The Somnus™ Model 6000 Disposable Tissue Coagulating Electrode is a modification of the Model 3000 Disposable Tri-Needle Coagulating Electrode cleared for commercial distribution under 510(k) #K963884. The Model 6000 device has a maximum of six needles configured in two rows of three needles each. The Model 3000 has a maximum of 3 needles in a single row. 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 6000 and Model 3000 are identical.

AI/ML Overview

The provided text, a 510(k) summary for the Somnus Model 6000 Disposable Tissue Coagulating Electrode, lacks detailed information regarding specific acceptance criteria, study designs, sample sizes for training/test sets, expert qualifications, or adjudication methods typically found in comprehensive performance studies for medical devices.

The primary focus of this document is to establish substantial equivalence to a predicate device (Somnus Model 3000 Disposable Tri-Needle Coagulating Electrode) rather than presenting a standalone clinical performance study with defined acceptance criteria and detailed results.

However, based on the available information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state specific quantitative acceptance criteria or detailed performance metrics like accuracy, sensitivity, or specificity. The "performance validation testing" mentioned is generalized, and its results are summarized as supporting "substantial equivalence."

Acceptance Criteria (Not explicitly stated, inferred from context)	Reported Device Performance
Functional Equivalence: Device performs its intended function (tissue coagulation) reliably.	The device is a modification of a previously cleared device (Model 3000). The description implies functional equivalence for tissue coagulation, with the primary change being the number of needles.
Safety: Device operates safely without posing undue risks.	The 510(k) submission, including "performance validation testing," concludes that the device is "safe and effective in its intended use," leading to an FDA finding of substantial equivalence.
Effectiveness: Device achieves its intended therapeutic effect (tissue coagulation).	The 510(k) submission, including "performance validation testing," concludes that the device is "safe and effective in its intended use," leading to an FDA finding of substantial equivalence.
Technological Characteristics: Similarities to predicate device.	"The Somnus has been carefully compared to legally marketed devices with respect to intended use and technological characteristics." The Model 6000 has a maximum of six needles (two rows of three), compared to the Model 3000's maximum of three needles in a single row. The handle grip configuration is identical.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not specified. The document mentions "performance validation testing" but does not provide details on the number of subjects, cases, or specific tests conducted for this validation.
Data Provenance: Not specified. There is no mention of the country of origin of any data, nor whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No. The document does not describe an MRMC study comparing human readers with and without AI assistance. The device is an electrosurgical tool, not an AI diagnostic or interpretive device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Not applicable as this is not an AI algorithm. The device is a physical electrosurgical electrode and its performance is inherently human-in-the-loop (qualified medical personnel).

7. The Type of Ground Truth Used

Type of Ground Truth: Not specified. For a device like this, ground truth would typically relate to observed physical effects (e.g., successful tissue coagulation, absence of unintended damage) during testing. The document refers generally to "performance validation testing," which would have established this through experimental observation, but specifics are missing.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable/Not specified. As this is a physical medical device (an electrosurgical electrode) and not an AI/machine learning system, the concept of a "training set" in the context of data-driven model development does not apply.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set Establishment: Not applicable. See point 8.

Summary

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K 9 7 0 8 3 9 JAN - 9 1998 510(k) Summary of Safety and Effectiveness Somnus Medical Technologies, Inc.TM Model 6000 Disposable Tissue Coagulating Electrode

Statement of Intended Use:

The Somnus™ Model 6000 Disposable Tissue Coagulating Electrode is intended for use in the coagulation of tissue.

This device 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:

Somnus™ Model 6000 Disposable Proprietary Name: Tissue Coagulating Electrode

Common/Usual Name: Electrosurgical Device Accessory

Classification Name: 878.4400)

Electrosurgical Device (per 21 CFR

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

Description:

Statement of Intended Use:

The Somnus Model 6000 Disposable Tissue Coagulating Electrode is 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 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 U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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: K970837

Trade Name: Somnus Model 6000 Disposable Tissue Coagulating Electrode Regulatory Class: II Product Code: GEI Dated: December 8, 1997 Received: December 9, 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 (OS) 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,

Joseph

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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K970837 510(k) Number (if known):

Device Name:

Somnus™ Model 6000 Disposable Tissue Coagulating Electrode

Indications For Use:

The Somnus Model 6000 Disposable Tissue Coagulating Electrode is intended for the coagulation of tissue.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of Sommus Medical Technologies

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.