(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.
§ 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.