K Number
K233140
Device Name
Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)
Date Cleared
2024-01-31

(126 days)

Product Code
Regulation Number
878.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The microwave ablation system is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Microwave ablation system is not intended for cardiac use. Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Sterile Microwave Ablation Probe is not intended for cardiac use.
Device Description
The Microwave Ablation Device with Sterile Microwave Ablation Probe is a device system which is intended for soft tissue coagulation. The Microwave Ablation Device consists of power supply, microwave power source, control system, temperature measurement system, RF connection cable, foot switch, and temperature probe. The Sterile Microwave Ablation Probe is a single-use sterile product, consisting of a handle, RF connector, RF coaxial cable, needle bar, inner tube, pinhead, temperature sensor and coolant tube. The Microwave Ablation Device also contains a single use Sterile Temperature Probe.
More Information

Not Found

No
The summary describes a standard microwave ablation system with components like a power supply, control system, and probes. There is no mention of AI, ML, or any features that would suggest the use of such technologies for tasks like image analysis, treatment planning, or outcome prediction. The performance studies focus on electrical safety, EMC, and basic performance metrics, not AI/ML model validation.

Yes
The device is described as a "Microwave Ablation System" that performs "soft tissue coagulation (ablation)," which are therapeutic procedures. It also lists "Microwave Therapeutic System" as a predicate device, explicitly using the term "therapeutic."

No

This device is designed for soft tissue coagulation (ablation), which is a treatment or therapy, not a diagnostic process. It uses heat (microwave energy) to destroy tissue.

No

The device description explicitly lists multiple hardware components including a power supply, microwave power source, control system, temperature measurement system, RF connection cable, foot switch, temperature probe, and a sterile probe with various physical parts.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "soft tissue coagulation (ablation)". This is a therapeutic procedure performed directly on the patient's body.
  • Device Description: The device description details components for generating and delivering microwave energy for tissue ablation. It does not mention any components or processes for analyzing biological samples (blood, urine, tissue, etc.) in vitro (outside the body).
  • Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on in vitro testing.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to physically alter tissue within the body.

N/A

Intended Use / Indications for Use

The microwave ablation system is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Microwave ablation system is not intended for cardiac use.

Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Sterile Microwave Ablation Probe is not intended for cardiac use.

Product codes (comma separated list FDA assigned to the subject device)

NEY

Device Description

The Microwave Ablation Device with Sterile Microwave Ablation Probe is a device system which is intended for soft tissue coagulation. The Microwave Ablation Device consists of power supply, microwave power source, control system, temperature measurement system, RF connection cable, foot switch, and temperature probe. The Sterile Microwave Ablation Probe is a single-use sterile product, consisting of a handle, RF connector, RF coaxial cable, needle bar, inner tube, pinhead, temperature sensor and coolant tube. The Microwave Ablation Device also contains a single use Sterile Temperature Probe.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

soft tissue

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare professionals in healthcare facilities.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Hygea completed the following non-clinical tests. The Microwave Ablation Device with Sterile Microwave Ablation Probe passed the testing in accordance with internal requirements, and international standards shown below. The test results support the device substantial equivalence to the predicate device:

Electrical Safety:
• ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. Electromagnetic Compatibility:
• IEC 60601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests. Performance:
• IEC 60601-2-6 Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment.

Software validation:
• Software validation is in compliance with FDA guidance for the content of premarket submissions for software contained in Medical devices.

Shelf Life:
• Accelerated aging and package tests were conducted to confirm the validity of the 3 year shelf life claim for the Sterile Microwave Ablation Probe.

Thermal Effects test and Temperature monitoring test:
· FDA Guidance Premarket Notification (510(K)) Submissions for Electrosurgical Devices for General Surgery.

Package Verification:
• ISO 11607-1:2016 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.

Sterilization validation:
• ISO 11135-1: 2014 Sterilization of health care products -- Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices.

Biocompatibility:
• The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. The Biological Evaluation Tests are in compliance with the standards of ISO 10993-1 and its applicable parts, "Biological Evaluation of Medical Devices".

Additional Bench Performance Tests:

  • Sterile Microwave Ablation Probe Stability Tests with maximum output power and extended treatment duration
  • · Temperature Sensor Measurement Accuracy Verification Tests

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K201262, K201265

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services - USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top of the word "ADMINISTRATION".

