TRIDENT RESECTION ABLATOR

K033748 · Linvatec Corp. · GEI · Dec 15, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K033748
• Device Name: TRIDENT RESECTION ABLATOR
• Applicant: Linvatec Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 15, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Trident Resection Ablator is intended to be used in arthroscopic procedures for resection and ablation of soft tissue, and hemostasis of blood vessels.

Device Story

Trident Resection Ablator combines 4.2mm arthroscopic shaver blade with monopolar electrode; provides mechanical resection, tissue ablation, and hemostasis. Used in arthroscopic procedures by surgeons. Device supplied sterile for single use. Modification involves change in electrical insulation coating material; does not alter fundamental technology or performance.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Combination device: 4.2mm mechanical shaver blade and monopolar electrosurgical electrode. Sterile, single-use. Modification to electrical insulation coating material.

Indications for Use

Indicated for patients undergoing arthroscopic procedures requiring soft tissue resection, ablation, and hemostasis of blood vessels.

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

• Resection Ablator (K013369)
• UltrAblator® (K030720)

Submission Summary (Full Text)

{0}------------------------------------------------

# November 26, 2003 KO33748 ( ( ( 0 ) of 2) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Device Act of 1990 and In acon 807.92, Linvatec Corporation is hereby submitting the Special 510(k) Summary of Safety and Effectiveness for the Trident Resection Ablator 510(k) Number _________

# Submitter A.

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294

### Company Contact B.

Laura D. Krejci, RAC Manager, Regulatory Affairs [phone] Telephone [phone] FAX

# C. Device Name

Trade Name: Trident™ Resection Ablator

Common Name: Shaver Blade, Electrosurgical Electrode

Arthroscope, 21 CFR 888.1100, Classification Names: Electrosurgical cutting and coagulation device and accessories, 21 CFR 878.4400

Proposed Class/Device: Class II

HRX, GEI Product Code:

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

KC33748 (pg 2 of 2)

Summary of Safety and Effectiveness Trident Resection Ablator 510(k) # November 26, 2003

### Predicate/Legally Marketed Devices D.

| Resection Ablator<br>Linvatec Corporation | 510(k) # K013369 |
|-------------------------------------------|------------------|
| UltrAblator®<br>Linvatec Corporation | 510(k) # K030720 |

#### E. Device Description

The Trident Resection Ablator is a combination of a 4.2mm Linvatec arthroscopic shaver blade and a Linvatec UltrAblator® monopolar electrode. The product configuration combines the mechanical resection of a shaver blade and the ablation and hemostasis functions of an electrode. The Trident Resection Ablator is supplied sterile, single use.

The modification to the Trident Resection Ablator described in this Special 510(k) is a change in the material formulation of the electrical insulation This modification does not affect the device's intended use, coating. fundamental scientific technology, performance specifications or labeling.

#### F. Intended Use

The Trident Resection Ablator is intended to be used in arthroscopic procedures for resection and ablation of soft tissue, and hemostasis of blood vessels.

#### Substantial Equivalence G.

The Trident Resection Ablator is substantially equivalent in design, technology and intended use to the existing Resection Ablator and UltrAblator Electrode. Testing has been conducted to assure that the change in the material formulation of the insulation coating does not raise any new issues regarding safety and effectiveness.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird-like figure.

DEC 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K033748

Trade/Device Name: Trident™ Resection Ablator Regulation Number: 21 CFR 878.4400; 21 CFR 888.1100 Regulation Name: Electrosurgical cutting and coagulation device and accessories; Arthroscope Regulatory Class: II Product Code: GEI, HRX Dated: November 26, 2003 Received: December 1, 2003

Dear Ms. Krejci:

We have reviewed your Scction 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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 Mcdical 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 docs 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); labcling (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.

{3}------------------------------------------------

Page 2 - Ms. Laura D. Krejci, RAC

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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

For 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

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

# Indications for Use

510(k) Number (if known): K033748

Device Name: Trident™ Resection Ablator

Indications For Use:

The Trident Resection Ablator is intended to be used in arthroscopic procedures for resection and ablation of soft tissue, and hemostasis of blood vessels.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D)

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

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

510(k) Number K033748