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The Biosense Webster CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath is indicated for introducing various cardiovascular catheters into the heart, including the left side of the interatrial septum.

The sheath curve can be visualized when used with compatible CARTO® 3 EP Navigation Systems.

The CARTO VIZIGO™ 8.5F Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, and fluid infusion. A handle equipped with a rotating collar to deflect the tip clockwise

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each bench test. For the preclinical study:

• Sample Size: Not explicitly stated as a number, but refers to "one Test or one Control sheath in the animal." This suggests a comparative animal study.
• Data Provenance: Pre-clinical testing performed "under simulated clinical conditions" and "in the animal." This indicates an animal study, which is often considered prospective in nature. The country of origin is not specified.

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

• The document does not provide information on the number of experts or their qualifications for establishing ground truth for either the bench tests or the pre-clinical study. The "Pass" results for bench tests imply internal testing against predetermined specifications, while the pre-clinical study endpoints would typically be assessed by veterinary or medical professionals, but this is not detailed here.

4. Adjudication Method for the Test Set

• The document does not specify an adjudication method. For bench tests, it's likely a pass/fail against internal criteria. For the pre-clinical study, the endpoints imply an assessment by the study investigators.

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

• No, an MRMC comparative effectiveness study was not conducted or described. The device is a guiding sheath, not an imaging analysis algorithm that would typically involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Not applicable. This device is a physical medical instrument (a guiding sheath), not an algorithm or AI system. While it has "visualization capabilities" with a compatible navigation system (CARTO® 3 EP Navigation System), the performance data presented focuses on the physical sheath itself rather than the performance of an independent algorithm for interpretation.

7. The Type of Ground Truth Used

• For Bench Tests: The ground truth is implied to be predefined engineering specifications and performance criteria. Each test has a "Pass" result, indicating it met these criteria.
• For Pre-Clinical Study: The ground truth for safety and performance refers to direct observation of the animal model for damage, leakage, thrombus, and tissue injury during and after the procedure. This could be considered outcomes data or direct observational data from a controlled biological setting.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.

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

• Not applicable, as there is no training set for this device.

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The LASSO® NAV Duo Loop eco 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® NAV Duo Loop 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 3.2.)

The LASSO*NAV Duo Loop eco Catheter has been designed to facilitate electrophysiological mapping of the atria of the heart with the CARTO® 3 EP Navigation System and a reference device. The catheter is deployed in the right or left atrium through an 8F guiding sheath. The bi-directional catheter 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 create a bi-directional fixed multi-loop high density circular diagnostic catheter for recording intracardiac signals and cardiac stimulation. The modifications consist of changing from a single variable loop to a fixed spiral loop, including an insertion tool with atraumatic tip to the catheter, and incorporating a bi-directional deflection in two directions) feature to the distal end of the catheter. The new catheter will retain the extended barrel ("pig tail") connector and will connect to the system cable by way of an accessory cable.

The LASSO® NAV Duo Loop eco Catheter features a fixed spiral loop design available in two diameters, 20mm diameter and 25mm diameter. Each catheter with 20 electrodes spaced along its multiple loops in a uni-polar configuration for the 20mm and either a uni-polar or bi-polar configuration for the 25mm.

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

The provided text describes a medical device, the LASSO® NAV Duo Loop eco Catheter, and its 510(k) summary (K130602). It focuses on demonstrating substantial equivalence to predicate devices for electrophysiological mapping.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

• Three times ethylene oxide (EtO) sterilization
• Thermal cycling
• Accelerated aging (equivalent to one year real-time)
• Simulated transportation conditions |
  | Compatibility with CARTO® 3 EP Navigation System | The proposed catheter was tested with the CARTO® 3 EP Navigation System (Version 3.2 or later) to demonstrate compatibility. |
  | Substantial Equivalence | Concluded that minor differences in design and use between the predicate device and the LASSO® NAV Duo Loop eco Catheter do not compromise safety and efficacy. Device is at least as safe and effective as legally marketed predicate devices. |
  | Technological Comparison | The technological comparison demonstrated safety and effectiveness for anatomic mapping of the heart and established equivalence. |

2. Sample size used for the test set and the data provenance

The document does not specify a sample size for a "test set" in the context of a clinical study involving patients or human data. The testing described primarily involves engineering and animal studies:

• Bench Testing: Performed on the device itself.
• Biocompatibility Testing: Likely performed on device materials or extracted components, not on human patients as a "test set."
• GLP Animal Study: Involves animal subjects, not human patients. The number of animals is not specified, nor is the country of origin of the study.
• System Level Testing: Involves the device interacting with the CARTO® 3 EP Navigation System.

The data provenance is primarily from non-clinical studies (bench, animal) conducted by the manufacturer, Biosense Webster, Inc. The country of origin of the data is not explicitly stated beyond the applicant's address in Diamond Bar, CA, USA. All this data is retrospective in the sense that it was generated prior to the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The document describes technical, biocompatibility, and animal studies, not studies where human experts establish ground truth for a diagnostic AI/algorithm's performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. Adjudication methods are typically relevant for clinical studies involving interpretation of data by multiple human experts, which is not described here.

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

No, a multi-reader, multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done or at least not reported in this document. The device is a physical catheter for electrophysiological mapping, not an AI-driven diagnostic software, and the testing focuses on its safety and physical performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is a physical catheter, not an algorithm. Therefore, no standalone algorithm-only performance study was conducted or reported.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Given the nature of the device (a catheter for electrical signal recording and stimulation), the "ground truth" for its performance validation is inherently different from that of a diagnostic algorithm.

• For Bench Testing, the ground truth would be engineering specifications and standards (e.g., integrity, electrical conductivity, mechanical properties).
• For Biocompatibility Testing, the ground truth is established by ISO standards and tests for material safety in biological environments.
• For the GLP Animal Study, the ground truth would be the physiological responses measured in the animals using established scientific methods, to confirm the catheter's ability to record signals and its safety in a living system.

8. The sample size for the training set

This information is not applicable as the device is a physical catheter, not a machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established

This information is not applicable as the device is a physical catheter and does not involve a training set.

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