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This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

The ASAHI Peripheral Guide Wires in this submission have a coil-type distal end or a plastic covered-type distal end. The coil is partly or entirely radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire's distal end by fluoroscopy.

The core shaft surface is coated with Polytetrafluoroethylene (PTFE). About 2cm of the distal end can be shaped. ASAHI INTECC detachable extension wire (hereafter "extension wire") (previously cleared as part of K083145 and K101985) is available to connect with the proximal end of the guide wire with a length of less than 300 cm. The total length of the system after the connection with be 300cm to 400cm. Torque device may be included in the same package.

The ASAHI Peripheral Guide Wires in this submission have an overall length range of 200 to 300 cm and a nominal outer diameter range of 0.36 to 0.45 mm.

This document is a 510(k) summary for ASAHI Peripheral Guide Wires, which includes three models: ASAHI Gladius, ASAHI Halberd, and ASAHI Gaia PV. The purpose of this summary is to demonstrate substantial equivalence to legally marketed predicate devices.

Here's the breakdown of the acceptance criteria and study information provided:

1. A table of acceptance criteria and the reported device performance:

The document broadly states that "The in vitro bench tests demonstrated that the ASAHI Peripheral Guide Wire met all acceptance criteria and performed similarly to the predicate devices." However, specific numerical acceptance criteria for each test (e.g., minimum tensile strength in Newtons, or maximum torque strength in N/cm) are not explicitly listed in the provided text. The performance is reported qualitatively as "met all acceptance criteria and performed similarly."

2. Sample size used for the test set and the data provenance:

The document mentions "Non clinical laboratory testing was performed," which implies a test set. However, the sample size used for the test set is not specified. The data provenance is also not specified beyond being "non clinical laboratory testing." It does not mention the country of origin of the data or whether it was retrospective or prospective, as these are typically not applicable to bench testing of this nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable or provided. For medical devices undergoing bench testing against engineering specifications, ground truth is established by physical measurements and engineering standards, not typically by expert review in the same way it would be for AI model validation in image interpretation, for example.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable or provided. Adjudication methods are typically relevant for human review of data, especially in clinical studies or when establishing ground truth for AI model training/testing. For bench testing, the results are typically objectively measured against established engineering specifications.

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:

This information is not applicable or provided. The device in question is a guide wire, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

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

This information is not applicable or provided. The device is a physical medical device (a guide wire), not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept for this product.

7. The type of ground truth used:

The ground truth for the bench tests would have been the engineering specifications and performance standards applicable to guide wires. These are based on industry standards, established medical device requirements, and the characteristics of the predicate devices.

8. The sample size for the training set:

This information is not applicable or provided. The document describes a physical medical device undergoing bench testing, not an AI system that requires a "training set."

9. How the ground truth for the training set was established:

This information is not applicable or provided for the same reason as point 8.

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