(257 days)
The air purifier 3707 UVC is used to reduce airborne particles, such as: dust, smoke, pollen, mold spores, animal hair, dust mites that may cause allergy in rooms of enclosed areas such as treatment rooms, hospital wards, intensive care hospital wards and residential homes.
Air Purifier 3707 UVC device is an adjustable and portable personal system for treating air in a specified area of a room. Air Purifier 3707 UVC device contains an air treatment system, including a housing unit with an air inlet and a treated air outlet, a blower and a filter for removing contaminants from the air flowing along Air Purifier 3707 UVC device contains also an air filtering the flow path. system with an Ultraviolet radiation tube which purified air.
The provided 510(k) summary for the Air Purifier 3707 UVC (K033448) does not contain information about specific acceptance criteria or a study proving that the device meets such criteria in the context of device performance metrics (e.g., efficacy in reducing airborne particles).
Instead, the submission focuses on:
- Substantial Equivalence: The primary assertion is that the Air Purifier 3707 UVC is substantially equivalent to the AiroCide TiO2 (K023830) in terms of intended use, characteristics, and device descriptions.
- Compliance with Standards: The device complies with the Standard for Electrostatic Air Cleaners, UL 867, and the Canadian Standard for Electrostatic Air Cleaners, CSA C22.2 No. 187-M1986. These are safety and performance standards for air cleaners in general, not specific clinical performance criteria.
Therefore, many of the requested elements for describing acceptance criteria and a detailed study proving device performance (especially those related to AI/algorithm performance, ground truth, expert review, and sample sizes for testing/training) are not applicable or not provided in this 510(k) submission.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (AiroCide TiO2 - K023830) | Deemed "substantially equivalent" for intended use, characteristics, and device descriptions by FDA. |
| Compliance with UL 867 (Standard for Electrostatic Air Cleaners) | Device "complies" with UL 867. |
| Compliance with CSA C22.2 No. 187-M1986 (Canadian Standard for Electrostatic Air Cleaners) | Device "complies" with CSA C22.2 No. 187-M1986. |
| Reduction of airborne particles (dust, smoke, pollen, mold spores, animal hair, dust mites) in enclosed areas for allergy sufferers (Intended Use) | This is the intended function, but specific performance metrics (e.g., percentage reduction, time to clear a specific volume) for these particles are not provided or quantified in the document. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This 510(k) submission does not describe a clinical study with a test set of data points or patients for evaluating the device's efficacy in reducing airborne particles. The primary "test" was demonstrating compliance with general air cleaner standards and substantial equivalence.
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 / Not provided. There was no "ground truth" to establish in the context of a clinical performance study as described. The determination of compliance with standards would involve testing by recognized certification bodies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No such adjudication method is mentioned as there was no expert review of a test set for clinical performance.
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 / Not provided. This device is an air purifier, not an AI-assisted diagnostic or interpretation system. Therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This device is a physical air purifier, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. For the purposes of this 510(k), the "ground truth" for demonstrating substantial equivalence and compliance would have been defined by the requirements of the predicate device's characteristics and the specified performance standards (UL 867, CSA C22.2 No. 187-M1986). There's no mention of clinical outcomes data for this product in this submission.
8. The sample size for the training set
- Not applicable / Not provided. This product does not involve machine learning or an AI algorithm, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no training set, this is not relevant.
In summary, the 510(k) submission for the Air Purifier 3707 UVC establishes substantial equivalence through comparison to a predicate device and compliance with general product safety and performance standards, rather than through a clinical performance study with specific acceptance criteria for efficacy in reducing airborne particles.
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JUL 1 2 2004
510(k) SUMMARY
Air Purifier 3707 UVC
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of 1 510Kk) Summary.
1 . Submitted By:
Dr. John Yuen John Manufacturing Ltd., 6/F., Yau Lee Center, 45 Hoi Yucn Road, Kwun Tong, Hong Kong China
2. Contact Person:
Dr. Arthur King Ma, JD DBA A GROUP 18780 Amar Road, STE 202-203 Walnut, CA 91789 Fax: 1-626-581-1291 Tel: 1-626-581-1290 Cell: 1-626-786-0075
3. Date Prepared:
October 27, 2003
Date Revised: April 02, 2004 June 2, 2004
4. Proprietary Name:
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Air Purifier 3707 UVC
Common/Usual Name: ડ.
Air Purifier
Classification Name: 6.
§ 880.6500 Medical Ultraviolet Air Purifier. A device designed to remove particles from air, as class II devices, product code FRA, and it is reviewed by General Hospital Devices.
Predicate Device: 7.
AiroCide TiO2 (K023830)
8. Device Description
Air Purifier 3707 UVC device is an adjustable and portable personal system for treating air in a specified area of a room. Air Purifier 3707 UVC device contains an air treatment system, including a housing unit with an air inlet and a treated air outlet, a blower and a filter for removing contaminants from the air flowing along Air Purifier 3707 UVC device contains also an air filtering the flow path. system with an Ultraviolet radiation tube which purified air.
ੇ. Intended Use:
The air purifier 3707 UVC is used to reduce airborne particles, such as: dust, smoke, pollen, mold spores, animal hair, dust mites that may cause allergy in rooms of enclosed areas such as treatment rooms, hospital wards, intensive care hospital wards and residential homes.
10. Performance Standards:
No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug and Cosmetic Act. However, the Air Purifier 3707 UVC complies with the Standard for Electrostatic Air Cleaners, UL 867 and the Canadian Standard for Electrostatic Air Cleaners, CSA C22.2 No. 187-M1986.
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- Substantial Equivalence:
The Air Purifier 3707 UVC is substantial equivalence to AiroCide TiO2 (K023830) in respect to intended use, characteristics and device descriptions.
End of 510(k) Summary
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. In the center of the seal is a stylized symbol that resembles an eagle or bird-like figure with three horizontal lines above it. The seal is black and white and appears to be a logo or emblem.
Public Health Service
JUL 1 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
John Manufacturing Limited C/O Mr. Arthur King Ma A GROUP, Incorporated 18780 Amar Road Suite 202-203 Walnut, California 91789
Re: K033448
Trade/Device Name: Air Purifier 3707 UVC Regulation Number: 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: II Product Code: FRA, FRF Dated: June 29, 2004 Received: June 29, 2004
Dear Mr. King Ma:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. King Ma
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Usc
510(k) Number (if known): K033448 .
Device Name:
Air Purifier 3707 UVC
The air purifier 3707 UVC is used to reduce airborne particles, such as: dust, smoke, The an purifici 9767 OVO boos mites that may cause allergy in rooms or enclosed polien, more spores, animal hen, cass stal wards, intensive care hospital wards and residential homes.
Prescription Use (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K033448
Page 1 of 1
§ 880.6500 Medical ultraviolet air purifier.
(a)
Identification. A medical ultraviolet air purifier is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation.(b)
Classification. Class II (performance standards).