VAPR Tripolar Suction Electrode

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked slightly offset from each other. The profiles are simple and abstract, with a flowing design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 3, 2015 DePuy Mitek Incorporated Ms. Susan Kagan Project Manager 325 Paramount Drive Raynham, Massachusetts 02067 Re: K143475 Trade/Device Name: VAPR® Tripolar 90" Suction Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 5, 2015 Received: March 6, 2015 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, listing 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. 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 {1}------------------------------------------------ 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. # Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K143475 Device Name VAPR® Tripolar90™ Suction Electrode Indications for Use (Describe) The VAPR Electrodes, for use with the VAPR VUE Radiofrequency System, are intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) ] Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ### 510(k) SUMMARY #### l. SUBMITTER DePuy Mitek, Inc. a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767 Telephone: 508-880-8097 Facsimile: 508-977-6955 e-mail: skagan@its.jnj.com Susan Kagan Project Manager, Requlatory Affairs Date Prepared: December 4, 2014 #### II. DEVICE | Name of Device: | VAPR® TRIPOLAR 90™ Suction Electrode | |----------------------|------------------------------------------------------------------------------------| | Common/Usual Name: | Electrosurgical cutting and coagulation device and accessories | | Classification Name: | Electrosurgical cutting and coagulation device and accessories:<br>21 CFR 878.4400 | | FDA Classification: | II | | FDA product code: | GEI | #### PREDICATE lll. Primary Predicate: CoolPulse 90 Electrode-K113545/ K100638 Reference Device: ArthroCare Super Turbovac-K120791 These predicate devices have not been the subject of a design related recall. #### DEVICE DESCRIPTION IV. The VAPR TRIPOLAR 90 Suction Electrode is a single use, one-piece bipolar RF suction electrode for use in a surgical setting by a surgeon trained in arthroscopic surgery. The VAPR TRIPOLAR 90 Suction Electrode is an RF device which incorporates 3 electrodes in the probe tip: one active electrode and two return electrodes. This configuration optimizes ablation and coagulation in a single device. {5}------------------------------------------------ It has been designed to facilitate access and control the delivery of RF energy to the joint space. The connector plug of the VAPR TRIPOLAR 90 Suction Electrode is designed to interface only with the VAPR VUE Radiofrequency Generator. It has an internal identification code which automatically adjusts the VAPR VUE Generator to the optimal default and accessible powers and waveforms. If required, the settings for the VAPR TRIPOLAR 90 Suction Electrode can be modified within safe pre-determined limits by accessing the generator or footswitch control. It is intended to be only operated with the VAPR VUE generator at pre-determined default settings specific for this device. The VAPR TRIPOLAR 90 Suction Electrode has three sets of buttons to address surgeon preference when holding the electrode. Each pair of buttons offers the same functionality and are ergonomically positioned for surgeon comfort. In addition the VAPR TRIPOLAR 90 Suction Electrode features vacuum fluid extraction which enhances the efficiency of the electrode and assists in the removal of bubbles and debris created during activation within the operating site. The design includes the ability to vary flow rate to allow the surgeon to make adjustments depending on particular procedural requirements. #### V. INDICATION FOR USE The VAPR Electrodes, for use with the VAPR VUE Radiofrequency System, are intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coaqulation of soft tissues in patients requiring arthroscopic surgery. The Indication for Use statement for the VAPR TRIPOLAR 90 Suction Electrode is not identical to the predicate devices however both the subject device and the predicates devices are intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image displays the logo for DePuy Synthes Mitek Sports Medicine. The logo features a circular graphic in gold on the left, followed by the text "DePuy Synthes" in a dark blue sans-serif font. Below that, "MITEK SPORTS MEDICINE" is written in smaller, uppercase letters. At the bottom, it says "COMPANIES OF Johnson & Johnson" in a smaller font. ### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PRIMARY PREDICATE