(63 days)
The VES 3001-m use is indicated whenever video display from an endoscope is required for more convenient viewing.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "VES 3001-M Complete Video Endoscopic System". This letter primarily addresses the regulatory clearance of the device and does not contain detailed information about acceptance criteria or performance studies as typically requested for AI/ML-driven devices.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment from this document. The document confirms that the device is "substantially equivalent" to predicate devices, but does not provide specific performance metrics or the studies that would demonstrate them.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird with three wing-like shapes above three wave-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 1998
Mr. John D. Plumadore Director of Engineering AngioLaz, Inc. P.O. Box 556 Industrial Park Bellows Falls, Vermont 05101
K982397 Re:
Trade Name: VES 3001-M Complete Video Endoscopic System Regulatory Class: II Product Code: FWF Dated: July 6, 1998 Received: July 9, 1998
Dear Mr. Plumadore:
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 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 regulations.
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Page 2 - Mr. John D. Plumadore
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and 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 CFR 807.97). Other general information on your responsibilities 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,
a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of l
510(K) Number (if known)
The VES 3001-m use is indicated whenever video display from an endoscope is required for more convenient viewing.
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Concurrence of CDRH, Office of Device Evaluation (ODE) -
A. Celesia
Or
(Division Sign-Off)
Division of General Restorative Devices K982397
510(k) Number
Prescription Use Use (Per 21 CFR 801 . 109)
Over-The-Counter
(Optional Format 1-2-96)
§ 878.4160 Surgical camera and accessories.
(a)
Identification. A surgical camera and accessories is a device intended to be used to record operative procedures.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.