(30 days)
The OPTRELL™ Mapping Catheter with TRUEref™ Technology is indicated for multiple electrophysiological mapping of cardiac structures in the heart, i.e., recording or simulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The cather provides location information only when used with a compatible version of the CARTO™ 3 System.
The OPTRELL™ Mapping Catheter with TRUEref™ Technology has been designed to facilitate electrophysiological mapping of the heart with the CARTO™ 3 System. The OPTRELL™ Mapping Catheter with TRUEref™ Technology is deployed in the heart through an 8.5 F guiding sheath. This bi-directional deflectable catheter includes six (6) parallel 2 Fr spines that are joined to form three (3) loops on the deflectable tip. Each spine has six (6) platinum electrodes that are used for stimulating and recording. The electrodes form a 6 by 6 (6x6) grid. A magnetic location sensor embedded in the deflectable tip transmits location information to the CARTO™ 3 EP Navigation System. Below the spines on the deflectable tip are three (3) electrodes that allow visualization of the tip on the CARTO™ 3 System. The TRUEref™ Electrode, which is embedded in the distal end of the irrigation lumen, can be used as an internal close unipolar reference electrode within the heart chamber. Rotating the catheter's Rocker Lever clockwise or counterclockwise deflects the tip; rotating the Rocker Lever to the neutral position straightens the tip. The catheter includes an irrigation lumen for connection to a source of continuous drip anticoagulant fluid. Lastly, the proposed catheter is offered in the same deflectable curve offerings as the predicate.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.
Important Note: The provided FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on proving de novo clinical effectiveness against a set of performance metrics as one might see for a completely novel device or an AI/ML product where clinical performance (e.g., accuracy, sensitivity, specificity) is a key outcome. This 510(k) is for a physical medical device (mapping catheter). Therefore, the "acceptance criteria" and "study" described herein are primarily related to bench and animal testing to show that the modified device performs similarly to its predicate and doesn't raise new safety or effectiveness concerns.
Given the nature of the device and the submission type, there is no mention of AI/ML or human reader studies (MRMC). The "metrics" are mechanical, electrical, and physiological performance in a simulated environment or animal model, not diagnostic accuracy based on human interpretation.
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Integrity | Passed all intended criteria |
| Deflection | Passed all intended criteria |
| Device Functionality | Passed all intended criteria |
| Simulated Use | Passed all intended criteria |
| Electrical Properties | Passed all intended criteria |
| Visualization | Passed all intended criteria |
| Shelf Life | Passed all intended criteria |
| Device Maneuverability | Passed all intended criteria |
| Signal Quality | Passed all intended criteria |
| Safety (Animal Testing) | Demonstrated safety equivalent to predicate |
| Effectiveness (Animal Testing) | Demonstrated effectiveness equivalent to predicate |
Study Details (Bench and Animal Testing)
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Sample Size and Data Provenance:
- Test Set Sample Size: Not explicitly stated numerically. The document states "Testing included mechanical integrity, deflection, device functionality, simulated use, electrical properties, visualization, shelf life, device maneuverability and signal quality, and animal testing". This implies a series of tests, each likely with its own sample size of devices or animal subjects, sufficient to meet engineering and GLP (Good Laboratory Practice) standards.
- Data Provenance: The studies were conducted by Biosense Webster, Inc. (the manufacturer). The animal testing would be prospective. Location of testing is not specified beyond the manufacturer's address in Irvine, California, and a manufacturing site in Juarez, Mexico.
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Number of Experts and Qualifications for Ground Truth:
- This type of submission for a physical device, especially for bench and animal testing, typically relies on objective measurements, engineering specifications, and established biological responses in animal models. There's no indication of human "experts" establishing a subjective "ground truth" for classification or diagnosis as there would be for an AI diagnostic device. The "ground truth" for mechanical and electrical properties is typically defined by the device's design specifications and accepted industry standards, while for animal studies, it would be physiological responses evaluated by qualified veterinarians/scientists.
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Adjudication Method for the Test Set:
- Not applicable in the context of bench and animal testing metrics. The results would be objectively measured and compared against defined thresholds or the predicate device's performance.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. This device is a mapping catheter, not an AI/ML diagnostic tool that assists human readers in interpretation. The study evaluates the physical and electrical performance of the catheter itself.
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Standalone Performance Study (Algorithm Only):
- Not applicable. This device does not contain a standalone algorithm. Its function is to obtain electrograms, which are then used by the CARTO™ 3 System. The "performance" described is of the catheter's ability to achieve its physical and electrical functions, not an algorithm's diagnostic performance.
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Type of Ground Truth Used:
- Engineering Specifications/Bench Standards: For mechanical integrity, deflection, electrical properties, etc., the ground truth would be defined by pre-determined engineering specifications, design requirements, and established industry standards.
- Physiological/Biological Outcomes (in Animal Model): For animal testing, the ground truth relates to the physiological responses within the animal model, observed and measured by qualified personnel, demonstrating the device's intended function (obtaining electrograms) and safety (e.g., lack of adverse tissue reactions).
- Predicate Device Performance: A key aspect of this 510(k) is demonstrating that the modified device performs "as well as or better than" the predicate device in these tests, making the predicate's established performance a de facto "ground truth" for comparison.
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Sample Size for the Training Set:
- Not applicable. This device is a physical medical instrument, not a machine learning model. Therefore, there is no "training set" in the computational sense. The design and development of the device would rely on engineering principles, material science, and prior knowledge from the predicate device, not machine learning training data.
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How Ground Truth for the Training Set was Established:
- Not applicable. As there is no training set for a machine learning model, this question does not apply.
§ 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).