MIS ELECTROSURGICAL ELECTRODE

K971829 · E-Tek, Inc. · GEI · Jan 28, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K971829
• Device Name: MIS ELECTROSURGICAL ELECTRODE
• Applicant: E-Tek, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MIS Electrosurgical Electrodes when used with an electrosurgical generator are intended to cut and coagulate tissue during minimally invasive surgical procedures.

Device Story

MIS Electrosurgical Electrode; accessory for electrosurgical generators. Used in minimally invasive surgery; operated by surgeons. Device delivers electrical energy to tissue to perform cutting and coagulation. Facilitates surgical procedures by providing precise tissue interaction. No complex software or automated processing involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical electrode; metallic construction; designed for compatibility with standard electrosurgical generators for tissue cutting and coagulation. Form factor specific to minimally invasive surgical access.

Indications for Use

Indicated for use in general surgery for cutting and coagulating tissue during minimally invasive surgical procedures.

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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three wavy lines extending from its head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 1998

Mr. Daniel S. Brown President E-TEK. Incorporated 16 Pennsylvania Street Denver, Colorado 80203-4115

Re: K971829

> Trade Name: MIS Electrosurgical Electrode Regulatory Class: II Product Code: GEI Dated: October 29, 1997 Received: October 31, 1997

Dear Mr. Brown:

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

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Page 2 - Mr. Brown

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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. ळ20/2

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

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11971829 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: MIS Electrosurgical Electrode

Indications For Use:

General surgery.

The MIS Electrosurgical Electrodes when used with an electrosurgical generator are intended to cut and coagulate tissue during minimally invasive surgical procedures.

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Concurrence of CDRH, Office of Device Evaluation

tiosell

(Division Sign-Off)
Division of General Restorative Devices, K971829..
510(k) Number

Prescription Use .... (Per 21 CFR 801.109)

OR

Over-The-Counter-Use .........................................................................................................................................................

(Optional Format 1-2-96)