January 31, 2024

Hygea Medical Technology Co., Ltd. Jinping Duan RA Manager Floor 6&7, West Area of Building No. 8, No.30 YuHua Road. Shunyi Beijing, Shunyi 101318 China

Re: K233140

Trade/Device Name: Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: NEY Dated: September 27, 2023 Received: September 27, 2023

Dear Jinping Duan:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See DICE website -(https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2024.01.31
10:25:27 -05'00'

Mark Trumbore, Ph.D. Assistant Director

2

DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K233140

Device Name Microwave Ablation Device Sterile Microwave Ablation Probe

Indications for Use (Describe)

The microwave ablation system is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Microwave ablation system is not intended for cardiac use.

Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Sterile Microwave Ablation Probe is not intended for cardiac use.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)☑ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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4

Microwave Ablation Device Sterile Microwave Ablation Probe

1. Submission Sponsor

Hygea Medical Technology Co., Ltd. Floor 6&7, West Area of Building No. 8, No.30 YuHua Road, Shunyi, Beijing, Beijing, 101318 PEOPLE'S REPUBLIC OF CHINA Jinping Duan RA Manager

2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Email: LST.AUS.ProjectManagement@ul.com Contact: Mei Li Title: Technical Consultant, QA/RA, China

3. Device Identification

Trade/Proprietary Name: Microwave Ablation Device Sterile Microwave Ablation Probe Classification Name: Electrosurgical cutting and coagulation device and accessories Regulation Number(s): 21 CFR 878.4400 NEY Product Code(s): Class: ll Classification Panel: General & Plastic Surgery

4. Legally Marketed Predicate Device(s):

Microwave Therapeutic System (K201262)

Disposable Microwave Therapeutic Antennas (K201265)

Manufacturer: Nanjing ECO Microwave System Co., Ltd.

5

K233140

5. Device Description

The Microwave Ablation Device with Sterile Microwave Ablation Probe is a device system which is intended for soft tissue coagulation. The Microwave Ablation Device consists of power supply, microwave power source, control system, temperature measurement system, RF connection cable, foot switch, and temperature probe. The Sterile Microwave Ablation Probe is a single-use sterile product, consisting of a handle, RF connector, RF coaxial cable, needle bar, inner tube, pinhead, temperature sensor and coolant tube. The Microwave Ablation Device also contains a single use Sterile Temperature Probe.

6. Indication for Use Statement

The microwave ablation system is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Microwave ablation system is not intended for cardiac use. Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Sterile Microwave Ablation Probe is not intended for cardiac use.

7. Substantial Equivalence Discussion

The following table compares the Microwave Ablation Device with Sterile Microwave Ablation Probe to the predicate devices with respect to indications for use, principles of operation, technological characteristics, materials, and performance, and forms the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.

6

K233140

FeatureMicrowave Ablation DeviceMicrowave Therapeutic System (K201262)Discussion
Device
ClassificationClass II
Electrosurgical cutting and coagulation device
and accessories.Class II
Electrosurgical cutting and coagulation device
and accessories.Same
Product CodeNEYNEYSame
Regulation No.21 CFR 878.440021 CFR 878.4400Same
ManufacturerHygea Medical Technology Co., Ltd.Nanjing ECO Microwave System Co., Ltd.-
Trade NameMicrowave Ablation Device.Microwave Therapeutic System.-
Indications for UseThe microwave ablation system is indicated for
soft tissue coagulation (ablation) by healthcare
professionals in healthcare facilities. Microwave
ablation system is not intended for cardiac use.The Microwave Therapeutic System is indicated for
the coagulation (ablation) of soft tissue. The
Microwave Therapeutic System is not intended for
cardiac use.Same
Prescription or OTCPrescriptionPrescriptionSame
Intended PurposeCoagulation and ablation of tissue.Coagulation and ablation of tissue.Same
DesignSingle channel.
The host of Microwave Ablation Device,
RF connection cable, foot switch, and Sterile
Temperature Probe.Single channel.
cooling-water cycle, thermal ablation, the probe of
TEMP, foot switch.Equivalent.
See Comment 1.
Operating PrincipleMicrowave energy is generated by Microwave
Ablation Device and then delivers to the applicator
tip through microwave cable to thermally heat the
target tissue, resulting in coagulation and ablation.
The Microwave Ablation Device refers to
equipment for treating diseases with microwaveMicrowave oscillating signals are generated by
a microwave transistor and amplified by a
microwave power amplifier. The generator
delivers microwave energy to the applicator tip
to thermally target tissue, resulting in coagulation
and ablation. A microwave therapeutic systemSame
FeatureMicrowave Ablation DeviceMicrowave Therapeutic System (K201262)Discussion
energy at a working frequency of 2450 MHz.
The liquid in the silicone tube is driven by the
rotation of the motor of pump to flow to the probe
to realize the purpose of probe cooling.refers to equipment for treating diseases with
microwave energy at a working frequency of 2450
MHz. The liquid in the silicone tube is driven by the
rotation of the motor to flow through the radiator
to realize the purpose of radiator cooling.
AC Input VoltageAC100-240V, 50/60Hz.AC100-240V, 50/60Hz.Same
Output Impedance$50 \Omega$$50\Omega$Same
Output Parameters2450MHz±50MHz
0-120W2450MHz±20MHz
0-100WDifferent.
See comment 2.
Treatment time30min max30min maxSame
Device
Temperature
MonitoringTemperature monitoring features used to ensure
system safety.Temperature monitoring features used to ensure
system safety.Same
Device coolingPumped, normal saline is used to cool the probe.Pumped, normal saline is used to cool the antenna.Same
Operational ModeFour modes, Mode A, Mode B, foot switch mode
and manual mode.Three modes can be selected by the user.
Timing method, foot switch control and manual
control.Different.
See comment 3.

