(108 days)
Not Found
No
The description focuses on the physical mechanism of microwave ablation and does not mention any AI/ML components or functions.
Yes
Explanation: The device is described as a "Microwave Ablation System" used for "coagulation (ablation) of soft tissue" and to achieve "microwave ablation therapy," indicating a direct therapeutic purpose. It is also referred to as "microwave therapy equipment" in the performance standards.
No
The device description clearly states its purpose is for "coagulation (ablation) of soft tissue" and "microwave thermal ablation therapy," which are therapeutic procedures, not diagnostic ones.
No
The device description clearly outlines hardware components including a microwave power source, coaxial transmission cable, and disposable microwave ablation needle, which are integral to its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "coagulation (ablation) of soft tissue." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details how the device delivers microwave energy to soft tissue in situ to cause thermal ablation. This is a direct treatment method.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) outside of the body to diagnose a condition, monitor a treatment, or screen for a disease.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device is used for direct therapeutic intervention on the body.
N/A
Intended Use / Indications for Use
The Microwave Ablation System is indicated for the coagulation (ablation) of soft tissue. The Microwave Ablation System is not intended for cardiac use.
Product codes
NEY
Device Description
The Microwave Ablation System is a microwave power (energy) source that can meet the needs of clinical soft tissue microwave thermal ablation therapy. The microwave energy is transmitted to the disposable microwave ablation needle through coaxial transmission cable, and the disposable microwave ablation needle is directly inserted into the targeted soft tissue, and the electromagnetic wave (microwave) is radiated from the front end of the disposable microwave ablation needle to cause the soft tissue to produce heat and rise. When it reaches the temperature of tissue coagulation and necrosis, in-situ inactivation is formed, that is, the purpose of microwave ablation therapy is achieved.
The Disposable Thermometer Needle and Foot Switch are accessories for the proposed device. And the proposed device is used in conjunction with the Disposable Microwave Ablation Needle made by our company.
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
Not Found
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)
Non-Clinical Testing:
Electrical Safety:
- IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Electromagnetic Compatibility: - EN 60601-1-2: 2015+A1: 2021/ IEC 60601-1-2: 2014+AMD1:2020 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbance - Requirements and tests
Performance: - IEC 60601-2-6: 2012, AMD1:2016 for use in conjunction with IEC 60601-1:2005 and with IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
Software life-cycle:
-ANSI AAMI IEC 62304:2006/A1:2016 Medical device software life cycle processes [Including Amendment 1 (2016)] - FDA Guidance: Content of Premarket Submissions for Device Software Functions.
Thermal Effects test and Temperature monitoring test: - FDA Guidance: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery
Clinical Testing:
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
November 13, 2023
Betters (Suzhou)Medical Co., Ltd. % Ada Wang Operation Manager APlus Healthcare Technology (Shanghai) Co., Ltd Room 223, Building 17, JY-WISDOMBAY Huging Road 158, Baoshan District Shanghai, Shanghai China
Re: K232240
Trade/Device Name: Microwave Ablation System (BD-GT) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: NEY Dated: July 28, 2023 Received: October 16, 2023
Dear Ada Wang:
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-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,
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.11.13 11:12:52 -05'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical
2
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) K232240
Device Name Microwave Ablation System
Indications for Use (Describe)
The Microwave Ablation System is indicated for the coagulation (ablation) of soft tissue. The Microwave Ablation 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)
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4
510(k) Summary
I Submitter
Betters(Suzhou) Medical Co., Ltd
Room 101, 201, 501, Building 7, 52 Yingang Road, Taicang Port Economic and Technological Development Zone Suzhou, Jiangsu Province, China, 215412
Contact person:
Lei Liu Operation Manager Tel.: +86-15261671606 E-mail: liulei(@baidemed.com
Preparation date: July 28, 2023
II Proposed Device
| Trade Name of Device: | Microwave Ablation System |
|---|---|
| Regulation Name: | Electrosurgical Cutting and Coagulation Device and Accessories |
| Regulation Number: | 21 CFR 878.4400 |
| Regulatory Class: | Class II |
| Product code: | NEY |
| Review Panel | General & Plastic Surgery |
III Predicate Devices
| 510(k) Number: | K201262 |
|---|---|
| Trade name: | Microwave Therapeutic System |
| Regulation Name: | Electrosurgical Cutting and Coagulation Device and Accessories |
| Classification: | Class II |
| Product code: | NEY |
| Manufacturer: | Nanjing ECO Microwave System Co., Ltd |
IV Device Description
The Microwave Ablation System is a microwave power (energy) source that can meet the needs of clinical soft tissue microwave thermal ablation therapy. The microwave energy is transmitted to the disposable microwave ablation needle through coaxial transmission cable, and the disposable microwave ablation needle is directly inserted into the targeted soft tissue, and the electromagnetic wave (microwave) is radiated from the front end of the disposable microwave ablation needle to cause the soft tissue to produce heat and rise. When it reaches the temperature of tissue coagulation and necrosis, in-situ inactivation is formed, that is, the purpose of microwave ablation therapy is achieved.
