(160 days)
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
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Safety and Performance Validation | Demonstrated through Bench Testing, Biocompatibility Testing, GLP Animal Study, and System Level Testing. Passed all intended criteria. |
| Integrity and Performance (post-sterilization, aging, transport) | Catheter integrity and performance validated after: |
- 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.
§ 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).