GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)
Device Facts
| Record ID | K021777 |
|---|---|
| Device Name | GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) |
| Applicant | Gyrus Ent LLC |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Aug 26, 2002 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The PlasmaKinetic Generator section of the GII RF Workstation is indicated for ablation of 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; Tonsillectomy; Traditional Uvulopalatoplasty (RAUP); Tumors; Tissue in the Uvula/Soft Palate for the Treatment of Snoring. The Gyrus ENT Somnoplasty TCRF Generator section of the GII 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 Head and Neck surgery.
Device Story
G II Radio-frequency Workstation combines two previously cleared generators: Somnoplasty TCRF Generator and PlasmaKinetic Generator. Device operates in monopolar and bipolar modes. Monopolar mode provides temperature-controlled RF energy for tissue coagulation; features controls for max temperature/energy and readouts for total energy, impedance, dual-thermocouple temperature, and time. Bipolar mode uses PlasmaCision/bipolar instruments for ablation, resection, and hemostasis; features controls for output waveform and power. Used in ENT surgical settings by qualified medical personnel. System includes workstation, electrodes, bipolar instruments, footswitch, and cables. Output allows surgeons to perform precise tissue reduction and hemostasis, benefiting patients by treating snoring, airway obstructions, and various ENT pathologies.
Clinical Evidence
Bench testing only. Performance testing validated the device against predicate devices, demonstrating similar performance characteristics.
Technological Characteristics
Electrosurgical generator with monopolar and bipolar modes. Monopolar mode: temperature-controlled RF, dual-thermocouple sensing. Bipolar mode: PlasmaCision/bipolar RF energy. Connectivity: front panel connectors for active/dispersive electrodes and dual bipolar instruments; rear panel footswitch connection. Form factor: workstation console.
Indications for Use
Indicated for ENT soft tissue ablation, resection, coagulation, and hemostasis in patients requiring head/neck/oral/sinus surgery, adenoidectomy, tonsillectomy, or snoring/airway obstruction treatment. Tonsil coagulation indicated for patients 13+. Contraindicated for patients with heart pacemakers or electronic implants, or when electrosurgery is 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
- Gyrus ENT Somnoplasty Generator (K020067)
- Gyrus Medical Inc PlasmaKinetic Generator (K003060)
- Arthrocare Sinus Electrosurgery Generator (K973478)
- Arthrocare ENTec Plasma Wands (K014290)
- ENTec EVac Plasma Wands (K011279)
- Gyrus ENT (Smith & Nephew) Hemostatix Scalpel (K002021)
- Gyrus ENT TCRF Somnoplasty Electrodes (K982717)
- Gyrus ENT TCRF Somnoplasty Electrodes (K973618)
- Gyrus ENT TCRF Somnoplasty Electrodes (K971450)
- Gyrus ENT TCRF Somnoplasty Electrodes (K020778)
Reference Devices
Submission Summary (Full Text)
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R.O.A.T.Y.
510(k) Summary of Safety and Effectiveness
# G II Radio-frequency Workstation & Accessories
| Submitted by: | Gyrus ENT<br>2925 Appling Rd.<br>Bartlett, TN 38133 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jeffrey W. Cobb |
| | Vice President, Regulatory/Clinical Affairs & Quality |
| Telephone: | 901-373-2673 |
| Facsimile: | 901-373-0242 |
| Date Summary Prepared: | August 19, 2002 |
| Name of the Device: | G II Radio-frequency Workstations |
| Common/Usual Name: | Electrosurgical Generator and Accessories |
| Classification Name: | Electrosurgical Cutting & Coagulation Device and<br>Accessories (per 21 CFR 878.4400) |
| Predicate Devices: | - Gyrus ENT Somnoplasty Generator (K020067)<br>- Gyrus Medical Inc PlasmaKinetic Generator<br>(K003060)<br>- Arthrocare Sinus Electrosurgery Generator (K973478)<br>- Arthrocare ENTec Plasma Wands (K014290)<br>- ENTec EVac Plasma Wands (K011279)<br>- Gyrus ENT (Smith & Nephew) Hemostatix Scalpel<br>(K002021)<br>- Gyrus ENT TCRF Somnoplasty Electrodes<br>(K982717), (K973618), (K971450), & (K020778) |
## Description:
The Gyrus ENT G II RF Workstation is a combination of two previously cleared radio-frequency generators:
- 1. The Gyrus ENT Somnoplasty Temperature-Controlled Radio-frequency Generator -K020067, and
- 2. The Gyrus Medical Inc. (formerly Everest Medical Corporation) PlasmaKinetic™ Generator - K003060.
