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LASSO® 2515 NAV eco Variable Catheter: The LASSO® 2515 NAV eco Variable Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart. The LASSO® 2515 NAV eco Variable Catheter provides location information when used with compatible CARTO® 3 EP Navigation Systems. (This catheter is not compatible with CARTO® 3 EP Navigation Systems prior to Version 2.3.)

LASSO® NAV eco Catheter: The LASSO® NAV eco Catheter is indicated for multiple electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart. The LASSO® NAV eco Catheter provides location information when used with compatible CARTO® 3.EP Navigation Systems. (This catheter is not compatible with CARTO® 3 EP Navigation Systems prior to Version 2.3.)

The LASSO 2515 NAV eco Variable Catheter and the LASSO NAV eco Catheter have been designed to facilitate electrophysiological mapping of the atria of the heart with the CARTO 3 EP Navigation System and a reference device. Both catheters are deployed in the right or left atrium through an 8F guiding sheath. Both deflectable catheters consists of a circular spine on the distal tip, with platinum/iridium electrodes that can be used for stimulation and recording. The purpose of this Premarket Notification is to modify the catheter connector, so that the Printed Circuit Board (PCB) can be removed from the single-use only catheter and placed in a reusable interface cable as part of the CARTO 3 EP Navigation System.

The LASSO 2515 NAV eco Variable Catheter features a Nitinol loop design that allows the expansion and contraction of the loop to custom-fit veins with different sizes, ranging from 25mm to 15mm diameter (± 15%).

The LASSO NAV eco Catheter is a fixed catheter with three fixed catheter sizes, namely 15, 20, and 25 mm loop sizes to accommodate different vein sizes. Each loop size will be available with either 10 or 20 electrodes.

The proposed catheters will continue to interface with standard recording equipment via interface cables and appropriate connectors.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain specific quantitative acceptance criteria or detailed reported device performance metrics in a tabular format as would typically be seen for a new device submission with novel claims. Instead, it focuses on demonstrating substantial equivalence to predicate devices through general safety and effectiveness.

The closest we can get to "acceptance criteria" based on this document is the overarching goal of showing the new devices are "safe and effective for anatomic mapping of the heart" and establish "equivalence... to their respective predicate devices." The performance data section broadly states:

2. Sample Size Used for the Test Set and Data Provenance

The text states that the devices underwent "Bench and Animal Testing."

• Test Set Sample Size: Not explicitly stated. The document refers to "Bench and Animal Testing" generally, without providing sample sizes for either.
• Data Provenance: Not explicitly stated. The document does not specify the country of origin for the "Bench and Animal Testing," nor does it classify them as retrospective or prospective. Animal testing is inherently prospective experimentation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: Not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The document describes "Bench and Animal Testing" to establish safety, effectiveness, and equivalence to predicate devices. There is no mention of human readers, comparative effectiveness with or without AI assistance, or effect size.

6. If a Standalone (Algorithm Only) Performance Study Was Done

• Standalone Performance Study: Not applicable. This device is an electrophysiological mapping catheter, not an AI algorithm. Its performance is intrinsically tied to its physical interaction with the heart and its interface with the CARTO 3 EP Navigation System. The "performance data" refers to the device's physical and functional characteristics, not an isolated algorithm.

7. The Type of Ground Truth Used

Based on "Bench and Animal Testing," the ground truth would likely be established through:

• Bench Testing: Engineering specifications, material properties, electrical measurements, mechanical stress tests, and functional tests against predefined criteria.
• Animal Testing: Physiological measurements (e.g., electrogram recording comparisons, navigation accuracy verification within the animal heart), histological analysis (if relevant for tissue interaction), and direct observation of device performance and integrity within a living biological system.

The document does not detail specific "ground truth" methodologies beyond these general categories.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a hardware medical device (catheter) with an updated connector design, not an AI system that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set Establishment: Not applicable, as detailed above.

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