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Introcan Safety® 3 Closed Intravascular Catheter is inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure or administer fluids and blood intravascularly.

The 18-24-gauge catheters may be used with power injectors at a maximum pressure of 300 psi with luer lock connection only.

The Introcan Safety® 3 Closed IV Catheter consists of an over-the-needle, peripheral intravascular catheter made of radiopaque polyurethane, an integrated bidirectional septum, a stabilization platform, and a passive safety needle-shielding mechanism.

Introcan Safety® 3 design is a closed IV catheter since it protects clinicians and patients from blood exposure. Since the needle is withdrawn through a septum that seals after the needle has been removed, blood is thus contained within the Introcan Safety® 3 device. The pressure exerted on the needle as it passes through the septum wipes blood from the needle further reducing potential blood exposure.

The Introcan Safety® 3 catheter has an integrated stabilization platform is designed to improve catheter stability while minimizing catheter movement within the vessel. The device controls the flow of blood, aiding in the prevention of blood exposure.

The passive safety needle-shielding mechanism of the Introcan Safety® 3 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 18-24 gauge catheters may be used with power injectors with a rate of injection based on gauge size and for which the maximum pressure setting is 300 psi with a luer lock connection only.

The provided text describes a 510(k) premarket notification for a medical device, the Introcan Safety® 3 Closed IV Catheter. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive new clinical trials. Therefore, the "acceptance criteria" discussed here are primarily focused on equivalence to existing devices and performance against relevant standards, rather than clinical efficacy targets. Similarly, the "study" is a series of non-clinical tests.

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

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

The document does not explicitly state "acceptance criteria" in a tabular format with corresponding "reported device performance" in the way one might expect for a novel device's clinical trial results. Instead, it details that bench testing was performed to support substantial equivalence and that the device meets internal specifications and relevant ISO standards.

Here's a synthesized table based on the "NONCLINICAL TESTING" section:

The document concludes that the "Results of the functional and performance testing conducted on the proposed devices demonstrate that the Introcan Safety® 3 Closed IV Catheters is as safe and effective as the predicate devices."

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

The document does not specify sample sizes for the non-clinical tests. It states "Bench testing performed on Introcan Safety® 3 Closed IV Catheters supports substantial equivalence of the proposed device."

The data provenance is implied to be from the manufacturer's internal testing ("internal specifications"), likely at their facility or a contracted lab. There's no mention of country of origin of data or whether it's retrospective or prospective as these are non-clinical bench tests, not patient studies.

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)

This information is not applicable to this type of regulatory submission. The "ground truth" for non-clinical testing of a medical device like an IV catheter is typically established by engineering standards, validated testing protocols, and physical measurements, rather than expert consensus on diagnostic interpretations.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 refer to a process where multiple experts review cases and resolve disagreements, often used in clinical trials or studies involving human judgment (e.g., image interpretation). The tests conducted here are bench tests for physical properties and performance against standards.

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 information is not applicable. The device is an IV catheter, not an AI-powered diagnostic tool. Therefore, MRMC studies or an analysis of "human readers improve with AI vs without AI assistance" are irrelevant to this submission. The device does not involve AI assistance.

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

This information is not applicable. The device is an IV catheter, not an algorithm, so "standalone algorithm performance" is not relevant.

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

For the non-clinical bench testing, the "ground truth" is based on engineering specifications, established international standards (ISO), and documented test methods. For example, for biocompatibility, the ground truth is "toxicity" as defined and measured by ISO 10993-1. For liquid tightness, the ground truth is "no leakage" when tested under specified pressure or conditions.

8. The sample size for the training set

This information is not applicable. This is a non-clinical device submission, not a machine learning or AI algorithm. There is no "training set" in this context.

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

This information is not applicable, as there is no training set for this device.

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