AMERICAN BIOSURGICAL ELECTROSURGICAL MONOPOLAR CABLE/CORD

K971540 · American Biosurgical, Inc. · GEI · Aug 14, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971540
• Device Name: AMERICAN BIOSURGICAL ELECTROSURGICAL MONOPOLAR CABLE/CORD
• Applicant: American Biosurgical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To transfer electrical current from generator to a surgical instrument

Device Story

Monopolar cable functions as electrical conduit; connects electrosurgical generator to monopolar surgical instrument. Used in clinical surgical settings by physicians/surgeons. Facilitates delivery of high-frequency electrical current for cutting or coagulation of tissue. Device is passive electrical accessory; no active processing or software components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Passive electrical cable; monopolar configuration; designed for compatibility with standard electrosurgical generators and instruments. No software, sensors, or active electronic components.

Indications for Use

Indicated for use in surgical procedures requiring the transfer of electrical current from an electrosurgical generator to a monopolar surgical instrument.

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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

AUG 1 4 1997

Re: K971540 Trade Name: Monopolar Cable Regulatory Class: II Product Code: GEI Dated: Undated Received: July 29, 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 (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. 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,

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

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| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|-------------------------|
| 510(k) Number (if known): | K971540 |
| Device Name: | Monopolar Cable |
| Indications For Use: | Monopolar Cable: |

to trans der electrical current from
nans

To transfer electrical current from
generator to a surgical instrument

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General Restorative Devices
510(k) Number ***_***_ K971540

Prescription Use V (Per 21 CFR. 801.109)

- ·

OR

Over-The-Counter Use

(Optional Formal 1-2-96)