(253 days)
The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. stimulation and recording only. The catheters are designed to obtain electrograms in the atrial regions of the heart.
The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters with navigation (Nav) capabilities provide location information when used with compatible Carto® 3 EP Navigation Systems. (These catheters are not compatible with Carto® 3 EP Navigation Systems prior to version 2.3.)
The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters are designed to facilitate electrophysiological mapping of the atria of the heart. They are deployed in the right or left atrium through an 8F guiding sheath. These deflectable catheters consist of a circular spine on the distal tip with platinum/iridium electrodes that can be used for stimulation and recording.
Models designated as NAV are compatible with the Carto® 3 EP Navigation System.
The provided text is a 510(k) summary for reprocessed medical devices, specifically electrophysiology catheters. This type of FDA submission focuses on demonstrating substantial equivalence to a predicate device rather than proving novel efficacy through clinical studies of an AI algorithm. Therefore, many of the requested elements for AI device performance studies (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and details on training sets) are not applicable or extractable from this document.
The document primarily outlines non-clinical testing to ensure the reprocessed devices maintain their original functionality and safety.
Here's an attempt to answer the questions based only on the provided text, indicating when information is not present or not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of quantitative acceptance criteria with corresponding reported performance values in the way one would for an AI algorithm's diagnostic metrics. Instead, it refers to validation of functional performance, cleaning, sterilization, biocompatibility, and packaging. The "reported device performance" is a general statement that the reprocessed devices "perform as originally intended."
| Criteria Type | Description | Reported Performance (Summary) |
|---|---|---|
| Functional Performance | Bench testing through simulated use, visual inspection, fatigue testing, and function testing to ensure the device performs as originally intended. | "Performance testing shows the Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters to perform as originally intended." |
| Cleaning Validation | Validation of the cleaning procedures. | Performed and validated. |
| Sterilization Validation | Validation of the sterilization procedures (ISO 11135, USP ). | Performed and validated. |
| Biocompatibility Testing | Testing for biological compatibility (ISO 10993-1). | Performed. |
| Ethylene Oxide Residual Testing | Testing for residual ethylene oxide (ISO 10993-7). | Performed. |
| Packaging Validation | Validation of the device packaging (ASTM D 4169, ASTM F 88, ASTM F 2096). | Performed and validated. |
| Shelf Life Validation | Validation of the device shelf life (ASTM F 1980). | Performed. |
| Manufacturing Process | Includes visual and validated functional testing of 100% of products reprocessed. Device rejected from further reprocessing after maximum of one (1) reprocessing cycle. | Validated testing performed on 100% of reprocessed products. Reprocessing limited to one cycle per device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "Representative samples" but does not specify the number of samples used for any of the non-clinical tests. The tests are benchtop, laboratory-based tests of the reprocessed physical device, not clinical studies involving patient data.
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)
This information is not applicable/not provided. Ground truth in the context of expert review for AI algorithms is not relevant here. The "ground truth" for these tests would be established by validated test methods and reference standards for the physical and chemical properties of the device (e.g., sterility, material strength).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods are typically used in clinical studies or expert review for diagnostic tasks, neither of which are 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
This information is not applicable/not provided. This document describes the reprocessing of physical medical devices, not an AI algorithm. Therefore, no MRMC study or AI assistance is mentioned or relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This document describes the reprocessing of physical medical devices, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable/not provided in the context of AI studies. For the functional and safety testing of the reprocessed catheters, the "ground truth" is based on established industry standards and validated test methodologies for medical device performance, sterility, biocompatibility, and integrity.
8. The sample size for the training set
This information is not applicable/not provided. This document does not describe an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided. This document does not describe an AI algorithm that requires 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).