ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER

K033448 · John Mfg., Ltd. · FRA · Jul 12, 2004 · General Hospital

Device Facts

• Record ID: K033448
• Device Name: ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER
• Applicant: John Mfg., Ltd.
• Product Code: FRA · General Hospital
• Decision Date: Jul 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6500
• Device Class: Class 2

Indications for 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.

Device Story

Portable air treatment system for enclosed spaces; utilizes blower to draw air through inlet; air passes through filter and ultraviolet (UVC) radiation tube for purification; treated air exits through outlet. Used in clinical settings (hospital wards, ICUs) and residential homes. Operates as standalone unit. Reduces airborne contaminants to benefit patients with allergies. Healthcare providers or patients operate device to maintain air quality in specific environments.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Portable air purifier; includes housing, blower, filter, and UVC radiation tube. Complies with UL 867 and CSA C22.2 No. 187-M1986 standards for electrostatic air cleaners. Standalone operation.

Indications for Use

Indicated for reduction of airborne particles (dust, smoke, pollen, mold spores, animal hair, dust mites) in enclosed areas including treatment rooms, hospital wards, intensive care units, and residential homes to mitigate allergy triggers.

Regulatory Classification

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.

Predicate Devices

• AiroCide TiO2 (K023830)

Submission Summary (Full Text)

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K033448

# 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: [phone] Tel: [phone] 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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11. 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 [phone]. 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 [phone] or [phone] 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

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