(47 days)
Not Found
No
The document describes a standard electrosurgical generator with controls for power, time, and temperature. There is no mention of AI, ML, image processing, or any data-driven decision-making processes that would indicate the use of these technologies.
Yes
The device is intended for the "coagulation of tissue," which is a medical procedure aimed at treating or addressing a health issue.
No
This device is described as an electrosurgical generator intended for the coagulation of tissue, which is a therapeutic function, not a diagnostic one. It doesn't mention imaging, analysis of physiological signals for diagnosis, or any other typical diagnostic functions.
No
The device description clearly states it is an "Electrosurgical Generator" with physical controls, connectors, and accessories like a power cable and footpedal, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "coagulation of tissue" using electrosurgery. This is a therapeutic procedure performed directly on the patient's tissue.
- Device Description: The device is an "electrosurgical generator" that delivers energy to tissue.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition. The device is used for direct intervention on the patient.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device performs a therapeutic action on the tissue itself.
N/A
Intended Use / Indications for Use
The Somnus™ Model 215 Electrosurgical Generator and Accessories are intended for use with the Somnus Tissue Coagulating Electrodes for the coagulation of tissue. The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
The Somnus Model 215 Electrosurgical Generator, in combination with various Somnus electrodes, is indicated for the coagulation of tissue.
This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
Product codes
GEI
Device Description
The SomnusTM Model 215 Electrosurgical Generator is an electrosurgical generator with controls for power delivered, time of energy delivery and in the automatic mode, maximum temperature. 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 an adapter for a dispersive electrode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tissue
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 (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.)
Not Found
Predicate Device(s)
Erbe ICC 200, Erbe ICC 50, VidaMed 50, VidaMed 7205
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
JUN 2 4 1997 510(k) Summary of Safety and Effectiveness Somnus Medical Technologies, Inc. TM Model 215 Electrosurgical Generator and Accessories
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Intended Use:
The Somnus™ Model 215 Electrosurgical Generator and Accessories are intended for use with the Somnus Tissue Coagulating Electrodes for 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. 285 North Wolfe Road 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) 617-3424
Date Summary Prepared:
May 6, 1997
Name of the Device:
| Proprietary Name: | Somnus ™ Model 215 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 contained herein may not be reproduced, used or disclosed without prior written consent of Somnus Medical Technologies, Inc.
1
Predicate Devices:
Somnus Model 215 Electrosurgical Generator Erbe ICC 200 Erbe ICC 50 VidaMed 50 VidaMed 7205
Description:
The SomnusTM Model 215 Electrosurgical Generator is an electrosurgical generator with controls for power delivered, time of energy delivery and in the automatic mode, maximum temperature. 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 an adapter for a dispersive electrode.
Statement of Intended Use:
The Somnus Model 215 Electrosurgical Generator and Tissue Coagulating Electrodes are intended for use in the coagulation of tissue.
This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
Comparison to Predicate Devices:
The Somnus Model 215 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 contained herein may not be reproduced, used or disclosed without prior written consent of Somnus Medical Technologies, Inc.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures.
JUN 24 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Eve A. Conner, Ph.D. Vice President, Clinical and Regulatory Affairs Somnus Medical Technologies, Inc. ........................................................................................................... 285 N. Wolfe Road Sunnyvale, California 94086
Re: K971711
Trade Name: Somnus™ Model 215 Electrosurgical Generator Regulatory Class: II Product Code: GEI Dated: May 6, 1997 Received: May 8, 1997
Dear Dr. Conner:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that. through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Eva A. Conner, Ph.D.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Alan Watts
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
K971711 Not Yet Assigned
Device Name:
SOMNUS™ MODEL 215 ELECTROSURGICAL GENERATOR AND ACCESSORIES
Indications For Use:
The Somnus Model 215 Electrosurgical Generator, in combination with various Somnus electrodes, is indicated for the coagulation of tissue.
This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
Contraindications for Use:
The use of the Somnus Model 215 Electrosurgical Generator and Accessories is contraindicated when, in the judgment of the physician, electrosurgical procedures would be contrary to the best interests of the patient.
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K971711
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of Somnus Medical Technologies, Inc.
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