(90 days)
A diagnostic electrophysiology catheter is used to record electrical activity from within the heart and to stimulate the heart in accordance with various programmed electrical stimulation protocols incorporated into an EP diagnostic study. All catheters connect physician stimulatorrecorder equipment to the desired region of the heart and carry analog signals. Data from the EP study is used to assess arrhythmia patient prognosis, guide therapy selection and evaluate the effectiveness of previously selected therapeutic interventions.
The Performr Series Catheter is a closed-lumen diagnostic electrophysiology catheter with a variable number of platinum alloy recording/stimulating electrodes (2-11) fixed around the catheter shaft. The most distal electrode is located at the catheter tip. The electrode bands are welded to electrical wires incorporated inside the shaft of the catheter that run from each electrical connector at the proximal end of the catheter. The outside diameter of the catheter is 5 to 7 French and the usable length ranges from 60 to 125 cm. A manipulator handle at the proximal end of the catheter permits the physician to vary the angle of curve of the catheter tips. Some models have controls in the handle to vary the radius of curvature, and the distal end of some models may be laterally deflected.
This document, a 510(k) summary for the Performr Series of Diagnostic Electrophysiology Catheters (K964272), does not contain the specific information required to complete the requested table and study description. It is focused on demonstrating substantial equivalence to predicate devices rather than providing detailed performance data from a standalone study with defined acceptance criteria and ground truth.
Here's a breakdown of why the information is not available and what is present:
Information NOT available in the provided text for the requested table and study description:
- Explicit Acceptance Criteria: The document does not define specific numerical or qualitative acceptance criteria for "device performance."
- Reported Device Performance: While it states "electrical and mechanical performance and reliability" were confirmed, it doesn't provide specific metrics (e.g., accuracy, sensitivity, specificity, or quantitative measurements for electrical/mechanical aspects).
- Sample size for the test set: Not mentioned.
- Data provenance (country of origin, retrospective/prospective): Not mentioned.
- Number of experts for ground truth: Not mentioned, as ground truth isn't explicitly discussed in the context of device performance metrics.
- Qualifications of experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
- Effect size of human readers improving with/without AI assistance: Not applicable, as this device is a diagnostic catheter, not an AI-powered diagnostic system.
- Standalone (algorithm-only) performance data: Not applicable, as this is a physical medical device, not an algorithm.
- Type of ground truth used: Not mentioned, as performance evaluation is described as "quantified and confirmed the adequacy of electrical and mechanical performance and reliability," implying engineering and physiological testing rather than diagnostic accuracy against a clinical ground truth.
- Sample size for the training set: Not applicable, as this is a physical device, not a machine learning model.
- How ground truth for the training set was established: Not applicable.
What the document does state regarding testing:
- Biocompatibility: Fulfilled via the predicate device (Medtronic CardioRhythm Marinr catheter) because materials are identical.
- Non-clinical and in-vivo testing: Conducted according to applicable FDA guidance and GLP (Good Laboratory Practice).
- Purpose of testing: "quantified and confirmed the adequacy of electrical and mechanical performance and reliability."
- Conclusion: These tests support the substantial equivalence of the Performr catheters with the predicate device.
In summary:
This 510(k) summary focuses on demonstrating that the new Performr catheter is "substantially equivalent" to existing, legally marketed predicate devices. For physical devices like this, substantial equivalence is often established by showing similar materials, design, intended use, and performance characteristics (which are often evaluated through engineering tests, biocompatibility, and sometimes limited animal or human use studies to ensure safety and functionality, rather than extensive diagnostic accuracy studies against a "ground truth" derived from expert consensus like an AI diagnostic system).
To fill out the requested table adequately, one would need a different type of document, typically a detailed study report or clinical trial results, which are not part of this 510(k) summary.
§ 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).