(108 days)
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.
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.
This document describes the 510(k) Premarket Notification for the Disposable Microwave Ablation Needle (K232241). The submission aims to demonstrate substantial equivalence to a predicate device (K201265). It does not include a study proving the device meets specific acceptance criteria as would be found in a clinical trial. Instead, it relies on demonstrating equivalence through non-clinical testing and comparison to an established predicate device.
Here's an analysis of the provided information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with direct performance metrics in the way a clinical study would for efficacy endpoints. Instead, it demonstrates compliance with recognized standards and addresses differences from the predicate device through non-clinical testing. The "performance" is primarily shown through compliance with these standards and the equivalence of the ablation mechanism.
Key Non-Clinical Tests and Standards of Compliance:
| Test Category | Standard | Reported Performance/Compliance |
|---|---|---|
| Electrical Safety | IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 | Designed and tested in accordance with these standards. |
| EMC | EN 60601-1-2: 2015+A1: 2021/IEC 60601-1-2: 2014+AMD1:2020 | Designed and tested in accordance with these standards. |
| Performance | IEC 60601-2-6: 2012, AMD1:2016 (for microwave therapy equipment in conjunction with IEC 60601-1) | Designed and tested in accordance with this standard. |
| Software Validation | ANSI AAMI IEC 62304:2006/A1:2016; FDA Guidance: Content of Premarket Submissions for Device Software Functions | Designed and tested in accordance with these standards/guidance. |
| Shelf Life | ASTM F 1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices machine | Tested for shelf life according to this standard. |
| Thermal Effects & Temp Monitoring | FDA Guidance: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery | Thermal Effects test and Temperature monitoring test performed as per FDA guidance. The results support the intended use, particularly for differences in radiation pole and max power ("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."). |
| Biocompatibility | ISO 10993 series standards | Conforms to the requirements for materials in patient contact. |
| Sterility | EO (SAL: 10-6) | Provided sterile with a Sterility Assurance Level (SAL) of 10-6, same as predicate. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document focuses on non-clinical testing, particularly in vitro tissue ablation studies. It does not specify a "sample size" for a test set in the context of human subjects or image data.
- Test Set Description: Not applicable in the context of human or image data. The testing involves "in vitro tissues" for thermal effects and temperature monitoring.
- Data Provenance: Not specified, but the manufacturing company is based in China. The testing appears to be primarily laboratory-based (in vitro), not drawn from human clinical data.
- Retrospective/Prospective: Not applicable, as this is laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This section is not applicable. The evaluations are based on engineering and scientific principles, compliance with international standards, and in vitro studies for performance, not on expert interpretations of medical images or patient outcomes in a diagnostic context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable for the type of non-clinical testing described. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies where expert interpretation is involved.
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 is not applicable. The device is a physical microwave ablation needle, not a software AI-driven medical device aimed at assisting human readers or improving diagnostic accuracy.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical therapeutic device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the in vitro ablation studies mentioned, the "ground truth" for thermal effects and ablation zone characteristics would typically be established by direct measurement and observation within the experimental setup, often validated against physical principles of microwave energy delivery and tissue heating properties. This is a scientific "ground truth" rather than a clinical one derived from patient data or expert medical opinion. For biocompatibility, the ground truth is established by adherence to ISO 10993 series standards.
8. The sample size for the training set
This is not applicable as there is no mention of a training set for an algorithm or AI model. The submission pertains to a physical medical device.
9. How the ground truth for the training set was established
This is not applicable as there is no training set mentioned in the document.
Summary of the Study and Device Proof:
The submitted document ("510(k) Summary") is not a detailed clinical study report but rather a regulatory filing to demonstrate substantial equivalence for a medical device. The "study" referenced is a series of non-clinical tests and analyses designed to show that the proposed Disposable Microwave Ablation Needle is as safe and effective as a legally marketed predicate device.
The proof that the device meets "acceptance criteria" comes from:
- Compliance with recognized international standards: IEC 60601-1, EN 60601-1-2, IEC 60601-2-6, ANSI AAMI IEC 62304, ASTM F 1980, and ISO 10993 series standards.
