The Somnoplasty System is intended for tissue coagulation (thermal ablation) in the inferior turbinates to treat the symptoms of nasal obstruction due to chronic turbinate hypertrophy. The System is intended for use only by qualified medical personnel, trained in the use of radio frequency tissue ablation.

Device Description

The SomnoplastyTM System is comprised of an Electrosurgical (RF) Generator and Tissue Coagulating Electrodes. The RF Generator has controls for target temperature, power delivered and time of energy delivery. The unit has readouts for total energy.delivered, impedance, number of active channels and temperature for up to 3 thermocouples per channel. Connectors on the front panel include connectors for coagulating and dispersive electrodes and a footpedal. The electrodes are provided with various handpiece configurations to facilitate the placement of the needles in the tissue to be ablated. Accessories included with the generator include a line power cable, single pedal footpedal and an adapter plug to accommodate dispersive electrodes from various manufacturers.

AI/ML Overview

The provided text is a 510(k) summary for the SomnoplastyTM System and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting detailed results from a clinical study directly within this document. Therefore, much of the requested information regarding specific acceptance criteria and detailed study results is not present.

However, based on the text, here's what can be inferred and what information is not available:

Acceptance Criteria and Device Performance (Not explicitly stated or defined in this document for the clinical study):

The document states: "Performance validation testing, including a clinical study, has been done to validate the performance of the device." However, it does not specify quantifiable acceptance criteria or reported device performance metrics from this clinical study.

Study Information:

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in this document.
- Data Provenance: Not specified (e.g., country of origin). The document mentions a "clinical study" but does not indicate if it was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The clinical study is mentioned in a general sense, but details about its methodology, including ground truth establishment and expert involvement, are not provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
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 versus without AI assistance:
- No. The SomnoplastyTM System is an electrosurgical device for tissue coagulation, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study with AI assistance is not applicable and not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is an electrosurgical device that requires direct human operation. The concept of a "standalone algorithm" is not applicable. The device's performance inherently involves human operators ("intended for use only by qualified medical personnel, trained in the use of radio frequency tissue ablation").
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. The clinical study's endpoint or how "performance" was validated is not detailed. Given the intended use (treating symptoms of nasal obstruction due to chronic turbinate hypertrophy), it's likely related to patient outcomes or symptom relief, but this is not explicitly stated.
The sample size for the training set:
- This is an electrosurgical device, not an AI or machine learning model that typically involves "training sets" in the conventional sense. The "training" referred to in the document is for the medical personnel using the device.
How the ground truth for the training set was established:
- As above, the concept of a "training set" for ground truth establishment is not applicable to this type of device.

Summary

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510(k) Summary of Safety and Effectiveness Somnus Medical Technologies, Inc. TM SomnoplastyTM System

DEC 19 1997

K973618

Intended Use:

Submitted by:

Somnus Medical Technologies, Inc. 285 North 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:

December 18, 1997

Name of the Device:

Somnus™ Medical Technologies, Inc. Proprietary Name: SomnoplastyTM System Common/Usual Name: Electrosurgical Generator and Accessories 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 215 Electrosurgical Generator Somnus Model S2 Electrosurgical Generator Somnus Tissue Coagulating Electrode Models 1000, 1100

Description:

Accessories included with the generator include a line power cable, single pedal footpedal and an adapter plug to accommodate dispersive electrodes from various manufacturers.

Statement of Intended Use:

The Somnoplasty™ System is intended for use in the coagulation of soft tissue in the inferior turbinates for the treatment of chronic hypertrophic rhinitis.

This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

Comparison to Predicate Devices:

The SomnoplastyTM System has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. Performance validation testing, including a clinical study, 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.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

REC. 19 1997

Re: K973618 Trade Name: Somnoplasty System Regulatory Class: II Product Code: GEI Dated: September 19, 1997 Received: September 23, 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,

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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K973618 510(k) Number (if known):

Somnoplasty System Device Name:

Indications For Use:

1. 1

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

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices	Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number	K973618

Prescription Use (Per 21 CFR 801.109)	X OR Over-The-Counter Use
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(Optional Format 1-2-96)

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.