(123 days)
GEI
Not Found
No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the basic function of tissue coagulation using electrodes and cables.
No
The device is intended for coagulation of soft tissue, which is a surgical procedure rather than a therapeutic treatment for a disease or condition.
No
The device is described as "intended for coagulation of soft tissue," which is a treatment function, not a diagnostic one. There is no mention of it identifying, analyzing, or interpreting any medical conditions.
No
The device description explicitly mentions "Tissue Coagulating Electrodes" and "Reusable Cables," which are hardware components. The intended use also describes a physical action on tissue.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "coagulation of soft tissue" and providing an "electrical connection" for this purpose. This describes a therapeutic or surgical intervention performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The description reinforces the function of "coagulating soft tissue," which is an in-vivo procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on a surgical procedure performed directly on the patient.
N/A
Intended Use / Indications for Use
The Somnus Tissue Coagulating Electrodes are intended for coagulation of soft tissue.
The Somnus Model RC-1 and RC-2 Reusable Cables are intended to provide an electrical connection between the Somnus Medical Technologies Model 1100, 1110 and 2110 Tissue Coagulating Electrodes and the Somnus Medical Technologies Electrosurgical (RF) Generators
Product codes
GEI
Device Description
The Somnus™ Tissue Coagulating Electrodes and Reusable Cables provide a reliable means of coagulating soft tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Somnus Medical Technologies, Inc. Tissue Coagulating Electrodes
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) Model 1110/2110, 9/26/97
JAN 3 0 1998
Trade Name: Models RC-1 and RC-2 Reusable Cables Regulatory Class: II Product Code: GEI Dated: November 21, 1997 Received: January 9: 1998
Dear Dr. Conner:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 rand we mannel w prohibitions against misbranding and adulteration.
If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions 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 - Dr. Conner
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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,
C. S. M. Witte, Ph.D., M.D.
Cella 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): K973701
Device Name:
Models RC-1 and RC-2 Reusable Cables
Indications For Use:
The Somnus Model RC-1 and RC-2 Reusable Cables are intended to provide an electrical connection between the Somnus Medical Technologies Model 1100, 1110 and 2110 Tissue Coagulating Electrodes and the Somnus Medical Technologies Electrosurgical (RF) Generators
(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 |
|---|---|
| ------------------------------------------ | --------------------------- |
(Optional Format 1-2-96)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K973701 |
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.