RESECTION ABLATOR

K013117 · Linvatec Corp. · HRX · Nov 29, 2001 · Orthopedic

Device Facts

• Record ID: K013117
• Device Name: RESECTION ABLATOR
• Applicant: Linvatec Corp.
• Product Code: HRX · Orthopedic
• Decision Date: Nov 29, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Resection Ablator combines mechanical arthroscopic shaver blade with monopolar electrode (UltrAblator). Device performs mechanical resection of soft tissue/bone, tissue ablation, and hemostasis. Used in arthroscopic procedures by surgeons. Supplied sterile for single use. Modification of existing Trident Resection Ablator (K002088).

Clinical Evidence

Bench testing only.

Technological Characteristics

Combination device: mechanical arthroscopic shaver blade and monopolar electrode. Sterile, single-use. Electrosurgical energy source.

Indications for Use

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

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

• Trident Resection Ablator (K002088)
• Advantage Drive System (K002523)

Submission Summary (Full Text)

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## SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Device Act of In accordance with the required. Sales Corporation is hereby submitting the 1990 and 21 CFR 007752/ Envilles for the Resection Ablator 510(k) Number K013117.

#### Submitter A.

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

#### Company Contact B.

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

#### Device Name C.

Trade Name: Resection Ablator

Common Name: Electrode

Electrosurgical Cutting and Coagulation Classification Names: Device and Accessories Surgical Instrument Motors and Accessories/Attachments

Class II Proposed Class: GEI, Electrosurgical Electrode Product Codes: GEY, Surgical Instrument Motors and Accessories/Attachments

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Summary of Safety and Effectiveness Resection Ablator 510(k) # K013117 9/17/01 Page 2 of 2

#### Predicate/Legally Marketed Devices D.

510(k) #K002088 Trident™ Resection Ablator Linvatec Corporation

Advantage Drive System Linvatec Corporation

510(k) #K002523

#### Device Description E.

The Resection Ablator is a combination of a 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 Resection Ablator is supplied sterile, single use.

This submission describes a modification to the existing Trident Resection Ablator that received marketing clearance under 510(k)# K002088 on March 6, 2001.

#### F. Intended Use

The Resection Ablator is intended to be used in arthroscopic procedures for resection of soft tissue and bone, 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 and arthroscopic shaver blades used with the Advantage Drive System. Performance testing has been conducted to show that the modifications to the Trident Resection Ablator do not raise any new questions regarding safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 9 2001

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

Re: K013117

Trade/Device Name: Resection Ablator Regulation Number: 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: September 17, 2001 Received: September 18, 2001

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.

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### Page 2 - Ms. Laura D. Seneff, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ogen maing of substantial equivalence of your device to a legally prematicated 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 If you desire specific ad 100 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Fart 007.10 for his mally, for questions on the promotion and advertising of Compliance at [phone]. The Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Tegulation chities, "Thisoranang of esponsibilities under the Act may be obtained from the Other general information on your securitional 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

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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11/7/01

510(k) Number: K013117

Device Name: Resection Ablator

The Resection Ablator is intended to be used in arthroscopic The Resection Ablator 15 incolnetter and bone, ablation of soft tissue and hemostasis of blood vessels.

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

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

(Optional Format 1-2-96)

Susan Walker

(Division Sign-Off) Division of General. Restorative and Neurological bevices

510(k) Number_ K613117