(126 days)
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.
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.
This is a 510(k) premarket notification for a medical device, which means the FDA has determined it is "substantially equivalent" to an existing legally marketed device (the predicate device). In this context, "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the non-clinical performance and testing performed to demonstrate that the new device is as safe and effective as the predicate, despite minor differences.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a formal table of acceptance criteria with specific numerical targets and corresponding reported performance for clinical efficacy. Instead, the "acceptance criteria" are implied by the successful completion of various non-clinical tests demonstrating compliance with regulatory standards and comparable performance to the predicate device.
| Test Category | Implied Acceptance Criteria (Demonstrated Compliance/Equivalence) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 | "Passed the testing in accordance with internal requirements, and international standards." Specifically, ES60601-1 was met. |
| EMC | Compliance with IEC 60601-1-2 | "Passed the testing in accordance with internal requirements, and international standards." Specifically, IEC 60601-1-2 was met. |
| Performance (Device Specific) | Compliance with IEC 60601-2-6 (Microwave Therapy Equipment) | "Passed the testing in accordance with internal requirements, and international standards." Specifically, IEC 60601-2-6 was met. |
| Software Validation | Compliance with FDA guidance for software in medical devices | "Software validation is in compliance with FDA guidance for the content of premarket submissions for software contained in Medical devices." |
| Shelf Life | Validity of 3-year shelf life claim for probe (accelerated aging, package tests) | "Accelerated aging and package tests were conducted to confirm the validity of the 3 year shelf life claim for the Sterile Microwave Ablation Probe." (Implies successful confirmation). |
| Thermal Effects Test | Comparable thermal effects to predicate, demonstrating no new safety/performance risks for power/length differences. | "The thermal effects test with ex vivo animal tissues device and does not raise new safety and performance risks." (Comment 2 & 4) |
| Temperature Monitoring Test | Functionality and accuracy of temperature monitoring. Demonstrates no new safety/performance risks for "Mode B". | "Tissue protection temperature need 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." |
| Package Verification | Compliance with ISO 11607-1:2016 | "Passed the testing in accordance with internal requirements, and international standards." Specifically, ISO 11607-1:2016 was met. |
| Sterilization Validation | Compliance with ISO 11135-1:2014 (Ethylene Oxide Sterilization) | "Passed the testing in accordance with internal requirements, and international standards." Specifically, ISO 11135-1:2014 was met. |
| Biocompatibility | Compliance with ISO 10993-1 and applicable parts | "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'." (Implies successful compliance) |
| Probe Stability Tests | Stability with maximum output power and extended treatment duration. | "Sterile Microwave Ablation Probe Stability Tests with maximum output power and extended treatment duration." (Implies successful completion and meeting requirements, though specific results not detailed). |
| Temperature Sensor Accuracy Verification | Accuracy of temperature sensor measurement. | "Temperature Sensor Measurement Accuracy Verification Tests." (Implies successful completion and meeting requirements, though specific results not detailed). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for specific tests. For the thermal effects test, it mentions "ex vivo animal tissues," but the number of samples is not provided. Other tests refer to compliance with standards rather than specific sample sizes of device units tested.
- Data Provenance: The tests are "non-clinical." This implies laboratory or bench testing. The origin of the animal tissues for the thermal effects test is not specified (e.g., country of origin). All tests were conducted by the manufacturer, Hygea Medical Technology Co., Ltd.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this submission. This is a 510(k) for a hardware device (Microwave Ablation Device and Probe) and the non-clinical tests described are primarily engineering and performance tests, not clinical evaluations requiring human expert interpretation of diagnostic images or outcomes. Therefore, there is no "ground truth" established by experts in the context of clinical data for this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies involving human readers and interpretations (e.g., radiologists reviewing images) to establish a consensus ground truth. The tests described are engineering and biochemical in nature and would not involve such adjudication.
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
This information is not applicable. This device is a microwave ablation system, not an AI-powered diagnostic or assistive tool, and the submission does not include any clinical studies, MRMC studies, or AI components.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical ablation system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" is generally defined by:
- Established engineering and performance standards: e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-6, ISO 11607-1, ISO 11135-1, ISO 10993-1.
