SOMNOPLASTY SYSTEM

K973618 · Somnus Medical Technologies, Inc. · GEI · Dec 19, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K973618
• Device Name: SOMNOPLASTY SYSTEM
• Applicant: Somnus Medical Technologies, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

The Somnoplasty System is an electrosurgical device used for thermal ablation of inferior turbinate tissue. It consists of an RF generator and tissue-coagulating electrodes. The physician inserts the electrode needles into the target turbinate tissue. The generator delivers radio frequency energy, controlled by target temperature, power, and time settings. The system monitors impedance, total energy delivered, and temperature via integrated thermocouples. The output is localized tissue coagulation, which reduces turbinate hypertrophy to alleviate nasal obstruction. The device is used in a clinical setting by trained medical personnel. The procedure provides a minimally invasive alternative to traditional surgical turbinate reduction, aiming to improve patient breathing by reducing nasal airway resistance.

Clinical Evidence

Clinical study performed to validate device performance and safety for the treatment of chronic hypertrophic rhinitis via inferior turbinate coagulation. Specific metrics and sample sizes not detailed in the summary document.

Technological Characteristics

Electrosurgical RF generator and tissue-coagulating electrodes. Features include adjustable target temperature, power, and time controls. System monitors impedance, total energy, and temperature via up to 3 thermocouples per channel. Includes footpedal and dispersive electrode adapter. Class II device (21 CFR 878.4400).

Indications for Use

Indicated for patients with nasal obstruction due to chronic turbinate hypertrophy requiring tissue coagulation (thermal ablation) of the inferior turbinates. Intended for use by qualified medical personnel trained in radio frequency tissue ablation.

Regulatory Classification

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.

Predicate Devices

• Somnus Model 215 Electrosurgical Generator (K973618)
• Somnus Model S2 Electrosurgical Generator (K973618)
• Somnus Tissue Coagulating Electrode Models 1000, 1100 (K973618)

Submission Summary (Full Text)

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

DEC 19 1997

K973618

#### Intended Use:

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.

# Submitted by:

Somnus Medical Technologies, Inc. 285 North Wolfe Road Sunnyvale, CA 94086 Tel: [phone] Fax: [phone]

#### Contact Person:

Eve A. Conner, Ph.D. Vice President Clinical and Regulatory Affairs Telephone: [phone]

# 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:

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.

### 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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.

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| (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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