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

Here's an analysis of the provided text regarding the ArthroCare ENT Plasma Wands, focusing on acceptance criteria and study details.

Based solely on the provided text, there is no information about a study that proves the device meets specific acceptance criteria.

The document is a 510(k) summary for a "Special 510(k)" submission. This type of submission is for modifications to a previously cleared device where the manufacturer attests that the changes do not significantly affect safety or efficacy. In such cases, a new clinical study to establish new acceptance criteria or performance is generally not required, as substantial equivalence to the predicate device is being claimed based on existing data and the minor nature of the changes.

Therefore, most of the requested fields cannot be answered definitively from this document.

Here's a breakdown of what can be extracted and what is explicitly not present:

1. Table of Acceptance Criteria and Reported Device Performance

Not present in the document. The document states: "The indications for use, technology, principle of operation, performance specifications, materials, and sterilization parameters of the Wands remain the same as in the predicate cleared 510(k)." This implies that the performance specifications (which would include acceptance criteria) reference the predicate a device (K030108), but the specifics are not detailed in this submission.

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

Not present in the document. As no new performance study is described for this "Special 510(k)," there is no mention of a test set, sample size, or data provenance.

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

Not present in the document. See point 2.

4. Adjudication Method for the Test Set

Not present in the document. See point 2.

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

No, one was not done (or at least not described in this document). This document primarily focuses on demonstrating substantial equivalence through design and material modifications, not through a new comparative effectiveness study.

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

Not applicable/Not present in the document. This is a physical electrosurgical device, not an AI algorithm.

7. The Type of Ground Truth Used

Not present in the document. See point 2.

8. The Sample Size for the Training Set

Not applicable/Not present in the document. See point 6.

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

Not applicable/Not present in the document. See point 6.

Summary of Device-Specific Information from the Text:

Device Name: ArthroCare® ENT Plasma Wands
Predicate Device: ArthroCare ArthroWands (K030108)
Modifications: Dimensional specifications, materials, and labeling.
Claim: These modifications are "not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices."
Intended Use: Ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery, with a comprehensive list of specific ENT procedures.

Summary

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OCT 3 0 2003

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

Page ①

510(k) Summary

ArthroCare Corporation ArthroCare ENT Plasma Wands KO33257

General Information

Submitter Name/Address:

ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936

Director, Regulatory Affairs

Establishment Registration Number:

2951580

Contact Person:

Date Prepared:

Device Description

Trade Name:

Generic/Common Name:

Classification Name:

October 8, 2003

Valerie Defiesta-Ng

ArthroCare® ENT Plasma Wands

Electrosurgical Device and Accessories

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

Predicate Devices

ArthroCare ArthroWands

K030108

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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page 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
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
에 Submucosal Palatal Shrinkage
발 Submucosal Tissue Shrinkage
Tonsillectomy
Traditional Uvulopalatoplasty (RAUP) 프
8 Tumors
Tissue in the Uvula/Soft Palate for the Treatment of Snoring

Substantial Equivalence

This Special 510(k) proposes modifications in dimensional specifications, materials, and labeling for the ArthroCare ENT Plasma Wands, which were previously cleared under K030108 on February 3, 2003. The indications for use, technology, principle of opcration, performance specifications, materials, and sterilization parameters of the Wands remain the same as in the predicate cleared 510(k).

Summarv of Safety and Effectiveness

The modified ArthroCare ENT Plasma Wands, as described in this submission, are substantially equivalent to the predicate Wands. The proposed modification in dimensional specifications, materials, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 0 2003

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

Re: K033257

Trade/Device Name: ArthroCare® ENT Plasma Wands Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 8, 2003 Received: October 10, 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, 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), please contact the Office of Compliance at (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

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:	ArthroCare ENT Plasma Wands
--------------	-----------------------------

KO33257 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 ■
트 Cysts
Head, Neck, Oral, and Sinus Surgery 지
트 Mastoidectomy
Myringotomy with Effective Hemorrhage Control 모
Nasal Airway Obstruction by Reduction of Hypertrophic 보 Nasal Turbinates
Nasopharyngeal/Laryngeal indications including Tracheal ■ Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
피 Neck Mass
Papilloma Keloids
Submucosal Palatal Shrinkage ■
Submucosal Tissue Shrinkage ■
Tonsillectomy 트
Traditional Uvulopalatoplasty (RAUP) ■
Tumors
Tissue in the Uvula/Soft Palate for the Treatment of 트 Snoring

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

Prescription Use

Over-the-Counter Use

(Per 21 CFR 801.109)

Miriam C. Provost

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

510(k) Number K033257

İ X

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.