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The Asahi Regalia XS 1.0 Peripheral Guide Wire 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 Regalia XS 1.0 Peripheral Guide Wire is steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 180 cm and 300 cm length. The extension wire is connected to the end of the guide wire outside the body. The wire is constructed from a stainless steel core wire. The core wire and coil are soldered. The distal tip of the guide wire has a radiopaque tip to achieve visibility, and is made flexible to bend easily at the vessel curve. There is polyurethane coating covered with hydrophilic coating applied to the distal section of the guide wire. The proximal section of this guide wire is coated with PTFE.

This document is a 510(k) summary for the Asahi Regalia XS 1.0 Peripheral Guide Wire. It asserts substantial equivalence to predicate devices, and therefore, does not contain information about acceptance criteria or a study proving the device meets new acceptance criteria.

The submission states: "This submission represents a change to the existing product labeling. Additional performance testing is not applicable." This indicates that no new performance studies were conducted for this specific 510(k) submission.

Therefore, the requested information cannot be filled from the provided text.

Here's how I would answer based only on the provided text, indicating what information is not available:

Acceptance Criteria and Device Performance Study for Asahi Regalia XS 1.0 Peripheral Guide Wire

Based on the provided 510(k) summary, the sponsor (Asahi Intecc Co., Ltd.) states that additional performance testing is not applicable for this submission, as it represents a change to existing product labeling. The device's substantial equivalence is asserted based on similarities in materials and dimensional specifications to already cleared predicate devices. Therefore, there are no specific, new acceptance criteria or a study described within this document that proves the device meets such criteria.

The document emphasizes substantial equivalence rather than presenting new performance data.

1. Table of Acceptance Criteria and Reported Device Performance:

   • Acceptance Criteria: Not specified as no new performance testing was conducted.
   • Reported Device Performance: Not reported as no new performance testing was conducted beyond asserting equivalence to predicate devices based on material and dimensional characteristics.

2. Sample size used for the test set and the data provenance: Not applicable. No new test set and data provenance for performance evaluation are described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new ground truth establishment for a test set is described.

4. Adjudication method for the test set: Not applicable. No test set requiring adjudication is described.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and 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 guide wire, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (guide wire), not an algorithm.

7. The type of ground truth used: Not applicable. No new ground truth for performance evaluation is described. The basis for clearance is substantial equivalence to legally marketed predicate devices.

8. The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable. No training set is described.

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