(236 days)
The Microwave Ablation System is intended for coagulation (ablation) of soft tissue. It is not intended for use in cardiac procedures.
The Microwave Ablation System M150E is microwave-based system intended to deliver energy through an antenna inserted into soft tissue for the purpose of coagulating (ablation) of a defined volume of that tissue. The Microwave Ablation System utilizes a 2450MHz generator to deliver power to single microwave ablation antenna or double microwave ablation antennas. The Microwave Ablation Generator provides for user setting of ablation time and ablation power. The proposed device consists of Microwave Ablation Generator, Microwave Ablation Electrode Kits, Temperature Probe and Foot Switch.
- Table of Acceptance Criteria and Reported Device Performance:
The document describes the device as a Microwave Ablation System. Rather than specific performance metrics like sensitivity/specificity for a diagnostic device, the acceptance criteria for this therapeutic device are based on demonstrating equivalent technical characteristics, safety, and performance to a predicate device.
| Acceptance Criteria / Performance Element | Predicate Device (Emprint™ Ablation System K133821) | Proposed Device (Microwave Ablation System M150E) | Result / Comparison |
|---|---|---|---|
| Indications for Use | Intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors. Not intended for use in cardiac procedures. | Intended for the coagulation (ablation) of soft tissues. Not intended for use in cardiac procedures. | Equivalent |
| Intended Purpose | coagulation and ablation of tissue | coagulation and ablation of tissue | Equivalent |
| Design | Single channel; cooling-water cycle, thermal ablation, TEMP probe, foot switch. | Double channels; cooling-water cycle, thermal ablation, TEMP probe, foot switch. (Note: Double channel is a difference, but determined not to affect safety/performance.) | Similar/Different |
| Operating Temperature | 10°C-30°C | 5°C-40°C | Similar |
| Operating Humidity | 20%~80% non condensation | 20%~80% non condensation | Equivalent |
| Output Parameters | 2450MHz±50MHz, 0-100W | 2450MHz±10MHz, 0-100W | Equivalent |
| Output Impedance | 50Ω nominal | 50Ω nominal | Equivalent |
| Voltage Supply | 100-240VAC 50-60 Hz | 100-240VAC 50-60 Hz | Equivalent |
| Fuse Rating | 6.3 A, 250V | 6.3 A, 250V | Equivalent |
| Physicochemical Properties | Not contain any medications, animal tissues or blood components, especially in contact with human tissue does not contain the above substances. | Not contain any medications, animal tissues or blood components, especially in contact with human tissue does not contain the above substances. | Equivalent |
| Working Principle | Microwave energy delivered via antenna to coagulate tissue; transforms into heat, raising temperature to lose bioactivity. | Same working principle. | Equivalent |
| Antenna Length (mm) | CA15L1: 150; CA20L1: 200; CA30L1: 300 | SS-MWA-1526C: 150; SS-MWA-1531C: 150; SS-MWA-2026C: 200; SS-MWA-2031C: 200; SS-MWA-2526C: 250; SS-MWA-2531C: 250 (Note: Different lengths, but stated not to affect safety/performance in terms of depth of tumor position.) | Different |
| Emission Area Length (mm) | CA15L1: 28; CA20L1: 28; CA30L1: 28 | SS-MWA-1526C: 26; SS-MWA-1531C: 31; SS-MWA-2026C: 26; SS-MWA-2031C: 31; SS-MWA-2526C: 26; SS-MWA-2531C: 31 (Note: Wider range, but stated not to affect safety/performance.) | Different |
| OD (mm) | CA15L1: 2.40; CA20L1: 2.40; CA30L1: 2.40 | SS-MWA-1526C: 2.08; SS-MWA-1531C: 2.08; SS-MWA-2026C: 2.08; SS-MWA-2031C: 2.08; SS-MWA-2526C: 2.08; SS-MWA-2531C: 2.08 (Note: Thinner diameter to reduce trauma, determined not to affect ablation area or safety/performance.) | Different |
| Antenna Material | Not explicitly stated for predicate in comparison table, but implied to be similar biocompatible material. | 304 stainless steel, biocompatible per ISO 10993-1. | Similar |
| Disposable/Single-use | Antennas are disposable and single-use. | Antennas are disposable and single-use. | Equivalent |
| Sterility | Accessories sterilized with EO (SAL: 10-6). | Accessories sterilized with EO (SAL: 10-6). | Equivalent |
| Biocompatibility | Patient-contacting materials are biocompatible. | Patient-contacting materials are biocompatible. | Equivalent |
| Device Temperature Monitoring | Temperature monitoring features used to ensure system safety. | Temperature monitoring features used to ensure system safety. | Equivalent |
| Device Cooling | Pumped normal saline is used to cool the Emprint™ Antenna. | Pumped normal saline is used to cool the antenna. | Equivalent |
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The submission states, "Clinical studies were not required to demonstrate the substantial equivalence of the microwave ablation system and the predicated device." The testing primarily involved non-clinical bench and lab testing (e.g., electrical safety, EMC, performance, thermal effects, temperature monitoring, shelf life, package verification, sterilization validation, biocompatibility).
- Data Provenance: Not applicable, as no clinical test set was used. The non-clinical testing data provenance is implied to be from the manufacturer's internal testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical test set was used that required expert ground truth establishment in this type of 510(k) submission.
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Adjudication method for the test set:
- Not applicable, as no clinical test set was used for adjudication.
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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:
- Not applicable. This device is a therapeutic microwave ablation system, not a diagnostic imaging AI device that would involve human readers or AI assistance for interpretation.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable in the context of diagnostic AI performance. The device is a physically operated medical system. However, software validation was performed, indicating the internal algorithms and software governing the device's operation were tested in a standalone manner (without human intervention in the algorithm's execution during ablation).
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The type of ground truth used:
- For the non-clinical tests, the "ground truth" was established by adherence to recognized national and international standards (e.g., IEC 60601-1, IEC 60601-2-6, IEC 60601-1-2, ISO 11607-1, ISO 11135, ISO 10993), and engineering specifications for system performance, thermal effects, and temperature monitoring. These standards and specifications themselves represent a form of "ground truth" for acceptable device characteristics and safety.
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The sample size for the training set:
- Not applicable, as this device does not involve machine learning or AI models that require a training set in the conventional sense. The "training" here refers to the device's design, development, and adherence to established engineering principles and standards.
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How the ground truth for the training set was established:
- Not applicable, as no machine learning training set was used. The "ground truth" for the device's design and operational parameters was derived from existing medical device standards, predicate device characteristics, and established engineering and physiological principles related to microwave ablation.
§ 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.