RESECTION ABLATOR

K013369 · Linvatec Corp. · GEI · Apr 4, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K013369
• Device Name: RESECTION ABLATOR
• Applicant: Linvatec Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Resection Ablator combines mechanical arthroscopic shaver blade with monopolar electrode; enables simultaneous soft tissue resection, ablation, and hemostasis. Used in arthroscopic procedures by surgeons. Device is sterile, single-use. Modifications from predicate include updated shaver blade design, ceramic tip material, insulation coating, and electrode strip configuration extended to distal tip.

Clinical Evidence

No clinical data provided; substantial equivalence supported by performance testing.

Technological Characteristics

Combination device: mechanical shaver blade and monopolar electrode. Features ceramic tip, insulation coating, and electrode strip. Sterile, single-use. No software or electronic processing components.

Indications for Use

Indicated for use in 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

• Trident™ Resection Ablator (K002088)

Submission Summary (Full Text)

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January 7, 2002

# 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 Resection Ablator, 510(k) Number K013369 .

#### Submitter A.

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

#### B. Company Contact

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

#### C. Device Name

Trade Name: Resection Ablator

Common Name: Electrosurgical Electrode

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

Proposed Class/Device: Class II Product Code GEI

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Summary of Safety and Effectiveness Resection Ablator 510(k)# K013369 January 7, 2002 Page 2 of 2

### Predicate/Legally Marketed Devices D.

Trident™ Resection Ablator Linvatec Corporation

510(k) #K002088

#### Device Description ய்

The Resection Ablator is a combination of a Linvatec arthroscopic shaver blade and a Linvatec UltrAblator® monopolar electrode. The product blado and a Lifratus s the mechanical resection of a shaver blade and the oblation and hemostasis functions of an electrode. The Resection Ablator is supplied sterile, single use.

This submission describes the next generation of the Resection Ablator rnie oubline. The shaver blade portion of the device has been changed, as well as materials of the ceramic tip, insulation coating and electrode. The ceramic tip and electrode strip configuration have also been changed to extend nearer the distal tip.

#### ட் Intended Use

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

#### Substantial Equivalence G.

The Resection Ablator is substantially equivalent in design, technology and intended use to Linvatec's existing Trident Resection Ablator. Performance testing has been conducted to show that the modifications to the Trident Resection Ablator do not raise any new issues regarding safety and effectiveness.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K013369

Trade/Device Name: Resection Ablator Regulation Number: 878.4400 and 888.1100 Regulation Name: Electrosurgical Device, Cutting & Coagulation & Accessories and Arthroscope Regulatory Class: II Product Code: GEI and HRX Dated: January 7, 2002 Received: January 9, 2002

Dear Ms. Seneff:

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.

APR = 4 2002

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## Page 2 - Ms. Laura Seneff

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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

CorCelia 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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January 7, 2002

510(k) Number (if known):_K013369

Device Name: Resection Ablator

Indications for Use:

The Resection Ablator is intended to be used in arthroscopic procedures for resection The Resection Ablator is Interiabulation to be acconsists of blood vessels.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-the-Counter Use_ OR Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Muriam C. Provost

Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number K013369