The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:

Arthroscopic and Orthopedic Procedures	Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and wrist)
Ablation and Debridement
ACL/PCL	Knee
Acromioplasty	Shoulder
Articular Cartilage	All Joints
Bursectomy	All Joints
Chondroplasty	All Joints
Facia	All Joints
Ligament	All Joints
Notchplasty	Knee
Scar Tissue	All Joints
Soft Tissue	All Joints
Subacromial Decompression	Shoulder
Synovectomy	All Joints
Tendon	All Joints
Excision and Resection
Acetabular Labrum	Hip
Articular Labrum	All Joints
Capsule	All Joints
Capsular Release	Knee
Cartilage Flaps	Knee
Cysts	All Joints
Discoid Meniscus	Knee
Frozen Shoulder Release	Shoulder
Glenoidale Labrum	Shoulder
Lateral Release	Knee
Ligament	All Joints
Loose Bodies	All Joints
Meniscal Cystectomy	Knee
Meniscectomy	Knee
Plica Removal	All Joints
Scar Tissue	All Joints
Soft Tissue	All Joints
Synovial Membrane	All Joints
Tendon	All Joints
Triangular Fibrocartilage (TFCC)	Wrist
Villusectomy	Knee
Coagulation
ACL/PCL	Knee
Articular Cartilage	All Joints
Carpal Ligaments	Wrist
Glenohumeral Capsule	Shoulder
Ligament	All Joints
Medial Retinaculum	Knee
Rotator Cuff	Shoulder
Tendon	All Joints
Wrist Tendons	Wrist

Device Description

The ArthroCare ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.

AI/ML Overview

This 510(k) summary does not contain information on acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. The document describes modifications to the ArthroCare ArthroWands, which were previously cleared, and asserts that these modifications are not substantial and do not significantly affect safety or efficacy. The review is for "substantial equivalence" to a predicate device, not for specific performance metrics based on new studies.

Therefore, the requested information cannot be extracted from the provided text.

Summary

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K082323

510(k) Summary

ArthroCare Corporation ArthroCare ArthroWands

AUG 2 8 2008

General Information

Submitter Name/Address:

Establishment Registration Number: Contact Person:

Date Prepared:

Device Description

Trade Name:

Generic/Common Name:

Classification Name:

ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-3523

2951580

Valerie Defiesta-Ng Director, Regulatory Affairs

August 11, 2008

ArthroCare® ArthroWands®

Electrosurgical Device and Accessories

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

Predicate Devices

ArthroCare® ArthroWands®

K072865

Product Description

The ArthroCare ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.

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Intended Uses

The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of The Tital Ocale TimboWands are ressels in arthroscopic and orthopedic procedures:

Arthroscopic and Orthopedic Procedures	Joint Specific or AllJoints (ankle, elbow,hip, knee, shoulder, andwrist)
Ablation and Debridement
• ACL/PCL	Knee
• Acromioplasty	Shoulder
• Articular Cartilage	All Joints
• Bursectomy	All Joints
• Chondroplasty	All Joints
• Facia	All Joints
• Ligament	All Joints
• Notchplasty	Knee
• Scar Tissue	All Joints
• Soft Tissue	All Joints
• Subacromial Decompression	Shoulder
• Synovectomy	All Joints
• Tendon	All Joints
Excision and Resection
• Acetabular Labrum	Hip
• Articular Labrum	All Joints
• Capsule	All Joints
• Capsular Release	Knee
• Cartilage Flaps	Knee
• Cysts	All Joints
• Discoid Meniscus	Knee
• Frozen Shoulder Release	Shoulder
• Glenoidale Labrum	Shoulder
• Lateral Release	Knee
• Ligament	All Joints
• Loose Bodies	All Joints
• Meniscal Cystectomy	Knee
• Meniscectomy	Knee

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Arthroscopic and Orthopedic Procedures	Joint Specific or AllJoints (ankle, elbow,hip, knee, shoulder, andwrist)
• Plica Removal	All Joints
• Scar Tissue	All Joints
• Soft Tissue	All Joints
• Synovial Membrane	All Joints
• Tendon	All Joints
• Triangular Fibrocartilage (TFCC)	Wrist
• Villusectomy	Knee
Coagulation
• ACL/PCL	Knee
• Articular Cartilage	All Joints
• Carpal Ligaments	Wrist
• Glenohumeral Capsule	Shoulder
• Ligament	All Joints
• Medial Retinaculum	Knee
• Rotator Cuff	Shoulder
• Tendon	All Joints
• Wrist Tendons	Wrist

Substantial Equivalence

This Special 510(k) proposes modifications in the materials specification and labeling for the ArthroCare ArthroWands, which were previously cleared in K072865 (October 23, 2007). The indications for use, technology, principle of operation, and sterilization parameters of the ArthroCare ArthroWands remain the same as in the predicate cleared 510(k)s.

Summary of Safety and Effectiveness

The modified ArthroCare ArthroWands, as described in this Special 510(k), are substantially equivalent to the predicate device. The proposed modifications in the 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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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Arthrocare Corporation % Ms. Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-3523

AUG 2 8 2008

Re: K082323

Trade/Device Name: ArthoCare® ArthroWands® Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 11, 2008 Received: August 14, 2008

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

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Page 2 - Ms. Valerie Defiesta-Ng

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,

Mark N Millman

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

к_082323 510(k) Number:

ArthroCare® ArthroWands® Device Name

Indications for Use:

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

510(k) Number K082323

The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:

Arthroscopic and Orthopedic Procedures	Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and wrist)
Ablation and Debridement
●	ACL/PCL	Knee
●	Acromioplasty	Shoulder
●	Articular Cartilage	All Joints
●	Bursectomy	All Joints
●	Chondroplasty	All Joints
●	Facia	All Joints
●	Ligament	All Joints
●	Notchplasty	Knee
●	Scar Tissue	All Joints
●	Soft Tissue	All Joints
●	Subacromial Decompression	Shoulder
●	Synovectomy	All Joints
●	Tendon	All Joints
Excision and Resection
●	Acetabular Labrum	Hip
●	Articular Labrum	All Joints
●	Capsule	All Joints
●	Capsular Release	Knee
●	Cartilage Flaps	Knee
●	Cysts	All Joints
●	Discoid Meniscus	Knee
●	Frozen Shoulder Release	Shoulder
●	Glenoidale Labrum	Shoulder
●	Lateral Release	Knee
●	Ligament	All Joints
●	Loose Bodies	All Joints
●	Meniscal Cystectomy	Knee
●	Meniscectomy	Knee

$$x$$

1000

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Arthroscopic and Orthopedic Procedures	Joint Specific or AllJoints (ankle, elbow,hip, knee, shoulder, andwrist)
• Plica Removal	All Joints
• Scar Tissue	All Joints
• Soft Tissue	All Joints
• Synovial Membrane	All Joints
• Tendon	All Joints
• Triangular Fibrocartilage (TFCC)	Wrist
• Villusectomy	Knee
Coagulation
• ACL/PCL	Knee
• Articular Cartilage	All Joints
• Carpal Ligaments	Wrist
• Glenohumeral Capsule	Shoulder
• Ligament	All Joints
• Medial Retinaculum	Knee
• Rotator Cuff	Shoulder
• Tendon	All Joints

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR X

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Mark A. Milliman

(Division Sign iorative, Div

ಚಿ

france fr

K0823

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.