AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD

K972901 · American Biosurgical, Inc. · GEI · Sep 19, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K972901
• Device Name: AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD
• Applicant: American Biosurgical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The American Biosurgical Inc. Bipolar Cables are intended to transfer electrical current from a electrosurgical generator to a coagulating instrument.

Device Story

Bipolar cable transfers electrical current from electrosurgical generator to coagulating instrument; used in surgical settings by clinicians. Device ensures electrical connectivity and insulation between generator and instrument. Benefits patient by enabling controlled electrosurgical coagulation during procedures.

Clinical Evidence

Bench testing only. Testing includes 100% visual inspection, electrical continuity testing, and cable insulation, leakage, and strain relief testing per ANSI/AAMI standards.

Technological Characteristics

Bipolar electrosurgical cable; designed to ANSI/AAMI standards. Features include electrical insulation, strain relief, and electrical continuity. No software or active electronic components.

Indications for Use

Indicated for use as a conduit to transfer electrical current from an electrosurgical generator to a coagulating instrument during surgical procedures. Prescription use only.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Submission Summary (Full Text)

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

Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, with three distinct lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 9 1997

Mr. Michael Socoloff President American Biosurgical, Inc. 6665-B Corners Industrial Court Norcross, Georgia 30092

Re: K972901

Trade Name: American Biosurgical Electrosurgical Bipolar Cable/Cord Regulatory Class: II Product Code: GEI Dated: August 4, 1997 Received: August 6, 1997

Dear Mr. Socoloff:

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 requirements , 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.

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

## Page 2 - Mr. Michael Socoloff

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,

Sincerely yours,

ia 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}------------------------------------------------

972901

## Exhibit A

## INDICATIONS FOR USE

The American Biosurgical Inc. Bipolar Cables are intended to transfer electrical current from a electrosurgical generator to a coagulating instrument.

Compliance: The American Biosurgical Inc. bipolar cables were designed and are manufactured in compliance with ANSI/AAMI Standards.

Testing Procedures: Testing Procedures have been established in the standard operating procedures of the American Biosurgical, Inc. GMP Manual to ensure all products are manufactured to the ANSUAAMI Standards.

Testing Procedures Include:

100% Visual Inspection Electrical Continuity Testing Cable Insulation, Leakage, and Strain Relief Testing

fccellle

of General Restorativ

Prescription Use
(Per 21 CFR 801.109)