Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, resembling a stylized bird. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 9, 2016 Venclose, Inc. % Ms. Pamela Buckman Pamela M. Buckman, MSN 2800 Pleasant Hill Road, Suite 175 Pleasant Hill, California 94523 Re: K160754 Trade/Device Name: Venclose™ Radiofrequency System (digiRF Generator, EVSRF Catheter) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: August 8, 2016 Received: August 11, 2016 Dear Ms. Buckman: 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 devicerelated adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth {1}------------------------------------------------ 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 Parts 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. Christopher J. Ronk-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) K160754 Device Name Venclose Radiofrequency System Indications for Use (Describe) The Venclose™ Radiofrequency System (Generator and Catheters) is intended for use in endovascular of blood vessels 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." {3}------------------------------------------------ # 510(K) SUMMARY ### K Number: K160754 # General Information | Date Prepared: | September 8, 2016 | |------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | Proprietary Name: | Venclose™ RF Generator and Catheter System | | Common Name: | Electrosurgical, Cutting & Coagulation & Accessories | | Classification Name and Reference: | Electrosurgical cutting and coagulation device and accessories<br>21 CFR §878.4400 | | Regulatory Class: | Class II | | FDA Panel: | General and Plastic Surgery | | Product Code: | GEI | | Applicant: | Venclose™, Inc.<br>2570 N. First St.<br>2nd Floor #221<br>Tel: 844 834 6292<br>Fax: 844 834 6293<br>Brady Esch, CEO<br>besch@venclose.com | | Contact: | Pamela M. Buckman, MSN<br>2800 Pleasant Hill Rd., Suite 175<br>Pleasant Hill, CA 94523<br>Tel: 925 980 7007<br>Fax: 925 705 7381<br>pmbuckman@gmail.com | #### Indication for Use: The Venclose™ Radiofrequency System (Generator and Catheters) is intended for use in endovascular coagulation of blood vessels in patients with superficial vein reflux. #### Predicate Device(s): The Venclose™ Radiofrequency System is substantially equivalent to the following predicate devices. | K040638 | VNUS RF Generator | |---------|---------------------------| | K061373 | VNUS ClosureFast Catheter | {4}------------------------------------------------ # Device Description: The Venclose RF System is composed of two basic components: an energy console or generator (digiRF) and catheters (EVSRF) designed specifically to be used with the generator. The Venclose RF System uses resistive radiofrequency ablation via energy delivery to heat the wall of an incompetent vein with temperature-controlled RF energy to cause irreversible luminal occlusion, followed by fibrosis and ultimately resorption of the vein. The blood then naturally reroutes to healthy veins. The technique involves percutaneous access and insertion of the EVSRF Catheter into the great saphenous vein (GSV) or other superficial vein under ultrasound guidance, injection of local anesthesia, and thermal energy from a radiofrequency generator (digiRF) applied into the target vein. As the EVSRF Catheter is withdrawn stepwise down the treated length of the vein, thermal damage is inflicted upon the venous endothelium and through the vein wall, resulting in contraction and ultimately destruction of the vessel. The procedure can be performed in an outpatient setting, without the need for general anesthesia, allowing for a walkin/walk-out procedure with minimal postoperative recovery time. # Materials: Materials for use in the console are consistent with industry practice for durable cases containing electronic elements. The console is supplied in a non-sterile condition and is not intended to be in contact with the surgical field or the patient. The catheters are made of industry-typical, biocompatible, nonpyroqenic materials and are provided packaged in a sterile condition. They are intended for use in a sterile surgical environment and will make contact with the patient. Biocompatibility data demonstrates that the catheters are in compliance with ISO 10993. # Comparative Summary of Technological Characteristics: The materials, design, energy source, software integration, sterility methods (EVSRF Catheter component only), environment of