Who is the manufacturer of Disposable Microwave Therapeutic Antennas?

Nanjing Eco Microwave System Co., Ltd. filed the 510(k) submission for Disposable Microwave Therapeutic Antennas (K201265).

What is the FDA product code for Disposable Microwave Therapeutic Antennas?

NEY. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Disposable Microwave Therapeutic Antennas?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Disposable Microwave Therapeutic Antennas?

Microwave Ablation System (K183153).

Who can help prepare an FDA 510(k) submission like Disposable Microwave Therapeutic Antennas?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Disposable Microwave Therapeutic Antennas

K201265 · Nanjing Eco Microwave System Co., Ltd. · NEY · Jul 23, 2021 · General, Plastic Surgery

Device Facts

Record ID	K201265
Device Name	Disposable Microwave Therapeutic Antennas
Applicant	Nanjing Eco Microwave System Co., Ltd.
Product Code	NEY · General, Plastic Surgery
Decision Date	Jul 23, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Disposable Microwave Therapeutic Antennas is used with the Microwave Therapeutic System, which is indicated for the coagulation (ablation) of soft tissue. The Disposable Microwave Therapeutic Antennas is not intended for cardiac use.

Device Story

Disposable Microwave Therapeutic Antennas are puncture needles used for soft tissue ablation. The device consists of a radiator (needle tip/shaft), handle, and microwave cable. During surgery, the antenna is placed into the tumor target area under imaging guidance (CT, US). The microwave generator transmits energy through the coaxial cable to the antenna, where it is radiated into tissue. Water molecules in the tissue absorb the microwave energy, transforming it into heat, which causes rapid temperature rise and loss of tumor tissue bioactivity. The device includes a thermocouple in the handle to monitor needle temperature, ensuring it does not exceed 45 degrees. Cooling is provided by pumped normal saline. The device is used in clinical settings by physicians, provided sterile for single use.

Clinical Evidence

No clinical data. Bench testing only, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), microwave therapy performance (IEC 60601-2-6), shelf-life validation, packaging verification (ISO 11607-1), sterilization validation (ISO 11135-1), and biocompatibility (ISO 10993). In vitro ablation studies were conducted to verify performance.

Technological Characteristics

Materials: Medical stainless steel (304SS), ceramics, ABS, nylon, PTFE. Sensing: Thermocouple for temperature monitoring. Energy: Microwave (2450MHz). Connectivity: Standalone antenna for use with microwave generator. Sterilization: Ethylene Oxide (EO). Software: None (mechanical/hardware accessory).

Indications for Use

Indicated for coagulation (ablation) of soft tissue. Not intended for cardiac use.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

Microwave Ablation System (K183153)

Reference Devices

Emprint™ Ablation System (K133821)

