ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE PATIENT CABLE; FOOT CONTROL; POWER CORD; WANDS

K030551 · Arthrocare Corp. · GEI · Mar 7, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030551
• Device Name: ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE PATIENT CABLE; FOOT CONTROL; POWER CORD; WANDS
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 7, 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:

Device Story

ArthroCare ArthroWands are bipolar, single-use, high-frequency electrosurgical devices. Used in arthroscopic and orthopedic procedures to resect, ablate, and coagulate soft tissue and achieve hemostasis. Operated by surgeons in clinical settings. Device delivers high-frequency energy to target tissue; principle of operation remains consistent with predicate. Modifications in this submission include dimensional specifications, materials, and labeling. Benefits include precise tissue management during minimally invasive joint surgery.

Clinical Evidence

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

Technological Characteristics

Bipolar, high-frequency electrosurgical device. Single-use. Materials and dimensional specifications modified from predicate. Sterilization parameters remain unchanged.

Indications for Use

Indicated for resection, ablation, coagulation of soft tissue and hemostasis in arthroscopic and orthopedic procedures (ankle, elbow, hip, knee, shoulder, wrist). Procedures include ACL/PCL, acromioplasty, chondroplasty, synovectomy, meniscectomy, and various ligament/tendon/capsule repairs.

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 (K020557)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for ArthroCare Corporation. Below the logo is the text "K030551" and a horizontal line. Under the line is the text "510(k) Summary".

MAR 0 7 2003

ArthroCare Corporation ArthroCare ArthroWands

| General Information | |
|---------------------------------------------|----------------------------------------------------------------------------------------|
| Submitter Name/Address: | ArthroCare Corporation<br>680 Vaqueros Avenue<br>Sunnyvale, CA 94085-2936 |
| Establishment Registration Number: | 2951580 |
| Contact Person: | Valerie Defiesta-Ng<br>Director, Regulatory Affairs |
| Date Prepared: | February 20, 2003 |
| 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<br>878.4400) |
| Predicate Devices<br>ArthroCare ArthroWands | K020557 |

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

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#### Continued

### Substantial Equivalence

This Special 510(k) proposes modifications in dimensional specifications, materials, and labeling for the ArthroCare ArthroWands, which were previously cleared under K020557 on March 21, 2002. The indications for use, technology, principle of operation, performance specifications, materials, 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 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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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

MAR 0 7 2003

Re: K030551

Trade/Device Name: ArthroCare® ArthroWands® Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: February 20, 2003 Received: February 21, 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

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Page 2 – Ms. Valerie Defiesta-Ng

(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. 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). Other general information on your responsibilities under the Act may be obtained 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,

iriam C. Provost

Col 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 ArthroWands

510(k) Number: K_030551

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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### 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 |
| <b>Coagulation</b> | |
| • 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

X

OR

Over-the-Counter Use

(Per 21 CFR
801.109)

iriam C. Provost

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

510(k) Number K630551

İX