Microwave Ablation System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 8, 2019 Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Guofang Ma Quality Director No.1 XinXing Yilu Road, Emerging Industrial Cluster Area Zonghan Subdistrict, Cixi City, Zhejiang, China 315300 Re: K183153 Trade/Device Name: Microwave Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: NEY Dated: November 2, 2018 Received: November 14, 2018 Dear Guofang Ma: 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. 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 located 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. 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You must comply with all the Act's {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and 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 the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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, Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K183153 Device Name Microwave Ablation System Indications for Use (Describe) The Microwave Ablation System is intended for coagulation (ablation) of soft tissue. It is not intended for use in cardiac procedures. | 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}------------------------------------------------ # Section III 510(k) Summary This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92. There is no prior submission for the device. ### 3.1 Submitter Information - 510(k) Submitter/Holder: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. No.1 Xinxing Yilu Road, Emerging Industrial Cluster Area, Zonghan Subdistrict, Cixi City, Zhejiang, China #### . Contact Guofang Ma Quality Director Telephone: +86-10-64116115 Fax: +86-10-64113261 Email: QARA@surgnova.com ● Date Prepared: August 02, 2018 ### 3.2 Proposed Device Information Device Common Name: Microwave ablation system and accessories Device Trade/Proprietary Name: Microwave Ablation System Model: M150E Classification Name: Electrosurgical cutting and coagulation device and accessories Regulation Number: 878.4400 Product Code: NEY Class: Il Panel: General & Plastic Surgery ### 3.3 Predicate Device 510(k) Number: K133821 Common Name: Microwave ablation system and accessories Device Trade/Proprietary Name: Emprint™ Ablation System Classification Name: Electrosurgical cutting and coagulation device and accessories Regulation Number: 878.4400 Product Code: NEY Class: II Panel: General & Plastic Surgery Manufacturer: Covidien LLC {4}------------------------------------------------ ### 3.4 Device Description The Microwave Ablation System M150E is microwave-based system intended to deliver energy through an antenna inserted into soft tissue for the purpose of coagulating (ablating) a defined volume of that tissue. The Microwave Ablation System utilizes a 2450MHz generator to deliver power to single microwave ablation antenna or double microwave ablation antennas. The Microwave Ablation Generator provides for user setting of ablation time and ablation power. The proposed device consists of Microwave Ablation Generator, Microwave Ablation Electrode Kits, Temperature Probe and Foot Switch. Wherein, The Microwave Ablation Electrode Kits consists of Microwave Ablation Antenna, water pipe and Coax cable, to be used for puncturing the patient's lesion position during operation and also for outputting microwave energy to ablate the tumor tissue through connection with Microwave Ablation Generator. The Temperature Probe is applied to monitor the temperature of the target location and to protect important organs and tissues in the periphery of the lesion from unexpected damage by microwave energy. It supports both power and temperature modes. #### Power mode Under the power mode, at the beginning, the system output microwave power according manually setting. When the tissue temperature reaches the target temperature, the system adjusts the duty cycle in real time according to the specific algorithm and load power to keep the tissue temperature on the target temperature. Two microwave ablation antennas can be used for microwave ablation. #### Temperature mode Under the temperature mode, at the beginning, the system output microwave power according manually setting. When the tissue temperature reaches the target temperature, the system adjusts the output of microwave power in real time according to the specific algorithm to keep the tissue temperature on the target temperature. Two microwave ablation antennas can be used for microwave ablation. The Microwave Ablation Generator is non-sterile, while Microwave Ablation Electrode Kits and Temperature Probe are sterile. The device is software-driven and the software validation is provided in Section of Software. {5}------------------------------------------------ ### 3.5 Comparison list of the technological characteristics Based on the comparison of the clinical and ablation antennas of the predicate device—Emprint™ ablation system, there are no significant differences between the material, the key technology, the design characteristics, the applicable population, the site of action, etc. Confirming that both devices are equivalent in terms of clinical performance and safety. The specific results are as follows: | Comparison Elements | Predicate Device<br>(K133821) | Proposed Device | Comparison<br>(Equivalent,<br>Similar,<br>Different) | | |---------------------|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Product Name | Emprint™ Ablation System | Microwave Ablation System | / | | | Regulation No. | 21 CFR 878.4400 | 21 CFR 878.4400 | Equivalent | | | Classification | II | II | Equivalent | | | Classification Name | Electrosurgical cutting and coagulation device and accessories | Electrosurgical cutting and coagulation device and accessories | Equivalent | | | Product Code | NEY | NEY | Equivalent | | | Clinical | Indications for Use | The Emprint™ Ablation System is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors.