star RF Electrode, VIVA RF Electrode

{0}------------------------------------------------ March 14, 2018 STARmed Co., Ltd. Jun-Young Jung QMR/Deputy General Manager B-dong, 4F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si Gyeonggi-do, Republic of Korea 10355 Re: K172012 Trade/Device Name: Star RF Electrode, VIVA RF Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 9, 2018 Received: February 12, 2018 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # David Krause -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) K172012 #### Device Name star RF Electrode, VIVA RF Electrode #### Indications for Use (Describe) star/VIVA RF Electrode is intended for use in percutaneous and intraoperative coagulation and ablation of tissue. Type of Use (Select one or both, as applicable) > 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) 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." {3}------------------------------------------------ # 510(k) Summary [As required by 21 CFR 807.92] This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92 #### 1. Date Prepared [21 CFR 807.92(a) (1)] 06/30/2017 ### 2. Submitter's Information [21 CFR 807.92(a) (1)] | Name of Sponsor: | STARmed Co.,Ltd. | |-----------------------|--------------------------------------------------------------------------------------------| | Address: | B-dong, 4F, 158, Haneulmaeul-ro, IlsanDong-gu, Goyang-si<br>Gyeonggi-do, Republic of Korea | | Contact Name: | Jun-Young Jung | | Telephone #: | +82-70-4673-8657 | | Fax #: | +82-31-816-4546 | | Email: | jjy3412@starmed4u.com | | Registration Number: | 3013557681 | | Name of Manufacturer: | Same as Sponsor | ## 3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)] | Model Name: | star RF Electrode, VIVA RF Electrode | |----------------------|------------------------------------------------------| | Common Name: | Electrosurgical Cutting and Coagulation Accessories | | Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories | | Regulation Number: | 21 CFR 878.4400 | | Product Code: | GEI | | Device Class: | 2 | | Review Panel: | General and Plastic Surgery | ## 4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)] | 510(k) Number: | K163450 | |----------------------|-------------------------------------------------------------------| | Applicant: | STARmed Co.,Ltd. | | Model Name: | VIVA combo RF System | | Common Name: | Electrosurgical Cutting and Coagulation Device and<br>Accessories | | Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories | | Regulation Number: | 21 CFR 878.4400 | | Product Code: | GEI | | Device Class: | 2 | {4}------------------------------------------------ #### 5. Description of the Device [21 CFR 807.92(a) (4)] The star/VIVA RF Electrodes are a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF generator (K163450). They are not intended to function with other RF generators. The star/VIVA RF Electrodes consists of the tubing set, PC pipe, PC plug and grounding pad. The grounding pad is FDA cleared (K163450). The star/VIVA RF Electrodes consist of an electrode tip, insulation part, handle and tubing. Patient contacting materials of star RF Electrode are stainless steel 304 and polyester, and patient contacting materials of VIVA RF Electrode are stainless steel 304 and polyimide. Cooling of the electrode is provided by chilled water which is pumped 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. The star/VIVA RF Electrodes are available in different lengths, different tip exposures and different thicknesses. The lengths that are available for the star RF Electrode range from 7 cm to 20 cm and VIVA RF Electrode range from 15 cm to 20 cm. The tip exposures available for the star RF Electrode range from 5 mm to 20 mm and VIVA RF Electrode range from 5 mm to 30 mm. The exposed length of the VIVA RF Electrode can be adjusted by the control button on the handle. The diameters available for the star RF Electrode diameters are 17 Gauge. The diameters available for the VIVA RF Electrode diameters are 15 Gauge and 17 Gauge. #### 6. Intended Use [21 CFR 807.92(a) (5)] star/VIVA RF Electrode is intended for use in percutaneous and intraoperative coagulation and ablation of tissue. ## 7. Technological Characteristics [21 CFR 807.92(a) (6)] The star/VIVA RF Electrodes consist of an electrode tip, insulation part, handle and tubing. The electrode tip of star RF Electrode is composed of stainless steel 304 and polyester, and the electrode tip of VIVA RF Electrode is composed of stainless steel 304 and polymide. 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. The conductive electrode tip delivers high frequency current onto a target tissue for coagulation and/or ablation during a surgical operation. The subject device is substantially equivalent to the predicate device in intended use and technological characteristics. There is no significant difference between the star/VIVA RF Electrodes and the predicate device that would adversely affect the use of the product. {5}------------------------------------------------ | Parameter | Subject Device | Predicate Device | | |------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------| | 510(k) Number | Unknown | K163450 | | | Model Name | star/VIVA RF Electrodes | star RF Electrodes<br>(17-15s30F, 17-20s30F) | | | Manufacturer | STARmed Co., Ltd. | | | | Common Name | Electrosurgical Cutting and Coagulation Accessories | | | | Classification Name | Electrosurgical, Cutting & Coagulation & Accessories | | | | Classification Panel | General and Plastic Surgery | | | | Classification Regulation | 21 CFR 878.4400 | | | | Product Code | GEI | | | | Device Class | Class II | | | | Intended Use | star/VIVA RF Electrode is<br>intended for use in percutaneous<br>and intraoperative coagulation<br>and ablation of tissue. | star RF Electrode is<br>intended for use in<br>percutaneous and<br>intraoperative coagulation<br>and ablation of tissue. | | | Energy Used | Radiofrequency | Radiofrequency | | | Operation Principle | Monopolar | Monopolar | | | Physical<br>Specifications | Electrode Length<br>(mm) | star RF 70, 150, 200<br>VIVA RF 150, 200 | 150, 200 | | | Exposure Length<br>(mm) | star RF 5, 7, 10, 20<br>VIVA RF 5, 10, 15, 20, 25, 30 | 30 | | | Diameters<br>(Gauge) | star RF 17, 18<br>VIVA RF 15, 17 | 17 | | Patient<br>Contacting<br>Materials | Electrode Tip<br>Materials | Stainless Steel 304 | Stainless Steel 304 | | | Insulation Part<br>Materials | star RF Polyester<br>VIVA RF Polyimide | Polyester | | Neutral<br>Electrodes | Conductive or<br>Capacitive | Conductive | Conductive | | | Physical<br>specifications | 187 x 145 (mm) | 187 x 145 (mm) | | | Materials<br>(Conductive area) | Hydrogel | Hydrogel | | Sterile | | EO Sterilization | EO Sterilization | | Single Use | | Single Use | Single Use | | Parameter | Subject Device | Predicate Device | | | Connector Type | 4 Pin | 4 Pin | | ## 8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92] {6}------------------------------------------------ When compared to the predicate devices (K163450), the star/VIVA RF Electrodes presented in this submission has the same of the followings: - Intended Use - · Technological Characteristics - · Energy Used - · Operation Principle - · Sterile - Single Use - Connector Type A few differences are as follows - · Physical Specifications - · Patient Contacting Materials (VIVA RF Electrode) There is no significant difference between the star/VIVA RF Electrodes and the predicate device that would adversely affect the use of the product. The subject device is substantially equivalent to the predicate device in intended use, technological characteristics, used energy, operation principle, sterile and single use. Even though the physical specifications and patient contacting materials of the predicate device and the subject device are different, the results of the safety testive electrode (IEC 60601-2-2 and AAMI HF 18), bench testing, ex vivo testing (thermal effects on tissue) and biocompatibility testing proved that the subject devices are substantially equivalent to the predicate device. {7}------------------------------------------------ #### 9. Summary of Non-Clinical Data The non-clinical performance tests were conducted to evaluate the effectiveness and safety of the star/VIVA RF Electrodes and its equivalence to the predicate device. A drop test, bending force test, electric conduction and flow rate test were performed to minimize the risks associated with mechanical failure and short circuiting. The temperature monitoring test was performed to demonstrate that the temperature sensing. The test on thermal effects was performed to evaluate the width and depth of thermally damaged zone in relation to the tip length, gauge, power setting, and duration for different tissue types. The test was performed on liver, kidney, and muscle tissue according to the FDA Guidance 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery'. star/VIVA RF Electrodes comply with the following international and FDA-recognized consensus standards: | IEC 60601-2-2: | Medical electrical equipment - Part 2-2: Particular<br>requirements for the safety of high frequency surgical<br>equipment | |----------------|----------------------------------------------------------------------------------------------------------------------------| | AAMI HF 18: | Electrosurgical Devices | | ISO 10993-1: | Biological evaluation of medical devices - Part 1:<br>Evaluation and testing within a risk management process | | ISO 10993-5: | Biological evaluation of medical devices - Part 5: Tests for<br>in vitro cytotoxicity | | ISO 10993-10: | Biological evaluation of medical devices - Part 10: Tests for<br>irritation and skin sensitization | | ISO 10993-11: | Biological evaluation of medical devices - Part 11: Tests for<br>systemic toxicity | The IEC 60601-2-2 standard only applies to the sections (101.3) and the AAMI HF 18 standard only applies to the sections (5.2 and 5.5) since the subject device only consists of active electrodes. The non-clinical tests all met the acceptance criteria specified in the standards. {8}------------------------------------------------ #### 10. Summary of Clinical Data No clinical studies were considered necessary and performed. ### 11. Conclusion [21 CFR 807.92(b) (3)] The subject Device is substantially equivalent to the currently marketed and predicate devices in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. Additionally, substantial equivalence was demonstrated through the non-clinical performance, which complied with the requirements specified in the international and FDA-recognized consensus standards, IEC60601-2-2, AAMI HF 18, ISO 10993-10, ISO 10993-11, ISO 10993-11, bench testing and ex vivo testing (thermal effects on tissue), which complied with the requirements specified in the CDRH's Guidance for Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery. The results of these tests demonstrate that star/VIVA RF Electrodes meet the acceptance criteria and is adequate for this intended use. The comparison of technological characteristics, nonclinical performance data, safety testing demonstrates that the device is as safe and effective as the predicate device and performs as well as the predicate device.