ARTHROCARE ENT COBLATOR SURGERY SYSTEM

K030108 · Arthrocare Corp. · GEI · Feb 3, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030108
• Device Name: ARTHROCARE ENT COBLATOR SURGERY SYSTEM
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 3, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ArthroCare ENT Coblator Surgery System is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) 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 Submucosal Tissue Shrinkage Tonsillectomy Traditional Uvulopalatoplasty (RAUP) Tumors Tissue in the Uvula/Soft Palate for the Treatment of Snoring

Device Story

ArthroCare ENT Coblator Surgery System is a bipolar, high-frequency electrosurgical system; used in ENT surgery for soft tissue ablation, resection, coagulation, and hemostasis. System components: electrosurgical generator (Controller), disposable bipolar Wands, and reusable Patient Cable. Device operates by delivering high-frequency energy to target tissue; enables precise tissue removal and vessel sealing. Used in clinical settings by ENT surgeons. Output allows for controlled tissue management; benefits patient through reduced thermal damage compared to traditional electrosurgery.

Clinical Evidence

No clinical data; substantial equivalence based on bench testing and comparison of performance/dimensional specifications to the predicate device.

Technological Characteristics

Bipolar, high-frequency electrosurgical system. Components: electrosurgical generator (Controller), disposable bipolar Wands, reusable Patient Cable. Operates via plasma-mediated ablation. Sterilization parameters remain consistent with predicate.

Indications for Use

Indicated for patients undergoing otorhinolaryngology (ENT) surgical procedures requiring soft tissue ablation, resection, coagulation, or hemostasis, including adenoidectomy, tonsillectomy, turbinate reduction, and laryngeal/tracheal procedures.

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

• ENTec® Plasma Wands (K021364)

Submission Summary (Full Text)

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FEB 0 3 2003

# 510(k) Summary 030108 ArthroCare Corporation ArthroCare ENT Coblator Surgery System

### General Information

Submitter Name/Address: ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936 [phone] Phone Number: Valerie Defiesta-Ng Contact Person: Director, Regulatory Affairs Date Prepared: January 10, 2003 Device Description Trade Name: ArthroCare ENT Coblator Surgery System Generic/Common Name: Electrosurgical Device and Accessories Electrosurgical Cutting and Coagulation Classification Name: Device and Accessories (21 CFR 878.4400) Predicate Devices ENTec® Plasma Wands K021364

#### Product Description

The ArthroCare ENT Coblator Surgery System is a bipolar, high frequency electrosurgical system consisting of three components: an electrosurgical generator called the Controller; a family of disposable, bipolar, single use Wands; and a reusable Patient Cable.

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## Intended Uses

The ArthroCare ENT Coblator Surgery System is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:

- 파 Adenoidectomy
- Cysts
- Head, Neck, Oral, and Sinus Surgery
- 트 Mastoidectomy
- Myringotomy with Effective Hemorrhage Control
- 파 Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
- 트 Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
- 트 Neck Mass
- Papilloma Keloids
- 트 Submucosal Palatal Shrinkage
- 트 Submucosal Tissue Shrinkage
- Tonsillectomy
- l Traditional Uvulopalatoplasty (RAUP)
- I Tumors
- Tissue in the Uvula/Soft Palate for the Treatment of Snoring

#### Substantial Equivalence

This Special 510(k) proposes a modification in the performance specifications. dimensional specifications, and labeling for the ArthroCare ENT Coblator Plasma Surgery System, which was previously cleared in K021364 on May 30, 2002. The indications for use, technology, principle of operation, materials, packaging, and sterilization parameters of the ArthroCare ENT Coblator Surgery System remain the same as in the predicate cleared 510(k).

#### Summary of Safety and Effectiveness

The modified ArthroCare ENT Coblator Surgery System, as described in this Special 510(k), is substantially equivalent to the predicate device. The proposed modifications in performance specifications, dimensional specifications, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above them that resemble a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 3 2003

Arthocare Corporation Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-2936

Re: K030108

Trade/Device Name: Arthrocare ENT Coblator Surgery System Regulation Number: 878:4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: January 10, 2003 Received: January 13, 2003

Dear Ms. Defiesta-Ng:

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 - Ms. Valerie Defiesta-Ng

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). 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,

Miriam C. Provost

ForCelia 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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## Indications for Use Statement

ArthroCare ENT Coblator Surgery System Device Name:

KO30108 510(k) Number:

#### Indications for Use:

The ArthroCare ENT Coblator Surgery System is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:

- Adenoidectomy l
- 트 Cysts
- Head, Neck, Oral, and Sinus Surgery .
- 트 Mastoidectomy
- Myringotomy with Effective Hemorrhage Control 트
- I Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
- 트 Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
- 트 Neck Mass
- 트 Papilloma Keloids
- 트 Submucosal Palatal Shrinkage
- 발 Submucosal Tissue Shrinkage
- 이 Tonsillectomy
- 이 Traditional Uvulopalatoplasty (RAUP)
- 해 Tumors
- Tissue in the Uvula/Soft Palate for the Treatment of 트 Snoring

X

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use

Over-the-Counter Use

(Per 21 CFR 801.109)

Miriam C. Provost

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

Number K630/08