(55 days)
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No
The description focuses on standard electrosurgical generator controls and readouts, with no mention of AI or ML capabilities.
Yes
The device is described as an electrosurgical generator intended for the coagulation of soft tissue, which is a medical intervention aimed at treating or managing a condition, thus making it a therapeutic device.
No
The device is an electrosurgical generator intended for the coagulation of soft tissue, which is a therapeutic function, not a diagnostic one. While it has readouts for various parameters, these appear to be for monitoring and controlling the therapeutic energy delivery, rather than for diagnosing a condition.
No
The device description explicitly mentions a physical electrosurgical generator with controls, readouts, and connectors for electrodes and a footpedal, as well as physical accessories like a power cable and footpedal. This indicates a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "coagulation of soft tissue." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is an "electrosurgical generator" used with "electrodes" to deliver energy for coagulation. This is a surgical tool.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The Somnus™ Model 615 Electrosurgical Generator is a therapeutic medical device used for surgical procedures, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
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Device 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
soft tissue
Indicated Patient Age Range
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Intended User / Care Setting
qualified medical personnel trained in the use of electrosurgical equipment.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Somnus Model 215, VidaMed Model 50, Vidamed Model 7205, Erbe ICC 50
Reference Device(s):
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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510(k) Summary of Safety and Effectiveness Somnus Medical Technologies, Inc.™ Model 615 Electrosurgical Generator and Accessories
9705
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 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.
000070
1
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.