Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)

{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 Department of Health & Human Services - USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top of the word "ADMINISTRATION". January 31, 2024 Hygea Medical Technology Co., Ltd. Jinping Duan RA Manager Floor 6&7, West Area of Building No. 8, No.30 YuHua Road. Shunyi Beijing, Shunyi 101318 China Re: K233140 Trade/Device Name: Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: NEY Dated: September 27, 2023 Received: September 27, 2023 Dear Jinping Duan: 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. {1}------------------------------------------------ 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" (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 QS 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-devices/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 DICE website -(https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe 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, Mark Digitally signed by Mark Trumbore -S Trumbore -S Date: 2024.01.31 10:25:27 -05'00' Mark Trumbore, Ph.D. Assistant Director {2}------------------------------------------------ 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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K233140 Device Name Microwave Ablation Device Sterile Microwave Ablation Probe #### Indications for Use (Describe) The microwave ablation system is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Microwave ablation system is not intended for cardiac use. Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Sterile Microwave Ablation Probe is not intended for cardiac use. | Type of Use (Select one or both, as applicable) | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------| | <table border="0"><tr><td><span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</span></td></tr><tr><td><span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</span></td></tr></table> | <span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</span> | | <span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</span> | | | | <span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</span> | | | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ # Microwave Ablation Device Sterile Microwave Ablation Probe ### 1. Submission Sponsor Hygea Medical Technology Co., Ltd. Floor 6&7, West Area of Building No. 8, No.30 YuHua Road, Shunyi, Beijing, Beijing, 101318 PEOPLE'S REPUBLIC OF CHINA Jinping Duan RA Manager # 2. Submission Correspondent Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Email: LST.AUS.ProjectManagement@ul.com Contact: Mei Li Title: Technical Consultant, QA/RA, China # 3. Device Identification Trade/Proprietary Name: Microwave Ablation Device Sterile Microwave Ablation Probe Classification Name: Electrosurgical cutting and coagulation device and accessories Regulation Number(s): 21 CFR 878.4400 NEY Product Code(s): Class: ll Classification Panel: General & Plastic Surgery # 4. Legally Marketed Predicate Device(s): Microwave Therapeutic System (K201262) Disposable Microwave Therapeutic Antennas (K201265) Manufacturer: Nanjing ECO Microwave System Co., Ltd. {5}------------------------------------------------ ### K233140 ### 5. Device Description The Microwave Ablation Device with Sterile Microwave Ablation Probe is a device system which is intended for soft tissue coagulation. The Microwave Ablation Device consists of power supply, microwave power source, control system, temperature measurement system, RF connection cable, foot switch, and temperature probe. The Sterile Microwave Ablation Probe is a single-use sterile product, consisting of a handle, RF connector, RF coaxial cable, needle bar, inner tube, pinhead, temperature sensor and coolant tube. The Microwave Ablation Device also contains a single use Sterile Temperature Probe. # 6. Indication for Use Statement The microwave ablation system is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Microwave ablation system is not intended for cardiac use. Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Sterile Microwave Ablation Probe is not intended for cardiac use. ### 7. Substantial Equivalence Discussion The following table compares the Microwave Ablation Device with Sterile Microwave Ablation Probe to the predicate devices with respect to indications for use, principles of operation, technological characteristics, materials, and performance, and forms the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device. {6}------------------------------------------------ # K233140 | Feature | Microwave Ablation Device | Microwave Therapeutic System (K201262) | Discussion | |-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------| | Device<br>Classification | Class II<br>Electrosurgical cutting and coagulation device<br>and accessories. | Class II<br>Electrosurgical cutting and coagulation device<br>and accessories. | Same | | Product Code | NEY | NEY | Same | | Regulation No. | 21 CFR 878.4400 | 21 CFR 878.4400 | Same | | Manufacturer | Hygea Medical Technology Co., Ltd. | Nanjing ECO Microwave System Co., Ltd. | - | | Trade Name | Microwave Ablation Device. | Microwave Therapeutic System. | - | | Indications for Use | The microwave ablation system is indicated for<br>soft tissue coagulation (ablation) by healthcare<br>professionals in healthcare facilities. Microwave<br>ablation system is not intended for cardiac use. | The Microwave Therapeutic System is indicated for<br>the coagulation (ablation) of soft tissue. The<br>Microwave Therapeutic System is not intended for<br>cardiac use. | Same | | Prescription or OTC | Prescription | Prescription | Same | | Intended Purpose | Coagulation and ablation of tissue. | Coagulation and ablation of tissue. | Same | | Design | Single channel.<br>The host of Microwave Ablation Device,<br>RF connection cable, foot switch, and Sterile<br>Temperature Probe. | Single channel.<br>cooling-water cycle, thermal ablation, the probe of<br>TEMP, foot switch. | Equivalent.<br>See Comment 1. | | Operating Principle | Microwave energy is generated by Microwave<br>Ablation Device and then delivers to the applicator<br>tip through microwave cable to thermally heat the<br>target tissue, resulting in coagulation and ablation.<br>The Microwave Ablation Device refers to<br>equipment for treating diseases with microwave | Microwave oscillating signals are generated by<br>a microwave transistor and amplified by a<br>microwave power amplifier. The generator<br>delivers microwave energy to the applicator tip<br>to thermally target tissue, resulting in coagulation<br>and ablation. A microwave therapeutic system | Same | | Feature | Microwave Ablation Device | Microwave Therapeutic System (K201262) | Discussion | | | energy at a working frequency of 2450 MHz.<br>The liquid in the silicone tube is driven by the<br>rotation of the motor of pump to flow to the probe<br>to realize the purpose of probe cooling. | refers to equipment for treating diseases with<br>microwave energy at a working frequency of 2450<br>MHz. The liquid in the silicone tube is driven by the<br>rotation of the motor to flow through the radiator<br>to realize the purpose of radiator cooling. | | | AC Input Voltage | AC100-240V, 50/60Hz. | AC100-240V, 50/60Hz. | Same | | Output Impedance | $50 \Omega$ | $50\Omega$ | Same | | Output Parameters | 2450MHz±50MHz<br>0-120W | 2450MHz±20MHz<br>0-100W | Different.<br>See comment 2. | | Treatment time | 30min max | 30min max | Same | | Device<br>Temperature<br>Monitoring | Temperature monitoring features used to ensure<br>system safety. | Temperature monitoring features used to ensure<br>system safety. | Same | | Device cooling | Pumped, normal saline is used to cool the probe. | Pumped, normal saline is used to cool the antenna. | Same | | Operational Mode | Four modes, Mode A, Mode B, foot switch mode<br>and manual mode. | Three modes can be selected by the user.<br>Timing method, foot switch control and manual<br>control. | Different.