1
5
The Disposable Thermometer Needle and Foot Switch are accessories for the proposed device. And the proposed device is used in conjunction with the Disposable Microwave Ablation Needle made by our company.
The supported models and specifications of the Disposable Microwave Ablation Needle and Disposable Thermometer Needle are shown in Table 1.
Table 1 Specifications of Disposable Thermometer Needle and Supported Disposable Microwave Ablation Needle
| Model | Name | Diameter(m
m) | Length(
mm) | Maximum
output power | Type of handle |
|----------|--------------------------------------------|------------------|----------------|-------------------------|-----------------|
| T-1408 | Disposable
Microwave
Ablation Needle | 1.4 | 80 | 60W | |
| T-1410 | | 1.4 | 100 | 60W | Straight handle |
| T-1608 | | 1.6 | 80 | 60W | |
| T-1610 | | 1.6 | 100 | 60W | |
| L-1815 | Disposable
Microwave
Ablation Needle | 1.8 | 150 | 70W | |
| L-1818 | | 1.8 | 180 | 70W | Curved handle |
| L-2015 | | 2.0 | 150 | 70W | |
| L-2018 | | 2.0 | 180 | 70W | |
| CWZ-1620 | Disposable
Thermometer
Needle | 1.6 | 200 | - | - |
| CWZ-1615 | | 1.6 | 150 | - | - |
V Indication for use
The Microwave Ablation System is indicated for the coagulation) of soft tissue. The Microwave Ablation System is not intended for cardiac use.
VI Comparison of technological characteristics with the predicate devices
The comparison and discussion between the proposed device and the predicate device are listed in Table 2.
| Item | Proposed device | Predicate device
(K201262) | Discussion |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Device/Trade name | Microwave Ablation System | Microwave Therapeutic System | -- |
| Manufacturer | Betters(Suzhou) Medical Co., Ltd | Nanjing ECO Microwave System
Co., Ltd | -- |
| Product Code | NEY | NEY | Same |
| Regulation No. | 21 CFR 878.4400 | 21 CFR 878.4400 | Same |
| Class | II | II | Same |
| Indication for use | The Microwave Ablation System is indicated for the coagulation (ablation) of soft tissue. The 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 |
| Intended purpose | Coagulation and ablation of tissue | Coagulation and ablation of tissue | Same |
| Operating principle | The Microwave Ablation System is a microwave power (energy) source that can meet the needs of clinical soft tissue microwave thermal ablation therapy. The microwave energy is transmitted to the disposable microwave ablation needle through coaxial transmission cable, and the disposable microwave ablation needle is directly inserted into the targeted soft tissue, and the electromagnetic wave (microwave) is radiated from the front end of the disposable microwave ablation needle to cause the soft tissue to produce heat and rise. When it reaches the temperature of tissue coagulation and necrosis, in-situ inactivation is formed, that is, the purpose of microwave ablation therapy is achieved. | Microwave oscillating signals are generated by a microwave transistor and amplified by a microwave power amplifier. Generator delivers microwave energy to the applicator tip to thermally target tissue, resulting in coagulation and ablation.
