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These guidewires are intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.

The materials of construction stainless steel, nitinol, platinum are consistent with guidewires presently in commercial distribution. The wires are available straight, or with "J" end. The wires range from .014" diameter through .065" diameter and lengths from 20cm. to 360 cm. The wires are coated with a transparent conformal coating.

The provided text is a 510(k) summary for a medical device (Galt Medical's Vascular Guidewires (Mandrel Type)). This type of submission to the FDA focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical or performance study.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving device performance in the way typically associated with AI/software medical devices.

Here's why and what information can be extracted:

• No Acceptance Criteria or Performance Study: The 510(k) summary for these guidewires operates on the principle of substantial equivalence. This means the manufacturer is asserting that their device is as safe and effective as a legally marketed predicate device, primarily based on similar technological characteristics and indications for use. They are not required to conduct a de novo clinical study to set and meet specific performance criteria (e.g., sensitivity, specificity, accuracy) akin to what would be expected for novel AI algorithms.
• Focus on Substantial Equivalence: The entire document revolves around demonstrating that "Galt Medical's Sitefinder guidewires are substantially equivalent to the currently marketed predicate devices" (K982559 and K021990). The "Conclusions" section explicitly states this.

Based on the provided text, I cannot complete the requested tables and sections because the document describes a 510(k) submission for a physical medical device (guidewires) based on substantial equivalence, not a performance study against acceptance criteria for an AI or software device.

However, I can extract the following relevant information about the device itself and the regulatory process:

Device Information from the 510(k) Summary:

• Device Name: Sitefinder Vascular Guidewire (Trade Name), Guidewire (Classification Name)
• Manufacturer: Galt Medical Corp.
• Device Description:
  • Materials: Stainless steel, nitinol, platinum (consistent with currently distributed guidewires).
  • Forms: Straight or with "J" end.
  • Dimensions: .014" to .065" diameter, 20cm to 360 cm length.
  • Coating: Transparent conformal coating.
• Intended Use/Indications for Use: "These guidewires are intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature." (Also mentions pacing leads in the FDA letter).
• Predicate Devices: K982559 and K021990.
• Regulatory Class: Class II
• Product Code: DQX

Why the requested information isn't present in this type of document:

This 510(k) summary is for a physical medical device, not a software or AI product. For physical devices seeking 510(k) clearance, the primary demonstration is substantial equivalence to a predicate device. This typically involves:

• Comparing indications for use.
• Comparing technological characteristics (materials, design, performance specifications, safety features).
• Bench testing to ensure the device performs as intended and is equivalent to the predicate, often against recognized standards.
• Biocompatibility testing.

It does not involve:

• Clinical studies with acceptance criteria based on diagnostic performance metrics (e.g., sensitivity, specificity for an AI).
• Human reader studies comparing AI-assisted vs. unassisted performance.
• Establishing ground truth with medical experts for an image dataset.

If this were an AI/software device, the 510(k) summary would look very different, and it would likely include information on performance metrics, study design, and ground truth establishment.

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These guidewires are intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.

The materials of construction stainless steel, nitinol, platinum are consistent with guidewires presently in commercial distribution. The wires are available straight, or with "J" end. The wires range from .014" diameter through .025" diameter and lengths from 20cm. to 360 cm. The wires may also be PTFE coated.

This document is a 510(k) summary for a medical device (guidewire) and does not describe an AI/ML device or a study involving acceptance criteria for such a device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or multi-reader multi-case studies, as these concepts are not applicable to the provided document.

The document discusses the substantial equivalence of Galt Medical's Vascular Guidewires (Mandrel Type) to previously marketed guidewires (predicate devices) based on non-clinical tests like tensile strength and torqueability. It's a regulatory submission for a traditional medical device, not a software or AI/ML product.

Ask a specific question about this device