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

Device Description

The Somnus™ Tissue Coagulating Electrodes and Reusable Cables provide a reliable means of coagulating soft tissue.

AI/ML Overview

This 510(k) submission (K973701) for the Somnus™ Tissue Coagulating Electrodes and Somnus Reusable Cable generally states that "performance validation testing has been done to validate the performance of the device." However, it does not provide any specific acceptance criteria or detailed study results proving the device meets said criteria. Therefore, most of the requested information cannot be extracted from the provided text.

Here is a breakdown of what can be inferred or determined from the given text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in the provided text	Not specified in the provided text

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for the test set: Not specified.
Data provenance: Not specified (country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not specified. The document indicates "performance validation testing," which suggests lab-based or engineering tests rather than human expert evaluation for ground truth in a clinical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified. Given the nature of the device (electrosurgical accessories), adjudication methods typically associated with image-based diagnoses or clinical outcomes are unlikely to be relevant here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC study: No. The device is a physical electrosurgical cable and electrodes, not an AI-powered diagnostic tool requiring human reader studies.
Effect size of human reader improvement with/without AI: Not applicable, as there is no AI component.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Standalone performance: The concept of "standalone performance" typically applies to AI algorithms. For this physical medical device, performance testing would involve demonstrating that the cable and electrodes transmit electrical energy effectively and safely to coagulate tissue as intended, which would be an "algorithm only" equivalent in the sense that it's the device's inherent function without human interpretive input. However, no details on such testing are provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not specified. For a device like this, ground truth would likely be based on engineering specifications, electrical performance metrics (e.g., impedance, power delivery), and possibly histological assessment of tissue coagulation in preclinical models or animal studies.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would require a "training set." Performance validation for a physical device focuses on its functional characteristics.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary of what is present:

The document primarily focuses on establishing substantial equivalence to predicate devices based on intended use and technological characteristics. It generally states that "performance validation testing has been done to validate the performance of the device," but it does not elaborate on the specific tests, acceptance criteria, methodologies, or results of this testing. The submission is a regulatory filing for a physical electrosurgical device and accessories, not a software or AI-based diagnostic tool, thus many of the requested categories (e.g., MRMC, AI assistance, training/test sets, expert adjudication) are not relevant to this specific device or the information provided.

Summary

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510(k) Model 1110/2110, 9/26/97

JAN 3 0 1998

<97370)

510(k) Summary of Safety and Effectiveness Somnus Medical Technologies, Inc.TM Reusable Cable for use with Somnus Tissue Coagulating Electrodes

Statement of Intended Use:

The Somnus™ Tissue Coagulating Electrodes are intended for coagulation of soft tissue.

Submitted by:

Somnus Medical Technologies, Inc. 285 N. 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) 773-9121

Date Summary Prepared:

September 26, 1997

Name of the Device:

Somnus™ Tissue Coagulating Proprietary Name: Electrodes and Somnus Reusable Cable

Common/ Usual Name: Electrosurgical Device and Accessories

Electrosurgical Device (per 21 CFR Classification Name: 878.4400)

000036

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Predicate Devices:

Somnus Medical Technologies, Inc. Tissue Coagulating Electrodes

Description:

.. : ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

.....

The Somnus™ Tissue Coagulating Electrodes and Reusable Cables provide a reliable means of coagulating soft tissue.

Comparison to Predicate Devices:

The Somnus Tissue Coagulating Electrodes and Reusable Cables have 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 U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 1998

Eve A. Conner, Ph.D. Vice President, Clinical and Regulatory Affairs Somnus Medical Technologies, Incorporated 285 North Wolfe Road Sunnyvale, California 94086

Re: K973701

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.

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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

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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
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(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.

Regulation Number and Section

§ 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.