(438 days)
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.
Disposable Microwave Therapeutic Antennas 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.
Disposable Microwave Therapeutic Antennas is composed of radiator, handle, microwave cable with/without cooling tubes. The microwave 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 operator. The radiator is composed of a needle tip, a needle shaft, a cooling tube, and a coaxial cable. The metal parts are connected by a welding process, and the non-metal parts are connected by qlue. The needle and needle shaft are made of medical stainless steel, and the shape of the needle is a trianqular pyramid tip or pyramid type tip, which is mainly used for percutaneous puncture and microwave radiation; the handle is made of ABS material, the cooling tube is made of stainless steel to cool the needle bar all the way, the thermocouple is arranged in the handle to effectively monitor the temperature of the ablation needle not to exceed 45 degrees.
Disposable Microwave Therapeutic Antennas is provided sterile, for single use.
The provided text details the 510(k) summary for "Disposable Microwave Therapeutic Antennas" (K201265), comparing it to a predicate device (K183153) and a reference device (K133821). The core of the submission is to demonstrate substantial equivalence, focusing on technical performance and safety rather than on clinical effectiveness in a comparative sense (e.g., human-in-the-loop studies or ground truth established by experts interpreting images).
Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on demonstrating substantial equivalence to the predicate device in terms of safety and functionality. The performance data provided is entirely non-clinical.
| Feature / Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate/Reference) | Reported Device Performance (Subject Device K201265) | Comments from Text |
|---|---|---|---|
| Intended Use | Coagulation (ablation) of soft tissue, not for cardiac use. | Same as predicate. | "The intended use description is the same." |
| Intended Purpose | Coagulation and ablation of tissue. | Same as predicate. | "Same" |
| Operating Principle | Microwave energy transmitted to antenna, radiated out, absorbed by water molecules in tissue, transforms to heat, causes tissue bioactivity loss. | Same as predicate. | "Same" |
| Classification/Regulation | Electrosurgical cutting and coagulation device and accessories, Class II, Product Code NEY. | Same as predicate. | "Same" |
| Electrical Safety | Compliance with ES60601-1. | Complies with ES60601-1. | Explicitly stated as met. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. | Complies with IEC 60601-1-2. | Explicitly stated as met. |
| Performance (Microwave Therapy Equipment) | Compliance with IEC 60601-2-6. | Complies with IEC 60601-2-6. | Explicitly stated as met. |
| Shelf Life | Valid for a specified duration (e.g., 2 years). | 2 years confirmed via accelerated aging tests. | Explicitly stated as met. |
| Thermal Effects | Compliance with FDA Guidance for Electrosurgical Devices. | Thermal effects test conducted in accordance with FDA guidance. | Explicitly stated as met. |
| Package Verification | Compliance with ISO 11607-1. | Complies with ISO 11607-1. | Explicitly stated as met. |
| Sterilization Validation | Ethylene Oxide sterilization validated per ISO 11135-1. | Sterilization validated per ISO 11135-1 (SAL: 10-6). | Explicitly stated as met. |
| Biocompatibility | Patient-contacting materials are biocompatible per ISO 10993. | Patient-contacting materials are biocompatible; Biological Evaluation Tests in compliance with ISO 10993. | Explicitly stated as met, addressing material differences. |
| Device Temperature Monitoring | Features to ensure system safety. | Same as predicate. | "Equivalent" |
| Device Cooling | Pumped, normal saline used to cool antenna. | Same as predicate. | "Equivalent" |
| Disposable/Single Use | Disposable, single patient procedure only. | Same as predicate. | "Same" |
| Output Parameters | 2450MHz, 0-100W, 50Ω nominal impedance. | 2450MHz±20MHz, 0-100W, 50Ω nominal impedance. | Frequency range ±10MHz for predicate vs ±20MHz for subject, but deemed "Equivalent" or "Similar" in output power. |
| Applicator Lengths | Various lengths (e.g., 150-300mm). | Wider range of applicator lengths (100-1200mm). | The text states this difference "only reflected in the depth of the position of the tumor to be ablated and does not affect the product's safety and performance." |
| Applicator Outer Diameter | Various diameters (e.g., 1.3-3.2mm). | Wider range of diameters (e.g., 17G to 8G). | The text states this difference relates to trauma size and ablation area, but "does not raise new safety and performance risks." |
| Emission Area (Exposed Length) | Various lengths (e.g., 26-31mm). | Various (e.g., 3.5-18mm for most, 6mm for others). | The text states "internal design details difference will affect the microwave emission area, resulting in a different ablation range and microwave radiation area. Our product has conduct ablation studies of in vitro tissues in accordance with FDA guidelines, and the study results support the intended use of our products, it does not raise new safety issues." |
| Max Power (W) | Up to 100W. | Varies by model (30W-100W). | The text states "the max power of subject devices was less than or equal to the predicate device's," and that "ablation studies of in vitro tissues in accordance with FDA guidelines, and the study results support the intended use of our products, it does not raise new safety issues." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of an AI/human-in-the-loop study. The "test set" here refers to non-clinical testing. For the in vitro tissue ablation studies, the sample size or details of the tissue models used are not explicitly stated. The type of data is non-clinical performance data from laboratory tests, including electrical safety, EMC, performance (IEC 60601-2-6), shelf life (accelerated aging), thermal effects, package verification, sterilization validation, and biocompatibility.
- Data Provenance: Not explicitly stated regarding the origin of the non-clinical data, but implied to be from internal testing by Nanjing ECO Microwave System Co., Ltd. The studies were not retrospective or prospective clinical studies but rather laboratory-based performance and safety evaluations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- This information is not applicable as the device is not an AI diagnostic/interpretative device requiring expert-established ground truth from medical images. The ground truth for this device's performance is established through physical measurements, material science testing, and engineering standards compliance in a laboratory setting.
4. Adjudication Method for the Test Set
- Not applicable. There is no "adjudication" of expert opinions for a test set, as this is a non-AI hardware device approval. Performance is measured against engineering specifications and regulatory standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study was not conducted or required for this 510(k) submission. This is a device for physical ablation, not for interpretation of medical images or aiding human readers in diagnosis. The submission explicitly states: "Clinical testing is not required."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is hardware; there is no standalone algorithm. Its performance is evaluated through physical and electrical tests, not as an algorithm's output.
7. The Type of Ground Truth Used
- The "ground truth" for this medical device is based on established engineering standards, material science properties, electrical safety parameters, and verified physical performance characteristics (e.g., achieving intended thermal effects/ablation in in vitro models). It is not expert consensus, pathology, or outcomes data in the clinical sense, as clinical testing was not required for this submission. The in vitro tissue ablation studies served as the proxy for functional ground truth related to the device's main purpose.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of an AI algorithm, as this is solely a hardware device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for it.
§ 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.