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 Description

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

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device (ArthroCare® ENT Plasma Wands) and does not describe a study that conducted testing with associated acceptance criteria. Instead, it describes a "Special 510(k)" submission for a material modification to a previously cleared device.

The key points from the text related to performance, acceptance criteria, and studies are:

Substantial Equivalence: The document states that the modified ArthroCare ENT Plasma Wands are "substantially equivalent" to a predicate device (K033257). This is a regulatory pathway and not a performance study demonstrating new acceptance criteria.
No new performance criteria: The submission explicitly states: "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)."
No new study presented: Because the performance specifications are stated to be the same, and the modification is primarily material, the document does not present a new study with acceptance criteria to demonstrate device performance. It relies on the substantial equivalence to the previously cleared device.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted from this specific document, as those types of studies were not included in this Special 510(k) submission.

Summary based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria or specific reported device performance data from a new study. It asserts that the "performance specifications... remain the same as in the predicate cleared 510(k)" (K033257).

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No new test set data is presented as part of this Special 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. No new test set requiring expert ground truth establishment is described.

4. Adjudication Method for the Test Set

Not applicable. No new test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not describe an MRMC comparative effectiveness study.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not applicable. This device is an electrosurgical wand; it is not an AI algorithm.

7. The Type of Ground Truth Used

Not applicable. No new study requiring ground truth is described.

8. The Sample Size for the Training Set

Not applicable. This device is an electrosurgical wand; there is no AI algorithm with a training set discussed.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set discussed.

Summary

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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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
---------------	---------

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.