<br><br>The Emprint™ Ablation System is not | The Microwave Ablation System is intended for the coagulation (ablation) of soft tissues.<br><br>The Microwave Ablation System is not intended for use in cardiac procedures. | Equivalent | {6}------------------------------------------------ | | | | intended for use in cardiac procedures. | | | | |----------------------|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|--|------------|--| | | Intended purpose | coagulation and ablation of tissue | coagulation and ablation of tissue | | Equivalent | | | Comparison Statement | | The proposed device has the same indications for use and classification as the predicate device. | | | | | | Technical | Design | Single channel | Double channels | | Different | | | | | cooling-water cycle, thermal ablation,<br>the probe of TEMP, foot switch | cooling-water cycle, thermal ablation,<br>the probe of TEMP, foot switch | | Equivalent | | | | Comparison<br>Statement | Compared with the predicate device, the proposed device has double channel to output energy. The two<br>channel not only can output energy at the same time but also can work respectively. | | | | | | | Operating<br>temperature | 10°C-30°C | 5°C-40°C | | Similar | | | | Operating<br>humidity | 20%~80% non condensation | 20%~80% non condensation | | Equivalent | | | | Comparison<br>Statement | The proposed device operating environment temperature is wider than that of the equivalent product. We<br>have confirmed through environmental tests that this temperature range does not affect the product's<br>safety and performance. | | | | | | | Output<br>Parameters | 2450MHz±50MHz,<br>0-100W | 2450MHz±10MHz,<br>0-100W | | Equivalent | | | | Output Impedance | 50Ω nominal | 50Ω nominal | | Equivalent | | {7}------------------------------------------------ | Premarket Notification 510(k) Submission—K183153 | | | | |--------------------------------------------------|--|--|--| |--------------------------------------------------|--|--|--| | Voltage Supply | 100-240VAC 50-60 Hz | 100-240VAC 50-60 Hz | Equivalent | | |-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------| | Fuse Rating | 6.3 A, 250V | 6.3 A, 250V | Equivalent | | | Physicochemical<br>Properties | Not contain any medications, animal<br>tissues or blood components, especially<br>in contact with human tissue does not<br>contain the above substances. | Not contain any medications, animal tissues<br>or blood components, especially in contact<br>with human tissue does not contain the<br>above substances. | Equivalent | | | Working Principle | During the surgery, the microwave<br>ablation antenna is accurately placed in<br>the tumor target area by imaging<br>techniques (such as CT, US, etc.). The<br>microwave energy generated by the<br>microwave generator transmits to the<br>microwave ablation antenna through the<br>coaxial cable, and then it is radiated out<br>through the microwave antenna and<br>absorbed by water molecules in the<br>tumor tissue. The microwave energy<br>transform into heat, and the<br>temperature rises rapidly result in tumor<br>tissue losing bioactivity. | During the surgery, the microwave ablation<br>antenna is accurately placed in the tumor<br>target area by imaging techniques (such as<br>CT, US, etc.). The microwave energy<br>generated by the microwave generator<br>transmits to the microwave ablation<br>antenna through the coaxial cable, and then<br>it is radiated out through the microwave<br>antenna and absorbed by water molecules in<br>the tumor tissue. The microwave energy<br>transform into heat, and the temperature<br>rises rapidly result in tumor tissue losing<br>bioactivity. | Equivalent | | | Comparison Statement | The proposed device and predicated device have the same working principle and similar technical<br>parameter. | | | | | Disposable<br>accessories- | Antenna Length<br>(mm) | CA15L1: 150 | SS-MWA-1526C: 150<br>SS-MWA-1531C: 150 | Different | | Ablation<br>Antennas | | CA20L1: 200 | SS-MWA-2026C: 200 | | | | | | SS-MWA-2031C: 200 | | | | | CA30L1: 300 | SS-MWA-2526C: 250 | | | | | | SS-MWA-2531C: 250 | | | | Comparison<br>Statement | The ablation antenna length of the proposed device is different from that of the predicate device, but<br>this difference is only reflected in the depth of the position of the tumor to be ablated and does not<br>affect the product's safety and performance. | | | | | Emission area<br>length (mm) | CA15L1: 28 | SS-MWA-1526C: 26 | Different | | | | CA20L1: 28 | SS-MWA-1531C: 31 | | | | | | SS-MWA-2026C: 26 | | | | | CA30L1: 28 | SS-MWA-2031C: 31 | | | | | | SS-MWA-2526C: 26 | | | | | | SS-MWA-2531C: 31 | | | | Comparison<br>Statement | The range of microwave emission area of the proposed device is wider than that of the predicate device,<br>We have proved through performance tests that this difference does not affect the product's safety and<br>performance. | | | | | OD(mm) | CA15L1: 2.40 | SS-MWA-1526C: 2.08 | Different | | | | | SS-MWA-1531C: 2.08 | | | | | CA20L1: 2.40 | SS-MWA-2026C: 2.08 | | | | | CA30L1: 2.40 | SS-MWA-2031C: 2.08 | | | | | | SS-MWA-2526C: 2.08 | | | | | | SS-MWA-2531C: 2.08 | | | | Comparison<br>Statement | Based on not affecting the area of the ablation, the diameter of the microwave antenna is thinner, so<br>that the trauma caused by the puncture is smaller. | | | | | Comparison<br>Statement | The 304 stainless steel usually has excellent corrosion resistance, good weldability and formability, good<br>resistance to hydrogen embrittlement, in addition to high ductility and toughness. The material of the<br>proposed device has passed the Bicompatibility test according to ISO 10993-1. | | | | | Disposable /Single-<br>use Device | The antennas are disposable and are to<br>be used within a single patient<br>procedure only. | The antennas are disposable and are to be<br>used within a single patient procedure only. | Equivalent | | | Sterility | The accessories are sterilized with<br>EO(SAL: 10-6) | The accessories are sterilized with EO(SAL:<br>10-6) | Equivalent | | | Biocompatibility | Patient-contacting materials are<br>biocompatible. | Patient-contacting materials are<br>biocompatible. | Equivalent | | | Device<br>Temperature<br>Monitoring | Temperature monitoring features used<br>to ensure system safety | Temperature monitoring features used to<br>ensure system safety | Equivalent | | | Device cooling | Pumped, normal saline is used to cool<br>the Emprint™ Antenna. | Pumped, normal saline is used to cool the<br>antenna. | Equivalent | | | Comparison Statement | | The proposed device and predicated device have the similar disposable accessories-Ablation Antennas and<br>same sterilization method. | | {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ ### 3.6 Indications for use The Microwave Ablation System is intended for the coagulation (ablation) of soft tissues. The MW Ablation System is not intended for use in cardiac procedures. ## 3.7 Testing #### Non-Clinical Testing The Microwave Ablation System and Accessories and the predicate device are substantially equivalent in design concepts, technologies and materials. The Microwave Ablation System and Accessories has been designed and will be manufactured in accordance with both mandatory and voluntary standards, including: • IEC 60601-1: 2005/A1:2012 Medical Electrical Equipment-Part 1: General requirements for safety. • IEC 60601-2-6:2012 Medical electrical equipment –Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment. • IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. •ISO 11607-1:2016 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems. • ISO 11135: 2014 Sterilization of health care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices The Software Validation is in compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. The Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices". The shelf life of Microwave Ablation Electrode Kits and Temperature Probe is 2 years. | No. | Test Name | |-----|---------------------------------------------------------------| | 1 | Electrical Safety Test According to IEC 60601-1 | | 2 | Electromagnetic Compatibility Test According to IEC 60601-1-2 | The list of non-clinical test performed on the proposed device. {11}------------------------------------------------ | 3 | Performance Test according to IEC 60601-2-6 | |----|---------------------------------------------------------------------------------------------------------------------------------------------------| | 4 | System Performance Test | | 5 | Thermal Effects test according to FDA Guidance Premarket Notification (510(K)) Submissions for Electrosurgical Devices for General Surgery | | 6 | Temperature Monitoring test according to FDA Guidance Premarket Notification (510(K)) Submissions for Electrosurgical Devices for General Surgery | | 7 | Shelf Life Test | | 8 | Package Verification Test according to ISO 11607-1 | | 9 | Sterilization validation according to ISO 11135 | | 10 | Irritation, Sensitization, Cytotoxicity, Pyrogenicity, Acute Systemic Toxicity Test according to ISO 10993 | #### Clinical Testing Clinical studies were not required to demonstrate the substantial equivalence of the microwave ablation system and the predicated device. ### 3.8 Determination of substantial equivalence The proposed device is equivalent with respect to the basic system design and function to that of the predicate device. The proposed device isn't the implants and high-risk device. And it doesn't have new intended purposes, new medical, new target populations, and new users and so on. What's more, it can't use the medicinal substances or animal tissues. So differences between the predicate and proposed device do not raise new questions of safety or effectiveness.