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The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessies using the Seldinger technique. VascuPuncture Guidewires are not indicated for use in the coronary or cerebral vasculature.

Device Description

The VascuPuncture™ PICC Guidewires are guidewires constructed of stainless steel and nickel titanium alloy with a lubricious coating. Devices are available in diameters of 0.014 and 0.018 inches and in lengths ranging from 45 to 145 cm.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the VascuPuncture™ PICC Guidewire with Hydro-Silk Coating. This is a medical device submission seeking clearance to market a new device by demonstrating its substantial equivalence to a legally marketed predicate device.

The study presented here is a substantial equivalence comparison, not a clinical study designed to test diagnostic or treatment efficacy. Therefore, many of the typical acceptance criteria and study design elements found in a clinical study (like multi-reader multi-case studies, ground truth establishment for a test set of patient data, training set information, etc.) are not applicable in this context.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance / Justification
Technological Characteristics	Functional design	The device is substantially equivalent to the predicate device in terms of functional design. (Implied: The functional design of the new device is the same or very similar to the predicate, with the addition of the Hydro-Silk coating).
	Principles of operation	The device is substantially equivalent to the predicate device in terms of principles of operation. (Implied: It operates on the same basic mechanism as the predicate).
	Performance characteristics	Functional and performance characteristics are "demonstrated through equivalence with the predicate device and testing of representative device samples." (Explicit testing was performed; the results of this testing led to the conclusion of substantial equivalence). The specific performance metrics (e.g., tensile strength, lubricity enhancement due to coating) are not detailed but are implied to meet the standards set by the predicate and internal testing.
Material/Biocompatibility	Biocompatibility (with the addition of Hydro-Silk coating)	"Biocompatibility is demonstrated through equivalence with legally marketed predicate devices and the result of biocompatibility testing." (Implied: Biocompatibility testing was conducted on the new coating/device, and the results confirmed its safety for human contact, likely meeting ISO 10993 standards or similar). The predicate also sets a benchmark for biocompatibility.
Indications for Use	Maintain the same indications for use as the predicate device.	"The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique. VascuPuncture Guidewires are not indicated for use in the coronary or cerebral vasculature." This matches the predicate's indications.
Substantial Equivalence	The device does not raise new questions of safety and effectiveness compared to the predicate device.	The conclusion is that the device "is substantially equivalent to the VascuPuncture™ PICC Guidewire" because "this device is substantially equivalent to the predicate device in terms of functional design, indications for use, principles of operation and performance characteristics." The FDA concurred with this determination.

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

For a 510(k) submission like this, the "test set" typically refers to the physical devices manufactured and subjected to bench testing or material characterization. It does not refer to patient-level data.

Sample Size for Bench/Performance Testing: The document states "testing of representative device samples." The exact number is not specified in the provided text.
Data Provenance: The data comes from internal testing conducted by NeoMetrics, Inc. The location of the testing is not specified, but it would have been performed by the manufacturer or a contract laboratory. This is retrospective in the sense that the test results are generated for the purpose of the submission after product development. It is not patient data, so "country of origin of the data" in a clinical sense is not applicable.

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

Not applicable for this type of submission. "Ground truth" in the context of patient data adjudicated by experts is not relevant here. The "ground truth" for demonstrating substantial equivalence rests on objective engineering and scientific testing to prove that the device performs as intended and is safe, similar to the predicate. The FDA (specifically the Division of Cardiovascular Devices) evaluates the submitted data to determine if substantial equivalence has been met.

4. Adjudication Method for the Test Set

Not applicable in the sense of expert adjudication of clinical outcomes or images. The "adjudication" for this submission is the FDA's review process, where their experts evaluate the provided test data and comparisons to the predicate to determine substantial equivalence.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic devices where human readers interpret patient data (e.g., radiology images). This submission is for a guidewire, a physical interventional device, and the clearance is based on substantial equivalence to an existing device, not on comparative clinical effectiveness with or without AI assistance.

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

Not applicable. This submission is for a physical medical device (a guidewire), not a software algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

Objective Engineering Standards and Bench Test Results: Performance characteristics (e.g., lubricity, tensile strength, kink resistance, coating integrity) are measured against established engineering standards and specifications.
Biocompatibility Testing Results: Data from tests conducted according to recognized standards (e.g., ISO 10993 series) to confirm the new material's safety in contact with the body.
Comparison to the Predicate Device: The established performance and safety profile of the legally marketed predicate device (VascuPuncture PICC Guidewire, K031652) serves as the primary benchmark.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of machine learning or AI algorithms for this type of physical device submission.

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

Not applicable. As a mechanical device, there is no training set for an algorithm described in this submission.

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