Related Devices

K241825 — Microwave Ablation Antennas · Canyon Medical, Inc. · Sep 20, 2024
K232241 — Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) · Betters(Suzhou) Medical Co., Ltd. · Nov 13, 2023
K253771 — Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13) · Nanjing Devin Medical Technology Co., Ltd. · Mar 2, 2026
K252632 — Microwave Ablation Device · Nanjing Dewen Medical Technology Co., Ltd. · Mar 2, 2026
K232240 — Microwave Ablation System (BD-GT) · Betters(Suzhou) Medical Co., Ltd. · Nov 13, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. May 18, 2022 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: K201265 Trade/Device Name: Disposable Microwave Therapeutic Antennas Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NEY Dear Hong Wei: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 23, 2021. Specifically, FDA is updating this SE Letter due to a typo in the IFU Statement as an administrative correction. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Long Chen, Ph.D., OHT4: Office of Surgical and Infection Control Devices, 301-796-6389, long.chen@fda.hhs.gov. Sincerely, Digitally signed by Long H. Chen Long H. Chen -S-s Date: 2022.05.18 12:57:58 -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 {1}------------------------------------------------ Image /page/1/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 23, 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: K201265 Trade/Device Name: Disposable Microwave Therapeutic Antennas 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). 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/cfpm/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. {2}------------------------------------------------ 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 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 (QS) 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 53 1 -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-continung-education/cdrl-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, Digitally signed by Long H. Chen Long H. Chen -S-s Date: 2021.07.23 14:07:05 -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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201265 Device Name Disposable Microwave Therapeutic Antennas Indications for Use (Describe) Disposable Microwave Therapeutic Antennas is used with the Microwave Therapeutic System, which is indicated for the coagulation (ablation) of soft tissue. The Disposable Microwave Therapeutic Antennas is not intended for cardiac use. Type of Use (Select one or both, as applicable) | 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." {4}------------------------------------------------ # 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 Industrial Park, No.15 Wanshou Road, Pukou District, 211800, Nanjing, Jiangsu, P.R.China. | | | | Contact person: | Hong Wei | | | | Title: | RA Manager | | | | E-mail: | weihong@njeco.com.cn | | | | Tel: | +86- 025-58872663 Ext: 8020 | | | # 2. Device Identification | Trade/Device Name: | Disposable Microwave Therapeutic Antennas | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Models: | ECO-100AI1, ECO-100CL28C, ECO-100CL27C, ECO- 100CL22C, ECO-100CL5, ECO-100CL5C, ECO-100AL23C, ECO-100AL13C, ECO-100CL11C, ECO-100CL10, ECO- 100CL10C, ECO-100CL8, ECO-100CL8C, ECO-100AI26, ECO- 100AI3, ECO-100AI18C, ECO-100AI25, ECO-100AI30, ECO- 100CL29, ECO-100AL29, ECO-100CL31 | | Device Common Name: | Microwave ablation system and accessories | | Regulation Number: | 21 CFR 878.4400 | | Regulation Name: | Electrosurgical cutting and coagulation device and accessories | | Regulation Class: | Class II | | Product Code: | NEY | # 3. Predicate Device | Predicate device: | | |------------------------------------|----------------------------------------------------------------| | 510(K) number: | K183153 | | Device Common Name: | Microwave ablation system and accessories | | Device Trade /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 | {5}------------------------------------------------ ## 510(k) Summary | Regulation Class: | Class II | |--------------------|----------------------------------------------------------------| | Product Code: | NEY | | Reference device: | | | 510(K) number: | K133821 | | Device Name: | EmprintTM 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 Disposable Microwave Therapeutic Antennas is a puncture needle with microwave energy transmission. It is inserted into the human body through puncture, and the tissue is ablated by the thermal energy transformed by the needle tip. Disposable Microwave Therapeutic Antennas is composed of radiator, handle, microwave cable with/without cooling tubes. The microwave cable connect the microwave ablation system to transmit microwaves to the ablation needle (radiator), a handle is set at the connection between the microwave cable and the ablation needle to facilitate the operator. The radiator is composed of a needle tip, a needle shaft, a cooling tube, and a coaxial cable. The metal parts are connected by a welding process, and the non-metal parts are connected by qlue. The needle and needle shaft are made of medical stainless steel, and the shape of the needle is a trianqular pyramid tip or pyramid type tip, which is mainly used for percutaneous