MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV

K972064 · Biological Controls, Inc. · FRA · Dec 1, 1997 · General Hospital

Device Facts

• Record ID: K972064
• Device Name: MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV
• Applicant: Biological Controls, Inc.
• Product Code: FRA · General Hospital
• Decision Date: Dec 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6500
• Device Class: Class 2

Indications for Use

The MICROCON air filtration system is used for filtering out airborne particles from air for medical purposes.

Device Story

The MICROCON air filtration system (models 800MUV, 400MUV, EXC-BUV, MAP-800MW, MAP-400MW, EX-BUV) functions as an air purifier designed to remove airborne particles. The device operates by drawing in ambient air, passing it through a filtration system to capture particulates, and exhausting filtered air back into the environment. It is intended for use in medical settings to improve air quality. The device is operated by healthcare staff or facility personnel. By reducing airborne contaminants, the system aims to support infection control and maintain a cleaner environment for patients and staff.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Air filtration system utilizing mechanical filtration principles to remove airborne particles. Device is a standalone unit. No software or complex algorithmic components described.

Indications for Use

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

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 1 1997

Mr. Gary D. Messina ·President Biological Controls Incorporated One Industrial Way West Building E, Unit M 07724 Eatontown, New Jersey

Re : K972064 Microcon 800MUV, Microcon 400MUV, Microcon Trade Name: EXC-BUV Requlatory Class: II Product Code: FRA Dated: September 25, 1997 Received: September 29, 1997

Dear Mr. Messina:

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Messina

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic emroagn 312 or on Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acincine in your tial equivalence of your device to a legally marketed predicate device results in a classification for your markets production overmits 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.fdalgov/cdrh/dsmamain.html".

Sincerely yours,

Timothy Ulatowski

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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a person with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 1 1997

Mr. Gary D. Messina ·President Biological Controls Incorporated One Industrial Way West Building E, Unit M 07724 Eatontown, New Jersey

Re : K972064 Microcon 800MUV, Microcon 400MUV, Microcon Trade Name: EXC-BUV Requlatory Class: II Product Code: FRA Dated: September 25, 1997 Received: September 29, 1997

Dear Mr. Messina:

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Messina

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic emroagn 312 or on Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acincine in your tial equivalence of your device to a legally marketed predicate device results in a classification for your markets production overmits 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.fdalgov/cdrh/dsmamain.html".

Sincerely yours,

Timothy Ulatowski

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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510(k) Number (if krown): K972064

Device Name: MICROCON MAP-800MW Air Purifier; MICROCON MAP-400MW Air Purifier; MICROCON EX-BUV AIr Purifier and MICROCON EXC-BUV AIr Purifier Indications For Usc:

The MICROCON air filtration system is used for filtering out airborne particles from air for medical purposes.

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Concertificance of CDRH, Office of Device Evaluation (ODE) (Division Sign-O Division of Dental, Info and General Hospital D

510(k) Number .

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Formal 1-2-96)