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.

AI/ML Overview

The provided text is a 510(k) Summary for the Airdog X8 Air Purifier. It lacks the details typically found in a study proving a device meets specific acceptance criteria, especially for an AI/ML-driven device with complex performance metrics like those involving human readers or expert consensus. This document pertains to an air purifier, and its "performance data" is focused on physical and biological filtration capabilities, not on an AI's diagnostic or assistive accuracy.

Therefore, I cannot extract information related to:

Sample size used for the test set and data provenance (e.g., country of origin, retrospective/prospective)
Number of experts used to establish ground truth and their qualifications
Adjudication method for the test set
Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size
Standalone (algorithm only) performance
Type of ground truth used (expert consensus, pathology, outcomes data)
Sample size for the training set
How ground truth for the training set was established

However, based on the provided text, I can infer the "acceptance criteria" and "reported device performance" related to the air purifier's function.

Here's a breakdown of what can be extracted:

1. A table of acceptance criteria and the reported device performance

While not explicitly called "acceptance criteria" with pass/fail thresholds in the typical AI/ML sense, the document lists specifications and test results that serve as performance benchmarks.

Acceptance Criteria (Implied)	Reported Device Performance
Biological Agent Reduction (H3N2 Influenza virus)	99.99% reduction with L5 speed operation (Airdog X8)
Biological Agent Reduction (Staphylococcus albus)	4 log reduction with L5 speed (Airdog X8)
Particle Filtration (PM2.5)	4-log reduction in PM2.5 particles in 120 minutes in a 30m³ chamber (Airdog X8)
Ozone Emission	Meets the requirements of UL867 (<50ppb) and USA CRB (Airdog X8)
Total Bacteria Counts Elimination Ratio	4-log elimination ratio of total bacteria counts (Airdog X8)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in terms of clinical or image-based samples. The performance metrics relate to controlled laboratory tests (e.g., "30m³ chamber" for particle filtration, specific test conditions for virus/bacteria inactivation).
Data Provenance: The tests appear to be laboratory-based ("Bench tests"). No human subject data or image data is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth for an air purifier's performance (e.g., particle reduction, virus inactivation) is established through standardized laboratory testing protocols, not expert clinical interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving human readers or subjective interpretations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an air purifier, not an AI diagnostic or assistance tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Performance data provided is "standalone" in the sense that it's the device's measured performance in controlled laboratory settings. There is no algorithm or AI component mentioned in the description that would operate independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance claims (e.g., 99.99% reduction of H3N2) is based on laboratory standard testing methodologies for air purification devices, measuring actual physical and biological reductions in controlled environments.

8. The sample size for the training set

Not applicable. This device is an air purifier, not an AI/ML system that requires a "training set."

9. How the ground truth for the training set was established

Not applicable. No training set is involved for this type of device.

In summary: The provided document is a 510(k) summary for an air purifier, not a report on an AI/ML diagnostic or assistive device. Therefore, most of the requested information regarding AI performance metrics, expert reviews, and study design for AI models is not present and not relevant to this specific device's clearance. The "performance data" focuses on its physical and biological purification capabilities as demonstrated through laboratory bench tests.

Summary

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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.

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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

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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

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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)
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☐ 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 ZhangPhone: +86-18626114866E-mail: yan@beiantech.com
Device Trade NameCommon NameClassification NameDevice ClassReview PanelRegelation NumberProduct Code	Airdog X8 Air Purifier (KJ800F-X8)Air Purifier/ Medical Recirculating Air CleanerCleaner, Air, Medical RecirculatingIIGeneral Hospital880.5045FRF
Device Description andTechnology Characteristics	The Airdog X8 Air Purifier (X8) is a mobile air cleaner. Theair from the room enters the X8 and passes a pre-filter,ionization frame, ionization field, collecting plates andcarbon filter that captures particular matter and biologicalagents from the air. The X8 contains multiple PCB modules,device status indicators, power switch and a display panel, itallows user to select between different operationparameters, including auto-mode, sleep mode and windspeed.The lonization wireframe and the collecting plate can becleaned routinely and are reusable. X8 is powered from anAC wall outlet. It is intended to be used indoors only. Thedevice is not intended to be connected to other instrumentsor medical devices.
Models	KJ800F-X8
Indications for Use	The Airdog X8 Air Purifier is a mobile air cleaner intended tobe used to remove particles from the air for medical

510(k) Summary

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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 RecirculatingAir Cleaner (modelKJ300F-X5)	-
510(k) #	K240696	K211507
Applicant	Suzhou Beiang SmartTechnology 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 amobile air cleaner intended tobe used to remove particlesfrom the air for medicalpurposes. The device isintended for indoor use only.The Airdog X8 has beendemonstrated to effectivelyinactivate H3N2 and reduceStaphylococcus albus by 4log with L5 speed.	The Airdog is a mobile aircleaner intended to be usedto remove particles from theair for medical purposes.The device is intended forindoor use only.The Airdog has beendemonstrated to effectivelyinactivate H3N2 and reduceStaphylococcus albus by 4log with L4 speed.	Same.Both devices areroomrecirculating aircleaners formedical purpose.
UseEnvironment	indoor	indoor	Same
Technology	Air from the room is passedthrough a plasma-ion field toneutralize airborne micro-organisms.negativeachargeddustcollectingelectrode traps the resultingdebris and a third carbonabsorbs any ozonestagegenerated as a byproduct.(ETL test results also showthat even if the carbon net isremoved, the ozone is lowerregulatorythantherequirements)	Air from the room is passedthrough a plasma-ion field toneutralize airborne micro-organisms.negativeacharged dust collectingelectrode traps the resultingdebris and a third carbonstage absorbs any ozonegenerated as a byproduct.(ETL test results also showthat even if the carbon net isremoved, the ozone is lowerregulatorythantherequirements)	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 12.04inch (W) x 12.44 inch (L)	Different
Reduction ofbiologicalagents	H3N2 Influenza virusreduced by 99.99%with operation with L5 speed	H3N2 Influenza virusreduced by 99.99%with operation with L4speed	Similar
Filtration ofparticles	Produces a 4-log reduction inPM2.5 particlesin 120 minutes in a 30m3chamber	Produces a 4-log reductionin PM2.5 particlesin 120 minutes in a 30m3chamber	Same
Ozoneemitted	Meet the requirements ofUL867(<50ppb)for ozone and USA CRB	Meet the requirements ofUL 867(<50ppb)for ozone and USA CRB	Same
Standardsused	ANSI C.63.18: 2014IEC 62304 ed.1.1ISO 14971UL 867:2011 Ed.5CSA C22.2#187:2020 Ed.5FCC Part 15 Subpart BICES-003 Issue 7: 2020IEC 60335-2-65	IEC 60601-1: 2005/A1:2012ANSI C.63.18: 2014IEC 62304 ed.1.1ISO 14971	Different

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Discussion onPerformance Data Non-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.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 ClinicalTest Performed	Not applicable.

Discussion onPerformance Data Non-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.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 ClinicalTest 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).

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).