(122 days)
The Luminary Cannulator™ Bideflectable Catheter with Lumen is indicated to provide a pathway for delivery and support of transvenous devices and fluids to the coronary sinus and coronary vasculature of the heart. The Luminary Cannulator™ Bideflectable Catheter with Lumen can also be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites when minimizing blood loss is essential.
The Luminary Cannulator™ Bideflectable Catheter with Lumen is designed for Cardiac Resynchronization Therapy procedures and can be used with St. Jude Medical (SJM) Catheter Delivery Systems. The Luminary Cannulator™ Bideflectable Catheter with Lumen features two deflectable curves in the catheter tip: a large curve for Coronary Sinus (CS) cannulation and a small curve for venous subselection. The large curve for cannulation comes in Large Curl and Extra Large Curl sizes for a wide range of heart failure patients, including those with enlarged atria. The small curve facilitates subselection of venous branches of the CS. The Luminary Cannulator™ Bideflectable Catheter with Lumen has an overall length of 108 cm (80 cm working length). The internal lumen of the catheter accommodates up to 0.035" guidewires. The Luminary Cannulator™M Bideflectable Catheter with Lumen has two distal platinum ring electrodes 1 mm in widths, which are spaced 10 mm apart. The bipolar electrode tip configuration provides electrical confirmation of CS access. The distal active tip is manipulated remotely by a control handle with actuator mechanism located at the proximal end of the catheter. An automatic steering lock holds the tip deflection position without the need for an extra locking mechanism. The proximal handle with deflection actuator contains a hemostasis valve system with sideport and stopcock for aspiration and fluid injection and an electrical connector for sensing of electrical activity and temporary pacing. Valve Bypass Tools, packaged with the Luminary Cannulator™ Bideflectable Catheter with Lumen, are used to direct compatible guidewires through the hemostasis valve from either direction (through the valve, or through distal tip), as well as for forceful manual injection of fluids.
The provided 510(k) summary describes a medical device, the Luminary Cannulator™ Bideflectable Catheter with Lumen, and its performance in comparison to predicate devices, but it does not include an AI-based component. The summary focuses on standard device performance testing for mechanical, functional, and biocompatibility aspects.
Therefore, many of the requested categories related to AI performance, such as sample size for test sets and training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, and AI-specific ground truth establishment, are not applicable to this document.
Here's the information that can be extracted based on the provided text, focusing on the device's acceptance criteria and the studies that demonstrate it meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench Testing (Comparison to Predicate) | Sub-selection of branches in the heart model was successful using the Luminary Cannulator™ Bideflectable Catheter in comparison to the Medtronic 7F Attain Prevail 6228 CTH Steerable Catheter System. |
| In-Vivo Study (Mechanical Performance) | Satisfactory performance in two adult canines, meeting all study objectives, including the ability to sub-select a branch off the Coronary Sinus or great cardiac vein. Analysis of vessels after the procedure showed good performance. |
| Device Integrity Testing | Met all specified design and performance requirements, including mechanical, functional, and packaging testing, supporting equivalency to predicate devices. |
| Biocompatibility | Material used demonstrated to be biocompatible in accordance with ISO 10993. |
| Sterilization Validation | Will be sterilized using existing validated Ethylene Oxide (EtO) sterilization process. |
2. Sample size used for the test set and the data provenance
- Bench Testing: The text mentions a "bench model of the human heart" for comparison testing. The sample size (e.g., number of attempts, specific models used) is not specified. Data provenance is a bench model, not from human patients.
- In-Vivo Study: "Two adult canines" were used for the in-vivo study. This represents the sample size for this specific test. Data provenance is animal (canine).
- Device Integrity, Biocompatibility, Sterilization: These are laboratory-based tests. Sample sizes for these types of tests are typically not specified in the 510(k) summary in terms of individual units, but rather the methods validated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the studies described are for the mechanical and functional performance of a physical device, not an AI algorithm requiring expert ground truth for classification or detection tasks. The performance was assessed based on physical properties and successful navigation/sub-selection.
4. Adjudication method for the test set
This is not applicable as the studies are for mechanical and functional performance, not for subjective interpretation or AI output requiring adjudication. The success criteria were likely objective functional outcomes.
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, an MRMC comparative effectiveness study was not done. The device does not involve an AI component or human interpretation in the context of "readers." The comparison was between two medical devices based on their physical performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance studies:
- Bench Testing: The "ground truth" was the physical ability to successfully sub-select branches in a heart model.
- In-Vivo Study: The "ground truth" was the successful cannulation and sub-selection of branches in an animal model, and analysis of vessels post-procedure for any damage or issues.
8. The sample size for the training set
This is not applicable as there is no AI component requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as there is no AI component requiring a training set or its associated ground truth establishment.
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).