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The Cook Vascular VITAL-JECT Power Injectable Safety Infusion Set is intended to be used to administer solutions and medications into vascular implant ports. When used with a power Injectable vascular implant port, the Cook Vascular Safety Infusion Set is indicated for power injection of contract media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s using contrast with a maximum viscosity of 11.8cP.

In addition, to minimize the risk of accidental needle stick after use, the attached safety guard fully encapsulates the needle when manually activated during withdrawal.

The Cook Vascular VITAL-JECT Power Injectable Safety Infusion Set is intended to administer solutions and medications into vascular implant ports. In addition, to minimize the risk of accidental needle stick after use, the attached safety guard fully encapsulates the needle when manually activated during withdrawal.

When used with a power Injectable vascular implant port, the Cook Vascular Safety Infusion Set is indicated for power injection of contract media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s using contrast with a maximum viscosity of 11.8cP.

The device consists of a protector cap, female luer lock, PVC tubing, two each 4 inch tubing length, a pinch clamp, with a needle free y-site, a butterfly wing, a safety needle guard, an AISI 304 (19 ga) stainless steel needle and a needle sheath.

The components and the processes use to manufacture these solution administration sets are the same as the currently legally marketed by Command Medical, K033515 HuberPRO™ Safety Huber Infusion Set.

Cook Vascular, Inc. will label and sterilize the final product. The proposed device is manufactured exactly the same as the currently marketed device. (K033515)

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Cook Vascular VITAL-JECT™ Power Injectable Safety Infusion Set:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria with specific pass/fail thresholds for each test. Instead, it describes general conclusions about performance. The key performance aspect highlighted is the ability to withstand power injection.

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

• Sample Size for Test Set:
  • For the performance tests (Dynamic Failure Flow, Instantaneous Burst, Static Pressure, Life Cycle Power Injection Tests), a specific sample size is not explicitly stated in the provided summary.
  • For Bioburden testing, nine individual infusion sets were tested.
• Data Provenance: The data appears to be prospective testing conducted by Cook Vascular, Inc. or its contractors. The country of origin is implicitly the USA, where Cook Vascular, Inc. is based and the submission was made to the FDA.

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

• Not applicable for this type of device and study. The testing described involves engineering and microbiological performance metrics, not clinical interpretation by experts to establish a "ground truth." The ground truth is objective performance characteristics measured through laboratory testing.

4. Adjudication Method for the Test Set:

• Not applicable. This study involves objective laboratory tests with measurable outcomes, not subjective assessments requiring adjudication by multiple experts.

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. This document describes a 510(k) submission for a physical medical device (infusion set), not an AI/software-as-a-medical-device. Therefore, no MRMC study or AI-related comparative effectiveness was performed or applicable.

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

• No. As mentioned, this is not an AI/algorithm-based device.

7. The Type of Ground Truth Used:

• The "ground truth" for the performance tests (flow, pressure, burst, life cycle) are engineering specifications and physical measurements designed to assess the device's functional integrity under intended use conditions.
• The "ground truth" for sterilization tests (Bioburden, Endotoxin, EO Residuals, Sterility) are established microbiological and chemical standards for medical device sterilization.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device. The design, components, and manufacturing processes leverage those of a previously cleared predicate device (K033515 HuberPRO™ Safety Huber Infusion Set), which serves as a benchmark for substantial equivalence rather than a training set in the AI sense.

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

• Not applicable. As there is no training set, there's no ground truth established for one. The basis for safety and effectiveness is substantial equivalence to a predicate device, supported by the described physical and microbiological testing.

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