V-STICK VASCULAR ACCESS SET by ARGON MEDICAL

The V•Stick™ Vascular Access Set assists in gaining vascular access for the placement of 0.035" and 0.038" guidewires into the vascular system using small needle access. It is composed of a 21ga puncture needle with and without silicone coating, and available with or without an echogenic tip. A coaxial introducer set with a 4F or 5F sheath and a standard or stiff 3F dilator is included. Finally a 0.018" stainless steel or Nitinol guidewire with a platinum or palladium alloy coil tip.

AI/ML Overview

The provided document K130730 describes the V•Stick™ Vascular Access Set, which is a medical device for gaining vascular access. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific clinical performance against acceptance criteria in the traditional sense of a diagnostic or AI device. Therefore, the device description and the study relate to non-clinical performance tests.

Here's a breakdown of the acceptance criteria and supporting information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Tests Performed	Reported Device Performance / Outcome
Functional/Mechanical	Dimensional Verification	Not explicitly detailed, but implied to be compliant with design specifications.
	Visual Inspection	Not explicitly detailed, but implied to be compliant with design specifications.
	Weld Strength	Not explicitly detailed, but implied to be compliant with design specifications.
	Radiopacity	Guidewire spring tip is made of radiopaque material (similar to predicate).
	Ultrasound Visibility	Distal tip of 21ga puncture needle may or may not have echogenic properties (similar to predicate).
	Sharpness	Not explicitly detailed, but implied to be compliant with design specifications.
	Stiffness Comparison	Not explicitly detailed, but implied to be compliant with design specifications.
	Tensile Strength	Not explicitly detailed, but implied to be compliant with design specifications.
Biocompatibility	Cytotoxicity	Results demonstrate substantial equivalence; no new safety questions.
	Sensitization	Results demonstrate substantial equivalence; no new safety questions.
	Acute systemic toxicity	Results demonstrate substantial equivalence; no new safety questions.
	Hemocompatibility	Results demonstrate substantial equivalence; no new safety questions.
	Irritation/intracutaneous reactivity	Results demonstrate substantial equivalence; no new safety questions.

Note: The document emphasizes substantial equivalence rather than explicit quantitative acceptance criteria for each test. The performance is reported as meeting the requirements for demonstrating substantial equivalence to predicate devices.

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

Sample Size: The document does not specify exact sample sizes for each non-clinical performance test. It broadly states that "Performance tests (Non-Clinical)" were conducted.
Data Provenance: The tests are non-clinical, meaning they were likely conducted in a laboratory setting. No information about country of origin of data or retrospective/prospective nature is applicable as these are not human subject studies.

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

This information is not applicable to this submission. The device is a vascular access set, and the studies performed are non-clinical (mechanical, material, biocompatibility). There is no "ground truth" in the context of expert interpretation for diagnostic performance.

4. Adjudication Method for the Test Set:

This information is not applicable to this submission as it pertains to non-clinical performance tests, not studies requiring expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data. The V•Stick™ Vascular Access Set does not involve human interpretation in its function.

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

No, this is not applicable. The V•Stick™ Vascular Access Set is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" in this context refers to established engineering standards, material specifications, and biocompatibility guidelines (e.g., ISO 10993-1). The device's performance was compared against these established benchmarks, and its characteristics were compared against those of the predicate devices.

8. The Sample Size for the Training Set:

This submission describes a medical device, not an AI or machine learning product. Therefore, there is no concept of a "training set" in this context.

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

As there is no training set for this type of device, this question is not applicable.

Summary

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).