SOMNUS TISSUE COAGULATING ELECTRODE

K973701 · Somnus Medical Technologies, Inc. · GEI · Jan 30, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K973701
• Device Name: SOMNUS TISSUE COAGULATING ELECTRODE
• Applicant: Somnus Medical Technologies, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Somnus Model RC-1 and RC-2 Reusable Cables are intended to provide an electrical connection between the Somnus Medical Technologies Model 1100, 1110 and 2110 Tissue Coagulating Electrodes and the Somnus Medical Technologies Electrosurgical (RF) Generators

Device Story

The Somnus Models RC-1 and RC-2 are reusable cables designed to establish an electrical connection between Somnus tissue coagulating electrodes (Models 1100, 1110, 2110) and Somnus electrosurgical (RF) generators. The cables facilitate the delivery of radiofrequency energy from the generator to the electrode, enabling the coagulation of soft tissue. These devices are intended for use in a clinical setting by healthcare professionals. The cables serve as a passive conduit for electrical current, ensuring reliable energy transfer during electrosurgical procedures. By maintaining the integrity of the electrical path, the cables allow the surgeon to perform tissue coagulation effectively, aiding in hemostasis or tissue management during surgical interventions.

Clinical Evidence

No clinical data. Performance validation testing was conducted to demonstrate safety and effectiveness.

Technological Characteristics

Reusable electrical cables designed for connection between electrosurgical electrodes and RF generators. The device functions as a passive electrical interface. No software or complex electronic components described.

Indications for Use

Indicated for use as an electrical interface between Somnus tissue coagulating electrodes and compatible electrosurgical RF generators for soft tissue coagulation.

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 Medical Technologies, Inc. Tissue Coagulating Electrodes

Submission Summary (Full Text)

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510(k) Model 1110/2110, 9/26/97

# JAN 3 0 1998

<97370)

# 510(k) Summary of Safety and Effectiveness Somnus Medical Technologies, Inc.TM Reusable Cable for use with Somnus Tissue Coagulating Electrodes

# Statement of Intended Use:

The Somnus™ Tissue Coagulating Electrodes are intended for coagulation of soft tissue.

#### Submitted by:

Somnus Medical Technologies, Inc. 285 N. Wolfe Road 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:

September 26, 1997

Name of the Device:

Somnus™ Tissue Coagulating Proprietary Name: Electrodes and Somnus Reusable Cable

Common/ Usual Name: Electrosurgical Device and Accessories

Electrosurgical Device (per 21 CFR Classification Name: 878.4400)

000036

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## Predicate Devices:

Somnus Medical Technologies, Inc. Tissue Coagulating Electrodes

#### Description:

.. : ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

.....

The Somnus™ Tissue Coagulating Electrodes and Reusable Cables provide a reliable means of coagulating soft tissue.

#### Comparison to Predicate Devices:

The Somnus Tissue Coagulating Electrodes and Reusable Cables have 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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 1998

JAN 3 0 1998

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

Re: K973701

> Trade Name: Models RC-1 and RC-2 Reusable Cables Regulatory Class: II Product Code: GEI Dated: November 21, 1997 Received: January 9: 1998

Dear Dr. Conner:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 rand we mannel w prohibitions against misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions 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 - Dr. Conner

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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,

C. S. M. Witte, Ph.D., M.D.

Cella 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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## 510(k) Number (if known): K973701

Device Name:

Models RC-1 and RC-2 Reusable Cables

#### Indications For Use:

The Somnus Model RC-1 and RC-2 Reusable Cables are intended to provide an electrical connection between the Somnus Medical Technologies Model 1100, 1110 and 2110 Tissue Coagulating Electrodes and the Somnus Medical Technologies Electrosurgical (RF) Generators

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | X OR Over-The-Counter Use |
|------------------------------------------|---------------------------|
|------------------------------------------|---------------------------|

(Optional Format 1-2-96)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K973701 |

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.