(186 days)
The LassoStar™ Circular Mapping Catheter is indicated for multiple electrophysiological recording and stimulation of the atrial region of the heart. The catheter is designed to obtain electrograms in the heart.
The Biosense Webster LassoStar™ Circular Mapping Catheter is a multi-electrode circular diagnostic catheter designed to facilitate electrophysiological mapping of the atria of the heart (recording and stimulation). The catheter's distal end is a circular spine with ten ring electrodes located circularly that are used for stimulation and recording within the atria. The loop is available in multiple diameters (15 mm, 20 mm and 25 mm) to achieve optimal contact in variably sized pulmonary veins. The device is provided sterile (EtO) and intended for single use.
This document is a 510(k) summary for the LassoStar™ Circular Mapping Catheter. It outlines the device's indications for use, technological characteristics, and performance data used to establish substantial equivalence to a predicate device. This is primarily a regulatory submission, not a detailed clinical study report on device performance based on specific acceptance criteria for diagnostic output.
Based on the provided text, there is no information present regarding specific acceptance criteria for diagnostic performance outcomes (e.g., sensitivity, specificity, accuracy) or a study proving the device meets such criteria in terms of diagnostic effectiveness.
The "Performance Data" section describes bench and animal testing related to the device's physical and functional integrity, not its diagnostic performance in identifying cardiac electrograms with a certain level of accuracy compared to a ground truth.
Here's a breakdown of why the requested information cannot be fully provided from this document:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: No specific performance acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity) are mentioned. The document states "similar pre-determined acceptance criteria as the predicate device" were used for bench and animal testing, which refers to physical and functional aspects like buckle force, tensile strength, impedance, etc.
- Reported Device Performance: The document generally states that "The results of the testing demonstrate the device in scope of this Premarket notification meet the product requirements." No specific quantitative performance metrics related to diagnostic accuracy are provided.
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Sample size used for the test set and the data provenance:
- No information about a "test set" for diagnostic performance is provided. The tests mentioned are for physical and functional characteristics (e.g., "Buckle force", "Tensile strength").
- There is a "GLP animal study" mentioned, but its sample size for evaluating "mapping capabilities" is not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as there is no mention of a diagnostic performance test set requiring expert ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
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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:
- Not applicable. This device is an electrophysiological catheter, not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the physical/functional tests, the "ground truth" would be engineering specifications and standards. For the animal study evaluating mapping capabilities, the "ground truth" would likely be the direct physiological recordings from the animal model, though this is not explicitly detailed.
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The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or diagnostic image analysis.
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How the ground truth for the training set was established:
- Not applicable.
Summary of available information related to performance:
The document focuses on establishing substantial equivalence to an existing predicate device (Lasso™ Deflectable Circular Mapping Catheter K002333) based on similar technology, intended use, and method of operation. The performance data presented relates to the safety and functional efficacy of the device's physical attributes, demonstrating that the design modifications (smaller outer diameter, different shaft material, no deflection) do not compromise safety or the ability to perform its intended function of "electrophysiological recording and stimulation of the atrial region of the heart" and "obtain electrograms."
Specific tests performed:
- Visual Inspections
- Electrical
- EEPROM Burn checks
- Buckle force
- Insertion
- Torque
- Tensile strength
- Impedance and resistance
- Visualization
- Packaging Sterile Barrier Gross Leak
- Transportation
- Biocompatibility
- Sterilization
- Simulated Use
- A GLP animal study to evaluate mapping capabilities (details not provided beyond its purpose).
§ 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).