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## Somnoplasty TCRF Generator Section of the GII RF Workstation
Statement of Intended Use: The Gyrus ENT Somnoplasty Generator section of the G II Radiofrequency Workstation is indicated for coagulation of soft tissue including:
| | Indication | Predicate Device 510(k) |
|----|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| 1. | The coagulation of enlarged tonsils in patients 13 years of age and older | K020778 |
| 2. | The reduction of the incidence of airway obstructions, e.g., base of tongue, soft<br>palate, etc., in patients suffering from UARS or OSAS | K982717<br>K971450 |
| 3. | Tissue coagulation in the inferior turbinates | K973618 |
| 4. | Tissue coagulation in the uvula/soft palate which may reduce the severity of<br>snoring in some individuals | K982717<br>K971450 |
## PlasmaKinetic Generator Section of the GII RF Workstation
The PlasmaKinetic Generator section of the GII RF Workstation uses those bipolar and PlasmaCision instruments described in our original submission (K021777) dated May 29, 2002, and subsequent correspondence related to K021777 dated July 10, 2002, and July 19, 2002.
As stated in the original submission, K021777, the PlasmaKinetic Generator section of the GII RF Workstation is substantially equivalent to the ArthroCare ENTec Plasma Wand cleared under 510(k) Nos. K014290, K013463, K011279, K000228, and K973478. Testing was presented in our July 19, 2002, supplement to K021777 that demonstrated the The PlasmaKinetic Generator section of the GII RF Workstation performed similarly to the ArthroCare ENTec Plasma Wand.
Statement of Intended Use: The PlasmaKinetic Generator section of the GII RF Workstation is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:
| | Indication | Predicate Device 510(k) |
|-----|--------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| 1. | Adenoidectomy | K014290 |
| 2. | Cysts | K014290 |
| 3. | Head, Neck, Oral, and Sinus Surgery | K014290 |
| 4. | Mastoidectomy | K014290 |
| 5. | Myringotomy with effective Hemorrhage Control | K014290 |
| 6. | Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates | K014290 |
| 7. | Nasopharyngeal / Laryngeal indications including Tracheal Procedures,<br>Laryngeal Polypectomy, and Laryngeal Lesion Debulking | K014290 |
| 8. | Neck Mass | K014290 |
| 9. | Papilloma Keloids | K014290 |
| 10. | Submucosal Palatal Shrinkage | K014290 |
| 11. | Tonsillectomy | K014290 |
| 12. | Traditional Uvulopalatoplasty (RAUP) | K014290 |
| 13. | Tumors | K014290 |
| 14. | Tissue in the Uvula/Soft Palate for the Treatment of Snoring | K014290 |
This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
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## The Gyrus ENT G II Radio-frequency Workstation has two modes of operation:
- The monopolar mode has controls for maximum temperature and energy delivered. The unit ﮯ 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 G II Radiofrequency Workstation include the PlasmaCision electrodes, bipolar instruments, connector cable, footswitch and a power cable.
### Comparison to Predicate Devices:
The Gyrus ENT G II Radio-frequency Workstation has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addition, performance testing has been done to validate the performance of the device. The comparison and validation results presented 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/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around it. Inside the circle is an abstract symbol resembling an eagle or a stylized human profile, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 6 2002
Gyrus ENT Jeffrey W. Cobb Vice-President, Regulatory/Clinical Affairs & Quality 2925 Appling Road Bartlett, Tennessee 38133
Re: K021777
Trade/Device Name: Gyrus G II Radio-frequency Workstation & Accessories Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting & coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 29, 2002 Received: May 30, 2002
Dear Mr. Cobb:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA), 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. Iisting 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 (PMA), 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 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply 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 forth in the quality systems (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 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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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# Exhibit A
## Indications for Use
### 510(k) Number (if known):
K021777
Device Name:
G II Radio-frequency Workstation & Accessories
### Indications For Use:
The PlasmaKinetic Generator section of the GII RF Workstation is indicated for ablation of 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
- · Tonsillectomy
- · Traditional Uvulopalatoplasty (RAUP)
- Tumors
- · Tissue in the Uvula/Soft Palate for the Treatment of Snoring
The Gyrus ENT Somnoplasty TCRF Generator section of the GII 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 Head and Neck surgery.
#### Contraindications for Use:
There are no known absolute contraindications to the use of radio-frequency surgery. The use of the GNT G II Radio-frequency Workstation is contraindicated when, in the physician, electrosurgical 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 electronic device implants.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use X<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
|--------------------------------------------|----|--------------------------------------------------|
|--------------------------------------------|----|--------------------------------------------------|
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
| 510(k) Number | K021777 |
|---------------|---------|
|---------------|---------|
