(322 days)
Not Found
No
The summary describes a physical filter for surgical smoke and does not mention any software, algorithms, or AI/ML terms.
No
The device is described as a filter for surgical smoke and incidental fluid, and it is explicitly stated that it is not intended for contact with the patient. It acts on the environment of the surgical procedure rather than directly treating a patient's medical condition.
No
The device is described as a filter for surgical smoke and fluid, with no indication of diagnosing conditions.
No
The 510(k) summary describes a physical filter device ("ViroSafe® ODR Filter") intended for removing smoke and fluid during surgical procedures. It does not mention any software 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.
- No mention of biological samples: IVDs are designed to test biological samples (blood, urine, tissue, etc.) to provide information about a person's health. There is no indication that this device interacts with or analyzes any biological samples.
- No diagnostic purpose: The device's function is to manage surgical byproducts, not to diagnose a disease or condition.
Therefore, the ViroSafe® ODR Filter, as described, falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
FYD
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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.
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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 (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
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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