Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 5, 2017 Ms. Kasey E. Newcomb Specialist I, Regulatory Affairs Angiodynamics, Inc. 26 Forest Street Marlborough, MA 01752 Re: K162449 Trade/Device Name: Solero Microwave Tissue Ablation (MTA) System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NEY Dated: March 31, 2017 Received: April 3, 2017 Dear Ms. Newcomb: 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 [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 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) {1}------------------------------------------------ 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 yours, # 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}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K162449 Device Name Solero Microwave Tissue Ablation (MTA) System Indications for Use (Describe) The Solero Microwave Tissue Ablation (MTA) System is indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not indicated for cardiac use. Type of Use (Select one or both, as applicable) Over-The-Counter Use (21 CFR 801 Subpart C) X Prescription Use (Part 21 CFR 801 Subpart D) 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." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ # 510(k) Summary – Solero Microwave Tissue Ablation (MTA) System Date Prepared: April 28, 2017 #### A. Submitter Information | Submitter | Angiodynamics Inc. | |-----------|----------------------------------| | | 26 Forest St | | | Marlborough, MA 01752 | | Tel: | (508) 658-7813 | | Fax: | (508) 263-7976 | | Contact: | Kasey E. Newcomb, | | | Regulatory Affairs, Specialist I | | Email: | knewcomb@angiodynamics.com | | | | ### Or Linda J. Varroso AngioDynamics, Inc. 26 Forest Street Marlborough, MA 01752 Tel: (508) 658-7967 Fax: (508) 263-7976 lvarroso@angiodynamics.com #### B. Trade Name System | Trade Name: | Solero Microwave Tissue Ablation (MTA)<br>System | |----------------------|-------------------------------------------------------------------| | Common Name: | Microwave Tissue Ablation System and<br>Accessories | | Classification Name: | Electrosurgical Cutting and Coagulation Device<br>and Accessories | | Regulation Number | 21CFR 878.4400 | | Product Code: | NEY | | Class: | II | {4}------------------------------------------------ #### C. Predicate Devices | Primary Predicate: | K122762 Acculis Accu2I pMTA Applicator and SulisVpMTA Generator | |----------------------|-------------------------------------------------------------------| | Reference Device: | K113237 NeuWave Medical, Inc - Certus 140 System | | Common Name: | Microwave Ablation System and Accessories | | Classification Name: | Electrosurgical Cutting and Coagulation Device<br>and Accessories | | Regulation Number | 21CFR 878.4400 | | Product Code | NEY | | Class: | II | #### D. Device Description The Solero Microwave Tissue Ablation (MTA) System is a softwarecontrolled, microwave generator with an integrated peristaltic pump that surgically ablates soft tissue through sterile applicators. The system may be used during open procedures for the ablation of soft tissue. The Solero Generator is distributed with a main power cable and a footswitch, which may be used as an alternate means of controlling microwave activation in place of the microwave button on the front of the generator. Power is delivered through the disposable Solero Applicator, which are provided separately. A chilled saline source is required to maintain the Solero Applicators at an appropriate temperature. #### E. Indications for Use The Solero Microwave Tissue Ablation (MTA) System and Accessories is indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use. {5}------------------------------------------------ #### F. Technological Characteristics | | Subject Device | Predicate Device | Reference Device | |--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Solero Microwave Tissue | K122762 | K113237 | | | Ablation (MTA) System | Acculis Accu2i pMTA | NueWave | | Feature | | Applicator and Sulis VpMTA | Certus 140 2.45 GHz | | | | Generator | Ablation System and | | | | | Accessories | | Indications For Use | The Solero Microwave<br>Tissue Ablation (MTA)<br>System is indicated for the<br>ablation of soft tissue during<br>open procedures. The<br>Solero MTA System is not<br>indicated for cardiac use. | Acculis Accu2i pMTA<br>Applicator with Sulis V<br>pMTA Generator software<br>release 2.1 is indicated for<br>the intraoperative<br>coagulation of soft tissue. | The NeuWave Medical<br>Certus 140'M 2.45 13Hz<br>Ablation System and<br>Accessories are intended for<br>the ablation (coagulation) of<br>soft tissue in percutaneous,<br>open surgical and in<br>conjunction with<br>laparoscopic<br>surgical settings. | | Applicator Features | Applicator with umbilical<br>cable, IV spike, saline tubing<br>and cartridge connector | Applicator with umbilical<br>cable, IV spike, saline tubing<br>and cartridge connector | Applicator with a handle, a<br>cannula, a radiating section<br>and a faceted tip for<br>insertion | | Generator Features | Generator touch screen<br>display provides information<br>on ablation/coagulation<br>time, microwave delivered<br>power, and system specific<br>information | Generator touch screen<br>display provides information<br>on ablation/coagulation<br>time, microwave delivered<br>power, temperature probe<br>readings and system specific<br>information | Generator touch screen<br>display provides information<br>on ablation time, power,<br>probe temperature and<br>system specific information | | Operating Principle | Generator delivers<br>microwave energy to the<br>applicator tip to thermally<br>target tissue, resulting in<br>coagulation and ablation | Generator delivers<br>microwave energy to the<br>applicator tip to