ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS

K020557 · Arthrocare Corp. · GEI · Mar 21, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020557
• Device Name: ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 21, 2002
• 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: (Table of procedures including ACL/PCL, Acromioplasty, Articular Cartilage, Bursectomy, Chondroplasty, Facia, Ligament, Notchplasty, Scar Tissue, Soft Tissue, Subacromial Decompression, Synovectomy, Tendon, Acetabular Labrum, Articular Labrum, Capsule, Capsular Release, Cartilage Flaps, Cysts, Discoid Meniscus, Frozen Shoulder Release, Glenoidale Labrum, Lateral Release, Loose Bodies, Meniscal Cystectomy, Meniscectomy, Plica Removal, Synovial Membrane, Triangular Fibrocartilage (TFCC), Villusectomy, Carpal Ligaments, Glenohumeral Capsule, Medial Retinaculum, Rotator Cuff, and Wrist Tendons across various joints including ankle, elbow, hip, knee, shoulder, and wrist).

Device Story

ArthroCare ArthroWands are bipolar, single-use, high-frequency electrosurgical devices; used in arthroscopic and orthopedic procedures. Device delivers electrical energy to soft tissue for resection, ablation, and coagulation; also provides hemostasis of blood vessels. Operated by surgeons in clinical settings. Output allows for precise tissue removal and bleeding control, facilitating minimally invasive joint surgery. Benefits include reduced tissue trauma and improved surgical efficiency.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and performance specifications compared to the predicate device.

Technological Characteristics

Bipolar, high-frequency electrosurgical device. Single-use. Designed for arthroscopic/orthopedic use. Materials and performance specifications modified from predicate. Sterilization parameters remain unchanged.

Indications for Use

Indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures involving the ankle, elbow, hip, knee, shoulder, and 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 (K013463)

Submission Summary (Full Text)

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## MAR 2 1 2002

## 510(k) Summary

ArthroCare Corporation ArthroCare ArthroWands

02055 T

General Information

Submitter Name/Address:

ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936

Establishment Registration Number:

2951580

Bruce Prothro Vice President, Regulatory Affairs, Quality Assurance, and Clinical Research

Date Prepared:

Contact Person:

Device Description

Trade Name:

Generic/Common Name:

Classification Name:

February 19, 2002

ArthroCare® ArthroWands®

Electrosurgical Device and Accessories

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

Predicate Devices

ArthroCare ArthroWands

K013463

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

xi

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#### Continued

#### Substantial Equivalence

This Special 510(k) proposes modifications in performance specifications, materials, and I ma openare on Arthro Wands, which were previously cleared under K013463 lucember 15, 2001. The indications for use, technology, principle of operation, dimensional specifications, packaging, and sterilization parameters of the ArthroWands remain the same as in the predicate cleared 510(k).

### Summary of Safety and Effectiveness

The modified ArthroWands, as described in this submission, are substantially equivalent to the predicate ArthroWands. The proposed modification in performance 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/3/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, symbolizing protection and care. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circle's perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2002

Mr. Bruce Prothro Vice President, Regulatory Affairs, Quality Assurance, and Clinical Research ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936

Re: K020557

Trade/Device Name: ArthroCare® Arthro Wands® Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 19, 2002 Received: February 20, 2002

Dear Mr. Prothro:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalled the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, de noos mat have been that do not require approval of a premarket approval application (PMA). and Oosmeter For (110) kes the device, subject to the general controls provisions of the Act. The r ou may, dicrorere, mains 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 If your device is olassined (600 aboverols. 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has mas and regulations administered by other Federal agencies. You must or any I vith 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 -- Mr. Bruce Prothro

This letter will allow you to begin marketing your device as described in your Section 510(k) r ms letter with ation. The FDA finding of substantial equivalence of your device to a legally premaince hourier 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 11 you desire specific and 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 O wision 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,

Muriane C. Rivort

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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## MAR 2 1 2002

# Indications for Use Statement

Device Name:

ArthroCare ArthroWands

510(k) Number:

K020557

Indications for use:

The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of The Firmoodie Tirano is 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 |

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#### Continued

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

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

X Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter Use

Muriann C. Provost

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

510(k) Number K020559

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