ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P

K052732 · Abracair, Inc. · FRA · Feb 24, 2006 · General Hospital

Device Facts

• Record ID: K052732
• Device Name: ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P
• Applicant: Abracair, Inc.
• Product Code: FRA · General Hospital
• Decision Date: Feb 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6500
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The ABRACAIR Air Cleaner is used to reduce the concentration of viable airborne bacteria, mold and spores within inhabitated spaces. The use of this device is not intended to treat a speicfic disease or medical condition. It should be used as part of a comprehensive air quality program.

Device Story

ABRACAIR Air Cleaner (models QTZ300-60, QTZ100-24) functions as medical ultraviolet air purifier; utilizes internal fan to draw ambient air through input filter into baffled chamber; air irradiated by 6-inch xenon flash lamp doped with titanium; device reduces concentration of viable airborne bacteria, mold, and spores in occupied medical spaces; intended for use in hospitals, nursing homes, and clinical environments; provides air quality maintenance; does not treat specific diseases.

Clinical Evidence

Bench testing only. Research Triangle Institute testing demonstrated reduction of aerosolized bacteria and fungi. Device tested to Underwriter Label safety standards and eligible for CSA Mark.

Technological Characteristics

Medical ultraviolet air purifier; utilizes 6-inch xenon flash lamp doped with titanium within reflecting chamber; internal fan-driven airflow (300 CFM or 100 CFM); baffled chamber design; electrical safety per Underwriter Label/CSA standards.

Indications for Use

Indicated for reduction of aerosolized mold and bacteria in hospitals, nursing homes, and medical facilities, including neonatal nurseries, hospital rooms, operating rooms, mortuaries, and embalming rooms.

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)
• Air Purifier 3707 UVC (K033448)

Submission Summary (Full Text)

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KD52732

# FEB 2 4 2016

### 510(k) SUMMARY

## ABRACAIR Air Cleaner, QTZ300-60 and QTZ100-24

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 one 510(k) Summery

#### 1. Submitted By:

: .. '

Dr. David Changaris, MD Synlabs. Inc. 204 N. 17th Street Louisville, Kentucky 40203-1212 U.S.A.

#### 2. Contact Person:

Dr. David Changaris 801 Barret Avenue Louisville, Kentucky 40204 Tel: [phone] Fax: [phone] Cell: 1-502-445-9471

#### 3. Date Prepared:

August 16, 2005

#### 4. Proprietary Name:

ABRACAIR Air Cleaner, QTZ300-60 ABRACAIR Air Cleaner, TI 100-30P

### 5. Common/Usual Name:

Air Purifier

#### 6. Classification Name:

\$ 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.

#### 7. Predicate Device:

AiroCide TiO2 (K023830) Air Purifier 3707 UVC (K033448)

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K052732

#### 8. Device Description:

ABRACAIR Air Cleaner, QTZ300-60 and QTZ100-24 are devices that use a 6inch xenon flash lamp, doped with titanium within a reflecting chamber to irradiate air as the air passes through a baffled chamber. An internal fan draws air through a input filter at approximately 300 cubic feet per minute (CFM) or 100 CFM determined by model number.

#### 9. Intended Use:

The ABRACAIR Air Cleaner is used to reduce the concentration of viable airborne bacteria, mold and spores within inhabitated spaces. The use of this device is not intended to treat a speicfic disease or medical condition. It should be used as part of a comprehensive air quality program.

#### 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 ABRACAIR Air Cleaner was tested by the Research Triangle Institute which showed ABRACAIR reduces aerosolized bacteria and fungi. The device has been tested to Underwriter Label safety standards and is eligible to bear the Canadian Standards Association (CSA) Mark with the C-US Indicator.

#### 11. Substantial Equivalence:

The ABRACAIR Air Cleaner, QTZ300-60 and QTZ100-24 are substantial equivalence to AiroCide TiO2 (K023830) and Air Purifier 3707, UVC (K033448) in respect to intended use, characteristics and device descriptions.

End of 510(k) Summary

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David Changaris Chief Executive Officer Abracair, Incorporated 801 Barret Avenue Louisville, Kentucky 40204

Re: K052732

Trade/Device Name: Abracair models QTZ300-60 and QTZ100-24 Regulation Number: 880.6500 Regulation Name: Medical ultraviolet air purifier Regulatory Class: II Product Code: FRA Dated: December 12, 2005 Received: February 7, 2006

FEB 2 4 2006

Dear Mr. Changaris:

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. David Changaris

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/industry/support/index.html.

Sincerely yours,

Clu L

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 Use

510(k) Number (if known): K052732

Device Name: Abracair models QTZ300-60 and QTZ100-24

Indications For Use: The Abracair Air Cleaner is intended for the reduction of aerosolized mold and bacteria within hospitals, nursing homes, medical facilities. The device may be used in occupied spaces within hospital environments such as baby an/or neonatal nurseries, hospital rooms, operating rooms, mortuaries, embalming rooms.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shali 17. M. Mighyly, MD 2/24/06

logy General Hospital
and Dental Services
/052732

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