ARTHROCARE ARTHROWANDS

K033584 · Arthrocare Corp. · GEI · Nov 28, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K033584
• Device Name: ARTHROCARE ARTHROWANDS
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 28, 2003
• 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. Operated by surgeons in clinical settings, the device performs resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels. The device functions via high-frequency electrical energy delivered to the target tissue. The surgeon uses the wand to precisely remove or coagulate tissue, facilitating surgical access and treatment. Benefits include controlled tissue management during minimally invasive orthopedic surgery.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Bipolar, single-use, high-frequency electrosurgical device. Materials modified from predicate. Energy source: high-frequency electrosurgical generator. Form factor: wand for arthroscopic/orthopedic 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) for patients requiring such surgical interventions.

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 System (K032504)

Submission Summary (Full Text)

{0}------------------------------------------------

NOV 2 8 2003

ArthroCare
CORPORATION

K0 33584

510(k) Summary

# 510(k) Summary

ArthroCare Corporation ArthroCare ArthroWands

Page ① of 3

### General Information

Submitter Name/Address:

ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-3523

Establishment Registration Number: Contact Person:

Valerie Defiesta-Ng Director, Regulatory Affairs

2951580

Date Prepared:

Device Description

Trade Name:

Generic/Common Name:

Classification Name:

ArthroCare® ArthroWands®

November 12, 2003

Electrosurgical Device and Accessories

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

Predicate Devices ArthroCare® System

K032504

#### Product Description

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

{1}------------------------------------------------

Page ② of 3

## 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) |
|----------------------------------------|--------------------------------------------------------------------------------------|
| 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 |

{2}------------------------------------------------

Page ③ g 3

#### Continued

| Arthroscopic and Orthopedic Procedures | Joint Specific or All<br>Joints (ankle, elbow,<br>hip, knee, shoulder, and<br>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 materials for the ArthroCare ArthroWands, which were previously cleared in K032504 on August 21, 2003. The indications for use, technology, principle of operation, packaging, sterilization parameters, and labeling of the ArthroCare ArthroWands remain the same as in the predicate cleared 510(k).

## 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 materials are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a wavy line.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 8 2003

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

Re: K033584

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: November 12, 2003 Received: November 13, 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.

{4}------------------------------------------------

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

sincerely yours,

Mark N Melbers

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

{5}------------------------------------------------

# Indications for Use Statement

Page ① of 2

Device Name ArthroCare ArthroWands

K 033584 510(k) Number:

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 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 |

Muhn Millen

ision Sign-Off)

icon el Cuponi. Restorative

od Neurological Devices

{6}------------------------------------------------

Page (3) of 2

| 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 |

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

Prescription Use (Per 21 CFR 801.109) X

OR

Over-the-Counter Use

fo Mark A Milkerson
(Division Mir-Off)

Division (1) Coperal, Restorative 1 Neurological Devices

Number K033584

X