- Physical measurements and observations in bench testing (e.g., temperature stability within ±3% tolerance, confirmation of thermal effects in ex vivo tissues, successful completion of stability tests).
- Successful software validation against established FDA guidance.
There is no "expert consensus, pathology, or outcomes data" mentioned as ground truth in this non-clinical submission.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The non-clinical tests are validating the device's physical and electrical performance.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set.
{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) |
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}------------------------------------------------
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
| Feature | Microwave Ablation Device | Microwave Therapeutic System (K201262) | Discussion |
|---|---|---|---|
| DeviceClassification | Class IIElectrosurgical cutting and coagulation deviceand accessories. | Class IIElectrosurgical cutting and coagulation deviceand accessories. | Same |
| Product Code | NEY | NEY | Same |
| Regulation No. | 21 CFR 878.4400 | 21 CFR 878.4400 | Same |
| Manufacturer | Hygea Medical Technology Co., Ltd. | Nanjing ECO Microwave System Co., Ltd. | - |
| Trade Name | Microwave Ablation Device. | Microwave Therapeutic System. | - |
| Indications for Use | The microwave ablation system is indicated forsoft tissue coagulation (ablation) by healthcareprofessionals in healthcare facilities. Microwaveablation system is not intended for cardiac use. | The Microwave Therapeutic System is indicated forthe coagulation (ablation) of soft tissue. TheMicrowave Therapeutic System is not intended forcardiac use. | Same |
| Prescription or OTC | Prescription | Prescription | Same |
| Intended Purpose | Coagulation and ablation of tissue. | Coagulation and ablation of tissue. | Same |
| Design | Single channel.The host of Microwave Ablation Device,RF connection cable, foot switch, and SterileTemperature Probe. | Single channel.cooling-water cycle, thermal ablation, the probe ofTEMP, foot switch. | Equivalent.See Comment 1. |
| Operating Principle | Microwave energy is generated by MicrowaveAblation Device and then delivers to the applicatortip through microwave cable to thermally heat thetarget tissue, resulting in coagulation and ablation.The Microwave Ablation Device refers toequipment for treating diseases with microwave | Microwave oscillating signals are generated bya microwave transistor and amplified by amicrowave power amplifier. The generatordelivers microwave energy to the applicator tipto thermally target tissue, resulting in coagulationand ablation. A microwave therapeutic system | Same |
| Feature | Microwave Ablation Device | Microwave Therapeutic System (K201262) | Discussion |
| energy at a working frequency of 2450 MHz.The liquid in the silicone tube is driven by therotation of the motor of pump to flow to the probeto realize the purpose of probe cooling. | refers to equipment for treating diseases withmicrowave energy at a working frequency of 2450MHz. The liquid in the silicone tube is driven by therotation of the motor to flow through the radiatorto realize the purpose of radiator cooling. | ||
| AC Input Voltage | AC100-240V, 50/60Hz. | AC100-240V, 50/60Hz. | Same |
| Output Impedance | $50 \Omega$ | $50\Omega$ | Same |
| Output Parameters | 2450MHz±50MHz0-120W | 2450MHz±20MHz0-100W | Different.See comment 2. |
| Treatment time | 30min max | 30min max | Same |
| DeviceTemperatureMonitoring | Temperature monitoring features used to ensuresystem safety. | Temperature monitoring features used to ensuresystem safety. | Same |
| Device cooling | Pumped, normal saline is used to cool the probe. | Pumped, normal saline is used to cool the antenna. | Same |
| Operational Mode | Four modes, Mode A, Mode B, foot switch modeand manual mode. | Three modes can be selected by the user.Timing method, foot switch control and manualcontrol. | 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.
