SOMNUS MODEL 225 ELECTRO SURGICAL GENERATOR (MODEL 225)

K963772 · Somnus Medical Technologies, Inc. · GEI · Oct 23, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K963772
• Device Name: SOMNUS MODEL 225 ELECTRO SURGICAL GENERATOR (MODEL 225)
• Applicant: Somnus Medical Technologies, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Somnus™ Model 225 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

RF electrosurgical generator; delivers energy to soft tissue via Somnus Soft Tissue Coagulating Electrodes. Inputs: user-defined power and time settings; thermocouple temperature data; impedance monitoring. Outputs: total energy delivered; impedance; active channel count; temperature readouts. Used in clinical settings by trained medical personnel. System includes generator, footpedal, electrode cables, and dispersive electrode. Provides controlled thermal coagulation of soft tissue; assists clinicians in achieving hemostasis or tissue reduction.

Clinical Evidence

Bench testing only; performance validation testing conducted to demonstrate safety and effectiveness.

Technological Characteristics

Electrosurgical generator; RF energy source. Features controls for power and time; monitoring for impedance, energy, and up to 6 thermocouples. Includes footpedal, electrode cables, and dispersive electrode. 21 CFR 878.4400 classification.

Indications for Use

Indicated for coagulation of soft tissue in patients requiring electrosurgical intervention; 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

• Erbe ICC 200
• Erbe ICC 50
• ZoMed
• VidaMed

Submission Summary (Full Text)

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Somnus Medical Technologies, Inc.
510(k) RF Generator, 09/17/96
k963772
OCT 23 1996

# 510(k) Summary of Safety and Effectiveness
## Somnus Medical Technologies, Inc.™
### Model 225 Electrosurgical Generator and Accessories

## Intended Use:
The Somnus™ Model 225 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]
Digital Pager: 1-800-586-1439

## Date Summary Prepared:
September 16, 1996

## Name of the Device:
Proprietary Name: Somnus™ Model 225 Electrosurgical Generator and Accessories
Common/Usual Name: Electrosurgical Generator and Accessories
Classification Name: Electrosurgical Device (per 21 CFR 878.4400)

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Somnus Medical Technologies, Inc.
510(k) RF Generator, 09/17/96

## Predicate Devices:

Erbe ICC 200
Erbe ICC 50
ZoMed
VidaMed

## Description:

The Somnus™ Model 225 Electrosurgical Generator is an electrosurgical generator has controls for power delivered and time of energy delivery. The unit has readouts for total energy delivered, impedance, number of active channels and temperature for up to 6 thermocouples. Connectors on the front panel include connectors for electrodes and a footpedal.

Accessories included with the generator include a line power cable, single pedal footpedal, cables to connect the electrodes to the generator and a dispersive electrode.

## Statement of Intended Use:

The Somnus Model 225 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 225 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.

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