Microwave Therapeutic System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 9, 2021 Nanjing ECO Microwave System Co., Ltd Hong Wei. RA Manager Third & Fourth Floors, J5 Building, No. 15 Wanshou Road, Pukou District Nanjing, Jiangsu 211800 China Re: K201262 Trade/Device Name: Microwave Therapeutic System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: NEY Dated: July 1, 2021 Received: July 6, 2021 Dear Hong Wei: 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). 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Chen -S-s Date: 2021.07.09 08:54:29 -04'00' 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) K201262 Device Name Microwave Therapeutic System Indications for Use (Describe) The Microwave Therapeutic System is indicated for the coagulation (ablation) of soft tissue. Therapeutic System is not intended for cardiac use. | 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. 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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." {3}------------------------------------------------ # 510(K) Summary Prepared in accordance with the requirements of 21 CFR Part 807.92 ## Prepared Date: July 8, 2021 ## 1. Submitter's Information The submitter of this pre-market notification is: | Name: | Nanjing ECO Microwave System Co., Ltd. | | | |-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | Address: | Third & Fourth Floors, J5 Building, NJUT Science & Technology<br>Industrial Park, No.15 Wanshou Road, Pukou District, 211800,<br>Nanjing, Jiangsu, P.R.China. | | | | Contact person: | Hong Wei | | | | Title: | RA | | | | E-mail: | weihong@njeco.com.cn | | | | Tel: | +86-025-58872663 Ext: 8020 | | | # 2. Device Identification | Trade/Device Name: | Microwave Therapeutic System | |------------------------|-------------------------------------------------------------------| | Models: | SABERWAVE ECO-200G | | Regulation Number: | 21 CFR 878.4400 | | Device Common<br>Name: | Microwave ablation system and accessories | | Regulation Name: | Electrosurgical cutting and coagulation device and<br>accessories | | Regulation Class: | Class II | | Product Code: | NEY | ## 3. Predicate Device | Predicate device: | | |------------------------------------|----------------------------------------------------------------| | 510(K) number: | K183153 | | Device Common<br>Name: | Microwave ablation system and accessories | | Device Trade<br>/Proprietary Name: | Microwave Ablation System | | Model: | M150E | | Manufacturer: | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | | Regulation Number: | 21 CFR 878.4400 | | Regulation Name: | Electrosurgical cutting and coagulation device and accessories | | Regulation Class: | Class II | | Product Code: | NEY | {4}------------------------------------------------ | Reference device: | | |--------------------|----------------------------------------------------------------| | 510(K) number: | K133821 | | Device Name: | Emprint™ Ablation System | | Manufacturer: | Covidien LLC | | Regulation Number: | 21 CFR 878.4400 | | Regulation Name: | Electrosurgical cutting and coagulation device and accessories | | Regulation Class: | Class II | | Product Code: | NEY | ## 4. Device Description The Microwave Therapeutic System is a host machine will be used together with Disposable Microwave Ablation Needle for ablation of soft tissue. The Microwave Therapeutic System consists of microwave source, control system, display system and temperature measurement system. It is a software-controlled microwave generator that deliver the microwave energy at a working frequency of 2450 MHz. The generator of the microwave therapeutic system is composed of a casinq, a power module, a control feedback unit, a display module, a microwave transmitting module, a water circulation module, and a temperature measurement module. ### 5. Indication for use The Microwave Therapeutic System is indicated for the coagulation (ablation) of soft tissue. The Microwave Therapeutic System is not intended for cardiac use. ## 6. Comparison to Predicate Device Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table. | Feature | Subject device<br>K201262 | Predicate device<br>K183153 | Comments | |--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer/K# | Nanjing ECO<br>Microwave System Co.,<br>Ltd. | Surgnova Healthcare<br>Technologies (Zhejiang)<br>Co., Ltd. | -- | | Trade name | Microwave Therapeutic<br>System<br>Model: SABERWAVE<br>ECO-200G | Microwave ablation<br>system<br>Model: M150E | -- | | Classification name and<br>Regulation Name | Electrosurgical cutting<br>and coagulation device<br>and accessories<br>Class : II<br>Product code : NEY | Electrosurgical cutting<br>and coagulation device<br>and accessories<br>Class : II<br>Product code : NEY | Same | | Indications for use | The<br>Microwave<br>Therapeutic System is<br>indicated for the<br>coagulation (ablation) of<br>soft tissue. The<br>Microwave Therapeutic<br>System is not intended<br>for cardiac use. | The Microwave Ablation<br>System is intended for<br>the coagulation<br>(ablation) of soft tissues.