ENTEC PLASMA WANDS

K014290 · Arthrocare Corp. · GEI · Mar 28, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K014290
• Device Name: ENTEC PLASMA WANDS
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ENTec 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

ENTec Plasma Wands are bipolar, high-frequency electrosurgical devices used with the ENTec Coblator Plasma Surgery System. Designed for ENT surgery; operated by physicians in clinical settings. Device delivers energy to soft tissue to perform ablation, resection, coagulation, and hemostasis. Enables precise tissue removal and vessel sealing during procedures like tonsillectomy, adenoidectomy, and turbinate reduction. Benefits include controlled tissue effect and reduced bleeding compared to traditional methods. Healthcare providers use the wand to manipulate tissue directly; output is the physical effect of plasma-mediated ablation or coagulation on the target site.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons to predicate devices.

Technological Characteristics

Bipolar, high-frequency electrosurgical device. Designed for use with the ENTec Coblator Plasma Surgery System. Utilizes plasma-mediated ablation and coagulation principles. Form factor is a handheld wand. Sterilization method not specified.

Indications for Use

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

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 Coblator™ Plasma Surgery System (K973478, K000036, K000778, and K011279)
• Somnus Somnoplasty System (K982717)
• Ethicon PowerStar Bipolar Scissors (K981361)
• Ellman Surgitron IEC II (K001253)
• Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAC) Surgical Lasers (K011703)
• Medtronic Xomed Monopolar Energized Blade (K002987)

Submission Summary (Full Text)

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ArthroCare
CORPORATION

MAR 2 8 2002

510(k) Summary ArthroCare Corporation ENTec® Plasma Wands™

KO14290

## General Information

Manufacturer:

ArthroCare, Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936

Establishment Registration Number:

Contact Person:

2951580

Bruce Prothro Vice President, Regulatory Affairs, Quality Assurance, and Clinical Research

Date Prcpared:

Device Description

Trade Namc:

ENTcc® Plasma Wands™M

December xx, 2001

Generic/Common Name:

Classification Name:

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

Electrosurgical Device and Accessories

### Predicate Devices

| Predicate Devices | |
|----------------------------------------------------------------------------------------------------------|-------------------------------------------|
| ENTec Coblator™ Plasma Surgery System | K973478, K000036,<br>K000778, and K011279 |
| Somnus Somnoplasty System | K982717 |
| Ethicon PowerStar Bipolar Scissors | K981361 |
| Ellman Surgitron IEC II | K001253 |
| Lumenis VersaPulse PowerSuite Holmium<br>(Ho:YAG) and Dual Wavelength<br>(Ho:YAG/Nd:YAC) Surgical Lasers | K011703 |
| Medtronic Xomed Monopolar Energized<br>Blade | K002987 |

680 Vaqueros Avenue • Sunnyvale, CA 94085 • [phone] • Fax: [phone]

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#### Intended Use

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

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

#### Product Description

The ENTec Plasma Wands are bipolar, high frequency electrosurgical devices designed to be used in conjunction with the ENTec Coblator Plasma Surgery System.

## Substantial Equivalence

In establishing substantial equivalence to the predicate devices, ArthroCare evaluated the indications for use, materials incorporated, product specifications, and energy requirements of those systems. The expansion of the indications to include specific ENT procedures does not raise any new issues of safety or efficacy.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol in the center, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

# MAR 2 8 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Bruce Prothro Vice President, Regulatory Affairs, Quality Assurance, and Clinical Research ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936

Re: K014290

Trade/Device Name: ENTec® Plasma Wands™ Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 27, 2001 Received: December 28, 2001

Dear Mr. Prothro:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surfal to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce pror to 114) 2011-01-11 in accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, alors, and controls 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 or any I vith 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. Bruce Prothro

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 [phone]. Additionally, for questions on the promotion and advertising of your device, 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

for Celia M. Witten, Ph.D., M.D.
Director 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

ENTec® Plasma Wands™ Device Name: K 014290 510(k) Number:

#### Indications for Use:

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

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

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|--------------------------------------------------------|------|----------------------|
| Prescription Use<br>(Per 21 CFR 801 109) | X OR | Over-the-Counter Use |

Miriam C. Provost

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

510(k) Number K014290