VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES

K041135 · Depuy Mitek, A Johnson & Johnson Company · HRX · May 10, 2004 · Orthopedic

Device Facts

• Record ID: K041135
• Device Name: VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES
• Applicant: Depuy Mitek, A Johnson & Johnson Company
• Product Code: HRX · Orthopedic
• Decision Date: May 10, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The VAPR 3 Electrosurgical System, when used with a VAPR Electrode, is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, andle, elbow and wrist. The VAPR LD and LP Suction Electrodes, when used with the VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, andle, elbow and wrist.

Device Story

VAPR 3 Electrosurgical System comprises generator, handpiece, cable, electrodes, and footswitch; designed for soft tissue ablation, contouring, cutting, and hemostasis during arthroscopic procedures. LD and LP Suction Electrodes integrate with system to remove bubbles from operating site during activation. Operated by surgeons in clinical/OR settings. System transforms electrical energy into RF output for tissue interaction; output visualized by surgeon via arthroscope to guide resection/coagulation. Clinical benefit includes precise tissue management and improved visibility via suction functionality.

Clinical Evidence

Bench testing only. Validation testing performed to support device modifications and confirm performance characteristics against predicate standards.

Technological Characteristics

Electrosurgical system utilizing RF energy for tissue ablation/coagulation. Components include generator, handpiece, cable, and suction-enabled electrodes. System operates via standard electrosurgical principles for cutting/coagulation. Design complies with 21 CFR 820.30 design controls.

Indications for Use

Indicated for patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and wrist for soft tissue resection, ablation, excision, hemostasis, and coagulation.

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

• VAPR II Electrosurgical System (K002402)
• VAPR 2.3 Side Effect Electrode (K992876)
• VAPR 3.5 Suction Electrode (K002422)

Submission Summary (Full Text)

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

# MAY 1 0 2004

## 510(k) Summary

Page 1 of 2

# VAPR 3 Electrosurgical System and VAPR LD SUCTION and LP SUCTION Electrodes

KO 41135

| Submitter's Name and<br>Address: | DePuy Mitek<br>a Johnson & Johnson company<br>249 Vanderbilt Avenue<br>Norwood, MA 02062 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ruth C. Forstadt<br>Project Management Lead, Regulatory Affairs<br>DePuy Mitek<br>a Johnson & Johnson company<br>249 Vanderbilt Avenue<br>Norwood, MA 02062<br>Telephone: [phone]<br>Facsimile: 781-278-9578<br>e-mail: [e-mail] |
| Name of Medical Device | Classification Name: Electrosurgical cutting and coagulating device<br>and accessories<br>Common/Usual Name: Electrosurgical System and Electrodes<br>Proprietary Name: VAPR 3 Electrosurgical System, VAPR LD<br>SUCTION and LP SUCTION Electrodes |
| Substantial Equivalence | VAPR 3 Electrosurgical System is substantially equivalent to theVAPR<br>II Electrosurgical System (K002402, 8/31/2000).<br><br>The VAPR LD Suction Electrode is substantially equivalent to the<br>VAPR 2.3 Side Effect Electrode (K992876, 9/24/1999) and the VAPR<br>3.5 Suction Electrode (K002422, 8/31/2000)<br><br>The VAPR LP Suction Electrode is substantially equivalent to the<br>VAPR LD Suction Electrode, a modification to the VAPR 2.3 Side<br>Effect Electrode (K992876, 9/24/1999) and the VAPR 3.5 Suction<br>Electrode (K002422, 8/31/2000). |
| Device Classification | Electrosurgical cutting and coagulating device and accessories have<br>been classified as Class II, GEI (21 CFR 878.4400). |
| Device Description | VAPR 3 Electrosurgical System is designed to provide soft tissue<br>ablation (vaporization), contouring, cutting and hemostasis of blood |

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

Page 2 of 2

vessels during arthroscopic surgical procedures. The components of the system include a generator, handpiece and cable, electrodes, and footswitch.

The VAPR LD and LP Suction Electrodes are soft tissue ablation and dessication devices intended for use with the VAPR System. They extend the utility of the system by removing bubbles created during activation from the operating site.

The VAPR 3 Electrosurgical System, when used with a VAPR Electrode, is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, andle, elbow and wrist.

The VAPR LD SUCTION and LP SUCTION Electrodes, when used with the VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, andle, elbow and wrist.

In support of the 510(k), Mitek has provided certification of compliance to 21 CFR 820.30 Design Control requirements, descriptions of Mitek's subcontractor Design Control and Risk Analysis procedures, and the results of validation testing (performance testing) for the device modification.

Based on the Indications for Use, technological characteristics and safety and performance testing, the VAPR 3 Electrosurgical System and VAPR LD and LP Suction Electrodes have been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

Indications for Use

#### Safety and Performance

ecial 510(k) /APR 3, LD and LP Suction Electrodes 70

CONFIDENTIAL

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

Image /page/2/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird or other winged creature.

MAY 1 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mrs. Ruth C. Forstadt Project Management Lead, Regulatory Affairs DePuy Mitek 249 Vanderbilt Avenue Norwood, Massachusetts 02062

Re: K041135

Trade/Device Name: VAPR 3 Electrosurgical System 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: April 29, 2004 Received: April 30, 2004

Dear Ms Forstadt:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave revea your your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrease , 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, de needs marre neen rollated 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 r ou may, mererere, mains 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 may or subject to outsil 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 I hat FDA has made a determination that your device complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny i ederal station and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of K in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in and ation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 - Mrs. Ruth C. Forstadt

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letet notification. The FDA finding of substantial equivalence of your device to a legally premaince no licate 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

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): KO41135

VAPR 3 Electrosurgical System Device Name:_ VAPR LD and LP Suction Electrodes

Indications For Use:

The VAPR 3 Electrosurgical System, when used with a VAPR Electrode, is intended for The +AI It's Licettoourgious By of tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, andle, elbow and wrist.

The VAPR LD and LP Suction Electrodes, when used with the VAPR Electrosurgical System, The VAI K LD and EI- Cablation, excision of soft tissue, hemostasis of blood vessels and are intention of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, andle, elbow and wrist.

Prescription Use x_

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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_________________________________________________________________________________________________________________________________________________________________

Page 1 of _

CONFIDENTIAL

ﻢ ﮐﮯ