(322 days)
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.
Not Found
This is a 510(k) premarket notification for the Buffalo Filter Virosafe ODR Filter, a smoke evacuation filter. The document indicates that the device has been found substantially equivalent to a predicate device marketed prior to May 28, 1976. This type of regulatory submission primarily focuses on demonstrating equivalence rather than conducting a de novo study to establish acceptance criteria and prove performance through a new clinical trial.
Therefore, the provided text does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment. These aspects are typically found in a de novo submission or a more extensive clinical study report, which are not part of this 510(k) clearance letter.
Based on the provided document, the following information is not available:
- A table of acceptance criteria and the reported device performance: This document does not specify performance acceptance criteria or report specific device performance data. It focuses on regulatory clearance based on substantial equivalence.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance information is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information on expert review or ground truth establishment for a test set is present.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no test set evaluation details are provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a filter, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a filter, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth information is provided as it's not a diagnostic device requiring such validation in this context.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device that would require a training set.
- How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.
The "Indications for Use" section (Page 3) briefly describes the intended function of the device: "for the removal and filtration of the smoke and incidental fluid produced during electrosurgery, laser surgery, or other smoke plume producing devices." However, it does not state specific performance metrics or acceptance criteria related to filtration efficiency, flow rate, or other technical specifications that would typically be associated with such a filter and evaluated in a performance study.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its wings.
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.
{1}------------------------------------------------
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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Also, please note the regulation Compliance at (301) 594-4639. 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
{2}------------------------------------------------
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.
( 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
(Division Sign-Off) Division of Dental, Infection Control, and General Hospit 510(k) Number
§ 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.