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Medtronic [ProVia™ and Intuition™] GTX guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.

Medtronic [Thunder™] PTCA guidewire is indicated to facilitate the placement of balloon dilatation catheters during PTCA and/or PTA.

Medtronic [Zinger™] guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. [Zinger™] guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.

Medtronic Cougar™ wire is intended for placement of balloon dilatation catheters during PTCA and/or PTA.

Device Description

Medtronic PTCA Guidewires are steerable guidewires that are used during the Percutaneous Coronary Intervention (PCI) to reach a lesion or vessel segment by serving as a guide for other diagnostic or interventional devices in the coronary and peripheral vasculature. The guidewires may also be used to reach and cross a target lesion within the coronary and peripheral vasculature excluding the cerebral vasculature. Once the tip of the guidewires arrive at a target destination within the vasculature, it acts as a guide that larger catheter can rapidly follow for easier delivery to the treatment site in the coronary and peripheral vasculature.

Medtronic Guidewires consist of a corewire covered with spring coils and terminated in a variable tip design to impart varied characteristic to the distal section of the wire, such as tip stiffness. Medtronic guidewires are coated to impart sufficient lubricity to reach and cross target lesions. There are marker bands on few Medtronic Guidewires to help in gauging guidewire position in the vasculature.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Medtronic PTCA Guidewires (Cougar™, Zinger™, Thunder™, ProVia™, and Intuition™) based on the provided K140695 510(k) Summary:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Coating Integrity	Not explicitly stated, implied to be comparable to predicate.	Performed in accordance with relevant FDA guidance to demonstrate substantial equivalence.
Particulate evaluation	Not explicitly stated, implied to be comparable to predicate.	Performed in accordance with relevant FDA guidance to demonstrate substantial equivalence.
Outer Diameter Measurement	Not explicitly stated, implied to be comparable to predicate.	Performed in accordance with relevant FDA guidance to demonstrate substantial equivalence.
Biocompatibility	ISO 10993-1: 2009- Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.	Performed and demonstrated that the modified PTCA Guidewires are safe, effective, and perform as well or better than the predicate device. No new safety or effectiveness concerns were raised.

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

The provided document describes nonclinical data (bench tests and biocompatibility tests). There is no "test set" in the context of clinical data for human or animal subjects mentioned for this 510(k) submission.

Sample Size: Not specified for each individual bench test. The document states "The following bench tests were performed..."
Data Provenance: Not applicable as these are bench tests, not clinical data involving geographical origin. The tests were performed to demonstrate substantial equivalence in accordance with FDA guidance.
Retrospective/Prospective: Not applicable for bench testing.

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

Not applicable. Ground truth for the bench tests would refer to established engineering and material science standards and measurement techniques, not expert consensus on clinical findings.

4. Adjudication Method for the Test Set

Not applicable for bench testing. Adjudication typically refers to resolving discrepancies in expert interpretations of clinical data.

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

No. The document explicitly states: "No clinical investigation has been performed on the modified device." Therefore, no MRMC study was conducted.

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

Not applicable. This submission is for physical medical devices (guidewires), not an algorithm or AI.

7. The Type of Ground Truth Used

For the nonclinical (bench) tests, the "ground truth" would be established by:

Established scientific principles, engineering standards, and validated measurement methods for properties like coating integrity, particulate evaluation, and outer diameter.
The ISO 10993-1: 2009 standard for biocompatibility, which provides a framework for evaluating biological responses to medical devices.

8. The Sample Size for the Training Set

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

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

Not applicable.

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