ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD AND WANDS

K063538 · Arthrocare Corp. · GEI · Dec 1, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K063538
• Device Name: ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD AND WANDS
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 1, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ArthroCare ENT Plasma Wands are 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 Plasma Wands are bipolar, single-use, high-frequency electrosurgical devices. Used in ENT surgery for soft tissue ablation, resection, coagulation, and hemostasis. Operated by surgeons in clinical settings. Device delivers high-frequency energy to target tissue; principle of operation involves plasma-mediated tissue effect. Output allows precise tissue removal and bleeding control, aiding surgical efficiency and patient recovery.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material modification assessment.

Technological Characteristics

Bipolar, single-use, high-frequency electrosurgical device. Principle of operation: plasma-mediated tissue ablation/coagulation. Sterilization parameters remain consistent with predicate.

Indications for Use

Indicated for patients undergoing otorhinolaryngology (ENT) surgery requiring soft tissue ablation, resection, coagulation, or hemostasis, including procedures such as adenoidectomy, tonsillectomy, turbinate reduction, and laryngeal/nasopharyngeal surgeries.

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® ENT Plasma Wands (K033257)

Submission Summary (Full Text)

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# Artl ArthroCare ENT Plasma Wauds

DEC - 1 2006

Page 1 of 2

General Information

Submitter Name/Address:

ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936

Establishment Registration Number:

Contact Person:

Director, Regulatory Affairs

Valerie Defiesta-Ng

November 21, 2006

2951580

Date Prepared:

Device Description

Trade Name:

Generic/Common Name:

Classification Name:

ArthroCare® ENT Plasma Wands

Electrosurgical Device and Accessories

Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400)

Predicate Devices ArthroCare® ENT Plasma Wands

K033257, cleared 10/30/03

### Product Description

The ArthroCare ENT Plasma Wands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in otorhinolaryngology (ENT) surgery.

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K063538

Page 2 of 2

#### Intended Use

The ArthroCare ENT Plasma Wands are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:

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

#### Substantial Equivalence

This Special 510(k) proposes a material modification in for the ArthroCare ENT Plasma Wands, which were previously cleared under K033257 on October 30, 2003. The indications for use, technology, principle of operation, dimensional specifications, performance specifications, labeling and sterilization parameters of the Wands remain the same as in the predicate cleared 510(k).

#### Summary of Safety and Effectiveness

The modified ArthroCare ENT Plasma Wands, as described in this submission, are substantially equivalent to the predicate Wands. The proposed material modification is not a substantial change or modification, and does not significantly affect the safety or efficacy of the devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC = 1 2006

ArthroCare Corporation % Ms. Valerie Defiesta-Ng Director, Regulatory Affairs 680Vaqueros Avenue Sunnyvalc, California 94085

Re: K063538

Trade/Device Name: ArthroCare® ENT Plasma Wands Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 21, 2006 Received: November 24, 2006

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, 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 mav 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). 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/industry/support/index.html.

Sincerely yours,

Foe
Mark N. Malkerson

Mark N. Melkerson 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

Device Name: ArthroCarc® ENT Plasma Wands

кобз538 510(k) Number:

Indications for use:

The ArthroCare ENT Plasma Wands are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:

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

| Prescription Use | X | OR | Over-the-Counter Use |
|----------------------|---|----|----------------------|
| (Per 21 CFR 801.109) | | | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

| 510(k) Number | L063538 |
|---------------|---------|
|---------------|---------|