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510(k) Data Aggregation
(262 days)
The Epix® Electrosurgical Probes with Smoke Evacuation (spatula, L-hook, needle tips) are intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate tissue during laparoscopic (inclusive of endoscopic) surgical procedures where the device is introduced into the body through a cannula. The device may be used for the evacuation of smoke created by electrosurgery at the surgical site.
Electrosurgical probes are designed for electrosurgical cutting and coagulation of tissue during general laparoscopic procedures. The device also has a smoke evacuation feature. The subject device has an angled shaft that fits through 10mm trocar cannulas and must be connected to a standard electrosurgical generator and a vacuum source in order to operate according to its intended use. The shaft can be rotated 360 degrees using a knob on the handpiece.
The probes are available in the following tip configurations:
- Spatula Tip
- L-Hook Tip
- Needle Tip
Here's a breakdown of the acceptance criteria and study information for the Epix Electrosurgical Probe with Smoke Evacuation, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criterion | Reported Device Performance |
|---|---|---|
| Safety Standards Adherence | IEC 60601-1: General requirements for safety of medical electrical equipment. | Designed/evaluated to meet this standard. |
| IEC 60601-1-2: Electromagnetic compatibility requirements and tests. | Designed/evaluated to meet this standard. | |
| IEC 60601-2-2: Particular requirements for basic safety and essential performance of high-frequency surgical equipment. | Designed/evaluated to meet this standard. | |
| ISO 10993: Biological Evaluation of Medical Devices. | Designed/evaluated to meet this standard. | |
| Functional Performance (Electrosurgery) | Thermal spread during electrosurgical cutting and coagulation should be similar to predicate and reference devices. | Thermal spread was found to be similar between the subject device (Epix Electrosurgical Probe), the predicate (Microline™ Electrosurgical Cautery Probes K981188), and the reference device (Applied Medical Epix Electrosurgical S/I Probes K132300). This was tested across high, medium, and low settings on a monopolar generator. |
| Functional Performance (Smoke Evacuation) | Aspiration flow rate (for smoke evacuation) should be comparable to a reference device. | Aspiration flow rate (smoke evacuation feature) comparison testing showed the subject device was comparable to the reference device (Applied Medical Suction/Irrigator cleared in K003443). |
| Substantial Equivalence | Overall safety and effectiveness should be substantially equivalent to the predicate device. | The device was found to be substantially equivalent in safety and effectiveness to the Microline™ Electrosurgical Cautery Probes (K981188), with the additional capability of removing smoke from the operative site. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a numerical sample size for the test set used in the performance testing. However, it indicates:
- Sample Size: "Testing was performed in vitro using tissue that is representative of what the device may encounter during general laparoscopic procedures." This implies the use of a sufficient amount of tissue samples to conduct the comparison testing across various electrosurgical settings. Specific numbers of tissue samples are not provided.
- Data Provenance: The testing was "in vitro." The document does not specify a country of origin for the data beyond that it was performed in vitro. It is a retrospective study in the sense that it's a submission for a pre-market notification, relying on data collected for this purpose, not a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish a "ground truth" for the performance testing. The comparison was based on objective measurements of thermal spread and aspiration flow rate against established predicate and reference device performance.
4. Adjudication Method for the Test Set
Not applicable. The testing was objective performance testing (thermal spread, aspiration flow rate) and comparison against predicate/reference devices, not a diagnostic or interpretive task requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document describes in-vitro performance testing comparing the new device to existing predicate and reference devices. It does not describe a MRMC comparative effectiveness study involving human readers or assessing improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The performance testing described is standalone in that it evaluates the physical device's performance characteristics (thermal spread, smoke aspiration) directly, without human interpretation in a diagnostic context. It's not an "algorithm" in the AI sense, but the device's functional performance was assessed on its own merits and in comparison to other devices.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing was:
- Measured physical properties: Direct measurements of thermal spread in tissue and aspiration flow rate.
- Comparison to established predicate/reference performance: The performance of the predicate (Microline™ Electrosurgical Cautery Probes K981188) and reference devices (Applied Medical Suction/Irrigator K003443 and Applied Medical Epix Electrosurgical S/I Probes K132300) served as the benchmark for "truth." The claim is that the subject device performs similarly or comparably to these legally marketed devices.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set. It is a physical electrosurgical probe.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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