(108 days)
Not Found
No
The summary describes a physical medical device (ablation needle) and its function (thermal ablation). There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is used for the "ablation of soft tissue," which is a therapeutic intervention, and the predicate device is explicitly named "Disposable Microwave Therapeutic Antennas."
No
The device, a Disposable Microwave Ablation Needle, is used for the ablation of soft tissue, which is a therapeutic rather than diagnostic function. It is designed to administer treatment (ablation) by destroying tissue with thermal energy, not to identify medical conditions or diseases.
No
The device description clearly outlines physical components like a needle, handle, and cables, indicating it is a hardware device, not software-only.
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 "ablation of soft tissue during open procedures." This describes a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a "puncture needle with microwave energy transmission" that is "inserted into the human body through puncture, and the tissue is ablated by the thermal energy transformed by the needle tip." This clearly describes an invasive therapeutic device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue biopsies, etc.) or providing diagnostic information based on such analysis. The device's function is to deliver energy to tissue for therapeutic purposes.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Disposable Microwave Ablation Needle is used with the Microwave Ablation System. which is indicated for the ablation of soft tissue during open procedures. The Disposable Microwave Ablation Needle is not intended for cardiac use.
Product codes
NEY
Device Description
Disposable Microwave Ablation Needle is a puncture needle with microwave energy transmission. It is inserted into the human body through puncture, and the tissue is ablated by the thermal energy transformed by the needle tip.
The Disposable Microwave Ablation Needle is composed of an inlet pipe, an outlet pipe, a handle, a needle rod, a medium tube, a radiation pole, and a coaxial transmission cable. It is a sterile disposable product. The coaxial transmission cable connect the Microwave Ablation System to transmit microwaves to the ablation needle (radiator), a handle is set at the connection between the microwave cable and the ablation needle to facilitate the operation of the operator.
The Disposable Microwave Ablation Needle is provided sterile, for single use.
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
The proposed device has conducted ablation studies of in vitro tissues in accordance with FDA guidance, and the study results support the intended use of the proposed device.
Key Metrics
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 APlus Healthcare Technology (Shanghai) Co., Ltd Room 223, Building 17, JY-WISDOMBAY Huging Road 158, Baoshan District Shanghai, Shanghai China
Re: K232241
Trade/Device Name: Disposable Microwave Ablation Needle (T-1408, T-1410, T-1610, L-1815, L-1818, L-2015, L-2018) 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 11:07:30 -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) K232241
Device Name Disposable Microwave Ablation Needle
Indications for Use (Describe)
Disposable Microwave Ablation Needle is used with the Microwave Ablation System. which is indicated for the ablation of soft tissue during open procedures. The Disposable Microwave Ablation Needle 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) |
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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 Position: Operation Manager Tel.: +86-15261671606 E-mail: liulei@baidemed.com
Preparation date: July 28, 2023
II Proposed Device
| Trade Name of Device: | Disposable Microwave Ablation Needle |
|---|---|
| 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: | K201265 | |
|---|---|---|
| Trade/Device Name: | Disposable Microwave Therapeutic Antennas | |
| Regulation Name: | Electrosurgical Cutting and Coagulation Device and Accessories | |
| Classification: | Class II | |
| Product Code: | NEY | |
| ManufacturerNanjing ECO Microwave System Co., Ltd. |
IV Device Description
Disposable Microwave Ablation Needle is a puncture needle with microwave energy transmission. It is inserted into the human body through puncture, and the tissue is ablated by the thermal energy transformed by the needle tip.
The Disposable Microwave Ablation Needle is composed of an inlet pipe, an outlet pipe, a handle, a needle rod, a medium tube, a radiation pole, and a coaxial transmission cable. It is a sterile disposable product. The coaxial transmission cable connect the Microwave Ablation System to transmit microwaves to the ablation needle (radiator), a handle is set at the connection between the microwave cable and the ablation needle to facilitate the operation of the operator.
1
5
The Disposable Microwave Ablation Needle is provided sterile, for single use.
The proposed Disposable Microwave Ablation Needle are available in different model is shown as Table 1.
Image /page/5/Figure/3 description: The image contains two schematic diagrams of a curved handle. The first diagram is labeled "FIG. 1 Schematic diagram of the Curved handle" and shows the handle with a water inlet pipe and exhalent iphon. The diagram also indicates the part of the handle that comes into contact with the human body. The second diagram shows a similar handle with a water inlet pipe, RF connector, exhalent iphon, and temperature measuring plug, and also indicates the part that comes into contact with the human body.
