HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C

K984116 · Abatement Technologies, Inc. · FRF · Jun 24, 1999 · General Hospital

Device Facts

• Record ID: K984116
• Device Name: HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C
• Applicant: Abatement Technologies, Inc.
• Product Code: FRF · General Hospital
• Decision Date: Jun 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5045
• Device Class: Class 2

Indications for Use

The HEPA-CARE/Air filtration systems are used for filtering out airborne particles from the air for medical purposes.

Device Story

HEPA-CARE Air Filtration Systems (Models HC800F/HFS800F, HC800C/HFS800C, HC400C/HFS400C, HC400CW II) function as air cleaners designed to remove airborne particulates. Device operates by drawing ambient air through high-efficiency particulate air (HEPA) filters to reduce airborne contaminants in medical settings. Used by healthcare facility staff to maintain air quality; output is purified air. Benefits include reduction of airborne particles, potentially lowering risk of exposure to contaminants in clinical environments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Air filtration system utilizing HEPA filtration technology. Models include various configurations (HC/HFS series). Standalone unit. No software or electronic algorithm components described.

Indications for Use

Indicated for filtering airborne particles from the air for medical purposes in clinical or healthcare environments.

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

JUN 2 4 1999

Mr. David J. Willyard Vice President of Sales Abatement Technologies®, Incorporated 2220 Northmont Parkway, Suite 100 Duluth, Georgia 30096-5895

Re : K984116 HEPA-CARE Air Cleaner, Models Trade Name: HC800F/HFS800F, HC800C/HFS800C, HC400C/HFS400C, HC400CW II Regulatory Class: Product Code: FRF June 8, 1999 Dated: Received: June 11, 1999

Dear Mr. Willyard:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Speciāl Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Willyard

this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fdag.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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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Page ***_ of _***

510(k) Number (if known): K984116
Device Name: Hepacare @ Air Cleaner/American Air Filter
Air Filtration System
Indications For Use:

HEPA-CARE Air Filtration Systems

Indications for Use: The HEPA-CARE/Air filtration systems are used for filtering out airborne particles from the air for medical purposes.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Qian S. Lin

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)