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 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.

AI/ML Overview

The provided text details the 510(k) summary for "Disposable Microwave Therapeutic Antennas" (K201265), comparing it to a predicate device (K183153) and a reference device (K133821). The core of the submission is to demonstrate substantial equivalence, focusing on technical performance and safety rather than on clinical effectiveness in a comparative sense (e.g., human-in-the-loop studies or ground truth established by experts interpreting images).

Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on demonstrating substantial equivalence to the predicate device in terms of safety and functionality. The performance data provided is entirely non-clinical.

Feature / Acceptance Criteria Category	Specific Criteria (Implicitly based on Predicate/Reference)	Reported Device Performance (Subject Device K201265)	Comments from Text
Intended Use	Coagulation (ablation) of soft tissue, not for cardiac use.	Same as predicate.	"The intended use description is the same."
Intended Purpose	Coagulation and ablation of tissue.	Same as predicate.	"Same"
Operating Principle	Microwave energy transmitted to antenna, radiated out, absorbed by water molecules in tissue, transforms to heat, causes tissue bioactivity loss.	Same as predicate.	"Same"
Classification/Regulation	Electrosurgical cutting and coagulation device and accessories, Class II, Product Code NEY.	Same as predicate.	"Same"
Electrical Safety	Compliance with ES60601-1.	Complies with ES60601-1.	Explicitly stated as met.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2.	Complies with IEC 60601-1-2.	Explicitly stated as met.
Performance (Microwave Therapy Equipment)	Compliance with IEC 60601-2-6.	Complies with IEC 60601-2-6.	Explicitly stated as met.
Shelf Life	Valid for a specified duration (e.g., 2 years).	2 years confirmed via accelerated aging tests.	Explicitly stated as met.
Thermal Effects	Compliance with FDA Guidance for Electrosurgical Devices.	Thermal effects test conducted in accordance with FDA guidance.	Explicitly stated as met.
Package Verification	Compliance with ISO 11607-1.	Complies with ISO 11607-1.	Explicitly stated as met.
Sterilization Validation	Ethylene Oxide sterilization validated per ISO 11135-1.	Sterilization validated per ISO 11135-1 (SAL: 10-6).	Explicitly stated as met.
Biocompatibility	Patient-contacting materials are biocompatible per ISO 10993.	Patient-contacting materials are biocompatible; Biological Evaluation Tests in compliance with ISO 10993.	Explicitly stated as met, addressing material differences.
Device Temperature Monitoring	Features to ensure system safety.	Same as predicate.	"Equivalent"
Device Cooling	Pumped, normal saline used to cool antenna.	Same as predicate.	"Equivalent"
Disposable/Single Use	Disposable, single patient procedure only.	Same as predicate.	"Same"
Output Parameters	2450MHz, 0-100W, 50Ω nominal impedance.	2450MHz±20MHz, 0-100W, 50Ω nominal impedance.	Frequency range ±10MHz for predicate vs ±20MHz for subject, but deemed "Equivalent" or "Similar" in output power.
Applicator Lengths	Various lengths (e.g., 150-300mm).	Wider range of applicator lengths (100-1200mm).	The text states this difference "only reflected in the depth of the position of the tumor to be ablated and does not affect the product's safety and performance."
Applicator Outer Diameter	Various diameters (e.g., 1.3-3.2mm).	Wider range of diameters (e.g., 17G to 8G).	The text states this difference relates to trauma size and ablation area, but "does not raise new safety and performance risks."
Emission Area (Exposed Length)	Various lengths (e.g., 26-31mm).	Various (e.g., 3.5-18mm for most, 6mm for others).	The text states "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."
Max Power (W)	Up to 100W.	Varies by model (30W-100W).	The text states "the max power of subject devices was less than or equal to the predicate device's," and that "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."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable in the context of an AI/human-in-the-loop study. The "test set" here refers to non-clinical testing. For the in vitro tissue ablation studies, the sample size or details of the tissue models used are not explicitly stated. The type of data is non-clinical performance data from laboratory tests, including electrical safety, EMC, performance (IEC 60601-2-6), shelf life (accelerated aging), thermal effects, package verification, sterilization validation, and biocompatibility.
Data Provenance: Not explicitly stated regarding the origin of the non-clinical data, but implied to be from internal testing by Nanjing ECO Microwave System Co., Ltd. The studies were not retrospective or prospective clinical studies but rather laboratory-based performance and safety evaluations.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable as the device is not an AI diagnostic/interpretative device requiring expert-established ground truth from medical images. The ground truth for this device's performance is established through physical measurements, material science testing, and engineering standards compliance in a laboratory setting.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication" of expert opinions for a test set, as this is a non-AI hardware device approval. Performance is measured against engineering specifications and regulatory standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study was not conducted or required for this 510(k) submission. This is a device for physical ablation, not for interpretation of medical images or aiding human readers in diagnosis. The submission explicitly states: "Clinical testing is not required."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is hardware; there is no standalone algorithm. Its performance is evaluated through physical and electrical tests, not as an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" for this medical device is based on established engineering standards, material science properties, electrical safety parameters, and verified physical performance characteristics (e.g., achieving intended thermal effects/ablation in in vitro models). It is not expert consensus, pathology, or outcomes data in the clinical sense, as clinical testing was not required for this submission. The in vitro tissue ablation studies served as the proxy for functional ground truth related to the device's main purpose.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI algorithm, as this is solely a hardware device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for it.

