(28 days)
The EPi-Sense Guided Coagulation System with VisiTrax is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, and laparoscopic surgical techniques.
The EPi-Sense Guided Coagulation System with VisiTrax may be used for temporary cardiac signal sensing and recording during surgery when connected to an external recording device.
The EPi-Sense Guided Coagulation System flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical RF Generator (nonsterile, re-useable) connected through an Instrument Cable (sterile). The device is designed to produce local tissue heating which results in coagulation of cardiac tissue. A temporary sensing electrode feature may be used with an off-the-shelf electrogram recording system with the use of an additional instrument cable (non-sterile).
The Subtle Cannula is a sterile, single-use access tool used to introduce the EPi-Sense probe into the chest cavity. The cannula is a 30 cm or 40 cm long device with a large central lumen to accommodate both the EPi-Sense probe and a commercially available laparoscope for visualization. The cannula is comprised of a distal tip, a shaft with a textured grip at the proximal end, a vacuum line and an integrated quidewire.
The Sensing Cable is a reusable, non-sterile cable that provides connection for the sensing electrodes of the EPi-Sense probe to a commercially available external electrogram recording system.
The Subtle Cannula and Sensing Cable are accessories to the EPi-Sense Guided Coagulation System.
Here's an analysis of the provided text regarding the acceptance criteria and study for the EPi-Sense Guided Coagulation System with VisiTrax:
Summary of Device and Changes:
The device in question is the EPi-Sense Guided Coagulation System with VisiTrax. The submission (K193162) is for modifications to two accessories: the Sensing Cable and the Subtle Cannula. The core EPi-Sense system itself (and its intended use) remains unchanged from its previously cleared version (K142084).
Acceptance Criteria and Device Performance (Based on the provided text):
The document states that the modified devices met "the new and existing predetermined acceptance criteria." However, it does not explicitly list the specific acceptance criteria or the reported device performance metrics in a quantitative manner. Instead, it refers to general categories of testing and compliance.
Since specific criteria and metrics are not provided in the text, a table can only indicate the categories of testing performed and the general outcome.
| Acceptance Criteria Category | Reported Device Performance (General Statement) |
|---|---|
| Mechanical Performance | Demonstrated equivalency to predicate device. |
| System Compatibility | Demonstrated equivalency to predicate device. |
| Compliance to IEC 60601-2-2 | Was met. |
| Safety and Effectiveness | No new issues raised. |
| Conformance to Design Controls and Specifications | Verified. |
Detailed Study Information:
Based on the provided text, the study conducted was a design verification and validation testing for modifications made to existing accessories (Sensing Cable and Subtle Cannula) of a previously cleared device. It was not a standalone performance study of the entire system or a multi-reader, multi-case comparative effectiveness study.
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Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "Mechanical design verification testing" but does not quantify the number of units or tests performed.
- Data Provenance: The study was internal, conducted "per AtriCure's Quality System." There is no mention of country of origin for data or whether it was retrospective or prospective in the sense of patient data. This appears to be engineering verification testing rather than clinical study data.
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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. This was a technical design verification study, not a clinical study involving expert interpretation of data or images. Ground truth, in this context, would be engineering specifications and standards, not clinical consensus.
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Adjudication method for the test set:
- Not applicable for this type of technical verification testing.
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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:
- No. The document explicitly states, "No changes were made in operating principle, or specifications of performance" for the core device. The testing focused on demonstrating that the modifications to the accessories did not negatively impact mechanical performance or system compatibility, and that the device still complied with a relevant electrical safety standard (IEC 60601-2-2). There is no mention of AI, human readers, or clinical effectiveness studies in this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in the sense that the testing was focused on the components themselves, independent of direct clinical human-in-the-loop interaction for performance evaluation. However, it's not an "algorithm-only" study as the device is a physical electrosurgical system, not a software algorithm in the typical sense of AI/ML. The "standalone" here refers to the device being tested against specifications.
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The type of ground truth used:
- Engineering specifications, design controls, and recognized standards (e.g., IEC 60601-2-2). The goal was to demonstrate conformance to these predefined technical requirements and equivalency to the previously cleared predicate device's mechanical and system compatibility characteristics.
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The sample size for the training set:
- Not applicable. This was design verification for hardware modifications, not an AI/ML model for which a "training set" would typically be used.
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How the ground truth for the training set was established:
- Not applicable, as there was no training set in the context of an AI/ML algorithm.
§ 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.