VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN

K113545 · Depuy Mitek, A Johnson & Johnson Company · GEI · Feb 27, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K113545
• Device Name: VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN
• Applicant: Depuy Mitek, A Johnson & Johnson Company
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mitek VAPR VUE Radiofrequency System is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery. The Mitek VAPR II Electrode 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. The VAPR 3 Electrode 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. The DePuy Mitek VAPR Electrodes for use with the VAPR VUE Radiofrequency System are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, 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 tissues, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.

Device Story

VAPR system is a bipolar electrosurgical device for arthroscopic procedures; includes generator, electrodes, and footswitch. Electrodes deliver radiofrequency energy to joint space for soft tissue ablation, contouring, cutting, and coagulation. Used in OR by surgeons. System provides temperature control during tissue treatment. Output is controlled by surgeon via footswitch/handcontrol. Benefits include precise tissue management in arthroscopic joint surgery. No changes to device hardware; submission adds hip arthroscopy indication.

Clinical Evidence

Bench testing only. No clinical studies required. Performance testing included device insertion, shaft bending, and active tip engagement, all of which passed.

Technological Characteristics

Bipolar electrosurgical system; includes generator and various electrodes (CoolPulse, Suction). Energy source: radiofrequency. Connectivity: standalone. Sterilization: not specified. Software: not specified.

Indications for Use

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

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

• Serfas RF System (K041810)

Submission Summary (Full Text)

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| | | FEB 27 2012 K113545 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| | | Pg 1 of 4 |
| Date Prepared | November 30, 2011 | |
| Submitter's Name and Address: | DePuy Mitek, Inc.<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767 | |
| Contact Person | Susan Kagan<br>Project Manager, Regulatory Affairs<br>DePuy Mitek, Inc.<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767, USA<br>Telephone: [phone]<br>Facsimile: 508-977-6911<br>e-mail: [e-mail] | |
| Name of Medical Device | Classification Name: Electrosurgical cutting and coagulation device and accessories: 21 CFR 878.4400 | |
| | Common/Usual Name: Electrosurgical cutting and coagulation device and accessories: Arthroscope | |
| | Proprietary Name: VAPR® VUE™ Radiofrequency System<br>VAPR III Electrode Surgical System<br>VAPR II Electrode Surgical System<br>P90 Electrode<br>CP90 Electrode<br>CP90 Electrode with Handcontrol<br>LDS Electrode<br>LPS Electrode | |
| | FDA Classification: II | |
| | FDA product code: GEI | |

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The VAPR system is electrosurgical system that utilizes bipolar technology Device Description specifically designed to provide a range of arthroscopic surgical treatments including soft tissue ablation, contouring, cutting and coagulation and temperature control. The VAPR system includes a generator, electrodes which facilitate access and control the delivery of energy to the ioint space. and accessories such as a footswitch and electrodes. This premarket notification is submitted to add HIP arthroscopy to the Description of indication for use for the VAPR Generators and VAPR Electrodes listed in Change this section. As a result, the Instructions for Use (IFU) will be updated to add the hip indication. In addition the following modifications have also been made to the VAPR system Manuals and Electrode IFU's: . Removing Arthroscopic joint surgery examples from VAPR VUE, VAPR II and VAPR III manuals. Add an electrode shaft bending caution. � There have been no changes to the devices which are the subject of this submission. The purpose of this submission is to evaluate the performance testing to support the addition of hip indication. Indications for Use VAPR VUE Radiofrequency system The Mitek VAPR VUE Radiofrequency System is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery. VAPR II Electrosurgical system The Mitek VAPR II Electrode 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. VAPR 3 Electrosurgical system The VAPR 3 Electrode 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.

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K113545
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### VAPR CoolPluse Electrodes

The DePuy Mitek VAPR Electrodes for use with the VAPR VUE Radiofrequency System are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.

VAPR Suction Electrodes (P90, CP90, CP90 with Handcontrol) The DePuy Mitek VAPR Electrodes for use with all VAPR Electrosurgical Systems are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.

### VAPR Suction Electrodes (LDS and LPS Electrode)

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

# Substantial Equivalence

With the addition of the Hip indication, the VAPR Systems and electrodes which are the subject of this submission will have the same indication as the following electrodes currently on the market:

- A Serfas RF System: K041810
Safety and Performance Verification and Validation of the VAPR Electrodes included performance testing to demonstrate that the device is appropriate for hip arthroscopy. A summary of testing is provided in Table 1.

| T | able | 1 |
|---|------|---|
|---|------|---|

| Testing | Results |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Device Insertion | Pass: No visible cracks or missing portions at the<br>distal tip of the electrodes. |
| Shaft Bending | Pass: No visible splitting of heatshrink after one cycle<br>of bending and straightening of the electrode handle<br>and shaft. |
| Active Tip Engagement | Pass: The electrodes withstood with no breakage at<br>the active tip. |

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| Clinical Testing | No clinical studies are required to demonstrate safety and efficacy of the<br>device in support of an application for premarket clearance. The VAPR<br>System and Electrodes, when used for hip arthroscopic surgeries, do not<br>differ from the predicate devices in fundamental scientific technology. |
| Conclusion | Results of safety and performance and testing have demonstrated that the<br>modified device is suitable for its intended use.<br><br>Based on the indications for use and fundamental scientific technology, the<br>VAPR System, along with the VAPR Electrodes are shown to be appropriate<br>for arthroscopy of the hip as well as substantially equivalent to the<br>predicate devices under the Federal Food, Drug and Cosmetic Act. |

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FEB 2 7 2012

Depuy Mitek, a Johnson & Johnson Company % Ms. Susan Kagan Project Manager, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767

Re: K113545

Trade/Device Name: VAPR VUE Radiofrequency System

VAPR II Electrosurgical System

VAPR III Electrosurgical System

VAPR CoolPulse Electrodes (CP90, CP90 with Handcontrol)

VAPR Suction Electrodes (PD90, LDS, and LPS Electrode)

Regulation Number: 21 CFR 878.4400

Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, HRX

Dated: November 30, 2011

Received: December 1, 2011

Received. December 1, 2011

Dear Ms. Kagan:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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## Page 2 - Ms. Susan Kagan

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson
Director

Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 113545

Pg 1. of 2

# Indications for Use

510(k) Number (if known):

Device Name: VAPR Generator

Indications for Use:

## VAPR VUE Radiofrequency system

VAN TV CE Radionequency System is intended for resection, ablation, excision of soft tissue, r ne micel v .. 11 10 U nearly and coagulation of soft tissue in patients requiring arthroscopic surgery.

### VAPR II Electrosurgical system

VAPR'II Liectrode System, when used with a VAPR™ Electrode, is intended for resection, r he miles will in it it it it is a coasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery.

### VAPR III Electrosurgical system

VAPR 3 Electrode System, when used with a VAPR™ Electrode, is intended for resection, ablation, rne VAI it 3 Licetious bystems of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery.

Prescription Use (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)

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Page 1 of 1

(Division Sign-O Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113545

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# Indications for Use

K113545
PS 2 of 2

510(k) Number (if known):

Device Name: VAPR Electrodes

Indications for Use:

VAPR CoolPulse Electrodes (CP90, CP90 with Handcontrol)

The DePuy Mitek VAPR Electrodes for use with the VAPR VUE Radiofrequency System are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.

VAPR Suction Electrodes (P90, LDS and LPS Electrode)

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

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)

signature

Page 1 of 1

(Division Sign-Oir)
Division of Surgical, Orthopedic, Division of Restorative Devices

510(k) Number K113545