GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)

K041285 · Gyrus Medical , Ltd. · GEI · Sep 10, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041285
• Device Name: GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)
• Applicant: Gyrus Medical , Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gyrus G3 System is intended for use for ablation. resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (Head and Neck) surgery coagulation of soft tissue. This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

Device Story

Gyrus G3 System is an electrosurgical generator for ENT surgery; provides monopolar and bipolar modes. Monopolar mode controls max temperature/energy; monitors total energy, impedance, temperature (via two thermocouples), and delivery time. Bipolar mode controls output waveform and power. Inputs include active/dispersive electrodes and bipolar instruments; foot pedal operated. System transforms electrical energy into RF output for tissue ablation, resection, and coagulation. Used in clinical settings by trained medical personnel. Output displayed on front panel; informs surgeon of energy/impedance/temperature status. Enables precise tissue management and hemostasis; benefits include controlled soft tissue reduction and vessel sealing.

Clinical Evidence

Bench testing only. Performance validation conducted to confirm device functionality and substantial equivalence to the predicate device.

Technological Characteristics

Electrosurgical generator; monopolar and bipolar modes. Features thermocouple inputs for temperature monitoring, impedance sensing, and energy delivery control. Includes footswitch, electrodes, and cables. Connectivity via front panel connectors for active/dispersive electrodes and bipolar instruments. Software-controlled power and waveform output.

Indications for Use

Indicated for ablation, resection, coagulation of soft tissue and hemostasis in ENT surgery (e.g., adenoidectomy, tonsillectomy, UPPP, sinus/laryngeal procedures). Somnoplasty electrodes indicated for coagulation of enlarged tonsils (age 13+), airway obstruction reduction (UARS/OSAS), and turbinate/uvula/soft palate coagulation for snoring. Contraindicated for patients with pacemakers or active implants, or when electrosurgery is deemed contrary to patient interest.

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

• G2 Radio-frequency Workstation & Accessories (K021777)

Submission Summary (Full Text)

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Gyrus Medical, Cardiff, UK 11 May 2004

SEP 1 0 2004

510(k) Premarket Notification Gyrus G3 Generator System & Accessories

K041285

Page 1 of (2)

510(k) Summary of Safety and Effectiveness

### Gyrus G3 System (Generator & Accessories)

| Submitted by: | Gyrus Medical Ltd<br>Fortran Road<br>St Mellons,<br>Cardiff CF30LT<br>UK |
|------------------------|---------------------------------------------------------------------------------------|
| Contact Person: | Andrew Dzimitrowicz<br>Quality Manager |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Date Summary Prepared: | 11 ^th May 2004 |
| Name of the Device: | |
| Proprietary Name: | Gyrus G3 System (Generator & Accessories) |
| Project Name: | G3 |
| Common/Usual Name: | Electrosurgical Generator and Accessories |
| Classification Name: | Electrosurgical Cutting & Coagulation Device and<br>Accessories (per 21 CFR 878.4400) |
| Brand Name: | Not yet assigned |
| Predicate Devices: | K021777 (G2 Radio-frequency Workstation &<br>Accessories) |

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Page 2 of (2)

Gyrus Medical, Cardiff, UK 11 May 2004

510(k) Premarket Notification Gyrus G3 Generator System & Accessories

Description:

The Gyrus G3 System Generator has two principal modes of operation:

- The monopolar mode has controls for maximum temperature and energy delivered. The unit has readouts for total energy delivered, impedance. temperature for two thermocouples and time of energy delivery.
- -The bipolar mode has controls for output waveform type and power. The unit has readouts for set power and waveform.

Connectors on the front panel include the monopolar connector for active electrode and dispersive electrode and separate dual bipolar connectors for PlasmaCision electrodes and bipolar instruments. The foot pedal is connected on the back panel.

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

## Statement of Intended Use:

The Gyrus G3 System is intended for use for ablation. resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (Head and Neck) surgery coagulation of soft tissue.

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

The Gyrus G3 System has been carefully compared to Comparison to Predicate Devices: legally marketed devices with respect to intended use technological and characteristics. In addition. performance 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

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

SEP 1 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Andrew Dzimitrowicz Director of RA/QA Gyrus Medical Ltd. Fortran Road, St. Mellons Cardiff United Kingdom CF3 OLT

Re: K041285

Trade/Device Name: Gyrus G3 Radio-Frequency Workstation and Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 13, 2004 Received: July 16, 2004

Dear Mr. Dzimitrowicz:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becament be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to commerce proc to ritly 20, 1978, as excerdance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Costherior (110) that as nevice, subject to the general controls provisions of the Act. The 1 ou may, mererore, mainer 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 to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 r reaso be actived a determination that your device complies with other requirements of the Act that I Dr has Intacted and regulations administered by other Federal agencies. You must or unly with all the 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 CI It Fat 80 77, 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. Andrew Dzimitrowicz

This letter will allow you to begin marketing your device as described in your Section 510(k) This iciter will anow you've begin finding of substantial equivalence of your device to a legally premailed 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), please If you desire spocents acrive ice 3 at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnal 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,

Miriam 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 Medical, Cardiff, UK 11 May 2004

510(k) Premarket Notification Gyrus G3 Generator System & Accessories

### Indications for Use

510(k) Number (if known):

Not Yet Assigned

K041285

Device Name:

Gyrus G3 Radio-frequency workstation & Accessories

Indications For Use:

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The Bipolar Generator section of the G3 RF Workstation is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (Head and Neck) surgery including:

- Adenoidectomy .
- Cysts .
- Head, Neck, Oral, and Sinus Surgery
- Mastoidectomy
- Myringotomy with effective Hemorrhage Control
- Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
- Nasopharyngeal / Laryngeal indications including Tracheal Procedures, Laryngeal
- Polypectomy, and Laryngeal Lesion Debulking
- Neck Mass
- Papilloma Keloids
- Submucosal Palatal Shrinkage
- Tonsillectorny
- Traditional Uvulopalatoplasty (RAUP)
- Tumors
- Tissue in the Uvula/Soft Palate for the Treatment of Snoring
- Uvulopaiatopharyngoplasty (UPPP)
- Parotidectomy
- Radical Neck Disection

The Gyrus Somnoplasty TCRF Generator section of the G3 RF Workstation with the Temperature Controlled Radio-frequency (Somnoplasty®) Electrodes is indicated for coagulation of soft tissue including:

> The coagulation of enlarged tonsils in patients 13 years of age and older; the reduction of the incidence of airway obstructions, e.g., base of tongue, soft palate, etc., in patients suffering from UARS or OSAS: tissue coagulation in the inferior turbinates; and tissue coagulation in the uvula/soft palate which may reduce the severity of snoring in some individuals.

The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment and familiar with potential complications that may arise during or following fead and Neck surgery.

#### Contraindications for Use:

There are no known absolute contraindications to the use of radio-frequency surgery. The use of the Gyrus G3 Radio-frequency Workstation is contraindicated when, in the judgement of the physician, electross urgal procedures would be contrary to the best interests of the patient. The use of the system is also contraindicated for patients with heart pacemakers or other active device implants.

Prescription Use X (Per 21 CFR 801.109) OH

Over-The-Counter Use (Optional Format 1-2-96)

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

Muriam C. Provost

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

510(k) Number K041285