ARTHROCARE CONTROLLER (SYSTEM 12000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS

K082666 · Arthrocare Corp. · GEI · Oct 15, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082666
• Device Name: ARTHROCARE CONTROLLER (SYSTEM 12000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 15, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ArthroCare System 12000 is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:

Device Story

ArthroCare System 12000 is a bipolar, high-frequency electrosurgical generator (Controller) used with disposable, bipolar, single-use Wands. Device operates in arthroscopic and orthopedic surgical settings; physician-operated. System delivers electrical energy to Wands to perform soft tissue ablation, resection, coagulation, and hemostasis. Output allows precise tissue management during joint procedures; benefits include controlled tissue removal and bleeding management. No complex AI/ML algorithms; standard electrosurgical power delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bipolar high-frequency electrosurgical generator. System includes Controller and disposable bipolar Wands. Energy type: high-frequency electrical. Connectivity: standalone. Sterilization: not specified for generator; Wands are single-use.

Indications for Use

Indicated for soft tissue resection, ablation, coagulation, and hemostasis in arthroscopic and orthopedic procedures across all joints (ankle, elbow, hip, knee, shoulder, wrist). Specific procedures include ACL/PCL repair, acromioplasty, chondroplasty, meniscectomy, 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® System 12000 (K071709)

Submission Summary (Full Text)

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OCT 1 5 2008

82666

Page 173

## 510(k) Summary

# ArthroCare Corporation ArthroCare® System 12000

## 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: | September 11, 2008 |

**Device Description**

| Trade Name: | ArthroCare® System 12000 |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| Generic/Common Name: | Electrosurgical Device and Accessories |
| Classification Name: | Electrosurgical Cutting and Coagulation<br>Device and Accessories (Class II, 21 CFR<br>878.4400, Product Code GEI) |

**Predicate Devices**

| ArthroCare® System 12000 | K071709 |
|--------------------------|---------|
|--------------------------|---------|

### Product Description

The ArthroCare® System 12000 is a bipolar, high frequency, electrosurgical generator called the Controller that is intended to be used with a family of disposable, binolar, single use Wands.

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#### Intended Uses

The ArthroCare System 12000 is 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 |
| • | Fascia | 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 |
| 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 a modification in the performance specifications and labeling for the ArthroCare System 12000, which was previously cleared in K071709 on August 7, 2007. The indications for use, technology, principle of operation, materials, packaging, and sterilization parameters of the ArthroCare System 12000 remain the same as in the predicate cleared 510(k).

#### Summary of Safety and Effectiveness

The modified ArthroCare System 12000, as described in this Special 510(k), is substantially equivalent to the predicate device. The proposed modifications in performance specifications and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K082666

Trade/Device Name: ArthroCare System 12000 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 25, 2008 Received: September 29, 2008

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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Prosmarket, Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 N. Millman

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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Page 1 of 2

# Indications for Use Statement

ArthroCare System 12000 Device Name

K_____________________________________________________________________________________________________________________________________________________________________________ 510(k) Number:

Indications for Use:

The ArthroCare System 12000 is 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 |
| • Fascia | 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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s.666

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 |

(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) OR

Over-the-Counter Use

D.A.

X

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

**510(k) Number** k082666