Summary

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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

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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.

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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'

Enclosure

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Indications for Use

510(k) Number (if known) K201265

Device Name Disposable Microwave Therapeutic Antennas

Indications for Use (Describe)

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)	☐

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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 & TechnologyIndustrial 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 CommonName:	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 CommonName:	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

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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 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 deviceK201265	Predicate deviceK183153	Reference deviceK133821	Comments
Manufacturer	Nanjing ECOMicrowave SystemCo., Ltd.	Surgnova HealthcareTechnologies(Zhejiang) Co., Ltd.	Covidien LLC	--

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Trade name	DisposableMicrowaveTherapeuticAntennas	Microwave ablationsystemModel: M150E	Emprint™ AblationSystem	--		microwaveantenna andabsorbed by watermolecules in thetumor tissue. Themicrowave energytransform into heat,and the	microwave antennaandabsorbed by watermolecules in thetumor tissue. Themicrowave energytransform into heat,and the temperature	microwave antennaand absorbed bywater molecules inthe tumor tissue. Themicrowave energytransform into heat,and thetemperaturerises
ClassificationnameandRegulationName	Electrosurgicalcutting andcoagulation deviceand accessoriesClass : IIProduct code :NEY	Electrosurgicalcutting andcoagulation deviceand accessoriesClass : IIProduct code : NEY	Electrosurgicalcutting andcoagulation deviceand accessoriesClass : IIProduct code : NEY	Same		temperaturerises rapidly resultin tumor tissuelosing bioactivity.	rises rapidly result intumor tissue losingbioactivity.	rapidly result intumor tissue losingbioactivity.
Indicationsfor use	DisposableMicrowaveTherapeuticAntennas is usedwith the MicrowaveTherapeuticSystem, which isindicated for thecoagulation(ablation) ofsoft tissue.TheDisposableMicrowaveTherapeuticAntennas isnot intended for cardiacuse.	The MicrowaveAblation System isintended for thecoagulation (ablation)of soft tissues.The MW AblationSystem is notintended for use incardiac procedures.	The Emprint™Ablation System isintended for use inpercutaneous,laparoscopic, andintraoperativecoagulation(ablation) of softtissue, includingpartial or completeablation of non-resectable livertumors.TheEmprintTM AblationSystem is notintended for use incardiac procedures.	The microwavegenerator instrumentand antenna of thepredicate device arecombined to submit510k together, themicrowavegenerator instrumentand antenna ofsubject device aresubmitted 510kseparately.The intended usedescription is thesame.	AC inputVoltage	AC100-240V,50/60Hz	100-240VAC 50-60Hz	100-240VAC 50-60Hz	Same
Intendedpurpose	coagulation andablation of tissue	coagulation andablation of tissue	coagulation andablation of tissue	Same	OutputImpedance	50Ω nominal	50Ω nominal	50Ω nominal	Same
Operatingprinciple	During the surgery,the microwaveablation antenna isaccurately placedin the tumor targetarea by imagingtechniques (suchas CT, US, etc.).The microwaveenergy generatedby the microwavegenerator transmitsto the microwaveablation antennathrough the coaxialcable, and thenit is radiated out	During the surgery,the microwaveablation antenna isaccurately placed inthe tumor target areaby imagingtechniques (such asCT, US, etc.). Themicrowave energygenerated by themicrowave generatortransmits to themicrowave ablationantenna through thecoaxial cable, andthen it is radiated out	During the surgery,the microwaveablation antenna isaccurately placed inthe tumor target areaby imagingtechniques (such asCT, US, etc.). Themicrowave energygenerated by themicrowave generatortransmits to themicrowave ablationantenna through thecoaxial cable, andthen it is radiated out	Same	Outputparameters	2450MHz±20MHz,0-100W	2450MHz±10MHz,0-100W	2450MHz±50MHz,0-100W	Equivalent
ApplicatorPatientContactingMaterials	1. Ceramics2. SUS 304 withdouble tefloncoating3. US 304 withsingle tefloncoating4. Nylon5.Polytetrafluoroethylene	304SS, polyethleneterephthalate,ceramics	fiberglass, resin,ceramics	Different, The mainstructure of theneedle is composedof 304SS stainlesssteel and Ceramics.It is the same as thepredicate device,except that theexternal insulatorand coating aredifferent, thesedifferences do notaffect theperformance ofproduct, but onlyaffect thebiocompatibility ofthe material.The material used inthe ablation needlehas been performedbiocompatibility testaccording to the ISO10993-1, the resultsshows that thematerial isbiocompatibility, thedifference of materialdoes not raise thenew safety andeffective risk.
Applicators	ECO-100AI1:100	SS-MWA-1526C: 150	CA15L1: 150	Different, The

