(126 days)
The microwave ablation system is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Microwave ablation system is not intended for cardiac use.
Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Sterile Microwave Ablation Probe is not intended for cardiac use.
The Microwave Ablation Device with Sterile Microwave Ablation Probe is a device system which is intended for soft tissue coagulation. The Microwave Ablation Device consists of power supply, microwave power source, control system, temperature measurement system, RF connection cable, foot switch, and temperature probe. The Sterile Microwave Ablation Probe is a single-use sterile product, consisting of a handle, RF connector, RF coaxial cable, needle bar, inner tube, pinhead, temperature sensor and coolant tube. The Microwave Ablation Device also contains a single use Sterile Temperature Probe.
This is a 510(k) premarket notification for a medical device, which means the FDA has determined it is "substantially equivalent" to an existing legally marketed device (the predicate device). In this context, "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the non-clinical performance and testing performed to demonstrate that the new device is as safe and effective as the predicate, despite minor differences.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a formal table of acceptance criteria with specific numerical targets and corresponding reported performance for clinical efficacy. Instead, the "acceptance criteria" are implied by the successful completion of various non-clinical tests demonstrating compliance with regulatory standards and comparable performance to the predicate device.
| Test Category | Implied Acceptance Criteria (Demonstrated Compliance/Equivalence) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 | "Passed the testing in accordance with internal requirements, and international standards." Specifically, ES60601-1 was met. |
| EMC | Compliance with IEC 60601-1-2 | "Passed the testing in accordance with internal requirements, and international standards." Specifically, IEC 60601-1-2 was met. |
| Performance (Device Specific) | Compliance with IEC 60601-2-6 (Microwave Therapy Equipment) | "Passed the testing in accordance with internal requirements, and international standards." Specifically, IEC 60601-2-6 was met. |
| Software Validation | Compliance with FDA guidance for software in medical devices | "Software validation is in compliance with FDA guidance for the content of premarket submissions for software contained in Medical devices." |
| Shelf Life | Validity of 3-year shelf life claim for probe (accelerated aging, package tests) | "Accelerated aging and package tests were conducted to confirm the validity of the 3 year shelf life claim for the Sterile Microwave Ablation Probe." (Implies successful confirmation). |
| Thermal Effects Test | Comparable thermal effects to predicate, demonstrating no new safety/performance risks for power/length differences. | "The thermal effects test with ex vivo animal tissues device and does not raise new safety and performance risks." (Comment 2 & 4) |
| Temperature Monitoring Test | Functionality and accuracy of temperature monitoring. Demonstrates no new safety/performance risks for "Mode B". | "Tissue protection temperature need the subject device will monitor tissue temperature using the Sterile Temperature Probe. After tissue temperature reach the setup protection value, Microwave output to control the tissue temperature stable around the ±3% tolerance of the set temperature, the protection value range is 37.0 ℃~100.0 ℃. Mode B does not raise new safety and performance risks." |
| Package Verification | Compliance with ISO 11607-1:2016 | "Passed the testing in accordance with internal requirements, and international standards." Specifically, ISO 11607-1:2016 was met. |
| Sterilization Validation | Compliance with ISO 11135-1:2014 (Ethylene Oxide Sterilization) | "Passed the testing in accordance with internal requirements, and international standards." Specifically, ISO 11135-1:2014 was met. |
| Biocompatibility | Compliance with ISO 10993-1 and applicable parts | "The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. The Biological Evaluation Tests are in compliance with the standards of ISO 10993-1 and its applicable parts, 'Biological Evaluation of Medical Devices'." (Implies successful compliance) |
| Probe Stability Tests | Stability with maximum output power and extended treatment duration. | "Sterile Microwave Ablation Probe Stability Tests with maximum output power and extended treatment duration." (Implies successful completion and meeting requirements, though specific results not detailed). |
| Temperature Sensor Accuracy Verification | Accuracy of temperature sensor measurement. | "Temperature Sensor Measurement Accuracy Verification Tests." (Implies successful completion and meeting requirements, though specific results not detailed). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for specific tests. For the thermal effects test, it mentions "ex vivo animal tissues," but the number of samples is not provided. Other tests refer to compliance with standards rather than specific sample sizes of device units tested.
- Data Provenance: The tests are "non-clinical." This implies laboratory or bench testing. The origin of the animal tissues for the thermal effects test is not specified (e.g., country of origin). All tests were conducted by the manufacturer, Hygea Medical Technology Co., Ltd.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this submission. This is a 510(k) for a hardware device (Microwave Ablation Device and Probe) and the non-clinical tests described are primarily engineering and performance tests, not clinical evaluations requiring human expert interpretation of diagnostic images or outcomes. Therefore, there is no "ground truth" established by experts in the context of clinical data for this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies involving human readers and interpretations (e.g., radiologists reviewing images) to establish a consensus ground truth. The tests described are engineering and biochemical in nature and would not involve such adjudication.
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 information is not applicable. This device is a microwave ablation system, not an AI-powered diagnostic or assistive tool, and the submission does not include any clinical studies, MRMC studies, or AI components.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical ablation system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" is generally defined by:
- Established engineering and performance standards: e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-6, ISO 11607-1, ISO 11135-1, ISO 10993-1.
- Physical measurements and observations in bench testing (e.g., temperature stability within ±3% tolerance, confirmation of thermal effects in ex vivo tissues, successful completion of stability tests).
- Successful software validation against established FDA guidance.
There is no "expert consensus, pathology, or outcomes data" mentioned as ground truth in this non-clinical submission.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The non-clinical tests are validating the device's physical and electrical performance.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set.
§ 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.