SOMNUS MODEL 6000 DISPOSABLE TISSUE COAGULATING ELECTRODE

K970837 · Somnus Medical Technologies, Inc. · GEI · Jan 9, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K970837
• Device Name: SOMNUS MODEL 6000 DISPOSABLE TISSUE COAGULATING ELECTRODE
• Applicant: Somnus Medical Technologies, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Somnus Model 6000 Disposable Tissue Coagulating Electrode is intended for the coagulation of tissue. This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

Device Story

Disposable electrosurgical accessory; used for tissue coagulation. Device features handle grip and needle array; Model 6000 utilizes six needles in two rows of three; modification of Model 3000 (three needles in single row). Operated by qualified medical personnel in clinical settings. Device delivers electrosurgical energy to target tissue via needle electrodes to achieve coagulation. Benefits include reliable tissue coagulation method with ergonomic handle for ease of placement.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Disposable electrosurgical electrode; six-needle array configuration; handle grip; electrosurgical energy source. No specific material standards or software components described.

Indications for Use

Indicated for the coagulation of tissue in patients requiring electrosurgical procedures. Intended for use by qualified medical personnel.

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.

Predicate Devices

• Somnus Model 3000 Disposable Tri-Needle Coagulating Electrode (K963884)

Submission Summary (Full Text)

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Somnus Medical Technologies, Inc.
510(k) Model 6000 Tissue Coagulating Electrode, 3/4/97

# K 970837 JAN -9 1998

510(k) Summary of Safety and Effectiveness
Somnus Medical Technologies, Inc.™
Model 6000 Disposable Tissue Coagulating Electrode

## Statement of Intended Use:

The Somnus™ Model 6000 Disposable Tissue Coagulating Electrode is intended for use in the coagulation of tissue.

This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

## Submitted by:

Somnus Medical Technologies, Inc.
995 Benecia Avenue
Sunnyvale, CA 94086
Tel: [phone]
Fax: [phone]

## Contact Person:

Eve A. Conner, Ph.D.
Vice President
Clinical and Regulatory Affairs
Telephone: [phone]

## Date Summary Prepared:

March 4, 1997

## Name of the Device:

Proprietary Name: Somnus™ Model 6000 Disposable Tissue Coagulating Electrode

Common/Usual Name: Electrosurgical Device Accessory

Classification Name: Electrosurgical Device (per 21 CFR 878.4400)

Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of Somnus Medical Technologies, Inc.
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Somnus Medical Technologies, Inc.
510(k) Model 6000 Tissue Coagulating Electrode, 3/4/97

## Predicate Devices:

Somnus Model 3000 Disposable Tri-Needle Coagulating Electrode

## Description:

The Somnus™ Model 6000 Disposable Tissue Coagulating Electrode is a modification of the Model 3000 Disposable Tri-Needle Coagulating Electrode cleared for commercial distribution under 510(k) #K963884. The Model 6000 device has a maximum of six needles configured in two rows of three needles each. The Model 3000 has a maximum of 3 needles in a single row. Both devices provide a reliable method of performing coagulation on target areas of tissue using a handle grip for ease of placement. The configuration of the handle grip of the Model 6000 and Model 3000 are identical.

## Statement of Intended Use:

The Somnus Model 6000 Disposable Tissue Coagulating Electrode is intended for use in the coagulation of tissue.

This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

## Comparison to Predicate Devices:

The Somnus has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addition, performance validation testing has been done to validate the performance of the device. The comparison and validation results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and is safe and effective in its intended use.

Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of Somnus Medical Technologies, Inc.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Eve A. Conner, Ph.D.
Vice President Clinical and Regulatory Affairs
Somnus Medical Technologies, Incorporated
285 North Wolfe Road
Sunnyvale, California 94086

JAN - 9 1998

Re: K970837
Trade Name: Somnus Model 6000 Disposable Tissue Coagulating Electrode
Regulatory Class: II
Product Code: GEI
Dated: December 8, 1997
Received: December 9, 1997

Dear Dr. Conner:

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 - Dr. Conner

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,


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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Somnus Medical Technologies, Inc.
510(k) #K970837, December 8, 1997

510(k) Number (if known): K970837

Device Name: Somnus™ Model 6000 Disposable Tissue Coagulating Electrode

Indications For Use:

The Somnus Model 6000 Disposable Tissue Coagulating Electrode is intended for the coagulation of tissue.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ OR Over-The-Counter Use ☐
(Per 21 CFR 801.109)


(Optional Format 1-2-96)

Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of Somnus Medical Technologies
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