| Feature | Sterile Microwave Ablation Probe | Disposable Microwave Therapeutic Antennas ( | Discussion |
|---|---|---|---|
| K201265) | |||
| DeviceClassification | Class IIElectrosurgical cutting and coagulation deviceand accessories. | Class IIElectrosurgical cutting and coagulation deviceand accessories. | Same |
| Product Code | NEY | NEY | Same |
| Regulation No. | 21 CFR 878.4400 | 21 CFR 878.4400 | Same |
| Manufacturer | Hygea Medical Technology Co., Ltd. | Nanjing ECO Microwave System Co., Ltd. | - |
| Trade Name | Sterile Microwave Ablation Probe | Disposable Microwave Therapeutic Antennas | - |
| Indications for Use | Sterile Microwave Ablation Probe is used withMicrowave Ablation Device, which is indicated forsoft tissue coagulation (ablation) by healthcareprofessionals in healthcare facilities. SterileMicrowave Ablation Probe is not intended forcardiac use. | Disposable Microwave Therapeutic Antennas isused with the Microwave Therapeutic System,which is indicated for the coagulation (ablation)of soft tissue. The Disposable MicrowaveTherapeutic Antennas is not intended forcardiac use. | Same |
| Prescription or OTC | Prescription | Prescription | Same |
| Intended Purpose | Coagulation and ablation of tissue. | Coagulation and ablation of tissue. | Same |
| Operating Principle | During the surgery, the microwave ablationantenna is accurately placed in the tumor targetarea by imaging techniques (such as CT, US, etc.).The microwave energy generated by the microwavegenerator transmits to the microwave ablationantenna through the coaxial cable, and then it is | During the surgery, the microwave ablationantenna is accurately placed in the tumor targetarea by imaging techniques (such as CT, US,etc.). The microwave energy generated by themicrowave generator transmits to themicrowave ablation antenna through the | Same |
Table 2 – Comparison of Characteristics for Microwave Ablation Probe and Disposable Microwave Therapeutic Antennas
{9}------------------------------------------------
| Feature | Sterile Microwave Ablation Probe | Disposable 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 Voltage | A.C.100-240V, 50/60Hz. | AC100-240V, 50/60Hz. | Same |
| Output Impedance | $50 \Omega$ | $50\Omega$ | Same |
| Output Parameters | 2450MHz±50MHz0-120W | 2450MHz±20MHz0-100W | Different.See Comment 2 |
| TemperatureMonitoring | Temperature monitoring features used to ensure system safety. | Temperature monitoring features used to ensure system safety. | Same |
| Device Cooling | Pumped, sterile disposable saline solution to cool the probes. | Pumped, normal saline is used to cool the antenna. | Same |
{10}------------------------------------------------
| Feature | Sterile Microwave Ablation Probe | Disposable Microwave Therapeutic Antennas ( | Discussion |
|---|---|---|---|
| Applicators Length(mm) | HP-1805080U:80 | ECO-100AI26:100 | Different.See Comment 4. |
| HP-1605100U:100 | ECO-100AI3:100 | ||
| HP-1507200U:200 | ECO-100AI1:100 | ||
| HP-1512200U:200 | ECO-100AL29:1000 | ||
| HC-1814100U:100 | ECO-100AI30:1200 | ||
| HC-1814150U:150 | ECO-100CL29:1000 | ||
| HC-1814200U:200 | ECO-100CL31:1000 | ||
| HC-1614150U:150 | ECO-100CL8C:150 | ||
| HC-1614200U:200 | ECO-100CL10:200 | ||
| HC-1514150U:150 | ECO-100AI25:200 | ||
| HC-1514200U:200 | ECO-100CL27C:150 | ||
| HC-1414250U:250 | ECO-100CL28C:200 | ||
| HS-1425150U:150 | ECO-100CL5C:150 | ||
| HS-1425200U:200 | ECO-100CL5:150 | ||
| HT-1414200U:200 | ECO-100CL22C:200 | ||
| ECO-100CL8C:150 | |||
| ECO-100CL10C:200 | |||
