ANGIOLAZ VES-1CAM

K981819 · Angiolaz, Inc. · FWF · Aug 4, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981819
• Device Name: ANGIOLAZ VES-1CAM
• Applicant: Angiolaz, Inc.
• Product Code: FWF · General, Plastic Surgery
• Decision Date: Aug 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4160
• Device Class: Class 1

Intended Use

The VES-1CAM use is indicated when ever there is a need for the use of video in endoscopic procedure.

Device Story

VES-1CAM is a video camera system designed for endoscopic procedures. It captures visual data from an endoscope and transmits it to a display for real-time visualization by a physician. The device assists in clinical decision-making by providing enhanced visualization of internal anatomy during endoscopic interventions. It is intended for use in clinical settings by trained medical professionals.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Video camera system for endoscopic use. Class II device (Product Code: FWF).

Indications for Use

Indicated for use in endoscopic procedures requiring video visualization.

Regulatory Classification

Identification

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

Submission Summary (Full Text)

{0}------------------------------------------------

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 an abstract symbol resembling an eagle or a stylized human profile, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 4 1998

Mr. John D. Plumadore ·Director of Engineering AngioLaz, Inc. P.O. Box 556 Industrial Park Bellows Falls, Vermont 05101

Re: K981819 Angiolaz Ves-1Cam Trade Name: Regulatory Class: II Product Code: FWF Dated: May 20, 1998 Received: May 22, 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 (OS) 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.

{1}------------------------------------------------

## 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,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Page 1 of of

510(K) Number (if known) Device Name : VES-1CAM

Indications For Use:

The VES-1CAM use is indicated when ever there is a need for the use of video in endoscopic procedure.

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

..............................................................................................................................................................................

## Concurrence of CDRH, Office of Device Evaluation (ODE)

(Drysion Sign Off

to to Firster and F . . . . . DIV 510k) Number

Prescription Use
Use
(Per 21 CFR 801.109)

Or

Over-The-Counter

(Optional Format 1-2-96)