DEVICE | Component | VAPR CoolPulse90 Electrode | VAPR TRIPOLAR 90<br>Suction Electrode | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FDA Clearance | Predicate Device K100638/K113545 | Subject Device | | Indication for Use | The VAPR Electrodes for use with the<br>VAPR VUE Radiofrequency System<br>are intended for resection, ablation<br>and excision of soft tissue,<br>hemostasis of blood vessels and<br>coagulation of soft tissue in patients<br>requiring arthroscopic surgery of the<br>knee, shoulder, hip, ankle, elbow,<br>and wrist. | The VAPR Electrodes, for use<br>with the VAPR VUE<br>Radiofrequency System, are<br>intended for resection,<br>ablation and excision of soft<br>tissue, hemostasis of blood<br>vessels and coagulation of<br>soft tissues in patients<br>requiring arthroscopic<br>surgery. | | Working Length | 160mm | 155mm | | Tip Geometry | oval tip w/suction slot & partial<br>peripheral suction | near oval tip w/suction &<br>partial peripheral suction | | Integrated Cable and<br>Plug | Yes | Yes | | Integrated Hand<br>Control | Yes | Yes | | Integrated Suction | Yes | Yes | | RF Energy | Bipolar | Bipolar | | Sterilization | Gamma Irradiation | Gamma Irradiation | #### PERFORMANCE DATA VII. Biocompatibility The biocompatibility evaluation of the VAPR TRIPOLAR 90 Suction Electrode was conducted in accordance with FDA Blue Book Memorandum # G95-1 "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing," May 1, 1995 and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests: - Cytotoxicity - . Sensitization - . Irritation - Systemic toxicity ● {7}------------------------------------------------ Image /page/7/Picture/0 description: The image displays the logo for DePuy Synthes Mitek Sports Medicine, a company of Johnson & Johnson. The DePuy Synthes logo is in a dark blue font, with the words "Mitek Sports Medicine" in a smaller font below. The Johnson & Johnson logo is in red and is located below the DePuy Synthes logo. To the left of the DePuy Synthes logo is a circular graphic with overlapping shapes. The VAPR TRIPOLAR 90 Suction Electrode is considered an external communicating device used for a duration of less than 24 hours. # Electrical safety Electrical Safety was conducted on the VAPR TRIPOLAR 90 Suction Electrode when used with the VAPR VUE generator. The system complies with IEC 60601-1 "Medical electrical equipment -- Part 1: General requirements for safety and IEC 60601-2-2 "Medical electrical equipment -Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories" ### Software Status The VAPR TRIPOLAR 90 Suction Electrode is compatible only with the VAPR VUE generator. The generator was previously programed to recognize the VAPR TRIPOLAR 90 Suction Electrode so no software update was required. ### Performance Data The following performance data were provided in support off the substantial equivalence determination. | TEST | RESULTS | |------------------------------------|------------| | • Tissue Tests | Acceptable | | • Saline Outflow Temperature Test | Acceptable | | • Fingerswitching Tests | Acceptable | | • Suction Control | Acceptable | | • Area of Thermal Margin | Acceptable | | • Clogging Frequency | Acceptable | | • Active Tip Compression | Acceptable | | • Active Tip Side Load | Acceptable | | • Three Point Bend Test | Acceptable | | • Fluid Ingress | Acceptable | | • System Compatibility | Acceptable | | • Thermal Shock | Acceptable | | • In-joint Temperature Test | Acceptable | | • Surface Contact Temperature Test | Acceptable | ### Animal Study No animal studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance. The VAPR TRIPOLAR 90 Suction Electrode does not differ from the predicate device in fundamental scientific technology or intended use. ### Clinical Study No clinical studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance. The VAPR TRIPOLAR 90 Suction Electrode does not differ from the predicate device in fundamental scientific technology or intended use. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image contains the logo for DePuy Synthes Mitek Sports Medicine. The logo consists of a circular design on the left, followed by the text "DePuy Synthes" in a bold, sans-serif font. Below that, the text "MITEK SPORTS MEDICINE" is displayed in a smaller, sans-serif font. At the bottom, the text "COMPANIES OF Johnson & Johnson" is displayed. # VIII. CONCLUSION Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use. Based on the indications for use, fundamental scientific technology, and comparison to the predicate devices, the VAPR TRIPOLAR 90 Suction Electrode is shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.