CELON ENT SYSTEM

K032838 · Celon AG Medical Instruments · GEI · Sep 26, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032838
• Device Name: CELON ENT SYSTEM
• Applicant: Celon AG Medical Instruments
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

This application system, comprising the CelonLab ENT power control unit and the CelonProBreath, CelonProSleep, and CelonProSleep PLUS bipolar coagulation electrodes, is indicated for ablation and coagulation of soft tissue in otorhinolaryngology (ENT) surgery including: CelonProBreath: Submucosal tissue shrinkage for nasal airway obstruction by reduction of hypertrophic nasal turbinates; CelonProSleep: Submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring; CelonProSleep PLUS: Submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring. The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Device Story

Celon ENT System consists of CelonLab ENT power control unit and bipolar coagulation electrodes (CelonProBreath, CelonProSleep, CelonProSleep PLUS). Device delivers bipolar RF current to soft tissue; no neutral electrode required. Operator selects power level via unit display and activates via foot switch. System provides acoustic feedback proportional to tissue impedance; frequency changes indicate coagulation status. Automatic power control monitors impedance; if limit reached (coagulation complete), system emits pulsed tone and ceases output to prevent tissue overdose. Procedure time varies (3 seconds to minutes) based on applicator, tissue, and power. Used in clinical ENT settings by trained medical personnel. Benefits include controlled tissue shrinkage/coagulation for nasal obstruction and snoring treatment.

Clinical Evidence

Bench testing only. Performance validation testing conducted to confirm device functionality and safety. Materials verified for biocompatibility per ISO 10993 and USP 23 Class VI. Electrical safety and electromagnetic compatibility verified per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, and ANSI/AAMI HF-18.

Technological Characteristics

Bipolar electrosurgical coagulation system. Components: CelonLab ENT power control unit, bipolar electrodes (CelonProBreath, CelonProSleep, CelonProSleep PLUS), CelonFootSwitch. Materials: Biocompatible per ISO 10993/USP 23 Class VI. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ANSI/AAMI HF-18. Features: Automatic power control, impedance-based acoustic monitoring, automatic output cessation. Connectivity: Standalone unit.

Indications for Use

Indicated for ENT surgery patients requiring soft tissue ablation and coagulation, specifically for submucosal tissue shrinkage of hypertrophic nasal turbinates (nasal airway obstruction) or uvula/soft palate tissue (snoring treatment). Intended for use by trained medical personnel.

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

• ArthroCare AccENT Electrosurgery System (K973478)
• ArthroCare ENTec Reflex Wand Electrodes (K000036)
• ArthroCare ENTec Reflex Wand Electrodes (K000778)
• Somnus Somnoplasty System (K971450)
• Somnus Somnoplasty System (K973618)

Submission Summary (Full Text)

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### SEP 2 6 2003

# K032838 (pg 1 of 4)

### 510(k) Summary of Safety and Effectiveness

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.92

| Submitter: | Celon AG medical instruments<br>Rheinstrasse 8<br>14513 Teltow<br>Germany |
|------------------------|-------------------------------------------------------------------------------------|
| Contact Person: | André Roggan, Ph. D.<br>Director Research and Development |
| | Phone: [phone]<br>Fax: [phone] |
| United States Agent: | Donald R. Bruce<br>1005 California Ave.<br>San Jose, CA 95125 |
| | Phone: [phone]<br>Fax: [phone] |
| Date Summary Prepared: | June 27th, 2003 |
| Product Identification | |
| Proprietary Name: | Celon ENT System |
| Classification Name: | Electrosurgical cutting and coagulation<br>device and accessories (21 CFR 878.4400) |
| Common Name: | Electrosurgical Device and Accessories |
| Manufacturer: | Celon AG medical instrument<br>Rheinstrasse 8<br>14513 Teltow<br>Germany |
| Distributor: | pending |

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#### Legally Marketed Device:

The Celon ENT System is of comparable type and is substantially equivalent to the following currently marketed devices:

| Device | 510(k) Number | Date Cleared |
|-----------------------------------------|---------------|---------------------|
| ArthroCare AccENT Electrosurgery System | K973478 | January 9th, 1998 |
| ArthroCare ENTec Reflex Wand Electrodes | K000036 | February 4th, 2000 |
| ArthroCare ENTec Reflex Wand Electrodes | K000778 | May 3rd, 2000 |
| Somnus Somnoplasty System | K971450 | July 17th, 1997 |
| Somnus Somnoplasty System | K973618 | December 19th, 1997 |

It complies with the same or equivalent standards and has the same intended use.

