(336 days)
The Irreversible Electroporation Ablation Generator is indicated for the surgical ablation of soft tissue.
The Irreversible Electroporation Probe is used in conjunction with Irreversible Electroporation of CuraWay indicated for the surgical ablation of soft tissue.
The Irreversible Electroporation Ablation Generator consists of a generator, foot switch and power cord. The generator will be used together with the Irreversible Electroporation Probe and Neutral Electrode.
The Irreversible Electroporation Probe has two types: monopolar probe and bipolar probe. Monopolar probe also has two types: Standard Probe and Activation Probe.
The Irreversible Electroporation Ablation Generator has three working modes:
- A Mode 1: Monopolar steep pulse mode;
- A Mode 2: Bipolar steep pulse mode;
- A Mode 3: Needle Track Coagulation.
Mode 1 and Mode 2 are used for soft tissue ablation, the working principle is that the generator transfers non-thermal energy to electrodes which are placed at the target area, it will release high-voltage electrical pulses forming nano-scale permanent perforations on the soft tissues to disrupt the intracellular balance and induce cell apoptosis. The cells die and are removed by the human body's own lymphatic system.
The Mode 3 is used for the soft tissue coagulation during the process when the probe is pulled out. This module works at 480kHZ, the high frequency flows to the probe's tip and then is applied to the tissue. Frictional heat occurs and causes the ions to move between the negative pole and the positive pole 40,000 to 50,000 times per second. Heat generated from the tissue impedance induces tissue necrosis.
Subject device can work at ECG synchronization trigger mode. During this mode, an external R-wave detector must be connected. R-wave detector monitors the patient's cardiac rate and transfers it to R waves which will be detected by the generator and then a pulse will be triggered. Every time a R wave is detected, one pulse is triggered such that every time the heart beats, a pulse will be triggered, so that the electroporation pulses can be triggered and delivered in proper synchronization with the patient's cardiac rhythm.
This document is a 510(k) summary for a medical device and does not contain detailed acceptance criteria or a study proving the device meets specific acceptance criteria in the manner typically presented for AI/ML performance. The information provided focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
However, based on the information provided, we can infer some "acceptance criteria" through the comparative non-clinical studies.
Here's an analysis based on your request, adapting to the provided document's content:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative performance acceptance criteria in a dedicated table for the device's efficacy. Instead, it describes non-clinical tests designed to demonstrate "substantial equivalence" to a predicate device. The performance is assessed by comparing the subject device's effects to those of the predicate and reference devices in specific animal and ex-vivo models.
| Metric/Criteria (Inferred from Non-clinical Tests) | Acceptance (Inferred) | Reported Device Performance |
|---|---|---|
| Ex-vivo tissue testing (swine muscle, liver, kidney): Ablation effect and ablation zones | Substantially equivalent to predicate and reference devices. | "The result showed the ablation effect and ablation zones of the subject device is substantial equivalent to the predicate device and the reference device." |
| ECG synchronization trigger mode testing: Comparison to predicate device. | Performance is comparable to predicate device. | "ECG trigger mode testing was conducted to compare ECG synchronization trigger mode of subject to that of the predicate device." (Implies comparable performance was observed) |
| In-vivo animal testing (swine): Blood routine, blood biochemistry, myocardial enzymes, and diameter of ablation (compared to predicate device). | No significant adverse differences in blood parameters between groups. Ablation diameters are comparable. | "The long ablation diameter and short ablation diameter of subject device group was compared to those of predicate device." (Implies comparable results were found to support substantial equivalence). |
| Compliance with recognized standards: | Device complies with all relevant standards. | The device passed specific IEC, ISO, and ASTM standards (listed in the document). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Ex-vivo tissue testing: Swine muscle, liver, and kidney tissue. The specific number of tissue samples or experiments is not provided.
- In-vivo animal testing: Swine. The specific number of animals used in the subject device group and predicate device group is not provided.
- Data Provenance: The tests were conducted internally by the manufacturer or a contracted lab. The document does not specify a country of origin for the data beyond the manufacturer being based in China. The studies are non-clinical (ex-vivo and in-vivo animal), not human clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided as the studies are non-clinical. The assessment of "ablation effect and ablation zones" or "blood parameters" would typically be performed by trained lab personnel, veterinarians, or pathologists, but specific details on their qualifications or number are not available in this regulatory summary.
4. Adjudication Method for the Test Set
This information is not provided. Given that these are non-clinical studies evaluating physical effects and physiological parameters, typical clinical adjudication methods (like 2+1 or 3+1 consensus) are not directly applicable. The "ground truth" is derived from direct measurements and observations in the experimental setup.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This document describes a medical device, not an AI/ML diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an Irreversible Electroporation Ablation Generator and Probe, which is a physical medical device used for surgical ablation. It is not an AI algorithm. While it has embedded software, its performance is assessed as part of the overall device system, not as a standalone AI algorithm.
7. The Type of Ground Truth Used
For the non-clinical studies mentioned:
- Ex-vivo and in-vivo tests: The "ground truth" for evaluating ablation effect and ablation zones, blood parameters, etc., would be based on direct measurement, observation, and analysis by laboratory techniques (e.g., macroscopic and microscopic examination of tissue, blood tests). It's a form of objective measurement/pathology from the experimental models.
8. The Sample Size for the Training Set
Not Applicable. The device is not an AI/ML algorithm that requires a training set in the conventional sense. The "development" of the device would involve engineering design, prototyping, and iterative testing, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As explained above, there is no AI/ML training set for this 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.