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	ECO-100AI3:100ECO-100AI18C:150ECO-100CL8C:150ECO-100CL8:150ECO-100AL13C:150ECO-100CL5C:150ECO-100CL5:150ECO-100CL27C:150ECO-100CL28C:200ECO-100CL22C:200ECO-100AL23C:200ECO-100CL10:200ECO-100CL10C:200ECO-100AI25:200ECO-100CL11C:250ECO-100CL29:1000ECO-100AL29:1000ECO-100CL31:1000ECO-100AI30:1200	SS-MWA-1531C: 150SS-MWA-2026C: 200SS-MWA-2031C: 200SS-MWA-2526C: 250SS-MWA-2531C: 250(mm)	CA20L1: 200CA30L1: 300	length of theproposed device isdifferent from that ofthe predicatedevice, butthis difference isonly reflected in thedepth of the positionof the tumor to beablated and doesnotaffect the product'ssafetyandperformance.
ApplicatorsOuterDiameter(18G=1.3mm17G=1.4mm16G=1.6mm15G=1.8mm14G=2.0mm8G=3.2mm)	ECO-100AI1:17GECO-100AI26:18GECO-100AI3:16GECO-100AI18C:8GECO-100CL8C:14GECO-100CL8:14GECO-100AL13C:15GECO-100CL5C:16GECO-100CL5:16GECO-100CL27C:18GECO-100CL28C:18GECO-100CL22C:16GECO-100AL23C:15GECO-100CL10:14GECO-100CL10C:14GECO-100AI25:8GECO-100CL11C:14GECO-100CL29:14GECO-100AL29:14GECO-100CL31:11GECO-100AI30:14G	OD(mm):2.08	OD(mm):2.4	Different, Accordingto different humantissuesandExpected ablationvolume,theapplicators diameterrange is wider thanthat of predicatedevices. The onlyeffect of different ODis that the traumacaused by puncturesis smaller or bigger,based on theaffecting the area ofthe ablation, thedifferent applicatorlength does not raisenew safety andperformance risks.
Emissionarea length(exposedlength) (mm)	ECO-100AI1:3.5ECO-100AI26:3.5ECO-100AI3:3.5ECO-100AI18C:12ECO-100CL8C:12ECO-100CL8:11ECO-100AL13C:18ECO-100CL5C:12ECO-100CL5:12ECO-100CL27C:12ECO-100CL28C:12ECO-100CL22C:12ECO-100AL23C:18ECO-100CL10:11ECO-100CL10C:12ECO-100AI25:11ECO-100CL11C:12ECO-100CL29:6ECO-100AL29:6	SS-MWA-1526C: 26SS-MWA-1531C: 31SS-MWA-2026C: 26SS-MWA-2031C: 31SS-MWA-2526C: 26SS-MWA-2531C: 31	CA15L1: 28CA20L1: 28CA30L1: 28	Different, The internaldesign detailsdifference will affect themicrowave emissionarea, resulting in adifferent ablation rangeand microwaveradiation area. Ourproduct has conductablation studies of invitro tissues inaccordance with FDAguidelines, and thestudy results supportthe intended use of ourproducts, it does notraise new safetyissues.
	ECO-100CL31:6ECO-100AI30:6