puncture and microwave radiation; the handle is made of ABS material, the cooling tube is made of stainless steel to cool the needle bar all the way, the thermocouple is arranged in the handle to effectively monitor the temperature of the ablation needle not to exceed 45 degrees. Disposable Microwave Therapeutic Antennas is provided sterile, for single use. ## 5. Indication for use Disposable Microwave Therapeutic Antennas is used with the Microwave Therapeutic System, which is indicated for the coaqulation (ablation) of soft tissue. The Disposable Microwave Therapeutic Antennas 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 K201265 | Predicate device K183153 | Reference device K133821 | Comments | |--------------|----------------------------------------------|-------------------------------------------------------------|-----------------------------|----------| | Manufacturer | Nanjing ECO Microwave System Co., Ltd. | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Covidien LLC | -- | {6}------------------------------------------------ | Trade name | Disposable Microwave Therapeutic Antennas | Microwave ablation system Model: M150E | Emprint™ Ablation System | -- | | microwave antenna and absorbed by water molecules in the tumor tissue. The microwave energy transform into heat, and the | microwave antenna and absorbed by water molecules in the tumor tissue. The microwave energy transform into heat, and the temperature | microwave antenna and absorbed by water molecules in the tumor tissue. The microwave energy transform into heat, and the temperature rises | | |-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Classification name and Regulation Name | Electrosurgical cutting and coagulation device and accessories Class : II Product code : NEY | Electrosurgical cutting and coagulation device and accessories Class : II Product code : NEY | Electrosurgical cutting and coagulation device and accessories Class : II Product code : NEY | Same | | temperature rises rapidly result in tumor tissue losing bioactivity. | rises rapidly result in tumor tissue losing bioactivity. | rapidly result in tumor tissue losing bioactivity. | | | Indications for use | Disposable Microwave Therapeutic Antennas is used with the Microwave Therapeutic System, which is indicated for the coagulation (ablation) of soft tissue. The Disposable Microwave Therapeutic Antennas is not intended for cardiac 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. | 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. The EmprintTM Ablation System is not intended for use in cardiac procedures. | The microwave generator instrument and antenna of the predicate device are combined to submit 510k together, the microwave generator instrument and antenna of subject device are submitted 510k separately. The intended use description is the same. | AC input Voltage | AC100-240V, 50/60Hz | 100-240VAC 50-60 Hz | 100-240VAC 50-60 Hz | Same | | Intended purpose | coagulation and ablation of tissue | coagulation and ablation of tissue | coagulation and ablation of tissue | Same | Output Impedance | 50Ω nominal | 50Ω nominal | 50Ω nominal | Same | | Operating principle | During the surgery, the microwave ablation antenna is accurately placed in the tumor target area by imaging techniques (such as CT, US, etc.). The microwave energy generated by the microwave generator transmits to the microwave ablation antenna through the coaxial cable, and then it is radiated out | During the surgery, the microwave ablation antenna is accurately placed in the tumor target area by imaging techniques (such as CT, US, etc.). The microwave energy generated by the microwave generator transmits to the microwave ablation antenna through the coaxial cable, and then it is radiated out | During the surgery, the microwave ablation antenna is accurately placed in the tumor target area by imaging techniques (such as CT, US, etc.). The microwave energy generated by the microwave generator transmits to the microwave ablation antenna through the coaxial cable, and then it is radiated out | Same | Output parameters | 2450MHz±20MHz, 0-100W | 2450MHz±10MHz, 0-100W | 2450MHz±50MHz, 0-100W | Equivalent | | Applicator Patient Contacting Materials | 1. Ceramics 2. SUS 304 with double teflon coating 3. US 304 with single teflon coating 4. Nylon 5. Polytetrafluoroethyl ene | 304SS, polyethlene terephthalate, ceramics | fiberglass, resin, ceramics | Different, The main structure of the needle is composed of 304SS stainless steel and Ceramics. It is the same as the predicate device, except that the external insulator and coating are different, these differences do not affect the performance of product, but only affect the biocompatibility of the material. The material used in the ablation needle has been performed biocompatibility test according to the ISO 10993-1, the results shows that the material is biocompatibility, the difference of material does not raise the new safety and effective risk. | | | | | | | Applicators | ECO-100AI1:100 | SS-MWA-1526C: 150 | CA15L1: 150 | Different, The | | | | | | {7}------------------------------------------------ {8}------------------------------------------------ | | ECO-100AI3:100 ECO-100AI18C:150 ECO-100CL8C:150 ECO-100CL8:150 ECO-100AL13C:150 