VIVA combo RF System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 8, 2017 STARmed Co., Ltd. Jun-Young Jung Deputy General Manger B-dong, 4F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si Gyeonggi-do, 10355 Korea Re: K163450 Trade/Device Name: VIVA Combo RF System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: March 3, 2017 Received: March 7, 2017 Dear Jun-Young Jung: 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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" (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/ResourcesforYou/Industry/default.htm. Sincerely, # 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}------------------------------------------------ Image /page/2/Picture/1 description: The image contains the logo for STARmed. The logo features a stylized orange circle with the word "STAR" in orange, bold letters inside the circle. To the right of the circle, the word "med" is written in gray, sans-serif letters. The overall design is clean and modern, suggesting a company in the medical or healthcare industry. | | DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. | |--------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | | Indications for Use | | | 510(k) Number (if known) | K163450 | | | Device Name | VIVA combo RF System | | | Indications for Use (Describe) | The VIVA combo RF Ablation System is intended for use in percutaneous and intraoperative coagulation and ablation of tissue. | | Type of Use (Select one or both, as applicable) | <span> × Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | |-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| |-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image contains the logo for STARmed. The logo consists of the word "STAR" in orange, with the letters arranged inside of an orange circle. To the right of the word "STAR" is the word "med" in gray. The logo is simple and modern. B-dong, 4F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si Gyeonggi-do, Republic of Korea ## 510(k) Summary [As required by 21 CFR 807.92] ## 1. Date Prepared [21 CFR 807.92(a)(a)] December 6, 2016 #### Submitter's Information [21 CFR 807.92(a)[1]] 2. - . Name of Sponsor: STARmed Co., Ltd. Address: B-dong, 4F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si, -Gyeonggi-do, Republic of Korea - Contact Name: Jun-Young Jung Telephone No.: +82 70-4673-8628 -Fax No.: +82 31-816-4546 - - -Email Address: jjy3412@starmed4u.com - . Registration Number: In process - Name of Manufacturer: Same as Sponsor -Address: Same as Sponsor #### 3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] - . Trade Name: VIVA combo RF System . Common Name: Electrosurgical Cutting and Coagulation Device and Accessories - . Classification: | Classification Name | Electrosurgical, Cutting & Coagulation & Accessories | |---------------------------|------------------------------------------------------| | Classification Regulation | 21 CFR 878.4400 | | Product Code | GEI | | Device Class | II | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for STARmed. The logo consists of the word "STARmed" in a stylized font. The "STAR" portion of the name is in orange, while the "med" portion is in gray. To the left of the word "STAR" is an orange circular design that appears to be made of multiple curved lines. #### Identification of Predicate Device(s) [21 CFR 807.92(a)(3)] 4. The identified predicate devices within this submission are shown as follow: ### Predicate Device | • | 510(k) Number: | K042216 | |---|------------------|----------------------------------------------------------------| | • | Applicant: | Valleylab | | • | Regulation Name: | Electrosurgical cutting and coagulation device and accessories | | • | Trade Name: | Cool-tip™ RF Ablation System | There are no significant differences between VIVA combo RF System and the predicate device that would adversely affect the use of the product. It is substantially equivalent to these devices in indications for use and technology characteristics. #### 5. Description of the Device [21 CFR 807.92(a)[4]] The VIVA combo RF System consists of RF generator, active electrode, grounding pad and peristaltic pump for electrode cooling. This device is designed to produce local tissue heating at the tip of the electrodes causing the coagulation and ablation of tissue. The VIVA combo RF System is capable of delivering up to 200 W of RF power and the available power is limited through software control. This generator monitors the power, resistance, current and temperature. The active electrodes are a sterile, single-use, hand-held electrosurgical instrument designed for use with VIVA combo RF System. Cooling of the electrode is provided by chilled water which is pumped through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and the water is not to be in contact with the patient. #### Intended Use [21 CFR 807.92(a)(5)] 6. The VIVA combo RF System is intended for use in percutaneous and intraoperative coagulation and ablation of tissue. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for STARmed. The logo features the word "STAR" in orange, with the word "med" in gray next to it. To the left of the word "STAR" is an orange circle with a break in the upper left. #### 7. Technological Characteristics [21 CFR 807.92(a)(6)] The VIVA combo RF System is substantially equivalent to legally marketed predicate device with respect to indications for use and technology characteristics. The table below presents side by side comparisons for each major component of each device: | Item | Proposed Device | Primary Predicate | |----------------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K Number | Not known | K042216 | | Model | VIVA combo RF System | Cool-tip™ RF Ablation<br>System | | Manufacture | STARmed Co., Ltd. | Valleylab | | Intended Use | The VIVA combo RF System is<br>intended for use in<br>percutaneous and<br>intraoperative coagulation<br>and ablation of tissue. | The Cool-tip™ RF Ablation<br>System (Generator and<br>Accessories) is intended for<br>use in percutaneous,<br>laparoscopic and<br>intraoperative coagulation<br>and ablation of tissue, such as<br>partial or complete ablation<br>of non-resectable liver<br>lesions. | | Type of Use | Prescription Use | Prescription Use | | Component | Electrosurgical unit, active<br>electrode, grounding pad,<br>peristaltic pump and foot<br>pedal | Electrosurgical unit, active<br>electrode, grounding pad,<br>peristaltic pump and foot<br>pedal | | Electrosurgical Unit | | | | Output Frequency | $480 kHz \pm 10 \%$ | $480 kHz \pm 10\%$ | | Drive on Time | Up to 30 minutes | Up to 30 minutes | | Maximum Power Output | Up to 200 watts @ 50 ohm | Up to 200 watts @ 50 ohm | | Active Accessory | | | | Monopolar / Bipolar | Monopolar | Monopolar | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image contains the logo for STARmed. The logo features the word "STAR" in orange, with the word "med" in gray next to it. To the left of the word "STAR" is an orange circular design that is not fully closed. ## Non-clinical Test Summary - . Electrical Safety, Electromagnetic Compatibility and Performance: Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards: - Testing to confirm compliance with the safety requirements of standard AAMI -ES60601-1 - Testing to confirm compliance with EMC requirements of standard IEC 60601-1-2 - - Testing to confirm compliance with particular requirements of standard IEC 60601-2-2 - - . Software Validation The VIVA combo RF System contains MODERATE level of concern software. The software was designed and developed according to a software development process and was verified and validated. The software information is provided in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005. - Biocompatibility The following biocompatibility tests were performed: - Cytotoxicity - - Irritation/intracutaneous reactivity - - Sensitization - - Acute Systemic Toxicity - - . Sterilization and Shelf Life The active electrode of VIVA combo RF System is delivered in a sterile state and is intended for single use only. The sterilization method used is ethylene oxide and this device has a shelf life of 3 years. ## Clinical Test Summarv No clinical studies were considered necessary and performed. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for STARmed. The logo consists of the word "STARmed" in a stylized font. The "STAR" portion of the word is in orange, while the "med" portion is in gray. To the left of the word "STAR" is an orange circular design that appears to be a stylized atom. B-dong, 4F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si, Gyeonggi-do, Republic of Korea #### 8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92] When compared to the predicate devices, the VIVA combo RF System in this submission presented the same in terms of indications for use, components and technology characteristics. #### 9. Conclusion [21 CFR 807.92(b)(3)] In according to with the Federal food & Drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification STARmed Co., Ltd. concludes that VIVA combo RF System is substantially equivalent in safety and effectiveness to predicate device as described herein.