Table 1 – Comparison of Characteristics for Microwave Ablation Generator and Microwave Therapeutic System

7

K233140

Comment 1: The foot pedal switch and Sterile Temperature Probe of the same as the predicate device. The host of the subject product is equivalent to the predicate device and cooling-water cycle. RF connection cable of the subject device is connected between the host and probe to transmit microwave energy.

Comment 2: The max power of the subject device is different than the predicate device, and the max power of 120W is only suitable when used with the HS-1425150U and HS-142520U probes. The thermal effects test with ex vivo animal tissues device and does not raise new safety and performance risks.

Comment 3: The predicate device has three operation method, foot switch control and manual control. Timing method will countdown or forward timing during energy output based on user setup, foot switch to control device output and manual control mode is controlled by user with button click.

8

K233140

The subject device has four modes, which are Mode B, foot switch mode and manual mode. Mode A of the subject device is the same as timing method of the predicate devices, but with timer countdown only. Foot switch mode are also same as the predicate device, which control device output continuous or internittent by foot switch or user. Mode B of the subject device with Sterile Temperature Probe. Tissue protection temperature ned the subject device will monitor tissue temperature using the Sterile Temperature Probe. After tissue temperature reach the setup protection value, Microwave output to control the tissue temperature stable around the ±3% tolerance of the set temperature, the protection value range is 37.0 ℃~100.0 ℃. Mode B does not raise new safety and performance risks.

FeatureSterile Microwave Ablation ProbeDisposable Microwave Therapeutic Antennas (Discussion
K201265)
Device
ClassificationClass II
Electrosurgical cutting and coagulation device
and accessories.Class II
Electrosurgical cutting and coagulation device
and accessories.Same
Product CodeNEYNEYSame
Regulation No.21 CFR 878.440021 CFR 878.4400Same
ManufacturerHygea Medical Technology Co., Ltd.Nanjing ECO Microwave System Co., Ltd.-
Trade NameSterile Microwave Ablation ProbeDisposable Microwave Therapeutic Antennas-
Indications for UseSterile Microwave Ablation Probe is used with
Microwave Ablation Device, which is indicated for
soft tissue coagulation (ablation) by healthcare
professionals in healthcare facilities. Sterile
Microwave Ablation Probe is not intended for
cardiac use.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.Same
Prescription or OTCPrescriptionPrescriptionSame
Intended PurposeCoagulation and ablation of tissue.Coagulation and ablation of tissue.Same
Operating PrincipleDuring 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 isDuring 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 theSame

Table 2 – Comparison of Characteristics for Microwave Ablation Probe and Disposable Microwave Therapeutic Antennas