| ECO-100AI18C:150 | |||
| ECO-100CL11C:250 | |||
| ECO-100AL13C:150 | |||
| ECO-100AL23C:200 |
{11}------------------------------------------------
| Feature | Sterile Microwave Ablation Probe | Disposable Microwave Therapeutic Antennas ( | Discussion |
|---|---|---|---|
| K201265) | |||
| Applicators OuterDiameter(18G=1.3mm | HP-1805080U:18G | ECO-100AI26:18G | Different |
| 17G=1.4mm | HP-1605100U:16G | ECO-100AI1:17G | See Comment 4. |
| 16G=1.6mm | HP-1507200U:15G | ECO-100AI3:16G | |
| 15G=1.8mm | HP-1512200U: 15G | ECO-100CL29:14G | |
| 14G=2.0mm | HC-1814100U:18G | ECO-100AL29:14G | |
| 8G=3.2mm) | HC-1814150U:18G | ECO-100CL31:11G | |
| HC-1814200U:18G | ECO-100AI30:14G | ||
| HC-1614150U:16G | ECO-100CL8:14G | ||
| HC-1614200U:16G | ECO-100CL10:14G | ||
| HC-1514150U:15G | ECO-100AI25:8G | ||
| HC-1514200U:15G | ECO-100CL27C:18G | ||
| HC-1414250U:14G | ECO-100CL28C:18G | ||
| HS-1425150U:14G | ECO-100CL5C:16G | ||
| HS-1425200U:14G | ECO-100CL5:16G | ||
| HT-1414200U:14G | ECO-100CL22C:16G | ||
| ECO-100CL8C:14G | |||
| ECO-100CL10C:14G | |||
| ECO-100CL11C:14G | |||
| ECO-100AI18C:8G | |||
| ECO-100AL13C:15G | |||
| ECO-100AL23C:15G | |||
| Feature | Sterile Microwave Ablation Probe | Disposable Microwave Therapeutic Antennas (K201265) | Discussion |
| Emission Area Length (exposed length) (mm) | HP-1805080U:5HP-1605100U:5HP-1507200U:7HP-1512200U:12HC-1814100U:14HC-1814150U:14HC-1814200U:14HC-1614150U:14HC-1614200U:14HC-1514150U:14HC-1514200U:14HC-1414250U:14HS-1425150U:25HS-1425200U:25HT-1414200U:14 | ECO-100AI26:3.5ECO-100AI1:3.5ECO-100AI3:3.5ECO-100CL29:6ECO-100AL29:6ECO-100CL31:6ECO-100AI30:6ECO-100CL8:11ECO-100CL10:11ECO-100AI25:11ECO-100CL27C:12ECO-100CL28C:12ECO-100CL5C:12ECO-100CL5:12ECO-100CL22C:12ECO-100CL8C:12ECO-100CL10C:12ECO-100CL11C:12ECO-100AI18C:12ECO-100AL13C:18ECO-100AL23C:18 | Different.See Comment 4. |
| Max power (W) | HP-1805080U:40HP-1605100U:50HP-1507200U:80HP-1512200U:80HC-1814100U:50HC-1814150U:50HC-1814200U:50HC-1614150U:80HC-1614200U:80HC-1514150U:100 | ECO-100AI26:30ECO-100AI1:30ECO-100AI3:40ECO-100CL29:50ECO-100AL29:50ECO-100CL31:50ECO-100AI30:60ECO-100CL8:80ECO-100CL10:80ECO-100AI25:100 | Different.See Comment 2. |
| Feature | Sterile Microwave Ablation Probe | Disposable Microwave Therapeutic Antennas (K201265) | Discussion |
| Disposable /Single use Device | The 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 |
| Sterility | EO (SAL: $10^{-6}$ ). | EO (SAL: $10^{-6}$ ). | Same |
| Biocompatibility | Patient-contacting materials are biocompatible. | Patient-contacting materials are biocompatible. | Same |
| Patient Contacting Materials | 1. Ceramics.2. SUS 304 with double Teflon coating.3. Polytetrafluoroethylene. | 1. Ceramics.2. SUS 304 with double Teflon coating.3. US 304 with single Teflon coating.4. Nylon.5. Polytetrafluoroethylene. | Equivalent.See Comment 5. |
| HC-1514200U:100HC-1414250U:100HS-1425150U:120HS-1425200U:120HT-1414200U:100 | ECO-100CL27C:50ECO-100CL28C:50ECO-100CL5C:60ECO-100CL5:50ECO-100CL22C:60ECO-100CL8C:80ECO-100CL10C:100ECO-100CL11C:100ECO-100AI18C:100ECO-100AL13C:60ECO-100AL23C:60 |
{12}------------------------------------------------
{13}------------------------------------------------
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.
{14}------------------------------------------------
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
{15}------------------------------------------------
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.
§ 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.