thermally<br>target tissue, resulting in<br>coagulation and ablation | Generator delivers<br>microwave energy to the<br>applicator tip to thermally<br>target tissue, resulting in<br>coagulation and ablation | | Ablated/Coagulated Tissue | Near spherical volumes,<br>scalable to approximately 4<br>cm diameter in ≤ 6 minutes | Near spherical volumes,<br>scalable to approximately 4<br>cm diameter in ≤ 6 minutes | < 4cm ablation in all tissues<br>(PR),<br>< 7 cm ablations in liver,<br>< 6 cm in kidney (LK) | | Applicator Patient<br>Contacting Materials | Silicone coated shaft | Silicone coated shaft | Stainless steel, insulated<br>shaft | | Applicators Length | Standard: 14 cm<br>Intermediate: 19 cm<br>Long: 29 cm | Standard: 14 cm<br>Intermediate: 19 cm<br>Long: 29 cm | 15 cm<br>20 cm | | Applicators Outer Diameter | Stainless steel shaft 1.83mm<br>Stainless steel shaft with<br>silicone coating ≤2mm | 1.83 mm | 1.47mm | | Thermocouple Location | 2.7cm from the tip | 2.7cm from the tip | Unspecified | | | Subject Device | Predicate Device | Reference Device | | | Solero Microwave Tissue<br>Ablation (MTA) System | K122762 | K113237 | | Feature | | Acculis Accu2i pMTA<br>Applicator and Sulis VpMTA<br>Generator | NueWave<br>Certus 140 2.45 GHz<br>Ablation System and<br>Accessories | | Max Tip Temperature | Temperatures below 48°C,<br>they alert the user when the<br>coolant begins to become<br>warm (38°C), and an alarm<br>will sound and microwave<br>energy delivery will<br>terminate when the coolant<br>in the tip reaches 48°C | Temperatures below 48°C,<br>they alert the user when the<br>coolant begins to become<br>warm (38°C), and an alarm<br>will sound and microwave<br>energy delivery will<br>terminate when the coolant<br>in the tip reaches 48°C | Unspecified | | Cable Length | 295.25cm for all<br>applicator lengths | Standard: 200.1cm<br>Intermediate: 192.0cm<br>Long: 176.1cm | Unspecified | | Generator Frequency | 2.45 GHz | 2.45 GHz | 2.45 GHz | | Reflected Power Threshold | -5.4 dB | -5.4 dB | Unspecified | | System Output Power<br>Range | 60 to 140 watts in 20 watt<br>increments | 60 to 140 watts in 20 watt<br>increments | 95W per channel or up to<br>140W in a single channel | | Microwave Generation | Solid-state microwave<br>generator | Magnetron | Unspecified | {6}------------------------------------------------ {7}------------------------------------------------ #### G. Safety and Performance The results of verification and validation activities were performed in accordance with design control requirements per 21 CFR 820.30 and demonstrate that the proposed device Solero Microwave Tissue Ablation (MTA) System meets predetermined performance specifications. Performance testing that was completed included: - . Tip Puncture Force - Flexural Tip Strength ● - Removal Force - Flow Rate - Bag Spike - Cartridge Connection Force ● - Cartridge Alignment - Device Recognition - Power Output - Shaft to Applicator Tip Tensile - Handle to Shaft Tensile - Umbilical to Handle Tensile ● - Umbilical to Cartridge ● Tensile - . Pump Tubing to Cartridge Tensile - . Pump Tubing to Bag Spike Tensile - Saline Temperature - Multiple Ablations - Track Ablation ● - Temperature Control ● - Dielectric Strength ● - Cartridge Connection - Pump Compatibility - Cartridge Attachment Force ● - Cartridge Removal Force - . Generator Hardware testing - Complex programmable logic device - . Reliability Testing The performance evaluation plan included testing per the following recognized standards to assess conformance to IEC 60601 (300 Edition). | IEC 60601-1 | Medical Electrical Equipment – Part 1: General<br>Requirements for Safety | |---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1-2 | Medical Electrical Equipment – Part 2: General<br>Requirements for Basic Safety and Essential<br>Performance – Collateral Standard Electro<br>Magnetic Compatibility - Requirements and Test | Human Factors Evaluation: Simulated Use / Human Factors Testing has been conducted to evaluate the application of the Solero Microwave Tissue Ablation (MTA) System (i.e., Solero System) when used to ablate soft tissue. {8}------------------------------------------------ Animal Studies: Performance characterization was performed on three difference exvivo tissue; bovine liver, porcine kidney, and porcine lung, as these are considered to be comparable to human tissue. Testing was performed at varying time settings and power limits. The purpose of this testing was to support the recommended ablation settings, as well as demonstrate substantial equivalence to the predicate device. Two GLP compliant animal studies were performed. The first study was to evaluate and establish substantial equivalence of the Solero Microwave Tissue Ablation (MTA) System to its predicate device Acculis Accu2I pMTA Applicator and SulisVPMTA Generator (K122762) and reference device Certus 140 System (K113237). The study also looked at the fundamental operational characteristics for the Solero MTA System. Safety was assessed from: animal behavior, ECG's, respiration rates, and temperature. The second study's objective was to evaluate the safety and performance of the Solero Microwave Tissue Ablation (MTA) System to its predicate device Acculis Accu21 pMTA Applicator and SulisVpMTA Generator (K122762) during open surgical procedure in an acute porcine model. This study specifically evaluated and compared the safety at the highest power (140W) and time (6 minutes) of the two devices. #### H. Substantial Equivalence Conclusion The proposed device is equivalent with respect to the basic system design and function to that of the predicate device and reference device. The differences between the predicate, reference device and proposed device do not raise new questions of safety or effectiveness.