9

FeatureSterile Microwave Ablation ProbeDisposable Microwave Therapeutic Antennas (K201265)Discussion
radiated out through the microwave antenna and absorbed by water molecules in the tumor tissue. The microwave energy transforms into heat, and the temperature rises rapidly result in tumor tissue losing bioactivity.coaxial cable, and then it is radiated out through the microwave antenna and absorbed by water molecules in the tumor tissue. The microwave energy transforms into heat, and the temperature rises rapidly result in tumor tissue losing bioactivity.
AC Input VoltageA.C.100-240V, 50/60Hz.AC100-240V, 50/60Hz.Same
Output Impedance$50 \Omega$$50\Omega$Same
Output Parameters2450MHz±50MHz
0-120W2450MHz±20MHz
0-100WDifferent.
See Comment 2
Temperature
MonitoringTemperature monitoring features used to ensure system safety.Temperature monitoring features used to ensure system safety.Same
Device CoolingPumped, sterile disposable saline solution to cool the probes.Pumped, normal saline is used to cool the antenna.Same

10

FeatureSterile Microwave Ablation ProbeDisposable Microwave Therapeutic Antennas (Discussion
Applicators Length
(mm)HP-1805080U:80ECO-100AI26:100Different.
See Comment 4.
HP-1605100U:100ECO-100AI3:100
HP-1507200U:200ECO-100AI1:100
HP-1512200U:200ECO-100AL29:1000
HC-1814100U:100ECO-100AI30:1200
HC-1814150U:150ECO-100CL29:1000
HC-1814200U:200ECO-100CL31:1000
HC-1614150U:150ECO-100CL8C:150
HC-1614200U:200ECO-100CL10:200
HC-1514150U:150ECO-100AI25:200
HC-1514200U:200ECO-100CL27C:150
HC-1414250U:250ECO-100CL28C:200
HS-1425150U:150ECO-100CL5C:150
HS-1425200U:200ECO-100CL5:150
HT-1414200U:200ECO-100CL22C:200
ECO-100CL8C:150
ECO-100CL10C:200
ECO-100AI18C:150
ECO-100CL11C:250
ECO-100AL13C:150
ECO-100AL23C:200

11

FeatureSterile Microwave Ablation ProbeDisposable Microwave Therapeutic Antennas (Discussion
K201265)
Applicators Outer
Diameter
(18G=1.3mmHP-1805080U:18GECO-100AI26:18GDifferent
17G=1.4mmHP-1605100U:16GECO-100AI1:17GSee Comment 4.
16G=1.6mmHP-1507200U:15GECO-100AI3:16G
15G=1.8mmHP-1512200U: 15GECO-100CL29:14G
14G=2.0mmHC-1814100U:18GECO-100AL29:14G
8G=3.2mm)HC-1814150U:18GECO-100CL31:11G
HC-1814200U:18GECO-100AI30:14G
HC-1614150U:16GECO-100CL8:14G
HC-1614200U:16GECO-100CL10:14G
HC-1514150U:15GECO-100AI25:8G
HC-1514200U:15GECO-100CL27C:18G
HC-1414250U:14GECO-100CL28C:18G
HS-1425150U:14GECO-100CL5C:16G
HS-1425200U:14GECO-100CL5:16G
HT-1414200U:14GECO-100CL22C:16G
ECO-100CL8C:14G
ECO-100CL10C:14G
ECO-100CL11C:14G
ECO-100AI18C:8G
ECO-100AL13C:15G
ECO-100AL23C:15G
FeatureSterile Microwave Ablation ProbeDisposable Microwave Therapeutic Antennas (K201265)Discussion
Emission Area Length (exposed length) (mm)HP-1805080U:5
HP-1605100U:5
HP-1507200U:7
HP-1512200U:12
HC-1814100U:14
HC-1814150U:14
HC-1814200U:14
HC-1614150U:14
HC-1614200U:14
HC-1514150U:14
HC-1514200U:14
HC-1414250U:14
HS-1425150U:25
HS-1425200U:25
HT-1414200U:14ECO-100AI26:3.5
ECO-100AI1:3.5
ECO-100AI3:3.5
ECO-100CL29:6
ECO-100AL29:6
ECO-100CL31:6
ECO-100AI30:6
ECO-100CL8:11
ECO-100CL10:11
ECO-100AI25:11
ECO-100CL27C:12
ECO-100CL28C:12
ECO-100CL5C:12
ECO-100CL5:12
ECO-100CL22C:12
ECO-100CL8C:12
ECO-100CL10C:12
ECO-100CL11C:12
ECO-100AI18C:12
ECO-100AL13C:18
ECO-100AL23C:18Different.
See Comment 4.
Max power (W)HP-1805080U:40
HP-1605100U:50
HP-1507200U:80
HP-1512200U:80
HC-1814100U:50
HC-1814150U:50
HC-1814200U:50
HC-1614150U:80
HC-1614200U:80
HC-1514150U:100ECO-100AI26:30
ECO-100AI1:30
ECO-100AI3:40
ECO-100CL29:50
ECO-100AL29:50
ECO-100CL31:50
ECO-100AI30:60
ECO-100CL8:80
ECO-100CL10:80
ECO-100AI25:100Different.
See Comment 2.
FeatureSterile Microwave Ablation ProbeDisposable Microwave Therapeutic Antennas (K201265)Discussion
Disposable /Single use DeviceThe Sterile Microwave Ablation Probes are disposable and are to be used with in a single patient procedure only.The antennas are disposable and are to be used within a single patient procedure only.Same
SterilityEO (SAL: $10^{-6}$ ).EO (SAL: $10^{-6}$ ).Same
BiocompatibilityPatient-contacting materials are biocompatible.Patient-contacting materials are biocompatible.Same
Patient Contacting Materials1. Ceramics.
  1. SUS 304 with double Teflon coating.
  2. Polytetrafluoroethylene. | 1. Ceramics.
  3. SUS 304 with double Teflon coating.
  4. US 304 with single Teflon coating.
  5. Nylon.
  6. Polytetrafluoroethylene. | Equivalent.
    See Comment 5. |
    | | HC-1514200U:100
    HC-1414250U:100
    HS-1425150U:120
    HS-1425200U:120
    HT-1414200U:100 | ECO-100CL27C:50
    ECO-100CL28C:50
    ECO-100CL5C:60
    ECO-100CL5:50
    ECO-100CL22C:60
    ECO-100CL8C:80
    ECO-100CL10C:100
    ECO-100CL11C:100
    ECO-100AI18C:100
    ECO-100AL13C:60
    ECO-100AL23C:60 | |

