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The CPS Aim™ Universal II slittable inner catheter (subselector/cannulator) is designed for intracardiac access of the coronary sinus and subselection of the venous system of the heart, and to serve as a conduit during implantation for delivery of contrast medium and Abbott Medical devices (such as guidewires and implantable left heart leads). In addition, the CPS Aim™ Universal II slittable inner catheter (subselector/cannulator) can work with outer guide catheters as a system.

The CPS Aim™ Universal II Slittable Inner Catheter (subselector/cannulator) is used to facilitate left heart lead delivery procedures. It is an introducer that is used to cannulate the coronary venous system and act as a conduit for contrast medium, implantable coronary leads, or other devices.

The CPS Aim™ Universal II Slittable Inner Catheter design is based on the currently marketed CPS Aim™ Universal Slittable Inner Catheter design and components. Three modifications were made:

1. Modified hydrophilic coating: the subject device uses a different hydrophilic coating material as compared to the currently marketed CPS Aim Universal catheters.
2. Use of a modified braid design pattern to provide improved kink resistance: the predicate device braid is a single braided wire, and the subject braid contains paired braided wires.
3. Reduction in shelf-life from three (3) years to two (2) years.

The CPS Aim™ Universal II Slittable Inner Catheter will be added as a line extension to the currently marketed family of CPS catheters. New. unique model numbers will distinguish the CPS Aim™ Universal II inner catheter models from existing CPS catheter models.

The CPS Aim™ Universal II Slittable Inner Catheters will be available in the same working lengths, 59 cm and 65 cm, as the predicate device, and will be available with the same shape of curves as the predicate device. The key design features of the CPS Aim™ Universal II Slittable Inner Catheters have only undergone a minimal change to support the coating and braid change. There is no change to the accessories, including the slitter and valve bypass tool (VBT).

The key design features CPS Aim Universal and CPS Aim Universal II Slittable Inner Catheters and their accessory, the CPS Valve Bypass Tools include:

• Braid reinforced, varying durometer PEBAX catheter shaft with molded proximal hub.
• Inner diameter of the catheter is PTFE lined.
• Atraumatic distal soft tip.
• Embedded marker band on soft tip for fluoroscopic visibility.
• Outside surface of the catheter shaft is coated with a hydrophilic coating to provide lubricity during use.
• Hub of the catheter is fitted with a retention cap and an integrated valve that provides hemostasis and facilitates contrast injection. The hub also includes a sideport assembly with 3-way stopcock.
• The catheters are available in cannulator and sub-selector models.
• Accessories such as valve bypass tool (VBT) used to assist the insertion of Abbott Medical devices (leads, guidewires, inner catheters, etc.).

Similar to the existing CPS catheters, the CPS Aim™ Universal II Slittable Inner Catheters are supplied sterile (via ethylene oxide) in one package and are intended for single procedure.

There is no change in accessory product or process for the different models as a result of this line extension. The proposed indications for use is consistent with the cleared indications.

Based on the provided text, the device in question is a medical catheter, the CPS Aim™ Universal II Slittable Inner Catheter. The document describes a 510(k) premarket notification for this device, claiming substantial equivalence to a predicate device (CPS Aim™ Universal Slittable Inner Catheter, K130252). This type of submission generally focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving novel clinical efficacy. Therefore, the information provided primarily pertains to design verification and biocompatibility testing against established standards and the predicate device.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantified acceptance criteria for each test and then present the specific performance numbers. Instead, it states that "performance testing demonstrated that the CPS Aim™ Universal II Slittable Inner Catheter performs in a substantially equivalent manner to the currently marketed predicate device" and that the device "meets its design specifications and is as safe and effective as the predicate devices."

However, it does list the types of tests conducted, which imply the areas where performance was assessed:

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not specify the sample sizes (number of units or batches) used for each individual test (biocompatibility, design verification, shelf-life). It also does not mention the country of origin of the data or whether it was retrospective or prospective, as these types of studies typically involve laboratory bench testing and animal model testing (where applicable for biocompatibility).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information, relating to expert consensus or clinical adjudication for establishing ground truth, is not applicable or provided in this 510(k) summary. The studies described are bench tests and biocompatibility tests, not clinical performance evaluations that would require human expert interpretation of device output.

4. Adjudication Method for the Test Set

Not applicable for the types of tests described (bench and biocompatibility testing).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through bench and biocompatibility testing, not on comparative clinical effectiveness with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is a physical medical catheter, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable.

7. The Type of Ground Truth Used

For biocompatibility testing, the "ground truth" is adherence to established biological safety standards (ISO 10993-1, FDA GLP 21 CFR 58), and for specific tests, it would be the absence of toxic reactions, irritation, etc., as measured by standardized assays. For design verification, the "ground truth" is adherence to predefined engineering specifications and functional requirements. For shelf-life, it's the maintenance of performance characteristics over the specified period.

8. The Sample Size for the Training Set

This device is not an AI algorithm, and therefore there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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