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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

Study Details (Bench and Animal Testing)

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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The OPTRELL™ Mapping Catheter with TRUEref™ Technology is indicated for multiple electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation 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 is designed to facilitate electrophysiological mapping of the heart with the CARTO™ 3 System. It is designed for deployment in a heart chamber through an 8.5 Fr 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 eight (8) platinum electrodes that are used for stimulating and recording. The electrodes form a 6 by 8 (6x8) 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.

This document is a 510(k) summary for the OPTRELL™ Mapping Catheter with TRUEref™ Technology. It does not describe an AI medical device, but rather a traditional medical device (catheter). Therefore, the requested information regarding AI acceptance criteria, study details, training/test sets, expert ground truth establishment, and MRMC studies is not applicable to this document.

The document focuses on demonstrating substantial equivalence of the new device (OPTRELL™ Mapping Catheter) to a predicate device (CARTO® OCTARAY™ Mapping Catheter) based on similar technology, intended use, function, materials, and method of operation. The performance data presented refers to standard medical device testing, not AI model performance.

Key information provided in the document related to device performance and equivalence:

• Acceptance Criteria and Device Performance (General): The document states that the catheter passed all intended criteria in accordance with appropriate test criteria and standards for various performance parameters. Specific numerical acceptance criteria and reported device performance values are not detailed in this summary.
  • Testing Categories: Mechanical integrity, deflection, device functionality, simulated use, biocompatibility, electrical properties, visualization, sterilization, packaging, shelf life, device maneuverability and signal quality, and animal testing to assess device effectiveness and safety.
• Sample Size for Test Set and Data Provenance: Not applicable in the context of an AI device. The testing described includes bench, animal, and biocompatibility testing. No mention of a "test set" in the sense of an independent dataset for AI validation.
• Number of Experts and Qualifications for Ground Truth: Not applicable. Ground truth establishment as it relates to AI models is not relevant for this traditional medical device submission.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not applicable. This is not an AI-assisted device for human readers.
• Standalone Performance: Not applicable as it's not an AI algorithm.
• Type of Ground Truth: Not applicable to an AI device. For this traditional device, the "ground truth" would be established through established engineering principles, direct measurements, and animal study observations demonstrating the device's intended function and safety.
• Sample Size for Training Set: Not applicable. There is no AI model involved.
• How Ground Truth for Training Set was Established: Not applicable.

In summary, this 510(k) pertains to a hardware medical device and therefore does not contain the information typically presented for an AI/ML-based medical device.

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