(312 days)
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.
§ 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).