A microwave therapeutic system 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. | Equivalent1 |
| Design | One-way ring | Single channel | Same |
| | The device is mainly composed of
the microwave ablation instrument
with its built-in peristaltic pump
and external foot switch, as well as
coaxial transmission cable,
disposable thermometer needle and
water cooling system. | cooling-water cycle, thermal
ablation, the probe of TEMP, foot
switch. | |
| Main Function | The host is mainly composed of
solid state source and power
supply, general control system,
temperature control system, display
system and LCD touch screen, foot
switch, peristaltic pump and control
system, etc. | The generator of the microwave
therapeutic system is composed of
a casing, a power module, a
control feedback unit, a display
module, a microwave transmitting
module, a water circulation
module, and a temperature
measurement module. | Similar2 |
| AC input Voltage | 100-240V~, 50/60Hz | AC100-240V, 50/60Hz | Same |
| Output Impedance | 50Ω nominal | 50Ω nominal | Same |
| Output parameters | 2450MHz±25 MHz | 2450MHz±20MHz | Same |
| Device
Temperature
Monitoring | Temperature monitoring features
used to ensure system safety | Temperature monitoring features
used to ensure system safety | Same |
| Device cooling | Pumped, distilled water or saline is
used to cool the ablation needle | Pumped, normal saline is used to
cool the antenna | Same |
| Operational mode | Three modes: continuous mode,
pulse mode, foot mode | Three modes can be selected by
the user | Differen
t3 |
Table 2 General Comparison of Microwave Ablation System
6
7
1 The operating principle description of the proposed device is different from the predicate device. However, the proposed device and the predicate device have working frequency, deliver microwave energy to the target tissue for coagulation and ablation, and have a device temperature monitor and cooling component. The operating principle of the devices are equivalent.
2 The main function description of the proposed device is different from the predicate device. However, the performance test of proposed device has been conducted as same as the predicate device. The general control system of the proposed device has the same function as the power module, control feedback unit and microwave transmitting module of the predicate device; the peristaltic pump and the control system of the proposed device have the same function as the water circulation module of the predicate device. Therefore, the difference does not affect substantially equivalence.
8
3 The operational mode of the proposed device is different from the predicate device. The predicate device has three modes, and 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. The proposed device has three modes; continuous mode and foot mode. The different operational modes are designed to give users more operating options, and do not change the intended use and function of the device. Software verification has been conducted on the proposed device according to the FDA software guidance, and the test result proves the functions in each operational mode can be achieved. The difference does not raise a new risk.
VII Non-Clinical Testing
The proposed device and the predicate device are substantially equivalent in design concepts, technologies, which have been designed and tested in accordance with:
Electrical Safety:
-
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance Electromagnetic Compatibility:
-
EN 60601-1-2: 2015+A1: 2021/ IEC 60601-1-2: 2014+AMD1:2020 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbance - Requirements and tests
Performance:
- IEC 60601-2-6: 2012, AMD1:2016 for use in conjunction with IEC 60601-1:2005 and with IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment Software life-cycle:
-ANSI AAMI IEC 62304:2006/A1:2016 Medical device software life cycle processes [Including Amendment 1 (2016)]
- FDA Guidance: Content of Premarket Submissions for Device Software Functions.
Thermal Effects test and Temperature monitoring test:
- FDA Guidance: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery
VIII Clinical Testing
No clinical study is included in this submission.
IX Conclusion
The proposed device is equivalent with respect to the basic system design and function of the predicate device. The proposed device isn't the implants and high-risk device. And it doesn't have new intended purpose, new medical indication, new target population, or new intended user. The differences between the predicate device and proposed device do not raise new questions of safety or effectiveness. Based on the comparison and analysis above, the proposed device is determined to be substantially equivalent to the predicate device.