(557 days)
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.
The Airdog X5 Recirculating Air Cleaner is a floor-standing air cleaner with an air quality sensor. The air from the room enters the X5 and passes a pre-filter, ionization frame, ionization field, collecting plates and carbon layer that captures particular matter and virus from the air. The X5 contains multiple PCB modules, air quality sensor, device status indicators, power switch and a display panel it allows user to select between different operation parameter, including auto-mode, sleep mode and wind speed. The Ionization Wireframe and the Collecting Plate can be cleaned routinely and are reusable. X5 is powered from an AC wall outlet. It is intended to be used indoors only.
This document is a 510(k) Pre-market Notification from the FDA regarding the Airdog X5 Recirculating Air Cleaner (model KJ300F-X5). It's a regulatory approval document and thus primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed scientific study report with all the requested specifics.
Based on the provided text, here's the information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria / Predicate Performance (K200321 Novaerus NV1050) | Reported Device Performance (Airdog X5) |
|---|---|---|
| Reduction of Biological Agents | Bacillus Globigii endospores and MS2 phage reduced by 3 log in 10 minutes and 4 log in 15 minutes. | H3N2 Influenza virus inactivating by 99.99% (4 log) with L4 speed. Staphylococcus albus reduced by 99.99% (4 log) in 1 hour. |
| Filtration of Particles | 4 log reduction in 0.5 to 2.0 μm sized particles in 10 minutes in a 580ft³ (16.4m³) sealed room. | Produces a 4 log reduction in PM2.5 particles in 120 minutes in a 30 m³ chamber. |
| Ozone Emitted | Below 10 ppb (Implies meeting regulatory requirements, which are typically <50 ppb for air purifiers). | Meet the requirements of UL867 (<50ppb) for ozone and USA CRB. (ETL test results also show that even if the carbon net is removed, the ozone is lower than regulatory requirements). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes (e.g., number of replicates for each test run) for the biological agent inactivation, particle reduction, or ozone emission tests.
The data provenance is not explicitly stated as "retrospective" or "prospective." However, these were undoubtedly prospective bench tests conducted to evaluate the device's performance against specific standards and claims. The country of origin for the tests is not specified, but the manufacturer is BeiAng Air Tech Ltd. located in China.
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)
This is not applicable as the studies described are bench tests evaluating the physical and biological performance of an air cleaner, not human-centric studies requiring expert interpretation of data like medical image analysis. The "ground truth" for these tests would be established by scientific measurement standards and protocols in a controlled laboratory environment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for bench tests. These tests are quantitative measurements, not subjective evaluations 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 cleaner and does not involve human readers or AI assistance in a diagnostic context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is an air cleaner, not an algorithm. The performance described is its standalone mechanical and biological effectiveness.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the biological agent reduction and particle filtration, the "ground truth" is based on controlled laboratory measurements of the concentration of specific microorganisms or particles before and after air cleaner operation, relative to standard controls. For ozone emission, the "ground truth" is defined by regulatory standards (e.g., UL867) for maximum allowable ozone concentration.
8. The sample size for the training set
Not applicable. This is a physical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. (See #8)
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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
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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 -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
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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)
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510(k) Summary
Date November 22, 2022
| Manufacturer/ | BeiAng Air Tech Ltd. |
|---|---|
| 510(k) Owner | 175#, SONGBEI ROAD, SUZHOU INDUSTRIAL PARK,JIANGSU PROVINCE, 215000, CHINA |
| Contact Person | Yan ZhangPhone: +86-19951234257E-mail: yan@beiantech.com |
| 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 Descriptionand TechnologyCharacteristics | The Airdog X5 Recirculating Air Cleaner is a floor-standingair cleaner with an air quality sensor. The air from theroom enters the X5 and passes a pre-filter, ionizationframe, ionization field, collecting plates and carbon layerthat captures particular matter and virus from the air. TheX5 contains multiple PCB modules, air quality sensor,device status indicators, power switch and a display panelit allows user to select between different operationparameter, including auto-mode, sleep mode and windspeed. The lonization Wireframe and the Collecting Platecan be cleaned routinely and are reusable. X5 is poweredfrom an AC wall outlet. It is intended to be used indoorsonly. |
|---|---|
| --------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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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 AirCleaner(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 aircleaner intended to be usedto remove particles from theair for medical purposes. Thedevice is intended for indooruse only.The Airdog has beendemonstrated to effectivelyinactivate H3N2 andreduce Staphylococcusalbus by 4 log with L4 speed. | The Novaerus NV 1050 isintended as a roomrecirculating air cleaner. Thesystem is used for filteringout and inactivating airborneparticles form the air formedical purpose | Same.Both devices areroom recirculatingair cleaners formedical purpose. |
| Use Environment | Indoor | Indoor | Same |
| Technology | Air from the room is passedthrough a plasma ion field toneutralize airborne micro-organisms. A negativecharged 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 lowerthan the regulatoryrequirements) | Air from the room is passedthrough a plasma field toinactivate airborne micro-organisms. A HEPA filtertraps the resulting debrisand an activated carbonfilter absorbs any ozonegenerated as a byproductof the plasma field | Similar. Both havethe plasma filed andcarbon filter. Thepredicate deviceuse HEPA filter totraps the resultingdebris while thesubject device usesa negative chargeddust collectingelectrode. |
| Power Source | 100-240V~50-60Hz | 110V AC | Different |
| Weight(kg) | 10.7 | 51 | Different |
| Dimension | 25.59 inch (H)* 12.04 inch(W) *12.44 inch (L) | 36.5 inch (H) x 19.0 inch(W) x 19.1inch (L) | Different |
| Reduction ofbiological agents | H3N2 Influenza virusinactivating by 99.99%with operation with L4speed Staphylococcusalbus reduced by99.99% in 1 hour | Bacillus Globigiiendospores and MS2phage reduced by 3 logreduction in 10 minutesand 4 log reduction in 15minutes when operating atfull fan speed | Similar.Both are capable ofreducing specifiedbiological agents by4 log. |
| Filtration of particles | produces a 4 logreduction in PM2.5 particles in120 minutes in a 30 m3chamber | 4 log reduction in 0.5 to 2.0μmsized particles in 10minutes in a 580ft3(16.4m3) sealed room | Similar.Both are capable ofreducing particlesby 4 log |
| Ozone emitted | Meet the requirementsof ul867 (<50ppb) forozone and USA CRB | below 10 ppb | Similar.Both <50ppb |
| Standards used | IEC 60601-1: 2005/A1:2012IEC 60601-1-2: 2014IEC 62304 ed.1.1ISO 14971 | IEC 60601-1: 2005/A1:2012 | Different. |
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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.
§ 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).