<br>See comment 3. | # Table 1 – Comparison of Characteristics for Microwave Ablation Generator and Microwave Therapeutic System {7}------------------------------------------------ #### K233140 Comment 1: The foot pedal switch and Sterile Temperature Probe of the same as the predicate device. The host of the subject product is equivalent to the predicate device and cooling-water cycle. RF connection cable of the subject device is connected between the host and probe to transmit microwave energy. Comment 2: The max power of the subject device is different than the predicate device, and the max power of 120W is only suitable when used with the HS-1425150U and HS-142520U probes. The thermal effects test with ex vivo animal tissues device and does not raise new safety and performance risks. Comment 3: The predicate device has three operation method, foot switch control and manual control. Timing method will countdown or forward timing during energy output based on user setup, foot switch to control device output and manual control mode is controlled by user with button click. {8}------------------------------------------------ #### K233140 The subject device has four modes, which are Mode B, foot switch mode and manual mode. Mode A of the subject device is the same as timing method of the predicate devices, but with timer countdown only. Foot switch mode are also same as the predicate device, which control device output continuous or internittent by foot switch or user. Mode B of the subject device with Sterile Temperature Probe. Tissue protection temperature ned the subject device will monitor tissue temperature using the Sterile Temperature Probe. After tissue temperature reach the setup protection value, Microwave output to control the tissue temperature stable around the ±3% tolerance of the set temperature, the protection value range is 37.0 ℃~100.0 ℃. Mode B does not raise new safety and performance risks. | Feature | Sterile Microwave Ablation Probe | Disposable Microwave Therapeutic Antennas ( | Discussion | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | | | K201265) | | | Device<br>Classification | Class II<br>Electrosurgical cutting and coagulation device<br>and accessories. | Class II<br>Electrosurgical cutting and coagulation device<br>and accessories. | Same | | Product Code | NEY | NEY | Same | | Regulation No. | 21 CFR 878.4400 | 21 CFR 878.4400 | Same | | Manufacturer | Hygea Medical Technology Co., Ltd. | Nanjing ECO Microwave System Co., Ltd. | - | | Trade Name | Sterile Microwave Ablation Probe | Disposable Microwave Therapeutic Antennas | - | | Indications for Use | Sterile Microwave Ablation Probe is used with<br>Microwave Ablation Device, which is indicated for<br>soft tissue coagulation (ablation) by healthcare<br>professionals in healthcare facilities. Sterile<br>Microwave Ablation Probe is not intended for<br>cardiac use. | Disposable Microwave Therapeutic Antennas is<br>used with the Microwave Therapeutic System,<br>which is indicated for the coagulation (ablation)<br>of soft tissue. The Disposable Microwave<br>Therapeutic Antennas is not intended for<br>cardiac use. | Same | | Prescription or OTC | Prescription | Prescription | Same | | Intended Purpose | Coagulation and ablation of tissue. | Coagulation and ablation of tissue. | Same | | Operating Principle | During the surgery, the microwave ablation<br>antenna is accurately placed in the tumor target<br>area by imaging techniques (such as CT, US, etc.).<br>The microwave energy generated by the microwave<br>generator transmits to the microwave ablation<br>antenna through the coaxial cable, and then it is | During the surgery, the microwave ablation<br>antenna is accurately placed in the tumor target<br>area by imaging techniques (such as CT, US,<br>etc.). The microwave energy generated by the<br>microwave generator transmits to the<br>microwave ablation antenna through the | Same | Table 2 – Comparison of Characteristics for Microwave Ablation Probe and Disposable Microwave Therapeutic Antennas {9}------------------------------------------------ | Feature | Sterile Microwave Ablation Probe | Disposable Microwave Therapeutic Antennas (K201265) | Discussion | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | | radiated out through the microwave antenna and absorbed by water molecules in the tumor tissue. The microwave energy transforms into heat, and the temperature rises rapidly result in tumor tissue losing bioactivity. | coaxial cable, and then it is radiated out through the microwave antenna and absorbed by water molecules in the tumor tissue. The microwave energy transforms into heat, and the temperature rises rapidly result in tumor tissue losing bioactivity. | | | AC Input Voltage | A.C.100-240V, 50/60Hz. | AC100-240V, 50/60Hz. | Same | | Output Impedance | $50 \Omega$ | $50\Omega$ | Same | | Output Parameters | 2450MHz±50MHz<br>0-120W | 2450MHz±20MHz<br>0-100W | Different.