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Introcan Safety® IV Catheter is a passive anti-needle stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system. The catheters may be used with power injectors at a maximum pressure of 325 psi with a luer lock connection only.

The Introcan Safety® IV Catheter is a passive needle stick prevention device used for arterial and venous access for the infusion of fluids, drugs and/or blood components or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system. The catheters may be used with power injectors for which the maximum pressure setting is 325 psi. The Introcan Safety IV Catheter is available in 14 - 24 gauge sizes, and both winged and non-winged versions and consists of an over-the-needle, peripheral intravascular catheter made of radiopaque polyurethane, and a passive safety needle-shielding mechanism.

The passive safety needle-shielding mechanism of the Introcan Safety® IV Catheter is located inside the catheter hub. Upon withdrawal of the needle, the safety shield engages as the needle passes through the catheter hub and deploys automatically to shield the needle tip. The safety shield protects during disposal, aiding in the prevention of needlestick injuries. Once the safety shield engages and shields the needle tip, the user is unable to re-insert the needle which aids in the prevention of catheter shearing.

This device may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. The catheters may be used with power injectors with a maximum pressure setting is 325 psi with a luer lock connection only.

This document is a 510(k) summary for the Introcan Safety® IV Catheter from B. Braun Medical Inc. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission focuses on comparing the new device's characteristics and performance to an existing one, rather than presenting a study of the device's independent performance against predefined acceptance criteria for AI or a detailed clinical study with human readers.

Therefore, the requested information cannot be fully extracted or is not applicable in this context. Here's why and what information can be provided:

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

This document does not refer to "acceptance criteria" in the sense of performance metrics for an AI device (e.g., accuracy, sensitivity, specificity, AUC). Instead, it focuses on demonstrating that the proposed device performs comparably to its predicate device, particularly regarding "power injection capabilities" and "flow rate."

The relevant performance information is for the power injection capabilities and gravity flow rate, presented as a comparison:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: The document refers to "bench testing" but does not specify the sample size (number of catheters tested). It mentions testing for "flowrate and device pressure per ISO 10555-1 Section 4.10 9 AnnexG" and "burst pressure under static conditions per ISO 10555-1 Section 4.10 Annex F." The number of units needed to demonstrate equivalence per these standards would be part of the full submission, but not typically detailed in the public 510(k) summary.
• Data Provenance: This is not applicable in the typical sense of AI algorithm evaluation (country of origin, retrospective/prospective). The data comes from bench testing of the physical medical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable. This is a physical medical device (IV catheter), not an AI/imaging device requiring expert interpretation for ground truth establishment. The performance is assessed via engineering bench tests against industry standards (ISO).

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

This is not applicable. There is no human interpretation of data for ground truth establishment as it's a physical device being tested via engineering methods.

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:

This is not applicable. This is not an AI-powered diagnostic device; it's an IV catheter. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

This is not applicable. This is not an algorithm, but a physical medical device. Performance is measured through bench testing of the device itself.

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

The "ground truth" for the device's performance here is defined by standard engineering test methods (ISO 10555-1), which dictate how concepts like "flow rate" and "burst pressure" are measured objectively and quantitatively.

8. The sample size for the training set:

This is not applicable. This is a manufactured physical device, not a machine learning model that requires a training set.

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

This is not applicable for the same reason as point 8.

Summary of what the document focuses on:

The document focuses on demonstrating substantial equivalence of the Introcan Safety® IV Catheter to its predicate device (K020785 and K021094). The key "differences" and how they were addressed are:

• Increased Power Injection Pressure: The proposed device is capable of handling a maximum pressure of 325 psi, an increase from the predicate's 300 psi for certain gauges. This extended capability was supported by bench testing (Power Injection test for flowrate and device pressure per ISO 10555-1).
• Combined Indications for Use: The new 510(k) combines indications for use across the product family, which doesn't alter the device's fundamental performance but rather its labeling and marketing scope.
• e-IFU: The Instructions for Use were revised to align with other Introcan products and to utilize an electronic format.

The conclusion states that "Results of the testing conducted on the proposed devices demonstrate that the Introcan Safety® IV Catheters are substantially equivalent to the predicate device and are as safe and effective as the predicate device." This indicates that the bench testing results met the necessary criteria to show comparable safety and effectiveness, allowing for the 510(k) clearance despite the slight change in power injection capability.

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