ABLATOR ELECTRODE

K983652 · Linvatec Corp. · HRX · Mar 23, 1999 · Orthopedic

Device Facts

• Record ID: K983652
• Device Name: ABLATOR ELECTRODE
• Applicant: Linvatec Corp.
• Product Code: HRX · Orthopedic
• Decision Date: Mar 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ablator Electrode is designed for general surgical use, including orthopaedic and arthroscopic applications resection, ablation, excision of soft tissue, of hemostasis of blood vessels and in coagulating soft tissues. Arthroscopic surgery includes the following: Knee 1. Meniscectomy 2. Lateral Release 3. Chondroplasty 4. Synovectomy 5. ACL Debridement 6. Plica Removal 7. Meniscal Cystectomy Ankle 1. Fracture Debridement 2. Excision of Scar Tissue 3. Synovectomy 4. Chondroplasty Wrist 1. Synovectomy 2. Cartiledge Debridement 3. Fracture Debridement Shoulder 1. Labral Tear Resection 2. Synovectomy 3. Excision of Scar Tissue 4. Acromioplasty 5. Bursectomy 6. Subacromial Decompression 7. Chondroplasty Elbow 1. Synovectomy 2. Tendon Debridement 3. Chondroplasty

Device Story

Electrosurgical device for soft tissue management; includes electrode, pencil, and dispersive pad. Connects to electrosurgical generator to deliver energy for resection, ablation, excision, and coagulation. Used by surgeons in clinical/OR settings for orthopaedic and arthroscopic procedures. Provides precise tissue effect via electrical energy; aids in surgical visualization and tissue removal; benefits patient through minimally invasive access and controlled tissue destruction/hemostasis.

Clinical Evidence

Bench testing only.

Technological Characteristics

Electrosurgical electrode; kit includes pencil and dispersive pad. Connects to external electrosurgical generator. Class II device.

Indications for Use

Indicated for general surgical use, including orthopaedic and arthroscopic soft tissue resection, ablation, excision, and hemostasis/coagulation. Applicable to knee, ankle, wrist, shoulder, and elbow procedures. Prescription use only.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• ESA Electrodes (Linvatec Corporation)
• ArthroCare® Electrosurgery System 2000 (ArthroCare Corporation)
• VAPR™ (Mitek Products)

Submission Summary (Full Text)

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3/23/99

Image /page/0/Picture/1 description: The image shows the logo for Linvatec. The logo consists of a geometric shape on the left and the word "Linvatec" on the right. The geometric shape is a stylized diamond with three lines inside. The word "Linvatec" is in a bold, sans-serif font.

11311 Concept Boulevard Largo, Florida 33773 727 399-5334 Fax [phone]

Carol A. Weideman, Ph.D.

Director Compliance and Regulatory Affairs October 16, 1998

### SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the Ablator Electrode, 510(k) Number K 983653

#### A. Submitter

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

#### B. Company Contact

Carol A. Weideman, Ph.D. Director, Compliance and Regulatory Affairs

#### c. Device Name

| Trade Name: | : | Ablator Electrode |
|-----------------------------------------|---|--------------------------------------------------------------------------------|
| Common Name | : | Electrode |
| Classification Names | : | Electrosurgical cutting and<br>coagulation device and<br>accessories, 878.4400 |
| Proposed Class/Device :<br>Product Code | : | Class II, 79 JOS, Electrode,<br>Electrosurgical |

#### D. Predicate/Legally Marketed Devices

ESA Electrodes Linvatec Corporation

ArthroCare® Electrosurgery System 2000 ArthroCare Corporation

VAPR™ Mitek Products

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Summary of Safety and Effectiveness Ablator Electrode 510(k) # October 16,1998 Page 2 of 3

### E. Device Description

The Ablator Electrode is packaged in a kit containing an Electrode, pencil, and a Ablator electrosurgical dispersive pad. The electrode will also be individually. The electrode is connected sold to an electrosurgical generator via the electrosurgical pencil.

# F. Intended Use

The Ablator Electrode is designed for general surgical use, including orthopaedic and arthroscopic applications resection, ablation, excision of soft tissue, of hemostasis of blood vessels and in coagulating soft tissues. Arthroscopic surgery includes the following:

# Knee

- 1. Meniscectomy
- 2. Lateral Release
- 3. Chondroplasty
- 4. Synovectomy
- 5. ACL Debridement
- 6. Plica Removal
- 7. Meniscal Cystectomy

# Ankle

- 1. Fracture Debridement
- 2. Excision of Scar Tissue
- 3. Synovectomy
- 4. Chondroplasty

### Wrist

- 1. Synovectomy
- 2. Cartiledge Debridement
- 3. Fracture Debridement

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## Intended Use (cont.)

#### Shoulder

- 1. Labral Tear Resection
- 2. Synovectomy
- 3. Excision of Scar Tissue
- 4. Acromioplasty
- 5. Bursectomy
- 6. Subacromial Decompression
- 7. Chondroplasty

#### Elbow

- 1. Synovectomy
- 2. Tendon Debridement
- 3. Chondroplasty

#### G. Substantial Equivalence

The Ablator Electrode is substantially equivalent in design, function and intended use to the ESA Electrodes (Linvatec Corporation), ArthroCare® Electrosurgery System 2000 (ArthroCare Corporation), and VAPR™ (Mitek Products)

Testing has been done to prove safety and effectiveness of the devices.

The similarities/dissimilarities to the predicates are shown in the attached table.

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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 stylized image of an eagle with three curved lines representing its body and wings. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 1999

Ms. Laura D. Seneff Manager, Regulatory Affairs Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908

Re: K983652 Trade Name: Ablator Electrode Regulatory Class: II Product Code: HRX and GEI Dated: February 16, 1999 Received: February 17, 1999

Dear Ms. Seneff:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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# Page 2 – Ms. Laura D. Seneff

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Sincerely, John,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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3/23/99

Image /page/5/Picture/1 description: The image shows the logo for Linvatec. The logo consists of a geometric shape on the left and the word "Linvatec" on the right. The geometric shape is a black diamond with three white chevrons inside. The word "Linvatec" is written in a bold, sans-serif font.

11311 Concept Boulevard Largo, Florida 33773-4908 813 392-6464

October 16, 1998

Page 1 of 2

510(k) Number (if known): k983652

Device Name: Ablator Electrode

Indications for Use:

The Ablator Electrode is designed for general surgical use, including orthopaedic and arthroscopic applications of resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissues. Arthroscopic surgery includes the following:

### Knee

- 1. Meniscectomy
- 2. Lateral Release
- 3. Chondroplasty
- 4. Synovectomy
- 5. ACL Debridement
- 6. Plica Removal
- 7. Meniscal Cystectomy

#### Ankle

- 1. Fracture Debridement
- 2. Excision of scar tissue
- 3. Synovectomy
- 4. Chondroplasty

# Wrist

- 1. Synovectomy
- 2. Cartilage Debridement
- 3. Fracture Debridement

# Shoulder

- 1. Labral Tear Resection
- 2. Synovectomy
- 3. Excision of Scar Tissue
- 4. Acromioplasty
- 5. Bursectomy
- 6. Subacromial Decompression
- 7. Chondroplasty

bn Sign-Off) of General Restorative Devices

**Prescription Use**
(Per 21 CFR 801.109)

2

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# Intended Use (cont.)

Page 2 of 2

Elbow

- 1. Synovectomy
- 2. Tendon Debridement
- 3. Chondroplasty

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR

Over-the-Counter Use_

(Per 21 CFR 801.109)

(Optio

(Optional Format 1-296)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K983652