Table 1 Models, specifications and dimensions
FIG. 2 Schematic diagram of the straight stalk structure
| Serial
number | Type | d±0.2
(mm) | L±5
(mm) | Frequency (MHz) | Type of handle |
|------------------|--------|---------------|-------------|-----------------|-----------------|
| 1 | T-1408 | 1.4 | 80 | 2450 | Straight handle |
| 2 | T-1410 | 1.4 | 100 | 2450 | Straight handle |
| 3 | T-1608 | 1.6 | 80 | 2450 | Straight handle |
| 4 | T-1610 | 1.6 | 100 | 2450 | Straight handle |
| 5 | L-1815 | 1.8 | 150 | 2450 | Curved handle |
| 6 | L-1818 | 1.8 | 180 | 2450 | Curved handle |
| 7 | L-2015 | 2.0 | 150 | 2450 | Curved handle |
| 8 | L-2018 | 2.0 | 180 | 2450 | Curved handle |
6
V Indication for Use
Disposable Microwave Ablation Needle is used with the Microwave Ablation System, which is indicated for the ablation of soft tissue during open procedures. The Disposable Microwave Ablation Needle 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
(K201265) | Discussion |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Device/Trade name | Disposable Microwave
Ablation Needle | Disposable Microwave
Therapeutic Antennas | -- |
| 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 Disposable Microwave
Ablation Needle is used with
the Microwave Ablation
System, which is indicated for
the coagulation (ablation) of
soft tissue. The Disposable
Microwave Ablation Needle 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 |
| Intended purpose | Coagulation and ablation of
tissue | Coagulation and ablation of
tissue | Same |
| Operating principle | Microwave energy is delivered
to the lesion tissue by the
Disposable Microwave
Ablation Needle. The lesion
tissue contains a large number
of charged particles, water
molecules, and protein
molecules and these polar | During 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 | Equivalent1 |
| | molecules rotate with the
frequency of the applied
electric field. In the process of
rotation, friction with
neighboring molecules
generates heat, which causes
coagulation necrosis of the
lesion tissue. | microwave ablation antenna
through the coaxial cable, and
then
it is radiated out through the
microwave antenna and
absorbed by water molecules in
the tumor tissue. The
microwave energy transform
into heat, and the temperature
rises rapidly result in tumor
tissue losing bioactivity. | |
| AC input Voltage | 100-240V~, 50/60Hz | AC100-240V, 50/60Hz | Same |
| Output Impedance | 50Ω nominal | 50Ω nominal | Same |
| Output parameters | 2450MHz±25MHz | 2450MHz±20MHz | Same |
| Applicator | Tin Bronze | 1. Ceramics | Different2 |
| Patient
Contacting
Materials | Polytetrafluoroethylene
SUS 304 | 2. SUS 304 with double teflon
coating | |
| | | 3. US 304 with single teflon
coating | |
| | | 4. Nylon | |
| | | 5. Polytetrafluoroethylene | |
| Applicators
Length (mm) | T-1408: 80
T-1410: 100
T-1608: 80
T-1610: 100
L-1815: 150
L-1818: 180
L-2015: 150
L-2018: 180 | ECO-100AI1:100
ECO-100AI26:100
ECO-100A13:100
ECO-100AI18C:150
ECO-100CL8C:150
ECO-100CL8:150
ECO-100AL13C:150
ECO-100CL5C:150
ECO-100CL5:150
ECO-100CL27C:150
ECO-100CL28C:200 | Different3 |
| | | | |
| | | ECO-100CL22C:200 | |
| | | ECO-100AL23C:200 | |
| | | ECO-100CL10:200 | |
| | | ECO-100CL10C:200 | |
| | | ECO-100AI25:200 | |
| | | ECO-100CL11C:250 | |
| | | ECO-100CL29:1000 | |
| | | ECO-100AL29:1000 | |
| | | ECO-100CL31:1000 | |
| | | ECO-100AI30:1200 | |
| Applicators Outer
Diameter (mm) | T-1408: 1.4 | ECO-100AI1:17G | Different4 |
| (18G=1.3mm | T-1410: 1.4 | ECO-100AI26:18G | |
| 17G=1.4mm | T-1608: 1.6 | ECO-100AI3:16G | |
| 16G=1.6mm | T-1610: 1.6 | ECO-100AI18C:8G | |
| 15G=1.8mm | L-1815: 1.8 | ECO-100CL8C:14G | |
| 14G=2.0mm | L-1818: 1.8 | ECO-100CL8:14G | |
| | L-2015: 2.0 | ECO-100AL13C:15G | |
| 8G=3.2mm) | L-2018: 2.0 | ECO-100CL5C:16G | |
| | | ECO-100CL5:16G | |
| | | ECO-100CL27C:18G | |
| | | ECO-100CL28C:18G | |
| | | ECO-100CL22C:16G | |
| | | ECO-100AL23C:15G | |
| | | ECO-100CL10:14G | |
| | | ECO-100CL10C:14G | |
| | | ECO-100AI25:8G | |
| | | ECO-100CL11C:14G | |
| | | ECO-100CL29:14G | |
| | | ECO-100AL29:14G | |
| | | | |
Table 2 General Comparison of Disposable Microwave Ablation Needle
7
8
9
| ECO-100CL31:11G | |||
|---|---|---|---|
| ECO-100AI30:14G | |||
| Radiation Pole | |||
| (exposed length) | |||
| (mm) | T-1408: 3.5 | ECO-100AI1:3.5 | Different5 |
