Search Results

The Percu-Pro™ Steerable Introducer is intended to be used for the introduction of various cardiovascular catheters into the heart, including the left side of the heart through the inter-atrial septum.

The Cardiosolutions Percu-Pro™ Steerable Introducer is provided as a 9Fr and 14Fr Introducer. The set also consists of a dilator (14Fr only), stylet, and tear-away introducer sheath. The steerable introducer is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer provides both proximal tip and distal tip steering and is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The introducer sheath is reinforced Pebax and the distal tip has a radiopaque marker to improve fluoroscopic visualization. The device is provided in 65 cm working lengths. The device is provided sterile and is intended for single use only. The purpose of this submission is to add an additional device diameter; 9Fr has 65 cm working lengths.

This is a 510(k) premarket notification for a medical device, not a study evaluating an AI algorithm. Therefore, many of the requested categories are not applicable.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

• Visual Surface Inspection
• Dimensional Verification
• Corrosion Resistance
• Tensile Break Force
• Tip Separation Force
• Freedom from Leakage Under Pressure
• Air Leakage During Aspiration
• Luer Hub Compliance
• Flexural Fatigue Tolerance
• In Vitro Simulated Use Studies
• Functional Performance Testing
• Radiopacity | "All test results demonstrate that the properties and performance of the device are suitable for its intended use." (Specific quantitative results are not provided in this summary.) |
  | Material/Biocompatibility | New device materials should be biocompatible or identical to predicate device materials. | "The materials used in the 9Fr Percu-Pro™ Steerable Introducer are identical to the 14Fr Percu-Pro™ Steerable Introducer predicate device. No additional biocompatibility is required." |
  | Shelf Life | The device should maintain its properties and performance over its intended shelf life. | Shelf life testing was completed (specific results not provided). |
  | Substantial Equivalence | The device must be substantially equivalent to the predicate device in terms of intended use, design, materials, technology, and function, with no new issues of safety or effectiveness. | "The 9Fr Percu-Pro™ Steerable Introducer is substantially equivalent to the predicate devices in terms of intended use, design, materials, technology, and function. There are no differences between devices which would raise new issues of safety or effectiveness." |

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

The document does not provide specific sample sizes for each mechanical and functional test. It generally states that "Design verification testing performed on the 9Fr device consisted of mechanical testing conducted in accordance with..."

• Sample Size: Not explicitly stated as a number of devices/units. The testing generally applies to the 9Fr device.
• Data Provenance: Not applicable in the context of clinical data for AI. These are engineering/device performance tests.

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

Not applicable. This is a device performance evaluation, not an AI study requiring expert ground truth for classification.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, this is not an MRMC study.

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

Not applicable. This device is a medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" here is adherence to established engineering standards (ISO 10555) and FDA guidance for the performance of intravascular catheters. For material equivalence, the ground truth is the chemical composition of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm.

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

Not applicable. This is not an AI algorithm.

Ask a specific question about this device