(42 days)
The VES 1501-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 1501-M Video Endoscopic System." This document grants market clearance based on substantial equivalence to a predicate device, rather than providing details of new clinical efficacy or performance studies with acceptance criteria for the new device itself.
Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria. Specifically, the following information is not available in the provided text:
- A table of acceptance criteria and the reported device performance: The letter states the device is substantially equivalent to a predicate, not that it met specific performance criteria from a new study.
- Sample size used for the test set and the data provenance: No new test set data is discussed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new test set is described.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. The letter does not mention such a study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a video endoscopic system, not an AI algorithm.
- The type of ground truth used: Not applicable as no new study data is presented.
- The sample size for the training set: Not applicable as this is not an AI/algorithm-based device and no new training data is mentioned.
- How the ground truth for the training set was established: Not applicable.
The FDA 510(k) process for this type of device relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often by comparing technical characteristics and intended use. It does not typically involve the presentation of new efficacy studies with defined acceptance criteria in the same way a Premarket Approval (PMA) application might.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 21 1998
Mr. John D. Plumadore Director of Engineering AngioLaz, Inc. P.O. Box 556 Industrial Park Bellows Falls, Vermont 05101
Re: K982409 Trade Name: VES 1501-M Video Endoscopic System Regulatory Class: II Product Code: FWF Dated: July 6, 1998 Received: July 10, 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 (QS) 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,
Russell Ryan
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(K) Number (if known) Device Name VES 1501-m Complete Video Endoscopic System
The VES 1501-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) -
Nussell Rogers Jr.
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982409
Prescription Use
Use
(Per 21 CFR 801.109)
or
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.