(30 days)
ASAHI CHIKAI Neurovascular Guide Wire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature.
The ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) is a steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 200 cm and 300 cm lengths. The guide wire is constructed from a stainless steel core wire with platinum-nickel and stainless steel coils. The coil assembly consists of an inner coil and an outer coil, and the coil assembly is soldered to the core wire. The coil assembly construction is identical to the 510(k) cleared ASAHI CHIKAI Neurovascular Guide Wire (K110584). The distal end of the quide wire has a radiopaque tip to achieve visibility. This change introduces a rounded tip configuration designed to bend with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. The proximal section of the guide wire for 300 cm wire is coated with PTFE.
This document describes the premarket notification (510(k)) for the ASAHI CHIKAI Neurovascular Guide Wire (Round Curve). The information provided focuses on demonstrating substantial equivalence to a predicate device, rather than a standalone study with detailed performance metrics and ground truth establishment for an AI device.
Therefore, many of the requested categories for a study of an AI device's acceptance criteria and performance cannot be directly extracted from this document. However, I can provide the available information regarding the device's acceptance criteria and the testing performed.
1. Table of acceptance criteria and the reported device performance
The document states that the device "met all acceptance criteria" and "performed similarly to the predicate devices" for the performed tests. However, the specific quantitative acceptance criteria for each test are not provided in this summary. The reported performance is qualitative (met criteria, performed similarly).
| Test Performed | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance |
|---|---|---|
| Tensile Strength | (Unspecified quantitative threshold) | Met all acceptance criteria |
| Torque Strength | (Unspecified quantitative threshold) | Met all acceptance criteria |
| Torqueability | (Unspecified quantitative threshold) | Met all acceptance criteria |
| Tip Flexibility | (Unspecified quantitative threshold) | Met all acceptance criteria |
| Biocompatibility | Same as predicate device | Verified to be the same as the predicate |
The following information cannot be extracted from the provided document as it pertains to AI/algorithm studies, which is not the subject of this 510(k) submission:
- Sample size used for the test set and the data provenance: This is a physical medical device, not an AI/algorithm. Sample sizes for bench testing are not detailed in this summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for physical device bench testing.
- Adjudication method: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for physical device bench testing. The "ground truth" for these tests would be the established engineering and materials science standards for guide wires.
- The sample size for the training set: Not applicable (not an AI device).
- How the ground truth for the training set was established: Not applicable (not an AI device).
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.