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.

AI/ML Overview

The provided text describes a 510(k) summary for the Microwave Therapeutic System (K201262) and compares it to a predicate device (K183153). While it discusses device performance and testing, it explicitly states that clinical testing is not required and does not present data from a study that proves the device meets specific acceptance criteria based on a clinical outcome or a comparison to human performance with or without AI assistance. Instead, the submission relies on non-clinical data to demonstrate substantial equivalence to a legally marketed predicate device.

Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets them cannot be found in the provided text, as this type of study was not performed or required for this particular regulatory submission.

Here's a breakdown of what can be extracted or inferred from the text, and what is not present:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table for acceptance criteria of clinical or human performance, as no such study was conducted. It implicitly relies on the device meeting established electrical safety, EMC, and performance standards for microwave therapy equipment, and software validation guidance.

The "performance" criteria are based on compliance with standards rather than clinical outcomes. The text states:

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 (General): 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: In compliance with FDA guidance for software contained in Medical devices.
Shelf Life: "Accelerated aging tests were conducted to confirm the validity of the 8 years shelf life for 1 machine." (No specific acceptance criteria or results are given beyond "confirm the validity").
Thermal Effects test and Temperature monitoring test: Referencing "FDA Guidance Premarket Notification (510(K)) Submissions for Electrosurgical Devices for General Surgery." The text mentions "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". Again, no specific quantitative criteria or results are provided.

2. Sample size used for the test set and the data provenance

Test set sample size: Not applicable/provided. No clinical test set data is described. The non-clinical tests were conducted on the device itself.
Data provenance: Not applicable/provided. No human data for a test set is listed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: Not applicable. No human expert review was part of the reported performance evaluation.
Qualifications of experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Adjudication method: Not applicable. No human review or adjudication process is mentioned as part of the submission's performance evaluation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC study: No. The device is a Microwave Therapeutic System for ablation of soft tissue, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant to this device type and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone performance: The "performance" described pertains to the standalone operation of the microwave therapy device itself, based on engineering tests against established standards. This is not an AI algorithm's standalone performance, but the device's functional performance. The text indicates that these tests found the device to meet the respective standards, such as IEC 60601-2-6.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Ground truth: For the device's performance, the "ground truth" is defined by compliance with established international and FDA-recognized standards for electrical safety, EMC, and microwave therapy equipment (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-6), as well as FDA guidance for software validation and specific thermal effects testing. These are engineering and regulatory benchmarks, not clinical ground truth derived from patients or expert consensus on clinical outcomes.

8. The sample size for the training set

Training set sample size: Not applicable. This is a medical device, not an AI/ML algorithm that requires a training set of data for its primary function.

9. How the ground truth for the training set was established

Ground truth for training set: Not applicable, as there is no training set for this type of device.

Summary

{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). 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.

{1}------------------------------------------------

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-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Long H. Chen
Long H. 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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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
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 CommonName:	Microwave ablation system and accessories
Regulation Name:	Electrosurgical cutting and coagulation device andaccessories
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
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 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 deviceK201262	Predicate deviceK183153	Comments
Manufacturer/K#	Nanjing ECOMicrowave System Co.,Ltd.	Surgnova HealthcareTechnologies (Zhejiang)Co., Ltd.	--
Trade name	Microwave TherapeuticSystemModel: SABERWAVEECO-200G	Microwave ablationsystemModel: M150E	--
Classification name andRegulation Name	Electrosurgical cuttingand coagulation deviceand accessoriesClass : IIProduct code : NEY	Electrosurgical cuttingand coagulation deviceand accessoriesClass : IIProduct code : NEY	Same
Indications for use	TheMicrowaveTherapeutic System isindicated for thecoagulation (ablation) ofsoft tissue. TheMicrowave TherapeuticSystem is not intendedfor cardiac use.	The Microwave AblationSystem is intended forthe coagulation(ablation) of soft tissues.The MW AblationSystem is not intendedfor use in cardiacprocedures.	The microwavegenerator instrumentand antenna of thepredicate device arecombined to submit510k together, themicrowave generatorinstrument and antennaof subject device aresubmitted 510kseparately. The intendeduse description is thesame.
Intended purpose	coagulation and ablationof tissue	coagulation and ablationof tissue	Same
Operating principle	Microwave oscillatingsignals are generatedby a microwavetransistor and amplifiedby a microwave poweramplifier. Generatordelivers microwaveenergy to the applicatortip to thermally targettissue, resulting incoagulation andablation.A microwavetherapeutic systemrefers to equipment fortreating diseases withmicrowave energy at aworking frequency of2450 MHz.The liquid in the siliconetube is driven by therotation of the motor toflow through the radiatorto realize the purpose ofradiator cooling.	During the surgery, themicrowave ablationantenna is accuratelyplaced in the tumortarget area by imagingtechniques (such as CT,US, etc.). Themicrowave energygenerated by themicrowave generatortransmits to themicrowave ablationantenna through thecoaxial cable, and thenit is radiated out throughthe microwaveantenna and absorbedby water molecules inthe tumor tissue. Themicrowave energytransform into heat, andthe temperaturerises rapidly result intumor tissue losingbioactivity.	Equivalent.The microwavegenerator instrumentand antenna of thepredicate device arecombined to submit510k together, thesubject device onlyinclude generatorinstrument, the principleof generator instrumentis equivalent.
Design	Single channel	Double channels	Different, please refer tocomment 1.
	cooling-water cycle,thermal ablation,the probe of TEMP, footswitch	cooling-water cycle,thermal ablation,the probe of TEMP, footswitch	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
DeviceTemperatureMonitoring	Temperature monitoringfeatures used to ensuresystem safety	Temperature monitoringfeatures used to ensuresystem safety	Same
Device cooling	Pumped, normal salineis used to cool theantenna.	Pumped, normal salineis used to cool theantenna.	Same
Operational mode	Three modes can beselected by the user.	Only one operationalmode	Different, please refer tocomment 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.

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.