Search Results

The LASSO® NAV Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. This catheter is designed to obtain electrograms in the atrial regions of the heart.

The LASSO® NAV Catheter provides location information when used with compatible CARTO EP Navigation Systems.

The LASSO® NAV Catheter has been designed to facilitate electrophysiological mapping of the atria of the human heart. It is deployed in the right or left atrium through an 8 Fr guiding sheath. This deflectable catheter consists of a 4.5 Fr circular spine on its distal tip with platinum/iridium electrodes that can be used for stimulation and recording. The purpose of this Premarket Notification is to add location sensors to provide location/visualization when used with CARTO Electrophysiological (EP) Navigation Systems and a reference device.

The LASSO® NAV Catheter will be manufactured in three fixed loop sizes (15, 20, and 25 mm loop diameters) designed to diagnose veins with different sizes. There will be10 or 20 ring electrodes available on each of the three loop sizes for a total of six new models.

The proposed catheter with standard recording equipment via interface cables with appropriate connectors.

The provided text does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria for the LASSO® NAV Catheter that would allow for the filling out of some sections of the request. The document is primarily a 510(k) summary for regulatory approval.

Here's what can be extracted and what information is missing:

1. A table of acceptance criteria and the reported device performance

• Comment: The document states that the catheter passed "all intended criteria," but it does not specify what those criteria are or provide any quantitative performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified. The document mentions "Bench and Animal Testing" which implies prospective data collection, but no specifics on location or type of animals are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not applicable. The document describes "Bench and Animal Testing," not a study involving human experts establishing ground truth for a diagnostic device.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable.

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

• MRMC Study: No, an MRMC study was not done. The device is a physical catheter with location sensors, not an AI or diagnostic software subject to reader performance studies.

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

• Standalone Performance: While the device has "location sensors" that provide "location information when used with compatible CARTO EP Navigation Systems," the document does not detail a standalone algorithm-only performance study. The performance described is for the catheter itself in a functional, rather than analytical, context.

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

• Type of Ground Truth: For the "Bench and Animal Testing," the ground truth would likely be established through direct observation against specified physical and functional parameters, and potentially histology/pathology in animal studies for tissue safety, but this is not explicitly stated. It's not expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic or AI study.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable. This is not a machine learning or AI device that would have a training set.

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

• Ground Truth (Training Set): Not applicable.

Ask a specific question about this device

The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The LASSO 2515 NAV Variable Catheter is designed to obtain electrograms in the atrial regions of the heart.

The LASSO 2515 NAV Variable Catheter provides location information when used with compatible Carto EP Navigation Systems version 1.0 or higher.

The LASSO 2515 NAV Variable Catheter has been designed to facilitate electrophysiological mapping of the atria of the heart with the Carto 3 Navigation System and a reference device. It is deployed in the right or left atrium through an 8F guiding sheath. This deflectable catheter consists of a 4F circular spine on its distal tip, with platinum / iridium electrodes that can be used for stimulation and recording.

The LASSO 2515 NAV 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 catheter interfaces with standard recording equipment via interface cables with the appropriate connectors.

Here's a breakdown of the acceptance criteria and the study information for the Lasso 2515 NAV Variable Catheter, based on the provided text:

Important Note: The provided 510(k) summary is for a medical device (catheter) used for electrophysiological mapping, not an AI/ML powered device. Therefore, many of the requested fields (e.g., sample size for AI test/training sets, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable to this type of traditional medical device submission. The information below focuses on what is available in the document for a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "bench and animal testing" but does not provide specific sample sizes for these tests.
• Data Provenance: Not explicitly stated. The testing was conducted by or for Biosense Webster, Inc., with manufacturing sites in the USA and Mexico. The regulatory submission is to the US FDA.

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

• N/A. This is a physical medical device; the concept of "ground truth" established by experts in the context of an algorithmic diagnostic performance is not directly applicable. Performance was likely evaluated against engineering specifications, physiological measurements, and comparison to predicate devices by qualified engineers and scientists.

4. Adjudication method for the test set

• N/A. Not applicable for this type of device and testing.

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. This is not an AI-powered device.

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

• N/A. This is not an AI-powered device.

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

• Bench and Animal Testing Results/Engineering Specifications/Predicate Device Performance Comparison. The document states: "The Lasso 2515 NAV Variable Catheter underwent bench and animal testing. The Catheter passed all intended criteria in accordance with appropriate test criteria and standards." This implies the "ground truth" was based on established engineering specifications, performance metrics validated in preclinical (bench and animal) settings, and ultimately, by demonstrating equivalence to previously cleared predicate devices.

8. The sample size for the training set

• N/A. This is not an AI/ML powered device, so there is no "training set."

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

• N/A. This is not an AI/ML powered device, so there is no "training set" or "ground truth" for it in this context.

Ask a specific question about this device