Bovie J-Plasma Precise 360 Handpiece

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 2, 2015 Bovie Medical Corporation Mr. Brian Kunst Vice President, Regulatory Affairs and Quality Assurance 5115 Ulmerton Road Clearwater, Florida 33760 Re: K152570 Trade/Device Name: Bovie J-Plasma Precise 360 Handpiece Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 4, 2015 Received: September 10, 2015 Dear Brian Kunst: 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 and Part 809); 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 {1}------------------------------------------------ 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 . and Part 809), 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" (21 CFR 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/Resourcesfor You/Industry/default.htm. Sincerely yours, Joshua C. Nipper -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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K152570 Device Name Bovie J-Plasma Precise 360 Handpiece #### Indications for Use (Describe) The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparascopic surgical procedures. The Bovie J-Plasma Precise 360 Handpiece is compatible only with Bovie J-Plasma generators. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------| | <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.2222 4.11108L5.77778 11.5555L2.77778 8.55548" stroke="#000000" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.5"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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There is a registered trademark symbol to the right of the word. ### 510(k) SUMMARY – K152570 ### (Submitted As Required per 21 CFR 807.92) ### GENERAL INFORMATION: | Submitter Name: | Bovie Medical Corporation | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Establishment Registration<br>Number: | 3007593903 | | Submitter Address: | 5115 Ulmerton Road<br>Clearwater, Florida 33760-4004<br>United States of America | | Submitter Telephone Number: | (727) 803-8617 | | Submitter FAX Number: | (727) 322-4465 | | Contact Person: | Brian Kunst<br>Vice President, Regulatory Affairs and Quality<br>Assurance<br>5115 Ulmerton Road<br>Clearwater, Florida 33760-4004<br>United States of America | | Contact email: | brian.kunst@boviemed.com | | Date Prepared: | October 30, 2015 | | <b>DEVICE IDENTIFICATION:</b> | | | Proprietary Name: | Bovie J-Plasma Precise 360 Handpiece | | Common Name: | Electrosurgical Generator Accessory | | Classification Name: | Electrosurgical Cutting and Coagulation Device and<br>Accessories | | Model Numbers: | Multiple | | Classification: | 21CFR 878.4400; Class II; Product Code GEI | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "Bovie" in a stylized, cursive font. The word is rendered in a bright blue color. A horizontal line underlines the word, adding to the cursive effect. A registered trademark symbol is present to the right of the word. Legally Marketed Predicate Device(s): 510(k) Number: K151325 Predicate Device Name: Bovie J-Plasma Handpiece Manufacturer: Bovie Medical Corporation ## INTENDED USE/INDICATIONS The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparascopic surgical procedures. The Bovie J-Plasma Precise 360 Handpiece is compatible only with Bovie J-Plasma generators. ## DEVICE DESCRIPTION The Bovie J-Plasma Precise 360 Handpiece is a sterile, single-use electrosurgical accessory intended to be used in conjunction with Bovie J-Plasma electrosurgical generators for the delivery of helium gas plasma for cutting, coagulating and ablating of soft tissue. The Bovie J-Plasma Precise 360 Handpiece is available with a retractable needle tip, or with a retractable cutting blade tip for excising tissue. Both tip configurations serve as electrodes to generate helium plasma. A 30 degree angled shaft tip provides improved visibility during use, and a rotating knob is used to orient the angled shaft tip to the optimal position. The device is available with 33cm and 45cm shaft lengths. The device can be used in laparoscopic procedures using a standard 5mm trocar. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a medical device with a handle and a long, thin probe extending from it. The handle is white with blue accents, and the probe is black with a slight bend at the end. The device is likely used for minimally invasive surgical procedures, allowing doctors to access and treat areas inside the body without making large incisions. The brand name "Bovie" is visible in the upper left corner of the image. The primary differences between the proposed J-Plasma Precise 360 Handpiece and the predicate J-Plasma Handpiece are: - The J-Plasma Precise 360 Handpiece is available in 33cm and 45cm shaft lengths and the predicate J-Plasma Handpiece is available in 15cm, 33cm, and 45cm shaft lengths - The J-Plasma Precise 360 Handpiece has a rotating knob that controls an angled shaft tip . which provides improved visibility and optimal positioning at the surgical site. The angled shaft tip uses a medical-grade which is not present in the predicate device. The rotating knob utilizes material which is present on the predicate device. The predicate J-Plasma Handpiece has a straight shaft tip. The J-Plasma Precise 360 has the same intended use and energy source as the predicate device. There are no technological differences, no changes to the principle of operation or the method of application, and no changes to sterilization methods. Both devices require a Bovie J-Plasma electrosurgical generator and channel helium gas flow over an energized inner electrode to create a plasma stream. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "Bovie" in a stylized, cursive font. The word is a bright, light blue color. The font is slanted slightly upwards from left to right. There is a registered trademark symbol to the right of the word. ## PERFORMANCE TESTING Performance testing to assure that the Bovie J-Plasma Precise 360 meets performance requirements was performed and is summarized in the following table: | Test | Objective | Reports | |----------------------------------------------|-------------------------------------------------------------------------------------------------------|--------------------| | Mechanical Verification<br>and Functionality | Verify the mechanical functionality of the<br>device. | VR-1318<br>VR-1324 | | Electrical Verification | Verify the electrical functionality and safety of<br>the device. | VR-1318 | | Plasma Characteristics | Measure effect of generator settings on the<br>plasma stream, plasma stream characterization | VR-1324 | | Performance Evaluation | Confirm device performance on<br>various tissue types. | VR-1324 | | Usability Evaluation | To verify and validate the usability of the J-<br>Plasma Precise 360 as it relates to safety. | VP-1387 | | Shipping Study | Verify the device meets requirements after<br>shipping and handling. | VP-1384 | | Evaluation of Rotation<br>Effects | Evaluation of Shaft Rotation Effects on Plasma<br>stream for Bovie J-Plasma Precise 360<br>Handpieces | VR-1383 | | Biocompatibility Testing | Verify material safety | VR-1335 | | Shelf Life Testing | Confirm product and package performance at<br>labeled shelf life | VP-1326 | The Bovie J-Plasma Precise 360 Handpiece, and the predicate Bovie J-Plasma Handpiece, were designed in accordance with the following standards: | International Standard | Description | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC-60601-1, Edition 3.1 | Medical Electrical Equipment - Part 1: General Requirements<br>For Safety | | IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2: General requirements<br>for basic safety and essential performance - Collateral Standard:<br>Electromagnetic disturbances - Requirements and tests | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "Bovie" in a stylized, cursive font. The word is rendered in a light blue color. The "B" is capitalized and slightly larger than the other letters, with a curved flourish extending from the bottom of the "B" and underlining the rest of the word. A registered trademark symbol is located to the right of the "e". | IEC-60601-2-2 : 2009 | Particular requirements for the safety of high frequency surgical<br>equipment | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ANSI / AAMI / ISO 10993-1:2009 | Biological Evaluation of Medical Devices - Part 1: Evaluation<br>and Testing | | ANSI/AAMI/ISO 11135-1: 2007 | Sterilization of Healthcare Products - Ethylene Oxide - Part 1:<br>Requirements for the development, validation, and routine<br>control of a sterilization process for medical devices. | | ANSI / AAMI / ISO 10993-7:2008 | Biological Evaluation of Medical Devices – Part 7: Ethylene<br>Oxide Residuals | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "Bovie" in a stylized, cursive font. The word is in a bright blue color, and there is a registered trademark symbol to the right of the word. The font is thick and has a flowing, handwritten appearance. # 510(k) SUMMARY # SUBSTANTIAL EQUIVALENCE | Feature/<br>Characteristic | Bovie J-Plasma Precise 360<br>Current Submission | Bovie J-Plasma Handpiece<br>(Predicate K151325) | |---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use /<br>Indications for Use | The Bovie J-Plasma Precise 360 is<br>used for the delivery of helium gas<br>plasma for cutting, coagulation, and<br>ablation of soft tissue during open and<br>laparascopic surgical procedures.<br><br>The Bovie J-Plasma Precise 360 is<br>compatible only with Bovie J-Plasma<br>generators. | The Bovie J-Plasma Handpiece is used<br>for the delivery of helium gas plasma for<br>cutting, coagulation, and ablation of soft<br>tissue during open and laparascopic<br>surgical procedures.<br><br>The Bovie J-Plasma Handpiece is<br>compatible only with Bovie J-Plasma<br>generators. | | Energy Type | Helium gas plasma | Helium gas plasma | | Output | Monopolar | Monopolar | | User Interface | Pistol grip | Pistol grip | | Shaft Design | Angled | Straight | | Shaft Rotation | Yes | No | | Shaft Working Lengths | 33cm and 45cm | 15cm, 33cm, 45cm | | Shaft Configuration | Angled | Straight | | Shaft Outer Diameter | 5mm | 5mm | | Tip Configuration | Blade, Needle | Blade, Needle | | Blade Extension | Maximum 10mm | Maximum 10mm | | Blade Width x Thickness | 0.4mm x 0.08mm | 0.4mm x 0.08mm | | Compatibility | Only with Bovie J-Plasma Generators | Only with Bovie J-Plasma Generators | | Connector | Bovie Proprietary | Bovie Proprietary | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the word "Bovie" in a stylized, cursive font. The word is rendered in a bright, light blue color. A registered trademark symbol is located to the right of the word. # CONCLUSION There is no difference between the J-Plasma Precise 360 Handpiece and the legally marketed predicate device Bovie J-Plasma handpiece described in K151325 in terms of intended use, principle of operation, and the technology used for device performance. All features of the Bovie J-Plasma Precise 360 were subjected to verification testing. There is no new technology and no difference that would raise new or different questions of safety or efficacy. The angled shaft tip and rotating knob components are mechanical in nature and do not affect the technology of the device. The purpose of the angled tip and rotating shaft is to allow better positioning of the tip and better visualization of the target tissue. The devices exhibit substantially equivalent performance during bench testing, including equivalent depth of tissue effect.