<br>The MW Ablation<br>System is not intended<br>for use in cardiac<br>procedures. | The microwave<br>generator instrument<br>and antenna of the<br>predicate device are<br>combined to submit<br>510k together, the<br>microwave generator<br>instrument and antenna<br>of subject device are<br>submitted 510k<br>separately. The intended<br>use description is the<br>same. | | Intended purpose | coagulation and ablation<br>of tissue | coagulation and ablation<br>of tissue | Same | | Operating principle | Microwave oscillating<br>signals are generated<br>by a microwave<br>transistor and amplified<br>by a microwave power<br>amplifier. Generator<br>delivers microwave<br>energy to the applicator<br>tip to thermally target<br>tissue, resulting in<br>coagulation and<br>ablation.<br>A microwave<br>therapeutic system<br>refers to equipment for<br>treating diseases with<br>microwave energy at a<br>working frequency of<br>2450 MHz.<br>The liquid in the silicone<br>tube is driven by the<br>rotation of the motor to<br>flow through the radiator<br>to realize the purpose of<br>radiator cooling. | During the surgery, the<br>microwave ablation<br>antenna is accurately<br>placed in the tumor<br>target area by imaging<br>techniques (such as CT,<br>US, etc.). The<br>microwave energy<br>generated by the<br>microwave generator<br>transmits to the<br>microwave ablation<br>antenna through the<br>coaxial cable, and then<br>it is radiated out through<br>the microwave<br>antenna and absorbed<br>by water molecules in<br>the tumor tissue. The<br>microwave energy<br>transform into heat, and<br>the temperature<br>rises rapidly result in<br>tumor tissue losing<br>bioactivity. | Equivalent.<br>The microwave<br>generator instrument<br>and antenna of the<br>predicate device are<br>combined to submit<br>510k together, the<br>subject device only<br>include generator<br>instrument, the principle<br>of generator instrument<br>is equivalent. | | Design | Single channel | Double channels | Different, please refer to<br>comment 1. | | | cooling-water cycle,<br>thermal ablation,<br>the probe of TEMP, foot<br>switch | cooling-water cycle,<br>thermal ablation,<br>the probe of TEMP, foot<br>switch | Same | | | AC input Voltage | AC100-240V, 50/60Hz | 100-240VAC 50-60 Hz | | Output Impedance | 50Ω nominal | 50Ω nominal | Same | | Output parameters | 2450MHz±20MHz, | 2450MHz±10MHz, | Same | | | 0-100W | 0-100W | | | Device<br>Temperature<br>Monitoring | Temperature monitoring<br>features used to ensure<br>system safety | Temperature monitoring<br>features used to ensure<br>system safety | Same | | Device cooling | Pumped, normal saline<br>is used to cool the<br>antenna. | Pumped, normal saline<br>is used to cool the<br>antenna. | Same | | Operational mode | Three modes can be<br>selected by the user. | Only one operational<br>mode | Different, please refer to<br>comment 2. | {5}------------------------------------------------ {6}------------------------------------------------ Comment 1: Different, predicate device support double channels and two ablation needles can be inserted at the same time for tissue ablation. Our product only supports single channel and only one ablation needle for tissue ablation, Double-needle ablation speeds up the time of a single ablation, but there are injury and risks due to multiple punctures to patient. Single-needle ablation can also achieve the intended use and reduce the injury and risk of multiple punctures to the patient. The subject device has performed the Thermal effects test, performance test according to IEC 60601-2-6, temperature measurement accuracy test, the test result prove that single needle ablation can also achieve the intended use, the performance meet the requirements of IEC 60601-2-6, the temperature measurement accuracy meet the requirements of intended use, the difference does not affect the product's safety and performance. Comment 2: Different, predicate devices have only a single operation mode. We have designed three modes according to the expected usage scenarios, which are convenient for users to operate according to different tissue types and sizes. The main difference between these three modes is that timing method is countdown or forward timing, foot switch control or manual control, output is continuous or intermittent, these are just to give users more operating options, and do not change the intended use and function of the product, the subject device has been conducted software verification according to the FDA software quidance, the test result proves the functions in each operational mode can be achieved. This difference does not raise a new risk. All the differences don't affect the safety and effectiveness which is concluded after all the required testing, so no safety and effectiveness issues relating to the system come into conclusion. ### 7. Performance Data ### Clinical test: Clinical testing is not required. ### Non-clinical data Microwave Therapeutic System and predicate device are substantially equivalent in design concepts, technologies, which have been designed and tested in accordance with: ### Electrical Safety: - -ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) 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: {7}------------------------------------------------ ### 510(k) Summary - 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 tests were conducted to confirm the validity of the 8 years shelf life for l machine. Thermal Effects test and Temperature monitoring test: - FDA Guidance Premarket Notification (510(K)) Submissions for Electrosurgical Devices for -General Surgery ### 8. Conclusion 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. The differences between the predicate and proposed device do not raise new questions of safety or effectiveness.