| T-1410: 3.5 | ECO-100A126:3.5 | ||
| T-1608: 3.5 | ECO-100AI3:3.5 | ||
| T-1610: 3.5 | ECO-100AI18C:12 | ||
| L-1815: 10 | ECO-100CL8C:12 | ||
| L-1818: 10 | ECO-100CL8:11 | ||
| L-2015: 10 | ECO-100AL13C:18 | ||
| L-2018: 10 | ECO-100CL5C:12 | ||
| ECO-100CL5:12 | |||
| ECO-100CL27C:12 | |||
| ECO-100CL28C:12 | |||
| ECO-100CL22C:12 | |||
| ECO-100AL23C:18 | |||
| ECO-100CL10:11 | |||
| ECO-100CL10C:12 | |||
| ECO-100AI25:11 | |||
| ECO-100CL11C:12 | |||
| ECO-100CL29:6 | |||
| ECO-100AL29:6 | |||
| ECO-100CL31:6 | |||
| ECO-100A130:6 | |||
| Max power | |||
| (W) | T-1408: 60W | ECO-100AI1:30 | Different6 |
| T-1410: 60W | ECO-100AI26:30 | ||
| T-1608: 60W | ECO-100A13:40 | ||
| T-1610: 60W | ECO-100AI18C:100 | ||
| L-1815: 70W | ECO-100CL8C:80 | ||
| L-1818: 70W | ECO-100CL8:80 | ||
| L-2015: 70W | ECO-100AL13C:60 | ||
| L-2018: 70W | ECO-100CL5C:60 | ||
| ECO-100CL5:50 | |||
| ECO-100CL27C:50 | |||
| ECO-100CL28C:50 | |||
| ECO-100CL22C:60 | |||
| ECO-100AL23C:60 | |||
| ECO-100CL10:80 | |||
| ECO-100CL10C:100 | |||
| ECO-100AI25:100 | |||
| ECO-100CL11C:100 | |||
| ECO-100CL29:50 | |||
| ECO-100AL29:50 | |||
| ECO-100CL31:50 | |||
| ECO-100AI30:60 | |||
| Disposable /Single | |||
| use Device | The device is provided sterile, | ||
| for single use. | The antennas are disposable | ||
| and are to be used within a | |||
| single patient procedure only. | Same | ||
| Sterility | The device is sterilized with | ||
| EO (SAL: 10-6) | The accessories are sterilized | ||
| with EO (SAL: 10-6) | Same | ||
| Biocompatibility | Conforms to the requirements | ||
| of ISO 10993 series standards | Conforms to the requirements | ||
| of ISO 10993 series standards | 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 |
10
1 The operating principle description of the proposed device is different from the predicate device. However, the proposed device and the predicate device have function, which is to transmit the microwave energy generated by the microwave generator through the coaxial cable to the microwave ablation needle or antenna, and then the microwave energy is radiated out through the ablation needle or
11
antenna and absorbed by water molecules in the target tissue. The operating principle of the devices are equivalent.
2 There are some differences for the materials in direct contact with patient. The differences do not affect the performance of device, but only affect the biocompatibility of the material. Biocompatibility evaluation has been performed according to ISO 10993-1 on the material used in the proposed device, and the result shows that the material is biocompatibility, the difference of material does not raise new safety and effective risk.
3 The applicator length of the proposed device is different from that of the predicate device, but this difference is only reflected in the depth of the position of the target tissue to be ablated and does not affect the device's safety and performance.
4 The applicators outer diameter options are less than that of predicate device. The only effect of different OD is that the target tissue caused by puncture is smaller or bigger, based on the affecting area of the ablation. This difference does not raise new safety and performance risk.
5 The internal design difference will affect the microwave radiation field, resulting in a different ablation range. The proposed device has conducted ablation studies of in vitro tissues in accordance with FDA guidance, and the study results support the intended use of the proposed device. This difference does not raise new safety issue.
6 The difference of max power will affect the microwave emission area, resulting in a different ablation range and microwave radiation area. The proposed device ablation studies of in vitro tissues in accordance with FDA guidance, and the study results support the intended use of the proposed device. This difference does not raise new safety issue.
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 validation:
-
ANSI AAMI IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes
12
[Including Amendment 1 (2016)]
- FDA Guidance: Content of Premarket Submissions for Device Software Functions.
Shelf Life:
- ASTM F 1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices machine.
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.