(26 days)
The St. Jude Medical electrophysiology catheters can be used in the evaluation of a variety of cardiac arrhythmias.
The Evaluator™ Electrophysiology Catheter is a fixed-curve, electrode recording catheter with ring electrodes that are electrically coupled to conductor wires to pace the heart and sense and record bipolar intracardiac electrograms.
The provided text is a 510(k) Pre-Market Notification for the Evaluator™ Electrophysiology Catheter. This type of submission is for demonstrating "substantial equivalence" to a predicate device, rather than proving performance against specific acceptance criteria in the way a de novo or PMA submission might.
Therefore, the document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding test sets, expert involvement, or training data typically associated with performance studies.
Instead, the core of this submission is the comparison of technological characteristics to a legally marketed predicate device.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance:
- No explicit acceptance criteria or reported device performance are provided in the document. The submission relies on demonstrating substantial equivalence to a predicate device.
- The document states: "All technological characteristics of the Evaluator™ Electrophysiology Catheters are substantially equivalent to the predicate device including product design, sterilization, and labeling." This is the primary claim, but no quantitative or qualitative performance metrics are given.
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission does not describe a performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method for the test set:
- Not applicable. No test set or adjudication method is described.
5. 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. This device is an electrophysiology catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is an electrophysiology catheter, not an algorithm.
7. The type of ground truth used:
- Not applicable. No ground truth from a performance study is mentioned. The "ground truth" in a 510(k) for substantial equivalence is the predicate device's established safety and effectiveness.
8. The sample size for the training set:
- Not applicable. This submission does not describe a training set for a performance algorithm.
9. How the ground truth for the training set was established:
- Not applicable. No training set or ground truth establishment is described.
Summary of the 510(k) Submission Approach:
The St. Jude Medical, Daig Division's submission for the Evaluator™ Electrophysiology Catheter (K011766) is based on demonstrating substantial equivalence to their own predicate device, the Response™ Electrophysiology Catheter. This means they are asserting that the new device has the same intended use and similar technological characteristics to a legally marketed device, and therefore does not raise new questions of safety or effectiveness.
The document explicitly states:
- Predicate Device: Response™ Electrophysiology Catheter (St. Jude Medical, Daig Division)
- Basis for Equivalence: "All technological characteristics of the Evaluator™ Electrophysiology Catheters are substantially equivalent to the predicate device including product design, sterilization, and labeling."
The FDA's response confirms that they have "determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination is the "proof" in this context, rather than a detailed performance study with specific acceptance criteria.
§ 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).