<br>See Comment 2 | | Temperature<br>Monitoring | Temperature monitoring features used to ensure system safety. | Temperature monitoring features used to ensure system safety. | Same | | Device Cooling | Pumped, sterile disposable saline solution to cool the probes. | Pumped, normal saline is used to cool the antenna. | Same | {10}------------------------------------------------ | Feature | Sterile Microwave Ablation Probe | Disposable Microwave Therapeutic Antennas ( | Discussion | |----------------------------|----------------------------------|---------------------------------------------|------------------------------| | Applicators Length<br>(mm) | HP-1805080U:80 | ECO-100AI26:100 | Different.<br>See Comment 4. | | | HP-1605100U:100 | ECO-100AI3:100 | | | | HP-1507200U:200 | ECO-100AI1:100 | | | | HP-1512200U:200 | ECO-100AL29:1000 | | | | HC-1814100U:100 | ECO-100AI30:1200 | | | | HC-1814150U:150 | ECO-100CL29:1000 | | | | HC-1814200U:200 | ECO-100CL31:1000 | | | | HC-1614150U:150 | ECO-100CL8C:150 | | | | HC-1614200U:200 | ECO-100CL10:200 | | | | HC-1514150U:150 | ECO-100AI25:200 | | | | HC-1514200U:200 | ECO-100CL27C:150 | | | | HC-1414250U:250 | ECO-100CL28C:200 | | | | HS-1425150U:150 | ECO-100CL5C:150 | | | | HS-1425200U:200 | ECO-100CL5:150 | | | | HT-1414200U:200 | ECO-100CL22C:200 | | | | | ECO-100CL8C:150 | | | | | ECO-100CL10C:200 | | | | | ECO-100AI18C:150 | | | | | ECO-100CL11C:250 | | | | | ECO-100AL13C:150 | | | | | ECO-100AL23C:200 | | {11}------------------------------------------------ | Feature | Sterile Microwave Ablation Probe | Disposable Microwave Therapeutic Antennas ( | Discussion | |---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------| | | | K201265) | | | Applicators Outer<br>Diameter<br>(18G=1.3mm | HP-1805080U:18G | ECO-100AI26:18G | Different | | 17G=1.4mm | HP-1605100U:16G | ECO-100AI1:17G | See Comment 4. | | 16G=1.6mm | HP-1507200U:15G | ECO-100AI3:16G | | | 15G=1.8mm | HP-1512200U: 15G | ECO-100CL29:14G | | | 14G=2.0mm | HC-1814100U:18G | ECO-100AL29:14G | | | 8G=3.2mm) | HC-1814150U:18G | ECO-100CL31:11G | | | | HC-1814200U:18G | ECO-100AI30:14G | | | | HC-1614150U:16G | ECO-100CL8:14G | | | | HC-1614200U:16G | ECO-100CL10:14G | | | | HC-1514150U:15G | ECO-100AI25:8G | | | | HC-1514200U:15G | ECO-100CL27C:18G | | | | HC-1414250U:14G | ECO-100CL28C:18G | | | | HS-1425150U:14G | ECO-100CL5C:16G | | | | HS-1425200U:14G | ECO-100CL5:16G | | | | HT-1414200U:14G | ECO-100CL22C:16G | | | | | ECO-100CL8C:14G | | | | | ECO-100CL10C:14G | | | | | ECO-100CL11C:14G | | | | | ECO-100AI18C:8G | | | | | ECO-100AL13C:15G | | | | | ECO-100AL23C:15G | | | | | | | | | | | | | Feature | Sterile Microwave Ablation Probe | Disposable Microwave Therapeutic Antennas (K201265) | Discussion | | Emission Area Length (exposed length) (mm) | HP-1805080U:5<br>HP-1605100U:5<br>HP-1507200U:7<br>HP-1512200U:12<br>HC-1814100U:14<br>HC-1814150U:14<br>HC-1814200U:14<br>HC-1614150U:14<br>HC-1614200U:14<br>HC-1514150U:14<br>HC-1514200U:14<br>HC-1414250U:14<br>HS-1425150U:25<br>HS-1425200U:25<br>HT-1414200U:14 | ECO-100AI26:3.5<br>ECO-100AI1:3.5<br>ECO-100AI3:3.5<br>ECO-100CL29:6<br>ECO-100AL29:6<br>ECO-100CL31:6<br>ECO-100AI30:6<br>ECO-100CL8:11<br>ECO-100CL10:11<br>ECO-100AI25:11<br>ECO-100CL27C:12<br>ECO-100CL28C:12<br>ECO-100CL5C:12<br>ECO-100CL5:12<br>ECO-100CL22C:12<br>ECO-100CL8C:12<br>ECO-100CL10C:12<br>ECO-100CL11C:12<br>ECO-100AI18C:12<br>ECO-100AL13C:18<br>ECO-100AL23C:18 | Different.<br>See Comment 4. | | Max power (W) | HP-1805080U:40<br>HP-1605100U:50<br>HP-1507200U:80<br>HP-1512200U:80<br>HC-1814100U:50<br>HC-1814150U:50<br>HC-1814200U:50<br>HC-1614150U:80<br>HC-1614200U:80<br>HC-1514150U:100 | ECO-100AI26:30<br>ECO-100AI1:30<br>ECO-100AI3:40<br>ECO-100CL29:50<br>ECO-100AL29:50<br>ECO-100CL31:50<br>ECO-100AI30:60<br>ECO-100CL8:80<br>ECO-100CL10:80<br>ECO-100AI25:100 | Different.