- In vitro tissue ablation studies: These studies, conducted in accordance with FDA guidance documents, assessed the "Thermal Effects" and "Temperature monitoring" and the "ablation range" of the device, particularly addressing the differences in radiation pole and max power compared to the predicate device. The results of these studies supported the intended use of the proposed device.
- Comparison to a predicate device (K201265): The document meticulously compares the proposed device to the predicate across various characteristics (Table 2). Differences in operating principle description (equivalent), applicator material (biocompatibility assessed), applicator length (affects depth, not safety/performance), outer diameter (affects puncture area, not safety/performance), radiation pole (affects radiation field, in vitro studies support safety), and max power (affects ablation range, in vitro studies support safety) are analyzed and justified as not raising new questions of safety or effectiveness.
In conclusion, the acceptance criteria are largely implicit in the compliance with design, safety, and performance standards, and the demonstration through non-clinical testing that any differences from the predicate device do not introduce new safety or effectiveness concerns. No human clinical study was performed or included in this submission.
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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.
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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
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and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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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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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
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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
| Serialnumber | 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 |
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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 MicrowaveAblation Needle | Disposable MicrowaveTherapeutic Antennas | -- |
| Manufacturer | Betters(Suzhou) Medical Co.,Ltd | Nanjing ECO MicrowaveSystem 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 MicrowaveAblation Needle is used withthe Microwave AblationSystem, which is indicated forthe coagulation (ablation) ofsoft tissue. The DisposableMicrowave Ablation Needle isnot intended for cardiac use. | Disposable MicrowaveTherapeutic Antennas is usedwith the MicrowaveTherapeutic System, which isindicated for the coagulation(ablation) of soft tissue. TheDisposable MicrowaveTherapeutic Antennas is notintended for cardiac use. | Same |
| Intended purpose | Coagulation and ablation oftissue | Coagulation and ablation oftissue | Same |
| Operating principle | Microwave energy is deliveredto the lesion tissue by theDisposable MicrowaveAblation Needle. The lesiontissue contains a large numberof charged particles, watermolecules, and proteinmolecules and these polar | During the surgery, themicrowave ablation antenna isaccurately placed in the tumortarget area by imagingtechniques (such as CT, US,etc.). The microwave energygenerated by the microwavegenerator transmits to the | Equivalent1 |
| molecules rotate with thefrequency of the appliedelectric field. In the process ofrotation, friction withneighboring moleculesgenerates heat, which causescoagulation necrosis of thelesion tissue. | microwave ablation antennathrough the coaxial cable, andthenit is radiated out through themicrowave antenna andabsorbed by water molecules inthe tumor tissue. Themicrowave energy transforminto heat, and the temperaturerises rapidly result in tumortissue 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 |
| PatientContactingMaterials | PolytetrafluoroethyleneSUS 304 | 2. SUS 304 with double tefloncoating | |
| 3. US 304 with single tefloncoating | |||
| 4. Nylon | |||
| 5. Polytetrafluoroethylene | |||
| ApplicatorsLength (mm) | T-1408: 80T-1410: 100T-1608: 80T-1610: 100L-1815: 150L-1818: 180L-2015: 150L-2018: 180 | ECO-100AI1:100ECO-100AI26:100ECO-100A13:100ECO-100AI18C:150ECO-100CL8C:150ECO-100CL8:150ECO-100AL13C:150ECO-100CL5C:150ECO-100CL5:150ECO-100CL27C:150ECO-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 OuterDiameter (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
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| 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 /Singleuse Device | The device is provided sterile,for single use. | The antennas are disposableand are to be used within asingle patient procedure only. | Same |
| Sterility | The device is sterilized withEO (SAL: 10-6) | The accessories are sterilizedwith EO (SAL: 10-6) | Same |
| Biocompatibility | Conforms to the requirementsof ISO 10993 series standards | Conforms to the requirementsof ISO 10993 series standards | Same |
| DeviceTemperatureMonitoring | Temperaturemonitoringfeatures used to ensure systemsafety | Temperaturemonitoringfeatures used to ensure systemsafety | Same |
| Device cooling | Pumped, distilled water orsaline is used to cool theablation needle. | Pumped, normal saline is usedto cool the antenna. | Same |
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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
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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
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[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.
§ 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.