators, power switch, and a display panel. It is powered by an AC wall outlet. While software is mentioned in the performance studies, the device itself is a physical air purifier with integrated hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, the Airdog X8 Air Purifier is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics 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.
Airdog X8 Function: The Airdog X8 is an air cleaner. Its function is to remove particles and inactivate biological agents from the air in a room. It does not interact with or analyze specimens from the human body.
Intended Use: The intended use clearly states it's a "mobile air cleaner intended to remove particles from the air for medical purposes." This aligns with an air purification function, not an IVD function.
Device Description: The description details the air filtration process and components, all related to air cleaning.
Performance Studies: The performance studies focus on the device's ability to reduce particles and inactivate biological agents in the air, not on analyzing biological specimens.

While the device has a medical purpose (removing particles and inactivating biological agents from the air to potentially benefit health), this purpose is achieved through air purification, not through the in vitro examination of human specimens.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

FRF

Device Description

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

Not Found

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)

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.
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.”

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

H3N2 Influenza virus reduced by 99.99% with operation with L5 speed.
Produces a 4-log reduction in PM2.5 particles in 120 minutes in a 30m3 chamber.
Meet the requirements of UL867(

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).

Summary

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.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Christopher K. Dugard -S

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

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

Indications for Use

510(k) Number (if known) K240696

Device Name Airdog X8 Air Purifier (KJ800F-X8)

Indications for Use (Describe)

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)
--------------------------------------------------------------	-------------------------------------------------------------

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K240696 510(k) Summary

Date	Mar 14, 2024
Manufacturer/ 510(k)
Owner	Suzhou Beiang Smart Technology Co., Ltd.
175#, SONGBEI ROAD, SUZHOU INDUSTRIAL PARK,
JIANGSU PROVINCE, 215000, CHINA
Contact Person	Yan Zhang
Phone: +86-18626114866
E-mail: yan@beiantech.com
Device Trade Name
Common Name
Classification Name
Device Class
Review Panel
Regelation Number
Product Code	Airdog X8 Air Purifier (KJ800F-X8)
Air Purifier/ Medical Recirculating Air Cleaner
Cleaner, Air, Medical Recirculating
II
General Hospital
880.5045
FRF
Device Description and
Technology Characteristics	The Airdog X8 Air Purifier (X8) is a mobile air cleaner. The
air from the room enters the X8 and passes a pre-filter,
ionization frame, ionization field, collecting plates and
carbon filter that captures particular matter and biological
agents from the air. The X8 contains multiple PCB modules,
device status indicators, power switch and a display panel, it
allows user to select between different operation
parameters, including auto-mode, sleep mode and wind
speed.
The lonization wireframe and the collecting plate can be
cleaned routinely and are reusable. X8 is powered from an
AC wall outlet. It is intended to be used indoors only. The
device is not intended to be connected to other instruments
or medical devices.
Models	KJ800F-X8
Indications for Use	The Airdog X8 Air Purifier is a mobile air cleaner intended to
be used to remove particles from the air for medical

510(k) Summary

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
Air Cleaner (model
KJ300F-X5)	-
510(k) #	K240696	K211507
Applicant	Suzhou Beiang Smart
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
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 X8 has been
demonstrated to effectively
inactivate H3N2 and reduce
Staphylococcus albus by 4
log with L5 speed.	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.	Same.
Both devices are
room
recirculating air
cleaners for
medical purpose.
Use
Environment	indoor	indoor	Same
Technology	Air from the room is passed
through a plasma-ion field to
neutralize airborne micro-
organisms.
negative
a
charged
dust
collecting
electrode traps the resulting
debris and a third carbon
absorbs any ozone
stage
generated as a byproduct.
(ETL test results also show
that even if the carbon net is
removed, the ozone is lower
regulatory
than
the
requirements)	Air from the room is passed
through a plasma-ion field to
neutralize airborne micro-
organisms.
negative
a
charged dust collecting
electrode traps the resulting
debris and a third carbon
stage absorbs any ozone
generated as a byproduct.
(ETL test results also show
that even if the carbon net is
removed, the ozone is lower
regulatory
than
the
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
(W) x 14.96 inch (L)	25.59 inch (H) x 12.04
inch (W) x 12.44 inch (L)	Different
Reduction of
biological
agents	H3N2 Influenza virus
reduced by 99.99%
with operation with L5 speed	H3N2 Influenza virus
reduced by 99.99%
with operation with L4
speed	Similar
Filtration of
particles	Produces a 4-log reduction in
PM2.5 particles
in 120 minutes in a 30m3
chamber	Produces a 4-log reduction
in PM2.5 particles
in 120 minutes in a 30m3
chamber	Same
Ozone
emitted	Meet the requirements of
UL867(