MODIFICATION TO ENTEC PLASMA WANDS

K021364 · Arthrocare Corp. · GEI · May 30, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021364
• Device Name: MODIFICATION TO ENTEC PLASMA WANDS
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 30, 2002
• Decision: SESE
• Submission Type: Special
• 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, single-use, high-frequency electrosurgical devices. Used in ENT surgery for soft tissue ablation, resection, coagulation, and hemostasis. Operated by surgeons in clinical/OR settings. Device delivers high-frequency energy to target tissue; principle of operation involves plasma-mediated tissue effect. Output is controlled tissue modification (ablation/coagulation). Benefits include precise tissue removal and effective hemorrhage control during various ENT procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use identical to the predicate device.

Technological Characteristics

Bipolar electrosurgical wand; single-use; high-frequency energy source. Form factor designed for ENT surgical access. 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 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 Plasma Wands (K014290)

Submission Summary (Full Text)

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MAY 3 0 2002

Image /page/0/Picture/1 description: The image shows the logo for ArthroCare Corporation. The logo features a stylized letter "A" followed by the text "rthroCare" in a serif font. Below "rthroCare" is the word "CORPORATION" in smaller, sans-serif letters.

510(k) Summary 1021364 ArthroCare Corporation Electrosurgery Wands

General Information Submitters Name/Address: ArthroCare Corporation 680 Vaqueros Ave. Sunnyvale, CA 94085-2936 2951580 Establishment Registration Number: Valerie Defiesta-Ng Contact Person: Director, Regulatory Affairs [phone] Phone Number: April 29, 2002 Date Prepared: Device Description ENTec® Plasma Wands Trade Name: Electrosurgical Device and Accessories Generic/Common Name: Electrosurgical Cutting and Coagulation Classification Name: Device and Accessories (21 CFR 878.4400) Predicate Devices

ENTec Plasma Wands

K014290; cleared on March 28, 2002

#### Product Description

The Wands are bipolar, single use, high frequency electrosurgical devices designed for a variety of ENT applications.

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

## Substantial Equivalence

This Special 510(k) proposes a modification in labeling for the Wands, which were previously cleared under K014290 on March 28, 2002. The indications for use, technology, principle of operation, packaging, and sterilization parameters of the Wands remain the same as in the predicate cleared 510(k)s.

### Summary of Safety and Effectiveness

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2002

Ms. Valerie Defiesta-Ng Director, Regulatory Affairs ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936

Re: K021364

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: April 29, 2002 Received: April 30, 2002

Dear Ms. Defiesta-Ng:

We have reviewed your Section 510(k) premarket notification of intent to market the device w f nave roview your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass sured in the encreases)76 the enactment date of the Medical Device Amendments, or to econments that have been reclassified in accordance with the provisions of the Federal Food, Drug, de noos martie 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 r ou may , ateres, while 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. 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 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,

uriam 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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# Indications for Use Statement

Device Name:

ENTec® Plasma Wands

510(k) Number:

K 021364

Indications for use:

#### 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 I
- 프 Cysts
- Head, Neck, Oral, and Sinus Surgery 트
- 프 Mastoidectomy
- Myringotomy with Effective Hemorrhage Control ■
- Nasal Airway Obstruction by Reduction of Hypertrophic 피 Nasal Turbinates
- Nasopharyngeal/Laryngeal indications including 프 Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
- 이 Neck Mass
- 트 Papilloma Keloids
- 프 Submucosal Palatal Shrinkage
- Submucosal Tissue Shrinkage 피
- Tonsillectomy 해
- Traditional Uvulopalatoplasty (RAUP) 車
- Tumors 트
- 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)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use

Muriam C. Provost

(Division Sign-Off) (Division of General, Restorative Division ological Devices

510(k) Number K021364