SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615)

K970576 · Somnus Medical Technologies, Inc. · GEI · Apr 9, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970576
• Device Name: SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615)
• Applicant: Somnus Medical Technologies, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Somnus™ Model 615 Electrosurgical Generator and Accessories are intended for use with the Somnus Soft Tissue Coagulating Electrodes for the coagulation of soft tissue. The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Device Story

Electrosurgical generator for soft tissue coagulation; used with Somnus Soft Tissue Coagulating Electrodes. Inputs: temperature (up to 18 thermocouples), impedance. Controls: maximum temperature, power, energy, time. Outputs: total energy delivered, impedance, power, temperature readouts. Operated by trained medical personnel in clinical settings. Footpedal-controlled energy delivery. Provides precise thermal coagulation; aids in surgical hemostasis/tissue management.

Clinical Evidence

Bench testing only; no clinical data presented.

Technological Characteristics

Electrosurgical generator; controls for temperature, power, energy, and time. Interfaces: front panel connectors for electrodes and footpedal. Readouts: total energy, impedance, power, and temperature (up to 18 thermocouples).

Indications for Use

Indicated for coagulation of soft tissue. Intended for use by qualified medical personnel trained in electrosurgery.

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 215
• VidaMed Model 50
• Vidamed Model 7205
• Erbe ICC 50

Submission Summary (Full Text)

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Somnus Medical Technologies, Inc.
APR - 9 1997
510(k) Model 615 Electrosurgical Generator, 2/11/97

# 510(k) Summary of Safety and Effectiveness
Somnus Medical Technologies, Inc.™
Model 615 Electrosurgical Generator and Accessories

K 9705 76

## Intended Use:

The Somnus™ Model 615 Electrosurgical Generator and Accessories are intended for use with the Somnus Soft Tissue Coagulating Electrodes for the coagulation of soft tissue. The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

## 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:

February 11, 1997

## Name of the Device:

Proprietary Name: Somnus™ Model 615 Electrosurgical Generator and Accessories

Common/Usual Name: Electrosurgical Generator and Accessories

Classification Name: Electrosurgical Device (per 21 CFR 878.4400)

Proprietary Data: This document and the information herein may not be reproduced, used or disclosed without prior written consent of Somnus Medical Technologies, Inc.
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{1}

Somnus Medical Technologies, Inc.
510(k) Model 615 Electrosurgical Generator, 2/11/97

## Predicate Devices:

Somnus Model 215
VidaMed Model 50
Vidamed Model 7205
Erbe ICC 50

## Description:

The Somnus™ Model 615 Electrosurgical Generator is an electrosurgical generator has controls for maximum temperature, power delivered, energy delivered and time of energy delivery. The unit has readouts for total energy delivered, impedance, maximum power, temperature for up to 18 thermocouples. Connectors on the front panel include connectors for electrodes and a footpedal.

Accessories included with the generator include a line power cable and a single pedal footpedal.

## Statement of Intended Use:

The Somnus Model 615 Electrosurgical Generator and Soft Tissue Coagulating Electrodes are intended for use in the coagulation of soft tissue.

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

## Comparison to Predicate Devices:

The Somnus Model 615 Electrosurgical Generator and Accessories 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 herein may not be reproduced, used or disclosed without prior written consent of Somnus Medical Technologies, Inc.
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