(214 days)
This 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 Neurovascular Guide Wire ASAHI CHIKAI 008, ASAHI Neurovascular Guide Wire ASAHI CHIKAI black, and the ASAHI Neurovascular Guide Wire ASAHI CHIKAI black 18 (ASAHI CHIKAI series) is a line extension of the ASAHI CHIKAI (K110584) and the ASAHI CHIKAI 10 (K112979).
The ASAHI CHIKAI series of steerable guide wires are constructed from a stainless steel core wire with a coil assembly consisting of an inner and outer coil soldered to the core wire. Distal outer diameter and tip shape of the ASAHI CHIKAI series range from 0.008 inches (0.20mm) with a straight tip for the ASAHI CHIKAI 008, to 0.014 inches (0.36mm) Round Curve or Angled 90º tip for the ASAHI CHIKAI black, to 0.018 inches (0.45mm) with a Round Curve tip for the ASAHI CHIKAI 18. The ASAHI CHIKAI and ASAHI CHIKAI black 18 are 200cm long, and the ASAHI CHIKAI black is available in 200cm and 300cm lengths.
The provided text describes a 510(k) summary for the Asahi Neurovascular Guide Wire ASAHI CHIKAI series, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices through bench testing, rather than a clinical study involving human subjects or AI performance evaluation. Therefore, many of the requested categories related to AI performance, human readers, ground truth establishment for AI, and large-scale data provenance are not applicable to this submission.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (determined by) | Reported Device Performance |
|---|---|---|
| Tensile Strength | Evaluation of predicate devices and ASAHI's established tensile strength specifications. | All test articles met established tensile strength acceptance criteria. |
| Torque Strength | Evaluation of predicate devices and ASAHI's established torque strength specifications. | All test articles met the acceptance criteria. |
| Torqueability | Similar or better than predicate devices. | All test articles met the acceptance criteria. Torque response is similar or better than predicate. |
| Tip Flexibility | Evaluation of predicate devices and ASAHI's established Tip Flexibility specifications. | All test articles met established Tip Flexibility acceptance criteria. |
| Coating Adherence | Maintained integrity of the coating during simulated clinical use. | Test results confirmed that the integrity of the coating was maintained during simulated clinical use in all test articles. |
| Coating Integrity & Particulate Characterization | Characterization of coating integrity and particulate generation during simulated use. (No specific quantitative acceptance criteria mentioned, but the test characterized these aspects). | This testing characterized the coating integrity and particulate generation during simulated use. (This suggests the results were within acceptable ranges, though specific numbers are not given). |
| Catheter Compatibility | Similar or better than predicate devices regarding resistance to catheter withdrawal. | All test articles met the acceptance criteria. Resistance to catheter withdrawal is similar or better than predicate. |
| Bench (Simulated) Testing | Guide wire reached target area and interventional catheter was successfully advanced over guide wire to target site. | Test results on all test articles confirmed guide wire performance. Guidewire reached target area and interventional catheter was successfully advanced over guidewire to target site. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated as a number. The table mentions "All test articles" for each test. This implies that a sufficient number of devices were tested to draw conclusions, but the specific count is not provided in this summary.
- Data Provenance: The data is from bench testing (simulated use), not human patient data. Asahi Intecc Co., Ltd. is based in Japan, so the testing was likely conducted in an industrial or laboratory setting, potentially in Japan or at a contract lab. It is not retrospective or prospective in the clinical sense, as it does not involve patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is a bench study for a physical medical device (guide wire). There is no "ground truth" to be established by medical experts in the context of diagnostic interpretation or AI performance. The "ground truth" here is the physical performance of the device against predefined engineering and performance specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As this is a bench study, there is no need for expert adjudication like in diagnostic imaging studies. The results of the physical tests are measured directly by instruments or observed against clear criteria.
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
- Not Applicable. This document describes the premarket notification for a physical medical device (a guide wire), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This device is a manual medical instrument; there is no algorithm or AI component involved, thus no standalone algorithm performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context refers to the established engineering specifications, performance standards, and comparison to legally marketed predicate devices' performance. It is based on objective physical measurements and observations during bench testing, not medical expert consensus, pathology, or patient outcomes data.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. No training set exists for this type of 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.