Search Results

The St. Jude Medical CPS Direct™ Universal slittable outer guide catheter is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical devices (including implantable left heart leads and delivery tools), and support of fluids where minimizing blood loss is essential. In addition, CPS Direct Universal slittable outer guide catheters can work with inner catheters as a system

The CPS Direct™ Universal slittable outer catheter facilitates left heart lead delivery during cardiac resynchronization therapy (CRT) procedures. The CPS Direct Universal provides access to the coronary venous system and acts as a conduit for contrast medium. The CPS Direct TM Universal slittable outer catheters will be available in the same working lengths, 47 and 54 cm as the predicate and will be available with the same number of curves as the predicate. The key design features of the CPS Direct™ Universal slittable outer catheters have only undergone minimal changes to the inner diameter, outer diameter, and design of shaft and hub to accommodate change in diameter of the catheter and the accessories have not changed (See Section 9). The key design features are listed below:

• Braid reinforced, varying durometer PEBAX shaft with molded proximal . hub.
• Atraumatic distal soft tip. .
• The outside surface and inside surfaces of the catheter shaft are coated . with Siloxane to provide lubricity during use.
• The distal end of the shaft has gold marker bands and tungsten stripes for . fluoroscopic visibility.
• Hub contains a sideport with extension tubing for contrast delivery, . aspiration, or saline flush using a 3-way stopcock.
• Accessories such as VBT used to assist the insertion of SJM Devices . (leads, guidewires, inner catheters, etc)

This document is a 510(k) summary for a medical device called the "CPS Direct™ Universal slittable outer catheter". The purpose of this submission is to gain clearance for this device, which has undergone only minimal design changes compared to its predicate device, the CPS Direct® SLII slittable outer catheter (K092075).

Here's the information extracted from the provided text, formatted as requested:

Acceptance Criteria and Device Performance

This 510(k) pertains to a medical device (catheter) and does not include acceptance criteria or reported device performance in the form of metrics like sensitivity, specificity, or AUC, as would be common for AI/ML-driven diagnostic devices. Instead, the acceptance criteria are implicit in meeting design and performance specifications to demonstrate substantial equivalence to a predicate device.

The "reported device performance" section of the 510(k) states that:

1. A table of acceptance criteria and the reported device performance:

As indicated above, the acceptance criteria for this type of medical device clearance are primarily related to proving substantial equivalence to a predicate device through verification and validation activities, rather than specific performance metrics (e.g., accuracy, sensitivity) typically seen with AI/ML systems.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The provided text does not specify sample sizes for test sets, data provenance, or whether the study was retrospective or prospective. The document mentions "verification and validation activities" and "non-clinical test summary," implying engineering and bench-top testing rather than clinical study data with human subjects or retrospective/prospective data from a specific origin.

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):

The provided text does not mention the use of experts to establish 'ground truth' in the context of diagnostic performance, as this is a medical device clearance for a catheter based on substantial equivalence and engineering testing, not an AI/ML diagnostic system.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

The provided text does not mention any adjudication methods. This concept is not applicable to the type of device and clearance described.

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:

The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human reader performance or AI assistance. This is not an AI/ML-driven device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The provided text does not describe an algorithm-only standalone performance study. This is a hardware medical device (catheter) and the concept of an "algorithm" or "human-in-the-loop" is not relevant here.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

For this type of device, "ground truth" would equate to the established engineering specifications, material properties, and functional requirements verified through testing. The document does not specify a type of ground truth like expert consensus or pathology, but rather implies that the predicate device's established performance and the new device's adherence to its own specifications through "verification and validation activities" serve as the basis for claiming equivalence.

8. The sample size for the training set:

The provided text does not mention a "training set" sample size. This information is relevant for AI/ML models, not for this type of medical catheter clearance.

9. How the ground truth for the training set was established:

The provided text does not discuss a "training set" or how its ground truth was established, as it is not an AI/ML device.

Ask a specific question about this device