#### Device Description

The Celon ENT System is comprised of a power control unit (CelonLab EN7) and bipolar coagulation electrodes. The CelonLab ENT power control unit delivers a bipolar output via the bipolar coagulation electrodes of type CelonProBreath, CelonProSleep, and CelonProSleep PLUS. A neutral electrode (return conductor) is not required. The power control unit is user-friendly with a user display showing all the necessary process parameters. After switching on the equipment, the user selects the level of power and activates the radio frequency (RF) current by depressing the foot switch. The power control unit delivers an acoustic signal as an indicator of the coaqulation status. Usually, general electrosurgical units have a fixed activation tone. However, in the case of the CelonLab ENT power control unit, the frequency of the acoustic signal is proportional to the tissue impedance. This permits acoustic monitoring of the coagulation status by the operator, since the latter is directly correlated with the impedance. If the impedance increases above a certain limit, signifying that the coagulation process is complete, this is additionally indicated by a clock pulsed sound and the power output is ceased automatically. Overdose effects in the treated tissue area are excluded by this power control function. The procedure time will be set automatically by the power control unit. The time interval between activation of the power control unit and the end of the coagulation procedure depends on applicator type, tissue properties and power setting, and can vary between 3 seconds and several minutes.

Accessories included with the power control unit include a line power cable and single pedal foot pedal (CelonFootSwitch).

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## K032838 (pg 3 of 4)

Materials: Materials and construction of the Celon ENT System are compliant with the international electrical safety standards IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, and the American national standard ANSI/AAMI HF-18. Additionally, the materials used in the design and construction of the CelonProBreath, CelonProSleep, and CelonProSleep PLUS bipolar coagulation electrodes, which have direct contact with the patient, are biocompatible according to ISO 10993 or USP 23 Class VI.

Design: The system is designed to be a bipolar electrosurgical coagulation device with an automatic power control, including automatic output power reduction and acoustic monitoring of coagulation status.

#### Intended Use of the Device

This Celon ENT System has the same intended use as the legally marketed devices. This application system, comprising the CelonLab ENT power control unit and the CelonProBreath, CelonProSleep, and CelonProSleep PLUS bipolar coagulation electrodes, is indicated for ablation and coagulation of soft tissue in otorhinolaryngology (ENT) surgery including:

| CelonProBreath: | Submucosal tissue shrinkage for nasal airway obstruction by reduction of hypertrophic nasal turbinates |
|---------------------|----------------------------------------------------------------------------------------------------------|
| CelonProSleep: | Submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring |
| CelonProSleep PLUS: | Submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring |

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

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# K032838

#### Comparison with Legally Marketed Device:

It is the opinion of Celon AG medical instruments that the Celon ENT System is of a type and substantially equivalent to legally marketed devices with respect to intended use and technological characteristics. It will comply with the safety requirements of IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ANSI/AAMI HF-18 and applicable collateral and particular standards. Furthermore, the CelonProBreath, CelonProSleep, and CelonProSleep PLUS bipolar coagulation electrodes, which have direct contact with the patient, are biocompatible according to ISO 10993 or USP 23 Class VI. In addition, performance validation testing has been done to validate the performance of the device. The comparison results presented in this 510(k) notification show that the device is substantially equivalent to legally marketed devices and is safe and effective in its intended use.

### Conclusions

The Celon ENT System does not result in any new potential safety risks and performs as well as or better than devices legally on the market. Celon AG medical instruments consider the Celon ENT System to be equivalent to other marketed devices with the same indications for use and meeting similar standards.

#### Legal Notice

CelonProBreath® and CelonProSleep® are registered trademarks of Celon AG medical instruments.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread, composed of three thick, curved lines.

Public Health Service

SEP 2 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Celon AG Medical Instruments c/o Ms. Pamela Gwynn Underwriters Laboratories, Inc. 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, North Carolina 27709-3995

Re: K032838

Trade/Device Name: Celon ENT System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 18, 2003 Received: September 11, 2003

Dear Ms. Gwynn:

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, 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 (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 - Ms. Pamela Gwynn

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), please contact the Office of Compliance 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 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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#### Statement of Intended Use 6

| 510(k) Number: | pending KC32838 |
|----------------|-----------------|
|----------------|-----------------|

Device Name:

Celon ENT System

Indications For Use:

This application system, comprising the CelonLab ENT power control unit and the CelonProBreath, CelonProSleep, and CelonProSleep PLUS bipolar coagulation electrodes, is indicated for ablation and coagulation of soft tissue in otorhinolaryngology (ENT) surgery including:

| CelonProBreath: | Submucosal tissue shrinkage for nasal airway obstruction by reduction of hypertrophic nasal turbinates |
|---------------------|----------------------------------------------------------------------------------------------------------|
| CelonProSleep: | Submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring |
| CelonProSleep PLUS: | Submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring |

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X |
|-------------------------|---|
| OR Over-The-Counter Use | |

(Per 21 CFR 801.109)

Miriam C. Provost

(Division Sign-Off)

Division of General, Restorative
and Neurological Devices

| 510(k) Number | K032838 |
|---------------|---------|
|---------------|---------|