(232 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Specified | "This catheter passed all intended criteria in accordance with appropriate standards and test criteria." |
- 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.
§ 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).