ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS

K093165 · Arthrocare Corp. · GEI · Dec 4, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K093165
• Device Name: ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 4, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ArthroCare System 15000 is 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 System 15000 is a bipolar, high-frequency electrosurgical system used in arthroscopic and orthopedic surgery. It comprises a Controller (generator), disposable bipolar Wands, and a Foot Control. The system delivers high-frequency energy to the surgical site to perform soft tissue resection, ablation, coagulation, and hemostasis. Operated by surgeons in clinical/OR settings, the device provides precise tissue management through bipolar electrosurgical technology. The output allows for controlled tissue removal and bleeding management, potentially reducing surgical time and improving patient outcomes in joint procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and design modifications.

Technological Characteristics

Bipolar electrosurgical system; high-frequency generator (Controller); disposable bipolar Wands; Foot Control. Operates via bipolar electrosurgical cutting and coagulation principle. Sterilization parameters remain consistent with the predicate.

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).

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 15000 (K090393)

Submission Summary (Full Text)

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K093165

# DEC - 4 2009

### 510(k) Summary

## ArthroCare Corporation ArthroCare System 15000

### General Information

Submitter Name/Address:

Establishment Registration Number: Contact Person:

2951580

October 5, 2009

Valerie Defiesta-Ng Director, Regulatory Affairs

ArthroCare Corporation

680 Vaqueros Avenue Sunnyvale, CA 94085-3523

Date Prepared:

Device Description

Trade Name:

Generic/Common Name:

Classification Name:

ArthroCare System 15000

Electrosurgical Device and Accessories

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

#### Predicate Devices

ArthroCare System 15000

K090393

#### Product Description

The ArthroCare System 15000 consists of a bipolar, high frequency, electrosurgical generator called the Controller, a family of disposable, bipolar, single use Wands and Foot Control.

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### Intended Use

………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

The ArthroCare System 15000 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) |
|----------------------------------------|--------------------------------------------------------------------------------------|
| <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 |

21

۱ ,

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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) is requesting modifications in the material, physical specifications, performance and labeling for the ArthroCare System 15000 which consists of the ArthroCare 15000 RF Controller and specific ArthroCare ArthroWands (the Wands). The ArthroCare System 15000 was previously cleared in K090393 on June 23, 2009. The indications for use, technology, principle of operation, and sterilization parameters of the ArthroCare System 15000 remain the same as in the predicate cleared 510(k).

#### Summary of Safety and Effectiveness

The modified ArthroCare System 15000, as described in this Special 510(k), is substantially equivalent to the predicate device. The proposed modifications in 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 consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

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

DEC - 4 2009

Re: K093165

Trade/Device Name: ArthoCare System 15000 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 10, 2009 Received: November 12, 2009

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 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); medical device reporting (reporting of medical

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Page 2 - Ms. Valerie Defiesta-Ng

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

For

N. Melkerson

Dic

D.C.

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

510(k) Number: K

ArthroCare System 15000® Device Name

Indications for Use:

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

The ArthroCare System 15000 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 |
| • | 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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Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093165

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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 |

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

X

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)

FOR M-MELKERSON

(Division Sign-Off) (Division Sign-On) Orthopedic, Division of Surgical Mishorative Devices

510(k) Number K093165