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510(k) Data Aggregation
(243 days)
Electrodes Handpieces (BT, JET) are indicated for coagulation and ablation of soft tissue when used in conjunction with Mygen V-1000 radio frequency generator.
Electrodes Handpieces (BT, JET) are sterile, single-use electrosurgical electordes intended to be use in conjunction with Mygen V-1000 RF generator (K180999).
Electrodes Handpieces (BT, JET) consist of electrode tip, insulation part, handle.
Cooling of the electrode is provided by saline which is pumped (using the peristaltic pump) through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and saline does not contact the patient. For the electrodes (BT, JET), dispersive electrodes are provided so that electrical current flows through the tip of the electrodes, through the target tissue and to the dispersive electrodes.
This document (K193355/S002) is not for an AI/ML medical device, but rather for "Electrode Handpieces (BT, JET)" which are electrosurgical electrodes used for coagulation and ablation of soft tissue. Therefore, the questions related to AI/ML device acceptance criteria, study details, and human-in-the-loop performance are not applicable.
However, I can extract the acceptance criteria and study details that were performed for this specific medical device from the provided text.
Here's a breakdown of the information found, specifically addressing the device's performance data and acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility (ISO10993-1;2009) | Patient contact components and materials must meet ISO10993-1;2009 standards. | Tested and validated according to ISO10993-1;2009. Patient contact components and materials are identical to the predicate device. |
| Shelf-Life Testing | Packaging seal strength, packaging dye penetration, appearance, conduction, and sterility must meet acceptance criteria (ASTM F 1980 Accelerated Aging). | All testing results passed the acceptance criteria for packaging seal strength, packaging dye penetration, appearance, conduction, and sterility, in accordance with ASTM F 1980 Accelerated Aging method for a valid shelf life. |
| Medical Electrical Equipment Safety (IEC 60601-1) | General Requirements for basic safety and essential performance must be fulfilled. | The requirements of specified standards (IEC 60601-1) were fulfilled. |
| Electromagnetic Compatibility (IEC 60601-1-2) | General Requirements for basic safety and essential performance (collateral standards: electromagnetic compatibility) must be fulfilled. | The requirements of specified standards (IEC 60601-1-2) were fulfilled. |
| High Frequency Surgical Equipment Safety (IEC 60601-2-2:2009) | Particular requirements for the basic safety and essential performance must be fulfilled. | The requirements of specified standards (IEC 60601-2-2:2009) were fulfilled. |
| Temperature Sensor Accuracy (of V-1000 generator) | Measured values by the temperature sensor of V-1000 and the temperature calibrator must be within ±3°. | The test results confirmed that the values measured by the temperature sensor of V-1000 and the temperature calibrator were within the acceptance criteria (±3°). Tested in multiple power modes, three times for each power setting. |
| Bacterial Endotoxin Concentration (LAL Test) | Bacterial endotoxin concentration should be < 0.050 EU/device. Validity of the test criteria fulfilled. | Bacterial endotoxin concentration was less than 0.050 EU/device. The acceptance criteria for the validity of the test were fulfilled. No deviations from the study protocol. |
| Thermal Effect | Verify safety and effect on tissue and surrounding anatomical structures. Coagulated necrotic cells show markedly collapsed cellular architecture, and surrounding tissues are normal. | The test was conducted on pig's liver, kidney, and muscle tissue. Parameters of necrosis cross-sectional area show coagulated necrotic cells with markedly collapsed cellular architecture. By comparison, the surrounding liver, thyroid, muscle tissues were normal in appearance. |
Regarding the other questions, as this is not an AI/ML device, the following are not applicable or not mentioned in the document:
- Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML algorithm. The "test sets" here refer to specific physical samples or experimental setups for the non-clinical tests (e.g., pig tissue for thermal effect, device components for biocompatibility). Specific numbers for these are generally not detailed in a 510(k) summary beyond the fact that testing was conducted.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For the non-clinical tests (e.g., thermal effect), the "ground truth" is derived from direct measurements, observations, and histological analysis of the treated biological tissue and physical properties of the device. For other tests like biocompatibility and sterility, it's adherence to international standards and validated methods.
- The sample size for the training set: Not applicable (no AI/ML algorithm requiring a training set).
- How the ground truth for the training set was established: Not applicable.
Additional Information from the document:
- No clinical studies were considered for this submission. This explicitly states that the substantial equivalence determination was based solely on non-clinical performance data and technological comparisons.
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