(329 days)
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Not Found
No
The summary describes a disposable smoke evacuation filter and does not mention any AI or ML capabilities.
No
The device is described as a "Disposable Smoke Evacuation Filter" used for "removal and filtration of the smoke and incidental fluid produced during electrosurgery." It is not intended for patient contact or for treating a medical condition.
No
Explanation: The device is a filter for smoke evacuation during surgical procedures. Its purpose is to remove and filter smoke and fluid, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is a "Disposable Smoke Evacuation Filter," which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal and filtration of smoke and fluid produced during surgical procedures. This is a physical process performed during a medical procedure, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: It's described as a "Disposable Smoke Evacuation Filter," which aligns with its intended use in filtering surgical smoke.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, the ViroSafe EY Filter and Buffalo Filter® EY Prefilter are medical devices used in a surgical setting for air filtration, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
FYD
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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 (301) 594-4692. "Addressionally, ase contact the Office of advertising of your device, prease ochlasse note the regulation Compliance at (301) 394-4659. "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 (800) 638-2041 or (301) 443-6597 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