(230 days)
The VSI Micro-Introducer Sct is used for percutaneous introduction of up to an 0.038 inch guidewire or catheter into the vascular system following a small gauge needle stick.
The VS1 micro-introducer sets consist of a sheath and a dilator and are available in lengths of 10 cm to 30 cm. The sheath is available with either a 4 F or 5 F outer diameter (O.D.), and 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 shafts contains a stainless steel hypotube.
The provided text describes a 510(k) submission for the VSI Micro-Introducer Set. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific performance criteria through clinical trials. Therefore, much of the requested information (performance metrics, sample sizes for test/training sets, expert involvement, MRMC studies, ground truth details) is not typically part of a 510(k) summary for a device like a micro-introducer set.
However, I can extract the acceptance criteria and the types of studies performed as described in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test Performed | Reported Device Performance |
|---|---|
| Ink Adhesion | Qualified |
| Dimensional Verification | Qualified |
| Visual Inspection | Qualified |
| Radiopacity | Qualified |
| Guidewire Compatibility | Qualified |
| Insertion Force | Qualified |
| Corrosion Resistance | Qualified |
| Kink | Qualified |
| Liquid Leak | Qualified |
| Aspiration | Qualified |
| Tensile Strength | Qualified |
Biocompatibility Testing (per ISO 10993-1):
| Acceptance Criteria / Test Performed | Reported Device Performance |
|---|---|
| Cytotoxicity | Performed |
| Sensitization | Performed |
| Acute systemic toxicity | Performed |
| Hemocompatibility | Performed |
| Irritation/intracutaneous reactivity | Performed |
Additional Notes on Performance:
- The document states: "Results of design verification testing did not raise new safety or performance questions." This implies all tests met their predetermined acceptance criteria, which are not explicitly detailed (e.g., specific force values, leak rates, etc.) in this summary.
- The overall "performance" is establishing substantial equivalence to the predicate devices (Greatbatch Medical Coaxial Micro-Introducer Set - Standard, K990705, and Coaxial Micro-Introducer Set – Stiffen, K071574) based on functionality, technological characteristics, and Indications for Use.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided summary. For these types of engineering and biocompatibility tests, sample sizes are typically determined by standards and risk assessments but are not reported in this summary.
- Data Provenance: The tests are "design verification testing" performed by the manufacturer, Vascular Solutions, Inc., likely at their facilities (Minneapolis, MN, USA) or through contracted labs. This is internal company data, not clinical data from a specific country or population. The studies are prospective in the sense of being conducted as part of the device development and regulatory submission process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The "ground truth" for engineering and biocompatibility tests are defined by the test methods, specifications, and regulatory standards (e.g., ISO 10993-1). There are no "experts" in the sense of clinicians or radiologists establishing ground truth for these types of tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where human interpretation is involved. These are objective engineering and laboratory tests where the outcome is typically pass/fail against a predetermined specification.
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
- Not applicable. This device is a micro-introducer set, a physical medical instrument, not an AI-powered diagnostic or assistive tool. MRMC studies and AI-related performance metrics are irrelevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical medical instrument. There is no algorithm or standalone performance in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for these tests are the established specifications, test methods, and regulatory standards (e.g., ASTM standards for mechanical properties, ISO 10993-1 for biocompatibility). For example, a "kink" test would have an objective definition of what constitutes a "kink" and how much force is applied. "Guidewire compatibility" would involve ensuring a guidewire of a specified size can pass through without obstruction.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI-driven device or a diagnostic device relying on machine learning.
9. How the ground truth for the training set was established
- Not applicable for the same reasons as point 8.
§ 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).