MODIFICATON TO: ARTHROCARE ARTHROWANDS

K072865 · Arthrocare Corp. · GEI · Oct 23, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K072865
• Device Name: MODIFICATON TO: ARTHROCARE ARTHROWANDS
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 23, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

ArthroCare ArthroWands are bipolar, single-use, high-frequency electrosurgical devices. Used in arthroscopic and orthopedic procedures for soft tissue resection, ablation, coagulation, and hemostasis. Operated by surgeons in clinical settings. Device delivers high-frequency energy to target tissue; principle of operation involves electrosurgical cutting and coagulation. Output is controlled by the surgeon to achieve desired tissue effect, facilitating surgical intervention and potentially improving patient outcomes by enabling precise tissue management.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Bipolar, single-use, high-frequency electrosurgical device. Energy source: high-frequency electrosurgical generator. Sterilization: not specified. Form factor: wand/probe for arthroscopic use.

Indications for Use

Indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures (ankle, elbow, hip, knee, shoulder, wrist).

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

• ArthroCare ArthroWands (K071963)

Submission Summary (Full Text)

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K072865

# 510(k) Summary

OCT 2 3 2007

# ArthroCare Corporation ArthroCare ArthroWands

# General Information

| Submitter Name/Address: | ArthroCare Corporation<br>680 Vaqueros Avenue<br>Sunnyvale, CA 94085-3523 |
|------------------------------------|---------------------------------------------------------------------------|
| Establishment Registration Number: | 2951580 |
| Contact Person: | Valerie Defiesta-Ng<br>Director, Regulatory Affairs |
| Date Prepared: | October 4, 2007 |

Device Description

| Trade Name: | ArthroCare ^® ArthroWands ^® |
|----------------------|-------------------------------------------------------------------------------------|
| Generic/Common Name: | Electrosurgical Device and Accessories |
| Classification Name: | Electrosurgical Cutting and Coagulation<br>Device and Accessories (21 CFR 878.4400) |

Predicate Devices

| ArthroCare ^® ArthroWands ^® | K071963 |
|--------------------------------------------------|---------|
|--------------------------------------------------|---------|

### 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 soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:

| Arthroscopic and Orthopedic Procedures | Joint Specific or All<br>Joints (ankle, elbow,<br>hip, knee, shoulder, and<br>wrist) |
|----------------------------------------|--------------------------------------------------------------------------------------|
| <b>Ablation and Debridement</b> | |
| • 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 |
| <b>Excision and Resection</b> | |
| • 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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| Continued | |
|-----------|--|
| | |

| | Arthroscopic and Orthopedic Procedures | Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and wrist) |
|---|----------------------------------------|-----------------------------------------------------------------------------|
| • | 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 performance specifications, materials and labeling for the ArthroCare ArthroWands, which were previously cleared in K071963 (August 7, 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 performance, 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol resembling an abstract caduceus or a series of flowing lines, possibly representing human figures or a stylized bird.

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

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

OCT 2 3 2007

Re: K072865

Trade/Device Name: ArthroCare® ArthroWands® Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 4, 2007 Received: October 5, 2007

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 varie 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 [phone]. Also, please note the regulation on thitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You mon ontain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours.

P.K. Nohra Dr
123/n

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

510(k) Number:

к 072865

Device Name

ArthroCare® ArthroWands®

Indications for Use:

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<br>Joints (ankle, elbow,<br>hip, knee, shoulder, and<br>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 |

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| Arthroscopic and Orthopedic Procedures | Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and wrist) |
|----------------------------------------|-----------------------------------------------------------------------------|
| • 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 |

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)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________