(34 days)
Erbe ICC 200, Erbe ICC 50, ZoMed VidaMed
Not Found
No
The summary describes a standard electrosurgical generator with controls for power, time, and readouts for basic electrical parameters. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies. The performance studies focus on substantial equivalence to predicate devices, which are also standard electrosurgical units.
Yes
The device is described as an electrosurgical generator intended for the coagulation of soft tissue, which is a medical procedure used to treat patients.
No
The device is an electrosurgical generator intended for the coagulation of soft tissue. While it has readouts for certain parameters like impedance and temperature, its primary function is therapeutic (coagulation), not diagnostic. It does not state that it analyzes data to determine the presence, absence, or characteristics of a disease or condition.
No
The device description explicitly details hardware components such as an electrosurgical generator, controls, readouts, connectors, cables, and a footpedal, indicating it is not a software-only device.
Based on the provided information, the Somnus™ Model 225 Electrosurgical Generator and Accessories is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "coagulation of soft tissue" using electrosurgical energy. This is a therapeutic procedure performed directly on a patient's tissue, not a test performed on a sample taken from the body.
- Device Description: The device is an electrosurgical generator that delivers energy to tissue. This is consistent with a surgical or therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Somnus™ Model 225 is a therapeutic device used for surgical intervention.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
Device Description
The Somnus M 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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
Not Found
Predicate Device(s)
Erbe ICC 200, Erbe ICC 50, ZoMed VidaMed
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
963772
510(k) Summary of Safety and Effectiveness Somnus Medical Technologies, Inc.™ Model 225 Electrosurgical Generator and Accessories
OCT 23 1996
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: 408.773.9121 Fax: 408.773.9137
Contact Person:
Eve A. Conner, Ph.D. Vice President Clinical and Regulatory Affairs Telephone: (408) 524-6263 Digital Pager: 1-800-586-1439
Date Summary Prepared::
September 16, 1996
Name of the Device:
Somnus™ Model 225 Electrosurgical Proprietary Name: Generator and Accessories Electrosurgical Generator and Common/Usual Name: Accessories Electrosurgical Device (per 21 CFR Classification Name: 878.4400)
000051
1
Predicate Devices:
Erbe ICC 200 Erbe ICC 50 ZoMed VidaMed
Description:
The Somnus M 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.