ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM

K012549 · Healthway Products, Inc. · FRF · Feb 4, 2002 · General Hospital

Device Facts

• Record ID: K012549
• Device Name: ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM
• Applicant: Healthway Products, Inc.
• Product Code: FRF · General Hospital
• Decision Date: Feb 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5045
• Device Class: Class 2

Indications for Use

A device used to remove particles from the air for medical purposes

Device Story

Advanced Air Cleaner System functions as medical air purification device; removes airborne particles to improve air quality in clinical or medical environments. Device operates by drawing ambient air through filtration system; captures particulate matter; outputs cleaned air. Used in healthcare settings to reduce airborne contaminants; assists in maintaining sanitary environment. Healthcare providers utilize device to mitigate risks associated with airborne particles; benefits patients by reducing exposure to potential allergens or pathogens.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Air cleaner system; mechanical filtration principle. Class II device (Product Code FRF).

Indications for Use

Indicated for use as an air cleaner to remove particles from the air for medical purposes.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 4 2002

Mr. Dick Briggs Healthway Products, Incorporated P.O. Box 2729 Syracuse, New York 13220-2729

Re: K012549

Trade/Device Name: Advanced Air Cleaner System Regulation Number: 880.5045 Regulation Name: Air Cleaner Regulatory Class: II Product Code: FRF Dated: December 13, 2001 Received: December 14, 2001

Dear Mr. Briggs:

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 (1 x2 ), it 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.

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## Page 2 - Mr. Briggs

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone] . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_K012549

Device Name:__ADVANCED AIR CLEANER SYSTEM

Indications For Use:

"A device used to remove particles from the air for medical purposes"

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Olin S. Lin

IDivision Sign-Off) Division of Dental, Infection Control, and General Hospital,Dev F 1 (k) Number _