BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF

K983298 · Buffalo Filter Co., Inc. · FYD · Aug 16, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K983298
• Device Name: BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF
• Applicant: Buffalo Filter Co., Inc.
• Product Code: FYD · General, Plastic Surgery
• Decision Date: Aug 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5070
• Device Class: Class 2

Intended Use

The Indications for Use of the ViroSafe EY Filter and Buffalo Filter® EY Prefilter are for the removal and filtration of the smoke and incidental fluid produced during electrosurgery, 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

Device consists of disposable smoke evacuation filters (ViroSafe EY Filter, EY Prefilter) used during electrosurgery or other smoke-generating procedures. Filters capture smoke plume and incidental fluids; prevents release of surgical smoke into OR environment. Used in open or endoscopic surgery; operated by surgical staff. Protects healthcare personnel from inhalation of surgical smoke and particulate matter. Device is non-patient contacting.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Disposable smoke evacuation filter and prefilter. Mechanical filtration principle. Non-patient contacting. No electronic components, software, or energy source.

Indications for Use

Indicated for removal and filtration of smoke and incidental fluid produced during electrosurgery or other smoke plume-producing procedures. Intended for use in open or endoscopic surgical procedures. 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)

{0}------------------------------------------------

Public Health Service

Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

AUG 16 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re : K983298 Buffalo Filter Virosafe Erbium: Yag-Filter-Trade Name: ade name : - Buffalo Filter EY Prefiter-# BFEY04PF 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 market the device islared indications (for the indications for use stated in the enclosure) to devices marketed in interstate beated in the enay 28, 1976, the enactment date of the Medical commerce problem to hap to, devices that have been reclassified in Device Amendates, or os aions 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 babyout of the genrovisions 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 regulations 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 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. best areas and in and in addition, FDA may publish further 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 regulations.

{1}------------------------------------------------

Page 2 - Mr. Holland

This letter will allow you to begin marketing your device as This letter will arrow you co begin manifosaring . The FDA finding described in your 510\k) premarked hourse to a legally marketed of substantial equivalence of your development of your device and produce and produce predicate device rebaries to proceed to the market. thus, permits your device to processor device on our labeling If you desire specific advice for your additionally 809.10 for inxxitron regulation (21 CFR Farl our and active of Compliance at diagnostic devices), please contact on the promotion and [phone]. "Addressionally, ase contact the Office of advertising of your device, prease ochlasse note the regulation Compliance at [phone]. "Insol premarket notification" (21
entitled, "Misbranding by reference to premarket notification sbranding by reference on your responsibilities CFR 807.97). CFR 807.97). Other general in the Division of Small under the Act may be Obcainca From the ee number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Patricia Cucenbr for

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Page of

510(k) Number: Device Name: Proprietary/Trade Names: K983298 Disposable Smoke Evacuation Filter Buffalo Filter® ViroSafe® EY Filter - #VSEY1-4 Buffalo Filter® EY Prefilter - #BFEY04PF

## Indications for Use:

The Indications for Use of the ViroSafe EY Filter and Buffalo Filter® EY Prefilter are for the removal and filtration of the smoke and incidental fluid produced during electrosurgery, 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.

Clain S. Lohn

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K983298

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

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