VVR Generator system

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it. The full name reads "U.S. Food & Drug Administration". October 25, 2023 Starmed Co., Ltd. % Minsu Kim SR Consultant Mdas #302, 35, Dongtansancheok-ro 1-gil Hwaseong-si, Gyeonggi-do 18488 Korea. South Re: K222997 Trade/Device Name: VVR Generator system Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: September 22, 2023 Received: September 22, 2023 Dear Minsu Kim: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm___identifies combination product submissions. 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE website assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Image /page/1/Picture/7 description: The image shows the name "Mark Trumbore" in a simple, sans-serif font. The name is stacked vertically, with "Mark" on top and "Trumbore" below. The text is black against a white background, creating a clear contrast. Digitally signed by Mark Trumbore -S Date: 2023.10.25 08:58:21 -04'00' Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices {2}------------------------------------------------ Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K22997 Device Name VVR Generator System Indications for Use (Describe) VVR Generator system is intended for endovascular coagulation of Saphenous Veins in patients with superficial vein reflux. 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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 # K222997 #### 1. SUBMITTER INFORMATION | Manufacturer: | STARMED CO., LTD.<br>B-Dong, 4F&12F, 158, Haneulmaeul-Ro. Ilsandong-Gu, Goyang-Si<br>Gyeonggi, Republic of Korea | |-----------------|----------------------------------------------------------------------------------------------------------------------| | Contact Person: | Honggeun Lee/Q&R senior manager<br>Tel) +82-31-816-3546(209)<br>Fax) +82-31-816-4546<br>Email) lhg1186@STARmed4u.com | | Date Prepared: | September 26, 2022 | #### DEVICE INFORMATION 2. - . Trade Name: VVR Generator svstem - . Common Name: Electrosurgical System - . Requlation Number: 21 CFR 878.4400 - . Regulation Name: Electrosurgical, Cutting & Coagulation & Accessories - . Regulation Class: Class II - Product Code: GEI - . General & Plastic Surgery Review Panel: #### PREDICATE DEVICE INFORMATION 3. - Predicate Device (A): K040638 (VNUS Radiofrequency Generator, Model RFG2) . - . Predicate Device (B): K111887 (ClosureFAST Radiofrequency Catheter) #### 4. DESCRIPTION OF THE DEVICE VVR Generator System consists of Generator (VVR Generator), Active electrode (VENISTAR) and accessory such as foot switch and cooling pump. The generator generates, controls and monitors RF energy and delivers energy to the active electrode. The active electrode has an active coil and a receiver coil that allow the RF energy to flow through the tissue. The RF energy raises the temperature in the tissue, causing coagulation and occlusion of blood vessels. The single footswitch works as an on/off switch and the double footswitch works to increase the power output. A cooling pump circulates water around the electrodes to reduce the temperature of the electrodes and prevent tissue sticking to the electrodes. #### INDICATION FOR USE 5. VVR Generator system is intended for endovascular coagulation of Saphenous Veins in patients with superficial vein reflux. {5}------------------------------------------------ #### TECHNICLOGICAL CHARACTERISTICS 6. | | Comparison Item | Subject Device | Predicate Device (A) | Predicate Device (B) | |-----------|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | | 510(k) Number | K222997 | K040638 | K111887 | | | Proprietary Name | VVR Generator,<br>VIVA Pump,<br>VENISTAR | VNUS<br>Radiofrequency<br>Generator | ClosureFAST<br>Radiofrequency<br>Catheter | | | Model Number | VVR10,<br>VP01,<br>VP01-1,<br>3-VENI0030N,<br>7-VENI0070N,<br>3-VENI003090N,<br>7-VENI007090N | Model RFG2 | - | | | Manufacturer | STARMED CO., LTD. | VNUS Medical<br>Technologies, Inc. | Covidien | | | Regulatory Class | Class II | Class II | Class II | | | Regulation Number | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 | | | Product Code | GEI | GEI | GEI | | | Indication for Use | VVR Generator<br>system is intended for<br>endovascular<br>coagulation of<br>Saphenous Veins in<br>patients with<br>superficial vein reflux. | The VNUS<br>Radiofrequency<br>Generator is intended<br>for use with VNUS<br>radiofrequency<br>devices intended for<br>vessel and tissue<br>coagulation. | The VNUS<br>ClosureFAST<br>Catheter is intended<br>for endovascular<br>coagulation of blood<br>vessels in patients<br>with superficial vein<br>reflux | | | Prescription or OTC | Prescription | Prescription | Prescription | | | Generator | Monopolar or<br>Bipolar | Bipolar | Bipolar | | | Temperature<br>sensors | N/A | 10°C - 130°C | - | | | Impedance<br>monitor | 10-800 ohms | N/A | - | | | Continuity<br>monitor | Impedance and<br>Output | Temperature and<br>Output | - | | | Output<br>frequency | 480 kHz±10% | 460.8 kHz, | - | | | Power output | Max power output<br><40W@Venistar<br>Mode | 6 W/cm (40 W into<br>catheter 7 cm<br>heating element) | - | | | Active Electrode | Monopolar or<br>Bipolar | Bipolar | Bipolar | | | Length of Use | Single Use/<br>Disposable | - | Single<br>Use/ Disposable | | | Diameters | 7Fr | - | 7Fr | | | Insertable<br>Lengths | 65cm or 90cm | - | 60 cm or 100 cm | | | Heating<br>element<br>Lengths | 3cm or 7cm | - | 3cm or 7cm | | | Handle | Integral to Catheter | - | Integral to Catheter | | | Cable<br>& Connector | | | | | | Materials | STS 304 | | Unknown | | Accessory | Foot switch | Yes | No | | | | Cooling<br>Pump | Yes | No | | {6}------------------------------------------------ The predicate device and the VVR Generator System have similar design characteristics and technical specifications. The difference between the two devices is that the Predicate device delivers RF power output to the catheter electrode, heats the electrode to a constant temperature of 120 to coagulate the blood vessel, while the Venistar mode of the VVR Generator system controls power output by monitoring the impedance of the vascular tissue during the application. Ex vivo testing, animal studies and clinical evidence (RWD) have demonstrated that the two devices have similar performance characteristics and similar performance effects. #### 7. SUMMARY OF NON-CLINICAL DATA Non-clinical tests were conducted to verify that the subject device met all design specifications as was substantially equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: #### Sterilization and Shelf life ○ The subject device is supplied sterile and has a shelf life of 3 years from the date of manufacture. A sterilization assurance level of 10-6 is guaranteed through the EO gas sterilization process, and it has been verified according to the following standards. - AAMI TIR28: 2016 ● - ISO 11135:2014 - ISO 11138-1:2017 - ISO 11138-2:2017 - ISO 11737-1:2018 - ISO 11737-2:2009 - ISO 11607-1:2009 - ISO 11607-2:2006 - ISO 10993-7:2008 #### Biocompatibility O The subject device has a limited contact characteristic of less than 24 hours within blood vessels and complies with the following standards. - ISO 10993-1:2018 - ISO 10993-4:2017 - ISO 10993-5:2009 - ISO 10993-10:2010 - ISO 10993-11:2017 #### Electromagnetic Compatibility and Electrical Safety O The Subject device is an active device and complies with the following general and particular standards. - ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 - IEC 60601-1-2:2014 - IEC 60601-1-6:2013 - IEC 60601-2-2:2017 - Performance Testing Bench In order to verify the design characteristics of the subject device as specified in the comparison table, bench {7}------------------------------------------------ testing was performed in accordance with the FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" and "Premarket Notification for Bipolar Electrosurgical Vessel Sealers for General Surgery", including the test items below. - Thermal Effects on Tissue A comparative evaluation of the thermal effect area of the VVR Generator System and the predicate device was performed. The evaluation was performed on coagulation in typical modes for liver, kidney and muscle tissue using electrodes of the same size from both devices. As a result of the test, the devices had similar heat damage area sizes and there was no significant difference. - Power Output Versus Impedance The output of the VVR generator system was tested to verify that the output characteristics varied with impedance. The test results verified that the power output decreased as the impedance increased, which is in the intended design output of the VVR Generator System. # 10. SUMMARY OF ANIMAL AND CLINICAL DATA #### O Animal Study Animal testing was conducted to verify the effectiveness and safety of the subject device compared to a 510 (k) cleared device in a dog model. Seven dogs underwent ablation using the control device (ClosureFAST and RFG2) and the subject device (VENISTAR and VVR Generator), Ltd.) in the femoral and cephalic veins. The ablated vein was evaluated macroscopically (2,3,5-triphenyltetrazolium chloride stain, TTC), microscopically (hematoxylin and eosin stain) and ultrasonographic ally. The veins of 1 dog were evaluated on the day of ablation, while the ablated veins of the remaining 6 dogs were evaluated 2 weeks later. A total of 23 veins (control: 11 veins; subject: 12 veins) were ablated in 7 dogs. Non-TTC stained vein wall areas were identified in all ablated veins. No significant difference was observed in mean vein injury and mean vein wall thickness between the control and experimental devices. There was no blood flow in all veins ablated with the VS, whereas there was residual blood flow in 1 vein ablated with the control device. The control and subject devices appear to provide similar occlusion rates and degrees of vein wall damage without perivenous side effects. - Clinical Study. O To support the equivalence of the VVR Generator System, a clinical study that evaluated the safety and effectiveness of the subject device were referenced. A total of 60 patients (41 males and 19 females) with varicose veins treated with the VVR Generator System were treated in this study, including 79 cases of the great saphenous vein and 10 cases of the small saphenous vein. The mean follow-up was 190±130 days and the success rate of treatment with the VVR generator system was 97.7%. Complications included 20 cases of bruising, 3 cases of recanalization and 1 case of neovascularization. The VVR Generator System was effective and safe for the treatment of varicose veins. ## 11. CONCLUSION A comparison of the technical characteristics of the VVR Generator System and the Predicate Device shows that they are very similar in design characteristics and technical specifications. Non-clinical tests per FDA recognized international standards and the FDA guidance on Electrosurgical Devices for General Surgery, animal studies and clinical evidence (RWD) support that the target device conforms to the recognized standard and is substantially equivalent to the predicate device for the intended use. Therefore, VVR Generator System have been demonstrated to be equivalent to predicate devices.