(203 days)
The EnSite Multi-electrode Diagnostic Catheter used with the EnSite 3000 Electrophysiology Workstation is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters).
EnSite 3000 System Components
EnSite Multi-electrode Diagnostic Catheter
The EnSite Multi-electrode Diagnostic Catheter (EnSite catheter) is a single use, 9 French, percutaneous catheter. The EnSite catheter is designed for use only with the EnSite 3000 electrophysiology laboratory and for deployment in the right atrium. The proximal end contains the patient cable electrical connector, an inflation port for the distal balloon/ braid multi-electrode array (MEA), luer port compatible with a 0.035" guidewire, and a push shaft to facilitate expansion and deployment of the MEA. The shaft is a coaxial design with a polyurethane outer sheath. At the distal end in addition to the MEA, there are three ring electrodes, one distal and two proximal mounted at specific locations to the MEA. The tip of the catheter is a pigtail shape to minimize trauma to the endocardium. Biocompatible materials are used for all blood contacting surfaces.
EnSite 3000 electrophysiology workstation
The EnSite 3000 electrophysiology workstation is a computerized storage and display system for use in electrophysiology studies of the human heart. It is designed for use in the EP laboratory with the EnSite Multielectrode Diagnostic Catheter and in conjunction with other standard equipment found in the EP laboratory. This allows for the collection , storage, and display of intracardiac electrograms. The EnSite 3000 may be used in conjunction with standard electrode mapping catheters, programmable cardiac stimulators, ECG leads and other analog inputs.
The EnSite 3000 is comprised of a display workstation consisting of a Silicon Graphics Octane processor containing proprietary software and a 21" monitor and a Patient Interface Unit which accepts the signals from the patient and from other accessories and converts them to digital signal and sends them to the display workstation for processing.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information:
Acceptance Criteria and Device Performance
The provided document, a 510(k) Summary for the EnSite 3000 System, does not explicitly list quantitative acceptance criteria in a table format with specific performance metrics. Instead, it describes a foundational approach to demonstrating substantial equivalence through various tests and comparisons.
The "reported device performance" is described qualitatively as:
- Non-clinical performance data:
- The EnSite catheter underwent "a battery of in vitro tests including tensile, torsion, inflation, deflation testing."
- Biocompatibility was confirmed "in accordance with ISO 10993."
- The EnSite 3000 was tested and conforms to "IEC 601-1 and IEC 601-2-27 international standards."
- "Device validation testing was conducted in accordance with in house procedures."
- "Animal studies were utilized to show initial catheter and system safety of the catheter."
- Clinical Data:
- "Clinical studies were conducted which demonstrate that the EnSite 3000 System is as safe and effective as EP mapping catheter systems presently marketed."
- "The results indicate that it can map complex atrial arrhythmias."
Therefore, while no specific numerical acceptance criteria are given, the overarching acceptance criterion appears to be "as safe and effective as EP mapping catheter systems presently marketed" and the ability to "map complex atrial arrhythmias."
Study Details
Here's the breakdown of the study information based on the provided text:
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A table of acceptance criteria and the reported device performance:
As noted above, no quantitative table is provided. The acceptance criterion is broadly defined as "as safe and effective as EP mapping catheter systems presently marketed" and the ability to "map complex atrial arrhythmias." -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document states "Clinical studies were conducted," but neither the specific sample size nor the data provenance (country, retrospective/prospective) is mentioned for these clinical studies. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The text only vaguely refers to "EP mapping catheter systems" for comparison. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document. -
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 MRMC study is mentioned. The device is an electrophysiology cardiac mapping system, not specifically described as an AI-assisted diagnostic tool that human readers would interact with in a 'before-and-after' scenario to measure improvement. The comparison is between the EnSite 3000 System and "EP mapping catherer systems presently marketed" in terms of safety and effectiveness, implying a direct comparison of device performance rather than human reader performance with and without AI. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The clinical studies assess the "EnSite 3000 System," which includes the hardware and proprietary software algorithms. The statement "The EnSite 3000 connected to the EnSite catheter utilizes proprietary software algorithms to reconstruct and display right atrial endocardiograms" indicates the algorithm's direct role in the device's function. The clinical studies would inherently be evaluating this standalone performance as part of the system's overall function in diagnosing arrhythmias. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
While the clinical studies demonstrate the system "can map complex atrial arrhythmias," the specific method for establishing the "ground truth" (i.e., definitive diagnosis of these arrhythmias against which the device's mapping was compared) is not detailed. It's implied that conventional EP mapping techniques or expert clinical judgment would have served as the benchmark, but this is not explicitly stated. -
The sample size for the training set:
The document describes "proprietary software algorithms" but does not mention a "training set" in the context of machine learning or AI that would typically be associated with such a term. This submission predates the widespread regulatory focus on AI/ML training data. -
How the ground truth for the training set was established:
As no training set is explicitly mentioned, this information is not provided.
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).