(321 days)
The Indications for Use of the ViroSafe® 18 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.
Disposable Smoke Evacuation Filter
This document is a 510(k) clearance letter from the FDA for a medical device called the "Buffalo Filter ViroSafe 18 Filter." It is a regulatory approval document and does not contain information about the acceptance criteria or a study proving the device meets those criteria, nor any of the other requested details regarding a study.
Therefore, I cannot provide the requested information based on the input text. The document confirms that the device is "substantially equivalent" to previously marketed devices, which is a regulatory determination, not a performance study outcome as typically described in scientific literature or a clinical trial report.
To answer your request, I would need a document that describes the design and results of a performance study for the Buffalo Filter ViroSafe 18 Filter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 11 1999
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
K983364 Re : Buffalo Filter Virosafe 18 Filter-Cataloq #VS01801 Trade Name: Requlatory 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, Druq, 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, 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 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 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. 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 Additionally, for questions on the promotion and (301) 594-4692. advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation 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 (800) 638-2041 or (301) 443-6597 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: K983364 Disposable Smoke Evacuation Filter Buffalo Filter® ViroSafe® 18 Filter - #VS01801
Indications for Use:
The Indications for Use of the ViroSafe® 18 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 $\frac{\text{E}}{\text{}}$ OR
(Per 21 CFR 801.109)
Over-The-Counter-Use X (Optional Format 1-2-96
(Division Sign-Off) Division of Dental, Infection Control and General Hospital Devi 510(k) Number JLT
§ 878.5070 Air-handling apparatus for a surgical operating room.
(a)
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.(b)
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.