VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM

K982397 · Angiolaz, Inc. · FWF · Sep 10, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982397
• Device Name: VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM
• Applicant: Angiolaz, Inc.
• Product Code: FWF · General, Plastic Surgery
• Decision Date: Sep 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4160
• Device Class: Class 1

Intended Use

The VES 3001-m use is indicated whenever video display from an endoscope is required for more convenient viewing.

Device Story

VES 3001-M Complete Video Endoscopic System; provides video display for endoscopic procedures. Device accepts video signals from endoscopes; processes and displays images on a monitor for clinician viewing. Used in clinical environments to facilitate visualization during endoscopic examinations. System improves convenience of viewing for the physician; aids in clinical decision-making by providing clear visual feedback during procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Video endoscopic system; includes video display components. Technical specifications and materials not detailed in provided documentation.

Indications for Use

Indicated for use whenever video display from an endoscope is required for more convenient viewing in clinical settings.

Regulatory Classification

Identification

A surgical camera and accessories is a device intended to be used to record operative procedures.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)