ECO-100CL5C:150 ECO-100CL5:150 ECO-100CL27C:150 ECO-100CL28C:200 ECO-100CL22C:200 ECO-100AL23C:200 ECO-100CL10:200 ECO-100CL10C:200 ECO-100AI25:200 ECO-100CL11C:250 ECO-100CL29:1000 ECO-100AL29:1000 ECO-100CL31:1000 ECO-100AI30:1200 | SS-MWA-1531C: 150 SS-MWA-2026C: 200 SS-MWA-2031C: 200 SS-MWA-2526C: 250 SS-MWA-2531C: 250 (mm) | CA20L1: 200 CA30L1: 300 | length of the proposed device is different from that of the predicate device, but this difference is only reflected in the depth of the position of the tumor to be ablated and does not affect the product's safety and performance. | |---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicators Outer Diameter (18G=1.3m m 17G=1.4mm 16G=1.6mm 15G=1.8mm 14G=2.0mm 8G=3.2mm) | ECO-100AI1:17G ECO-100AI26:18G ECO-100AI3:16G ECO-100AI18C:8G ECO-100CL8C:14G ECO-100CL8:14G ECO-100AL13C:15G ECO-100CL5C:16G ECO-100CL5:16G ECO-100CL27C:18G ECO-100CL28C:18G ECO-100CL22C:16G ECO-100AL23C:15G ECO-100CL10:14G ECO-100CL10C:14G ECO-100AI25:8G ECO-100CL11C:14G ECO-100CL29:14G ECO-100AL29:14G ECO-100CL31:11G ECO-100AI30:14G | OD(mm):2.08 | OD(mm):2.4 | Different, According to different human tissues and Expected ablation volume, the applicators diameter range is wider than that of predicate devices. The only effect of different OD is that the trauma caused by punctures is smaller or bigger, based on the affecting the area of the ablation, the different applicator length does not raise new safety and performance risks. | | Emission area length (exposed length) (mm) | ECO-100AI1:3.5 ECO-100AI26:3.5 ECO-100AI3:3.5 ECO-100AI18C:12 ECO-100CL8C:12 ECO-100CL8:11 ECO-100AL13C:18 ECO-100CL5C:12 ECO-100CL5:12 ECO-100CL27C:12 ECO-100CL28C:12 ECO-100CL22C:12 ECO-100AL23C:18 ECO-100CL10:11 ECO-100CL10C:12 ECO-100AI25:11 ECO-100CL11C:12 ECO-100CL29:6 ECO-100AL29:6 | SS-MWA-1526C: 26 SS-MWA-1531C: 31 SS-MWA-2026C: 26 SS-MWA-2031C: 31 SS-MWA-2526C: 26 SS-MWA-2531C: 31 | CA15L1: 28 CA20L1: 28 CA30L1: 28 | Different, The internal design details difference will affect the microwave emission area, resulting in a different ablation range and microwave radiation area. Our product has conduct ablation studies of in vitro tissues in accordance with FDA guidelines, and the study results support the intended use of our products, it does not raise new safety issues. | | | ECO-100CL31:6 ECO-100AI30:6 | | | | | Max power (W) | ECO-100AI1:30 ECO-100AI26:30 ECO-100AI3:40 ECO-100AI18C:100 ECO-100CL8C:80 ECO-100CL8:80 ECO-100AL13C:60 ECO-100CL5C:60 ECO-100CL5:50 ECO-100CL27C:50 ECO-100CL28C:50 ECO-100CL22C:60 ECO-100AL23C:60 ECO-100CL10:80 ECO-100CL10C:100 ECO-100AI25:100 ECO-100CL11C:100 ECO-100CL29:50 ECO-100AL29:50 ECO-100CL31:50 ECO-100AI30:60 | 100 | 100 | Different, the max power of subject devices was less than or equal to the predicate device's, the difference of Max power will affect the microwave emission area, resulting in a different ablation range and microwave radiation area. Our product has conduct ablation studies of in vitro tissues in accordance with FDA guidelines, and the study results support the intended use of our products, it does not raise new safety issues. | | Disposable /Single use Device | The antennas are disposable and are to be used within a single patient procedure only. | The antennas are disposable and are to be used within a single patient procedure only. | The antennas are disposable and are to be used within a single patient procedure only. | Same | | Sterility | The accessories are sterilized with EO(SAL: 10-6) | The accessories are sterilized with EO(SAL: 10-6) | The accessories are sterilized with EO(SAL: 10-6) | Equivalent | | Biocompatibi lity | Patient-contacting materials are biocompatible. | Patient-contacting materials are biocompatible. | Patient-contacting materials are biocompatible. | Equivalent | | Device Temperature Monitoring | Temperature monitoring features used to ensure system safety | Temperature monitoring features used to ensure system safety | Temperature monitoring features used to ensure system safety | Equivalent | | Device cooling | Pumped, normal saline is used to cool the antenna. | Pumped, normal saline is used to cool the antenna. | Pumped, normal saline is used to cool the antenna. | Equivalent | {9}------------------------------------------------ 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 {10}------------------------------------------------ ## 510(k) Summary Disposable Microwave Therapeutic Antennas comply 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: - IEC 60601-2-6 Medical electrical equipment Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment Shelf Life: - Accelerated aging tests were conducted to confirm the validity of the 2 years shelf life for -Disposable Microwave Therapeutic Antennas. Thermal Effects 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, "Biological Evaluation of Medical Devices". ## 8. SE Conclusion The proposed device is equivalent with respect to the basic design and function to that of the predicate device. It doesn't have new intended purposed, new target populations, and new users. The differences between the predicate, reference device and proposed device do not raise new questions of safety or effectiveness. The proposed device is substantial equivalence to predicate device (K183153).