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K233140

Comment 4: The subject device has slightly different specifications including length. The thermal effects test with ex vivo animal tissues demonstrates the subject device and does not raise new safety and performance risks.

Comment 5: The subject device uses SUS 304 with double Teflon coating ceramics and Polytetrafluoroethylene, the materials are also used by the predicate device and does not raise new safety and performance risks.

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8. Non-Clinical Performance Data

Hygea completed the following non-clinical tests. The Microwave Ablation Device with Sterile Microwave Ablation Probe passed the testing in accordance with internal requirements, and international standards shown below. The test results support the device substantial equivalence to the predicate device:

Electrical Safety:

• ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. Electromagnetic Compatibility:

• IEC 60601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests. Performance:

• IEC 60601-2-6 Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment.

Software validation:

• Software validation is in compliance with FDA guidance for the content of premarket submissions for software contained in Medical devices.

Shelf Life:

• Accelerated aging and package tests were conducted to confirm the validity of the 3 year shelf life claim for the Sterile Microwave Ablation Probe.

Thermal Effects test and Temperature monitoring test:

· FDA Guidance Premarket Notification (510(K)) Submissions for Electrosurgical Devices for General Surgery.

Package Verification:

• ISO 11607-1:2016 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.

Sterilization validation:

• ISO 11135-1: 2014 Sterilization of health care products -- Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices.

Biocompatibility:

• The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. The Biological Evaluation Tests are in compliance with the standards of ISO 10993-1 and its applicable parts, "Biological Evaluation of Medical Devices".

Additional Bench Performance Tests:

  • Sterile Microwave Ablation Probe Stability Tests with maximum output power and extended treatment duration
  • · Temperature Sensor Measurement Accuracy Verification Tests

9. Clinical Performance Data

No clinical data was necessary to determine the substantial equivalence of this device.

10. Statement of Substantial Equivalence and Conclusion

The Microwave Ablation Device with Sterile Microwave Ablation Probe has the same intended use as the Microwave

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Therapeutic System and Disposable Microwave Therapeutic Antennas and similar technological characteristics. The differences in technological characteristics do not raise new or different questions of safety and effectiveness. Performance testing has demonstrated the Microwave Ablation Device with Sterile Microwave Ablation Probe is as safe and effective as the predicate devices. Therefore, the Microwave Ablation Device with Sterile Microwave Ablation Probe is substantially equivalent to the predicate devices.