HEPAIRX VENTILATING AIR PURIFIER

K112728 · Air Innovations, Inc. · FRF · Jan 23, 2013 · General Hospital

Device Facts

• Record ID: K112728
• Device Name: HEPAIRX VENTILATING AIR PURIFIER
• Applicant: Air Innovations, Inc.
• Product Code: FRF · General Hospital
• Decision Date: Jan 23, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5045
• Device Class: Class 2

Indications for Use

Filtering out airborne particulates from air for medical purposes. HEPAirX 100 is intended for over-the-counter use.

Device Story

HEPAirX 100 is a medical recirculating air cleaner; functions by filtering airborne particulates from the environment for medical purposes. Designed for over-the-counter use; intended to improve air quality by removing particulate matter. Device operates as a standalone unit; provides continuous air filtration. Benefits patient by reducing exposure to airborne contaminants in medical or home environments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Medical recirculating air cleaner; 21 CFR 880.5045; Product Code FRF. Standalone unit; utilizes mechanical filtration to remove airborne particulates.

Indications for Use

Indicated for filtering airborne particulates from air for medical purposes in an over-the-counter setting.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 23, 2013

Mr. Lawrence Wetzel Chairman Air Innovations, Incorporated 7000 Performance Drive NORTH SYRACUSE NY 13212

Re: K112728

Trade/Device Name: HEPAirX 100 Regulation Number: 21 CFR 880.5045 Regulation Name: Medical Recirculating Air Cleaner Regulatory Class: II Product Code: FRF Dated: January 9, 2013 Received: January 15, 2013

## Dear Mr. Wetzel:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucml15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony De min

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section 4.0 of Original Application

## Indications for Use

510(k) Number (if known): KU2728

Device Name: HEPAirX 100

Indications for Use:

Filtering out airborne particulates from air for medical purposes.

HEPAirX 100 is intended for over-the-counter use.

Prescription Use NO (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula A. Murphy @ Arts TMCB. Chf 1/23/2013

Sign-On)
of Anesthesiology, General Hospital on Control, Dental Devices

510(k) Number:

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