<br>See Comment 2. | | Feature | Sterile Microwave Ablation Probe | Disposable Microwave Therapeutic Antennas (K201265) | Discussion | | Disposable /Single use Device | The Sterile Microwave Ablation Probes are disposable and are to be used with in a single patient procedure only. | The antennas are disposable and are to be used within a single patient procedure only. | Same | | Sterility | EO (SAL: $10^{-6}$ ). | EO (SAL: $10^{-6}$ ). | Same | | Biocompatibility | Patient-contacting materials are biocompatible. | Patient-contacting materials are biocompatible. | Same | | Patient Contacting Materials | 1. Ceramics.<br>2. SUS 304 with double Teflon coating.<br>3. Polytetrafluoroethylene. | 1. Ceramics.<br>2. SUS 304 with double Teflon coating.<br>3. US 304 with single Teflon coating.<br>4. Nylon.<br>5. Polytetrafluoroethylene. | Equivalent.<br>See Comment 5. | | | HC-1514200U:100<br>HC-1414250U:100<br>HS-1425150U:120<br>HS-1425200U:120<br>HT-1414200U:100 | ECO-100CL27C:50<br>ECO-100CL28C:50<br>ECO-100CL5C:60<br>ECO-100CL5:50<br>ECO-100CL22C:60<br>ECO-100CL8C:80<br>ECO-100CL10C:100<br>ECO-100CL11C:100<br>ECO-100AI18C:100<br>ECO-100AL13C:60<br>ECO-100AL23C:60 | | {12}------------------------------------------------ {13}------------------------------------------------ #### K233140 Comment 4: The subject device has slightly different specifications including length. The thermal effects test with ex vivo animal tissues demonstrates the subject device and does not raise new safety and performance risks. Comment 5: The subject device uses SUS 304 with double Teflon coating ceramics and Polytetrafluoroethylene, the materials are also used by the predicate device and does not raise new safety and performance risks. {14}------------------------------------------------ #### 8. Non-Clinical Performance Data Hygea completed the following non-clinical tests. The Microwave Ablation Device with Sterile Microwave Ablation Probe passed the testing in accordance with internal requirements, and international standards shown below. The test results support the device substantial equivalence to the predicate device: ### Electrical Safety: • ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. Electromagnetic Compatibility: • IEC 60601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests. Performance: • IEC 60601-2-6 Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment. ### Software validation: • Software validation is in compliance with FDA guidance for the content of premarket submissions for software contained in Medical devices. # Shelf Life: • Accelerated aging and package tests were conducted to confirm the validity of the 3 year shelf life claim for the Sterile Microwave Ablation Probe. Thermal Effects test and Temperature monitoring test: · FDA Guidance Premarket Notification (510(K)) Submissions for Electrosurgical Devices for General Surgery. Package Verification: • ISO 11607-1:2016 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems. Sterilization validation: • ISO 11135-1: 2014 Sterilization of health care products -- Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices. Biocompatibility: • 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 10993-1 and its applicable parts, "Biological Evaluation of Medical Devices". Additional Bench Performance Tests: - Sterile Microwave Ablation Probe Stability Tests with maximum output power and extended treatment duration - · Temperature Sensor Measurement Accuracy Verification Tests ### 9. Clinical Performance Data No clinical data was necessary to determine the substantial equivalence of this device. ### 10. Statement of Substantial Equivalence and Conclusion The Microwave Ablation Device with Sterile Microwave Ablation Probe has the same intended use as the Microwave {15}------------------------------------------------ Therapeutic System and Disposable Microwave Therapeutic Antennas and similar technological characteristics. The differences in technological characteristics do not raise new or different questions of safety and effectiveness. Performance testing has demonstrated the Microwave Ablation Device with Sterile Microwave Ablation Probe is as safe and effective as the predicate devices. Therefore, the Microwave Ablation Device with Sterile Microwave Ablation Probe is substantially equivalent to the predicate devices.