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VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inch guidewire or catheter into the vascular system following a small gauge needle stick.

Device Description

The VSI micro-introducer kits consist of a sheath and are available in lengths of 10 cm to 30 cm. The sheath is available with either a 2.3 F, 4 F or 5 F outer diameter (O.D.) and with a straight or angled tip. The dilator is available with regular flexibility or in a 'stiffen' version. The sheath and dilator consist of a high-density polyethylene shaft and hub; the sheath shaft has a tapered distal tip that provides a smooth transition to the distal tip of the dilator. A rotating luer lock on the distal end of the dilator hub can be locked on to the sheath hub. The stiffen dilator shaft contains a stainless steel hypotube.

AI/ML Overview

The VSI Micro-Introducer Kit's acceptance criteria and the study proving it meets these criteria are detailed below, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (What the device should achieve)	Reported Device Performance (What the device actually achieved)
Bench Tests
Dimensional	Not explicitly stated, but implies meeting design specifications.	Results met specified acceptance criteria and did not raise different questions of safety and effectiveness.
Visual Inspection	Not explicitly stated, but implies meeting visual quality standards.	Results met specified acceptance criteria and did not raise different questions of safety and effectiveness.
Dilator Protrusion	Not explicitly stated, but implies meeting design specifications for protrusion.	Results met specified acceptance criteria and did not raise different questions of safety and effectiveness.
Luer Taper	Not explicitly stated, but implies meeting connection standards.	Results met specified acceptance criteria and did not raise different questions of safety and effectiveness.
Guidewire Passage	Not explicitly stated, but implies smooth passage of guidewires up to 0.018 or 0.038 inches.	Results met specified acceptance criteria and did not raise different questions of safety and effectiveness.
Insertion Force	Not explicitly stated, but implies an acceptable force for insertion.	Results met specified acceptance criteria and did not raise different questions of safety and effectiveness.
Kink	Not explicitly stated, but implies resistance to kinking during use.	Results met specified acceptance criteria and did not raise different questions of safety and effectiveness.
Aspiration	Not explicitly stated, but implies effective aspiration capabilities.	Results met specified acceptance criteria and did not raise different questions of safety and effectiveness.
Liquid Leak	Not explicitly stated, but implies no leakage of liquids.	Results met specified acceptance criteria and did not raise different questions of safety and effectiveness.
Hub Tensile	Not explicitly stated, but implies sufficient strength of the hub connection.	Results met specified acceptance criteria and did not raise different questions of safety and effectiveness.
Leveraged Tests (from predicate device)
Ink Adhesion	Not explicitly stated, but implies durability of markings.	Considered met as the tests were performed on the predicate and leveraged.
Corrosion (stiffen dilator only)	Not explicitly stated, but implies resistance to corrosion.	Considered met as the tests were performed on the predicate and leveraged.
Radiopacity (Sheath)	Not explicitly stated, but implies visibility under imaging.	Considered met as the tests were performed on the predicate and leveraged.
Biocompatibility Tests (from predicate device)
Cytotoxicity	Not explicitly stated, but implies non-toxic to cells.	Considered met as the tests were performed on the predicate and leveraged.
Sensitization	Not explicitly stated, but implies low potential for allergic reactions.	Considered met as the tests were performed on the predicate and leveraged.
Irritation/Intracutaneous Reactivity	Not explicitly stated, but implies low potential for irritation.	Considered met as the tests were performed on the predicate and leveraged.
Acute Systemic Toxicity	Not explicitly stated, but implies low potential for systemic toxicity.	Considered met as the tests were performed on the predicate and leveraged.
Hemocompatibility	Not explicitly stated, but implies compatibility with blood.	Considered met as the tests were performed on the predicate and leveraged.

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

Sample Size for Test Set: Not explicitly stated. The document mentions "The results of the design verification tests," implying a test set was used, but does not quantify its size.
Data Provenance: The study was conducted by Vascular Solutions, Inc. for the VSI Micro-Introducer Kit. It is a prospective study in the sense that new tests were performed on the subject device. However, some tests were "leveraged" from the predicate device, K101604, meaning past data from that device was used to support the subject device, which could be considered retrospective in nature for those specific tests. The origin of the data is the U.S. (Minneapolis, MN, USA).

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

This information is not provided in the document. The study primarily involves bench testing and leveraging data from a predicate device, not clinical performance requiring expert ground truth establishment in a conventional sense (e.g., image interpretation).

4. Adjudication Method for the Test Set

This information is not applicable as the study described is primarily bench testing and direct comparison to a predicate device, not a human reader or diagnostic assessment where adjudication would typically be needed.

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

No, an MRMC comparative effectiveness study was not done. This submission focuses on engineering and biocompatibility comparisons to a predicate device and does not involve human readers assessing device performance in a clinical setting.

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

This question is not applicable as the device is a VSI Micro-Introducer Kit, a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" was established based on the engineering specifications and performance standards for medical devices of this type, verified through laboratory testing. For the leveraged tests, the "ground truth" was the previously established performance and biocompatibility data of the predicate device (K101604).

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical device and not an AI/ML algorithm that requires a training set.

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

This question is not applicable as the device is a physical medical device and not an AI/ML algorithm.

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