MODIFICATION TO: ARTHROCARE ARTHROWANDS

K071963 · Arthrocare Corp. · GEI · Aug 7, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K071963
• Device Name: MODIFICATION TO: ARTHROCARE ARTHROWANDS
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 7, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

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:

Device Story

ArthroCare ArthroWands are bipolar, single-use, high-frequency electrosurgical devices used in arthroscopic and orthopedic surgery. Operated by surgeons, the device performs soft tissue resection, ablation, coagulation, and hemostasis. The device functions via high-frequency electrical energy to interact with tissue. It is used in clinical settings during orthopedic procedures to treat conditions such as ligament tears, cartilage damage, and joint inflammation. By providing precise tissue management, the device assists surgeons in performing minimally invasive joint repairs, potentially reducing patient recovery time and improving surgical outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, technological characteristics, and intended use comparisons to predicate devices.

Technological Characteristics

Bipolar, single-use, high-frequency electrosurgical device. Operates via electrosurgical cutting and coagulation principles. Designed for arthroscopic/orthopedic use.

Indications for Use

Indicated for resection, ablation, coagulation of soft tissue and hemostasis in arthroscopic and orthopedic procedures across all joints (ankle, elbow, hip, knee, shoulder, wrist). Specific procedures include ACL/PCL, acromioplasty, chondroplasty, synovectomy, meniscal cystectomy, and various ligament/tendon releases.

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 (K070958)
• ArthroCare System (K040338)

Submission Summary (Full Text)

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K071963
510(k) Summary

Page 1 of 3

# ArthroCare Corporation ArthroCare ArthroWands

AUG - 7 2007

### 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: | July 13, 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 ^® | K070958 |
|--------------------------------------------------|---------|
| ArthroCare System | K040338 |

#### 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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Ko 7 1963

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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) |
|--------------------------|----------------------------------------|--------------------------------------------------------------------------------------|
| 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 |

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K071963

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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 |
| 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 and labeling for the ArthroCare ArthroWands, which were previously cleared in K070958 (April 23, 2007) and K040338 (March 1, 2004). 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 modification in the material is a not substantial change or modification, and does not significantly affect the safety or efficacy of the devices.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, with three intertwined snakes ascending towards the right. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K071963

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: July 13, 2007 Received: July 16, 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.

AUG - 7 2007

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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 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/industry/support/index.html.

Sincerely yours,

Mark A. Millerson

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:

KO 71963

ArthroCare® ArthroWands® Device Name

Page 1 of 2

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 |

Mall. n Millan

on Sign-Off)
on of General, Restorative,
Neurological Devices

·

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Ko 71963

Page 2 of ②

| Continued | |
|----------------------------------------|--------------------------------------------------------------------------------|
| Arthroscopic and Orthopedic Procedures | Joint Specific or All<br>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

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 M. Mckenna

X

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

510(k) Number_

K071963