use and clinical applications for the Venclose™ Radiofrequency System are comparable to those identified for the predicate devices. {5}------------------------------------------------ | COMPARISON<br>ITEMS | VNUS RF<br>Generator<br>K040638 | VNUS Closurefast™<br>Catheter<br>K061373 | SUBJECT DEVICE<br>K160754 | |-------------------------------------|---------------------------------------------------------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------------------| | Instrument<br>Cable | Attached to<br>catheter, connects<br>to generator, eight<br>feet long | | Attached to catheter,<br>connects to<br>generator, eight feet<br>long | | Energy/<br>Frequency | Bipolar 460.8 kHz,<br>max 90 Volts | | Bipolar 460 kHz, max<br>24 Volts | | Software | Software<br>Controlled | | Software Controlled | | Maximum<br>Output Power | 6 W/cm (40 W into<br>catheter 7 cm<br>heating element) | | 6 W/cm (60 W into<br>catheter when<br>heating 10 cm<br>heating element) | | Temperature<br>functional limits | 10°C to 130°C | | 10°C to 130°C | | Input Voltage | 100/240 VAC 50-60<br>Hz | | 100/240 VAC 50-60<br>Hz | | Touch Screen | None | | Included 7in<br>touchscreen | | Weight | 20 lbs max | | 10 lbs max | | Dimensions | 38 cm x 38 cm x 19<br>cm (15 in x 15 in x<br>7.5 in) | | 23 cm x 25 cm x 17<br>cm<br>(9 in x 10 in x 7 in) | | Mode of Action | Delivers heat to<br>resistive element<br>within the catheter<br>component | | Delivers heat to<br>resistive element<br>within the catheter<br>component | | Foot Pedal | Not available | | Optional | | Length of Use | | Single<br>Use/Disposable | Single<br>Use/Disposable | | Catheters | | | | | Diameters | | 7F (2.3mm) | 6F (2.0 mm) | | Insertable<br>Lengths | | 60 cm or 100 cm | 60 cm or 100 cm | | Heating<br>element<br>Lengths | | 7cm (predicate<br>K061373) or separate<br>catheter with 3cm<br>(reference K111887) | Single, adjustable, 10<br>cm (default) or 2.5<br>cm | | Handle, Cable<br>& Connector | | Integral to Catheter | Integral to Catheter | | Heating Set<br>Temperature<br>Range | | 95-120°C — User<br>Select, default at<br>120°C | 120°C, non-<br>adjustable | {6}------------------------------------------------ ### Non-Clinical Testing: Device testing was conducted to evaluate conformance to product specifications and applicable standards. Bench testing included but not limited to the following tests: Catheter Simulation Test, Temperature Test, Pressure Test, Tensile Test, Fluid Test. Applicable Standards and Guidances are as follows: - . Guidance on Premarket Notification [510(k)] Submissions for Short-Term and Long-Term Intravascular Catheters, March 16, 1995. - ISO 10555-1:2013 Sterile, Single-Use Intravascular Catheters, Part 1: . General Requirements - EN ISO 13485:2012 Medical devices. Quality management systems. Requirements for regulatory purposes - EN ISO 14971:2012 Medical devices. Application of risk management to medical devices - IEC 62304:2006 Medical device software. Software life cycle processes - . IEC 62366:2008 Medical devices. Application of usability engineering to medical devices - . IEC 60601-1:2005 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - IEC 60601-1-6:2010 Medical electrical equipment Part 1-6: General . requirements for safety - Collateral Standard: Usability # Pre-clinical testing: Animal testing was conducted in a model previously used for research in endovenous ablation for similar devices. The chosen model provided great saphenous and common jugular veins that are sized similarly to human veins. The purpose of the study was to demonstrate proper functionality of the Venclose System in a pre-clinical environment. Objectives included insertion of the catheter though a sheath into the vein, navigation to the intended treatment site, ability to reach a predetermined treatment temperature within a specified time frame and then to hold that temperature for the remainder of the treatment cycle, and capability of reducing the diameter of the vein by an amount similar to that done with the predicate device. All of the objectives were met resulting in a satisfactory study conclusion. # Rationale for Substantial Equivalence Conclusions drawn from the non-clinical bench and animal testing demonstrate that the Venclose System is as safe, as effective and performs at least as safely and as effectively as the legally marketed devices (K040638 and K061373) for the requested intended use as identified in this Summary.