(81 days)
Not Found
None
No
The summary describes a standard electrosurgical device for tissue coagulation and makes no mention of AI, ML, image processing, or any related concepts.
Yes.
The device is intended for the "coagulation of tissue," which is a medical treatment and therefore therapeutic.
No
The device is described as a "Disposable Tri-Needle Coagulating Electrode" intended for "coagulation of tissue," which is a treatment function, not a diagnostic one.
No
The device description explicitly states it is an "electrosurgical device" and a "Disposable Tri-Needle Coagulating Electrode," indicating it is a hardware device with physical components for tissue coagulation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "coagulation of tissue." This is a therapeutic procedure performed directly on the patient's body, not a diagnostic test performed on a sample taken from the body.
- Device Description: It is described as an "electrosurgical device," which is consistent with a therapeutic device used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue samples), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to directly treat tissue through coagulation.
N/A
Intended Use / Indications for Use
The Somnus™ Model 3000 Disposable Tri-Needle Coagulating Electrode is intended for use in the coagulation of 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 Model 3000 Disposable Tri-Needle Coagulating Electrode is an electrosurgical device.
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
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.
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
510(k) Summary of Safety and Effectiveness Somnus Medical Technologies, Inc.™ Model 3000 Disposable Tri-Needle Coagulating Electrode 11-28-96
DEC 1 6 1996
Intended Use:
The Somnus™ Model 3000 Disposable Tri-Needle Coagulating Electrode is intended for use in the coagulation of 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 Tel: 408-524-6263 Facsimile: 408-524-6264
Name of Device:
Proprietary Name:
Common/Usual Name: Classification Name:
Somnus Model 3000 Tri-Needle Coagulating Electrode Electrosurgical Electrosurgical Device (per 21CFR 878.4400)
Description:
The Somnus Model 3000 Disposable Tri-Needle Coagulating Electrode is an electrosurgical device.
1
Comparison to Predicate Devices:
The Somnus Model 3000 Disposable Tri-Needle Coagulating Electrode 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.