(308 days)
The Somnus Model 30xx Disposable Tri-Needle Coagulating Electrode is indicated for use in the coagulation of tissue. This device is intended for use by qualified medical personnel trained in the use of Somnus Tissue Coagulating Electrodes.
The Somnus™ Model 30xx Disposable Tri-Needle Coagulating Electrode is a modification of the Model 3000 Disposable Tri-Needle Coagulating Electrode cleared under 510(k) #K963884. Both devices provide a reliable method of performing coagulation on target areas of tissue using a handle grip for ease of placement. The configuration of the handle grip of the Model 30xx is identical to the Model 3000 handle grip.
This 510(k) summary does not contain information on acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on demonstrating substantial equivalence to a predicate device. The document states:
"The Somnus 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."
However, it does not provide details about the specific 'performance validation testing,' including the acceptance criteria, study design, sample sizes, or ground truth establishment.
Therefore, I cannot populate the requested table or answer the specific questions about the study design, sample size, expert qualifications, or comparative effectiveness. The information is not present in the provided text.
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K970838
510(k) Summary of Safety and Effectiveness JAN - 9 1998 Somnus Medical Technologies, Inc.™ Model 30xx Disposable Tri-Needle Coagulating Electrode
statement of Intended Use:
The Somnus™ Model 30xx Disposable Tri-Needle Coagulating Electrode is intended for coagulation of tissues. The Model 30xx Tissue Coagulating Electrode is intended for use by qualified medical personnel trained in the use of electrosurgery.
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:
March 4, 1997
Name of the Device:
Proprietary Name:
Somnus™ Model 30xx Disposable Tri-Needle Coagulating electrode
Common/Usual Name: Electrosurgical Device
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.
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Predicate Devices:
Somnus Model 3000 Disposable Tri-Needle Coagulating Electrode, 510(k) #K963884
Description:
The Somnus™ Model 30xx Disposable Tri-Needle Coagulating Electrode is a modification of the Model 3000 Disposable Tri-Needle Coagulating Electrode cleared under 510(k) #K963884. Both devices provide a reliable method of performing coagulation on target areas of tissue using a handle grip for ease of placement. The configuration of the handle grip of the Model 30xx is identical to the Model 3000 handle grip.
Comparison to Predicate Devices:
The Somnus 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.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its wing and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Eve A. Conner, Ph.D. Vice President, Clinical and Regulatory Affairs Somnus Medical Technologies, Incorporated 285 North Wolfe Road Sunnyvale, California 94086
JAN - 9 1998
Re: K970838
Trade Name: Somnus Model 30XX Disposable Tissue Coagulating Electrode Regulatory Class: II Product Code: GEI Dated: December 1, 1997 Received: December 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 current Good Manufacturing Practice requirements , as set-forth-in-the Quality System-Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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
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Page 2 - Dr. Conner
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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,
Sincerely yours,
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
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510(k) Number (if known):
k 970838 Not Yet Assigned
Device Name: SOMNUS™ MODEL 30XX DISPOSABLE TRI-NEEDLE COAGULATING ELECTRODE
Indications For Use:
The Somnus Model 30xx Disposable Tri-Needle Coagulating Electrode is indicated for use in the coagulation of tissue.
This device is intended for use by qualified medical personnel trained in the use of Somnus Tissue Coagulating Electrodes.
Contraindications for Use:
The use of the Model 30xx Disposable Tri-Needle Coagulating Electrode is contraindicated when, in the judgment of the physician, electrosurgical procedures would be contrary to the best interest of the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | X |
| OR Over-The-Counter Use |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K970838 (Optional Format 1-2-96) |
Proprietary Data: This document and the information contained herein may not be reproduced, 1) () () () () () () () () () () () () () () () () () () () () () () () () () () ( used or disclosed without prior written consent of Somnus Medical Technologies, Inc.
§ 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.