(55 days)
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.
The Somnus Model 615 Electrosurgical Generator and Soft Tissue Coagulating Electrodes are intended for use in the coagulation of soft tissue.
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.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets such criteria. The document describes an electrosurgical generator, its intended use, and a comparison to predicate devices, but it does not detail any specific performance metrics, clinical studies, or acceptance criteria.
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510(k) Summary of Safety and Effectiveness Somnus Medical Technologies, Inc.™ Model 615 Electrosurgical Generator and Accessories
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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: 408.773.9121 Fax: 408.773.9137
Contact Person:
Eve A. Conner, Ph.D. Vice President Clinical and Regulatory Affairs Telephone: (408) 524-6263
Date Summary Prepared:
February 11, 1997
Name of the Device:
| Proprietary Name: | Somnus™ Model 615 ElectrosurgicalGenerator and Accessories |
|---|---|
| Common/Usual Name: | Electrosurgical Generator andAccessories |
| Classification Name: | Electrosurgical Device (per 21 CFR878.4400) |
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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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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§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.