BUFFALO FILTER VIROSAFE HRF- #VSHRFO1

K983333 · Buffalo Filter Co., Inc. · FYD · Aug 11, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K983333
• Device Name: BUFFALO FILTER VIROSAFE HRF- #VSHRFO1
• Applicant: Buffalo Filter Co., Inc.
• Product Code: FYD · General, Plastic Surgery
• Decision Date: Aug 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5070
• Device Class: Class 2

Intended Use

The Indications for Use of the ViroSafe® ODR Filter is for the removal and filtration of the smoke and incidental fluid produced during electrosurgery, laser surgery, or other smoke plume producing devices. This device is not intended for contact with the patient. It is intended to be used during either open or endoscopic surgical procedures.

Device Story

Disposable smoke evacuation filter; removes smoke and incidental fluid generated during electrosurgery or laser surgery. Used in open or endoscopic surgical procedures. Device captures surgical plume; prevents particulate and fluid release. Operated by surgical staff in clinical settings. Benefits include improved air quality and reduced exposure to surgical smoke for healthcare personnel.

Clinical Evidence

Bench testing only.

Technological Characteristics

Disposable smoke evacuation filter. Designed for filtration of surgical smoke and incidental fluids. Mechanical filtration principle. Non-patient contacting.

Indications for Use

Indicated for removal and filtration of smoke and incidental fluid produced during electrosurgery, laser surgery, or other smoke plume producing procedures. Intended for use in open or endoscopic surgery. Not for patient contact.

Regulatory Classification

Identification

Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.

Special Controls

*Classification.* Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 11 1999

Clinton R. Holland JR. Mr. Chief Technical Officer/Chief Operating Officer Buffalo Filter Company Incorporated 6000 North Bailey Aveune SUITE 9 Buffalo, New York 14226-5102

K983333 Re: Buffalo Filter Virosafe ODR Filter Trade Name: Regulatory Class: II Product Code: FYD Dated: June 08, 1999 Received: June 09, 1999

Dear Mr. Holland:

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 qeneral 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify Failure to comply with the GMP regulation may such assumptions. result in regulatory action. In addition, FDA may publish further
announcements concerning your device in the Federal Register. Please note: this response to your premarket notification 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 requlations.

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Page 2 - Mr. Holland

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 requlation (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 Also, please note the regulation Compliance at [phone]. entitled, "Misbranding by reference to premarket notification" (21 Other general information on your responsibilities CFR 807.97). 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.fda.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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510(k) Number: Device Name: Proprietary/Trade Names:

K983333 Disposable Smoke Evacuation Filter Buffalo Filter® ViroSafe® ODR Filter - #VSORD01

## Indications for Use:

The Indications for Use of the ViroSafe® ODR Filter is for the removal and filtration of the smoke and incidental fluid produced during electrosurgery, laser surgery, or other smoke plume producing devices. This device is not intended for contact with the patient. It is intended to be used during either open or endoscopic surgical procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|----------------------|--|
| (Per 21 CFR 801.109) | |

OR

Over-The-Counter-Use
(Optional Format 1-2-96

(Division Sign-Off) Division of Dental, Infection Control, and General Hospit 510(k) Number