Max power(W)	ECO-100AI1:30ECO-100AI26:30ECO-100AI3:40ECO-100AI18C:100ECO-100CL8C:80ECO-100CL8:80ECO-100AL13C:60ECO-100CL5C:60ECO-100CL5:50ECO-100CL27C:50ECO-100CL28C:50ECO-100CL22C:60ECO-100AL23C:60ECO-100CL10:80ECO-100CL10C:100ECO-100AI25:100ECO-100CL11C:100ECO-100CL29:50ECO-100AL29:50ECO-100CL31:50ECO-100AI30:60	100	100	Different, the maxpower of subjectdevices was lessthan or equal to thepredicate device's,the difference of Maxpower will affect themicrowave emissionarea, resulting in adifferent ablation rangeand microwaveradiation area. Ourproduct has conductablation studies of invitro tissues inaccordance with FDAguidelines, and thestudy results supportthe intended use of ourproducts, it does notraise new safetyissues.
Disposable/Single useDevice	The antennas aredisposable and areto be used within asingle patientprocedure only.	The antennas aredisposable and are tobe used within asingle patientprocedure only.	The antennas aredisposable and areto be used within asingle patientprocedure only.	Same
Sterility	The accessoriesare sterilized withEO(SAL: 10-6)	The accessories aresterilized withEO(SAL: 10-6)	The accessories aresterilized withEO(SAL: 10-6)	Equivalent
Biocompatibility	Patient-contactingmaterials arebiocompatible.	Patient-contactingmaterials arebiocompatible.	Patient-contactingmaterials arebiocompatible.	Equivalent
DeviceTemperatureMonitoring	Temperaturemonitoring featuresused to ensuresystem safety	Temperaturemonitoring featuresused to ensuresystem safety	Temperaturemonitoring featuresused to ensuresystem safety	Equivalent
Devicecooling	Pumped, normalsaline is used tocool the antenna.	Pumped, normalsaline is used to coolthe antenna.	Pumped, normalsaline is used to coolthe antenna.	Equivalent

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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

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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).

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.

Indications for Use

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510(K) Summary

Prepared Date: July 8, 2021

1. Submitter's Information

2. Device Identification

3. Predicate Device

510(k) Summary

4. Device Description

5. Indication for use

6. Comparison to Predicate Device

7. Performance Data

Clinical test:

Non-clinical data

510(k) Summary

8. SE Conclusion

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

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