(557 days)
Not Found
No
The document does not mention AI, ML, or any related technologies. The device description focuses on physical filtration and ionization processes, and the performance studies describe the effectiveness of these processes. The "auto-mode" mentioned is likely based on sensor readings and pre-programmed logic, not AI/ML.
Yes
The device is intended to remove particles from the air for "medical purposes" and has demonstrated effectiveness in inactivating viruses and reducing bacteria. These functions aim to improve health outcomes by reducing harmful airborne agents, which aligns with the definition of a therapeutic device.
No
Explanation: The device is an air cleaner intended to remove particles for medical purposes by inactivating viruses and reducing bacteria. It does not diagnose any condition or disease.
No
The device description clearly outlines physical hardware components such as a floor-standing unit, filters, ionization frame, collecting plates, PCB modules, sensors, switches, and a display panel. It is powered by an AC wall outlet, indicating it is a physical device, not software-only.
Based on the provided information, the Airdog X5 Recirculating Air Cleaner is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. They are used to diagnose diseases, conditions, or determine the state of health. Examples include blood tests, urine tests, and genetic tests.
- The Airdog X5 is an air cleaner. Its function is to remove particles and inactivate viruses and bacteria from the air in a room. It does not interact with or analyze human specimens.
- The intended use is to remove particles from the air for medical purposes. While it has a medical purpose (improving air quality to potentially reduce the spread of airborne pathogens), this is a function performed on the environment, not on a human specimen.
Therefore, the Airdog X5 falls under the category of an air purification device, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FRF
Device Description
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.
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 X5 produces 4-log reduction of particles, 4-log elimination ratio of total bacteria counts, a 4-log inactivation in H3N2 Influenza virus and produce ozone emission which meets the requirements of ul867 for ozone and USA CRB.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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 (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
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)
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3
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 Zhang |
| Phone: +86-19951234257 | |
| E-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 Description
and Technology
Characteristics | 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 lonization 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. |
| --------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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 | ||
| 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 | ||
| 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 Novaerus NV 1050 is | ||
| intended as a room | |||
| recirculating air cleaner. The | |||
| system is used for filtering | |||
| out and inactivating airborne | |||
| particles form the air for | |||
| medical purpose | 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. A negative | |||
| 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
than the regulatory
requirements) | Air from the room is passed
through a plasma field to
inactivate airborne micro-
organisms. A HEPA filter
traps the resulting debris
and an activated carbon
filter absorbs any ozone
generated as a byproduct
of the plasma field | Similar. Both have
the plasma filed and
carbon filter. The
predicate device
use HEPA filter to
traps the resulting
debris while the
subject device uses
a negative charged
dust collecting
electrode. |
| 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 of
biological agents | H3N2 Influenza virus
inactivating by 99.99%
with operation with L4
speed Staphylococcus
albus reduced by
99.99% in 1 hour | Bacillus Globigii
endospores and MS2
phage reduced by 3 log
reduction in 10 minutes
and 4 log reduction in 15
minutes when operating at
full fan speed | Similar.
Both are capable of
reducing specified
biological agents by
4 log. |
| Filtration of particles | produces a 4 log
reduction in PM2.5 particles in
120 minutes in a 30 m3
chamber | 4 log reduction in 0.5 to 2.0
μm
sized particles in 10
minutes in a 580ft3
(16.4m3) sealed room | Similar.
Both are capable of
reducing particles
by 4 log |
| Ozone emitted | Meet the requirements
of ul867 ( 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.