(308 days)
No
The document describes a simple tissue coagulation electrode and makes no mention of AI or ML.
Yes.
The device is indicated for "coagulation of tissue," which is a therapeutic intervention.
No
Explanation: The device is indicated for "coagulation of tissue," which is a treatment, not a diagnostic procedure.
No
The device description explicitly states it is a "Disposable Tri-Needle Coagulating Electrode," which is a physical hardware device used for tissue coagulation.
Based on the provided text, 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.
- Device Description: The device is a "Disposable Tri-Needle Coagulating Electrode" used for "performing coagulation on target areas of tissue." This describes a surgical or interventional tool.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Performing tests outside of the body (in vitro)
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device is used to directly treat tissue within the body.
N/A
Intended Use / Indications for 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.
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.
Product codes
GEI
Device 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.
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 electrosurgery.
qualified medical personnel trained in the use of Somnus Tissue Coagulating Electrodes.
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)
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
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.
000024
1
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.
2
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
3
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
4
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.