ARTHROCARE ARTHRO WANDS, ENETEC EVAC PLASMA WAND

K013463 · Arthrocare Corp. · GEI · Nov 15, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K013463
• Device Name: ARTHROCARE ARTHRO WANDS, ENETEC EVAC PLASMA WAND
• Applicant: Arthrocare Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 15, 2001
• 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. The ENTec EVac Plasma Wand is indicated for ablation, coagulation, and hemostasis of soft tissue in tonsillectomy and adenoidectomy procedures.

Device Story

Bipolar, single-use, high-frequency electrosurgical devices. Used in arthroscopic, orthopedic, tonsillectomy, and adenoidectomy procedures. Operated by surgeons in clinical/OR settings. Devices utilize plasma-based electrosurgical technology to perform tissue ablation, resection, and coagulation. Output is controlled by the surgeon to achieve precise tissue effects, facilitating surgical access and hemostasis. Benefits include controlled tissue removal and reduced bleeding during minimally invasive procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing of modified performance specifications and materials.

Technological Characteristics

Bipolar, high-frequency electrosurgical device. Single-use. Plasma-based ablation/coagulation principle. Materials and performance specifications modified from predicate; specific standards not listed. Sterilization parameters remain consistent with predicate.

Indications for Use

Indicated for patients undergoing arthroscopic/orthopedic procedures (resection, ablation, coagulation, hemostasis) or tonsillectomy/adenoidectomy (ablation, coagulation, hemostasis). Applicable to various joints including ankle, elbow, hip, knee, shoulder, and 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 ArthroWands ENTec EVac Plasma Wand (K011083)
• ArthroCare ArthroWands ENTec EVac Plasma Wand (K011279)

Submission Summary (Full Text)

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K 013463

NOV 1 5 2001

### Special 510(k) Summary of Safety and Effectiveness ArthroCare Corporation ArthroCare ArthroWands® ENTec® EVac™ Plasma Wand™

Manufacturer:

ArthroCare, Corporation 595 North Pastoria Avenue Sunnyvale, CA 94085-2936

Establishment Registration Number:

Contact Person:

2951580

October 17, 2001

Bruce Prothro Vice President, Regulatory Affairs, Quality Assurance, and Clinical Research

Date Prepared:

Device Description

Classification Name:

Trade Name:

878.4400) ArthroCare ArthroWands®

Electrosurgical Device and Accessories

Device and Accessories (21 CFR

Electrosurgical Cutting and Coagulation

ENTec® EVac™ Plasma Wand™

Generic/Common Name:

Predicate Devices

ArthroCare ArthroWands ENTec EVac Plasma Wand K011083 K011279

#### Intended Use

ArthroCare ArthroWands

- The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of . soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:

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

| Arthroscopic and Orthopedic Procedures | Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and 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 |
| • 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 |
| Medial Retinaculum | Knee |
| Rotator Cuff | Shoulder |
| Tendon | All Joints |
| Wrist Tendons | Wrist |

.

、

:

04

100 - 100 -

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#### ENTec EVac Plasma Wand

- The ENTec EVac Plasma Wand is indicated for ablation, coagulation, and hemostasis . of soft tissue in tonsillectomy and adenoidectomy procedures.
#### Product Description

The Wands are bipolar, single use, high frequency electrosurgical devices designed for specific indications.

#### Substantial Equivalence

This Special 510(k) proposes a modification in performance specifications and materials for the Wands, which were previously cleared under K011083 and K011279 on June 28, 2001 and July 19, 2001, respectively. The indications for use, technology, principle of operation, dimensional specifications, packaging, labeling, and sterilization parameters of the Wands remain the same as in the predicate cleared 510(k)s.

#### Summary of Safety and Effectiveness

The modified Wands, as described in this submission, are substantially equivalent to the predicate devices. The proposed modification in performance specifications and materials 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 Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Bruce Prothro Vice President, Regulatory Affairs, Quality Assurance, and Clinical Research ArthroCare Corporation 595 North Pastoria Avenue Sunnyvale, California 94085-2936

Re: K013463

K013403
Trade/Device Name: ArthroCare ArthroWands®, ENTec® Evac™ Plasma Wand™ Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 17, 2001 Received: October 18, 2001

NOV 1 5 2001

Dear Mr. Prothro:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector of the device is substantially equivalent (for the indications felerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encrosuly to regars) at tegally and the Medical Device Amendments, or to commerce prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices mat have been recuired in assee approval of a premarket approval application (PMA). and Cosmetic Act (11ct) that do not requent of the general controls provisions of the Act. The 1 ou may, therefore, mailes of the Act include requirements for annual registration, listing of general controls provisions of the ling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classinod (600 wor of als. Existing major regulations affecting your device can Inay oc subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Over cements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Dri 3155aantes over device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must of any I coclar statutes and regulations and admited to: registration and listing (21 comply with an the 71ct 31equirements, neller, each, ence, except station requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) regalates (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1

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

Page 2 - Mr. Bruce Prothro

This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and in you'ls comming of substantial equivalence of your device to a legally premailed predicated 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 and 11 you deeline operate the vitro diagnostic devices), please contact the Office of additionally 21 [phone]. Additionally, for questions on the promotion and advertising of Compination at (301) 59 - t 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 Oiner general informational 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,

Susan Walker, MD

Image /page/4/Picture/5 description: The image contains what appears to be a signature or stylized initials. The writing is cursive and somewhat abstract, with looping strokes and sharp angles. It is difficult to discern specific letters or words without additional context.

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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# NOV 1 5 2001

## Indications Statement

Device Name:

ArthroCare ArthroWands® ENTec® EVac™ Plasma Wand™

K 013463 510(k) Number:

Indications for use:

## ArthroCare ArthroWands

- The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of . The ArthroCare Arthro Wanas are menous are menomen 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 |

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

| • 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 |
| 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 |

ENTec EVac Plasma Wand

- . The ENTec EVac Plasma Wand is indicated for ablation, coagulation, and hemostasis of soft tissue in tonsillectomy and adenoidectomy procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | X |
|------------------------------------------|---|
| OR | |
| Over-the-Counter Use | |

Susan Wall
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
KOI'S 4

510(k) Number -