GYRUS ENT SOMNOPLASTY GENERATOR

K020067 · Gyrus Ent LLC · GEI · Apr 4, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020067
• Device Name: GYRUS ENT SOMNOPLASTY GENERATOR
• Applicant: Gyrus Ent LLC
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gyrus ENT Somnoplasty Generator, in combination with Gyrus ENT Somnoplasty Electrodes, is intended for use in the coagulation of soft tissue. This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

Device Story

Electrosurgical generator for soft tissue coagulation. Inputs: temperature and impedance data from thermocouples in compatible electrodes. Operation: user-controlled settings for maximum temperature, energy delivery, and time; front panel connectors for active and dispersive electrodes; rear-panel footswitch. Output: controlled electrical energy for tissue coagulation. Used in clinical settings by trained medical personnel. Provides real-time monitoring of energy and temperature to assist physicians in performing controlled electrosurgical procedures, potentially benefiting patients through precise tissue coagulation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Electrosurgical generator; 21 CFR 878.4400; Class II. Features include temperature monitoring via two thermocouples, impedance monitoring, and user-adjustable controls for energy, time, and temperature. Includes active and dispersive electrode connectors and footswitch. Standalone unit.

Indications for Use

Indicated for coagulation of soft tissue. Intended for use by qualified medical personnel trained in electrosurgery. Contraindicated when electrosurgical procedures are contrary to patient interest or in patients with compromised immune systems.

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 S1 (K000501)

Submission Summary (Full Text)

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Gyrus ENT, Memphis, TN January 8, 2002

## APR = 4 2002

# KO20067 510(k) Summary of Safety and Effectiveness

### Gyrus ENT Somnoplasty Generator

#### Submitted by:

Contact Person:

Gyrus ENT 2925 Appling Rd. Bartlett, TN 38133

Jeffrev W. Cobb Vice President Regulatory Affairs

901-373-2673 Telephone: [phone] Facsimile:

Date Summary Prepared:

January 7, 2002

Name of the Device:

Proprietary Name:

Proprietary Name:

Common/Usual Name:

Classification Name:

Predicate Device:

Description:

Gyrus ENT Somnoplasty Generator

COGENT 1

Electrosurgical Generator and Accessories

Electrosurgical Device (per 21 CFR 878.4400)

Somnus Model S1 (K000501)

The Gyrus ENT Somnoplasty Generator has controls for maximum temperature, energy delivered and time of energy delivery. The unit readouts for total energy delivered, has temperature for two impedance. and thermocouples. Connectors on the front panel include connector for active electrode and dispersive electrode. The foot pedal is connected on the back panel.

Accessories included with the generator are a power cable and a footswitch.

P51

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Gyrus ENT, Memphis, TN January 8, 2002

Statement of Intended Use:

The Gyrus ENT Somnoplasty Generator, in combination with Gyrus ENT Somnoplasty Electrodes, is intended for use in the coagulation of soft tissue.

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

Comparison to Predicate Devices:

The Gyrus ENT Somnoplasty Generator 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jeffrey W. Cobb Vice President Regulatory Affairs Gyrus ENT 2925 Appling Road Bartlett, TN 38133

Re: K020067

Trade/Device Name: Gyrus ENT Somnoplasty Generator Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 8, 2002 Received: January 9, 2002

Dear Mr. Cobb:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications ferenced above and harrsure) to legally marketed predicate devices marketed in interstate for use stated in the encrosale) to 10gary to 10gaily of the Medical Device American by D conninered phor to they 2019 103 103 103 100 100 100 100 100 100 100 1000 1000 1000 de necs that have been require approval of a premarket approval application (PMA). allu Cosmetic Treef, that to hevice, subject to the general controls provisions of the Act. The r ou may, diereleve, mains of the Act include requirements for annual registration, listing of general controls provision practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classined controls. Existing major regulations affecting your device can may or buyer to back as assist as a submit ons, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I toase of actives and I Drivision that your device complies with other requirements of the Act that I Dri has intatutes and regulations administered by other Federal agencies. You must or any I vatha bathe Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of R Part 807); accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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# Page 2 – Mr. Jeffrey W. Cobb

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premaince nevice 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Gyrus ENT, Memphis, TN January 8, 2002

510(k) Premarket Notification Gyrus ENT Somnoplasty Generator

#### Indications for Use

510(k) Number (if known):

Device Name:

Indications For Use:

Not Yet Assigned

K02 0067

Gyrus ENT Somnoplasty Generator ELECTROSURGICAL GENERATOR

The Gyrus ENT Somnoplasty Generator with the Gyrus ENT Soft Tissue Coagulating Electrodes is indicated for the coagulation of soft tissue.

The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Contraindications for Use:

The use of the Gyrus ENT Somnoplasty Generator is contraindicated when, in the judgment of the physician, electrosurgical procedures would be contrary to the best interests of the patient.

Somnoplasty may be contraindicated in patients with a compromised immune system.

(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) 1-2-96)

Over-The-Counter Use (Optional Format

uriam C. Provost

OR

Division Sign-Off) Division of General, Restorative and Neurological Devices

X020067 510(k) Number.