(172 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 CHIKAI Nexus 014 consists of a stainless-steel tapered core wire, with an inner coil and outer coil made of radiopaque Pt-Ni alloy and stainless-steel. Surrounding the inner coil and the distal core wire is a radiopaque Pt-Ni alloy and stainless-steel outer coil. The radiopaque distal tip enables the user to view the position of the tip under X-ray fluoroscopy. Outer and inner coils are soldered to the tapered core wire with Ag-Sn solder. A similar coil design is used with other ASAHI guide wires, such as the predicate CHIKAI black (K141751).
Additionally, the CHIKAI Nexus 014 employs hydrophilic, polyurethane, PTFE, and silicone coatings which are used in the predicate and reference devices.
The nominal outer diameter of the CHIKAI Nexus 014 is 0.36 mm (0.014 inch). The device is available in two lengths: 215 cm and 300 cm.
Both sizes are available with straight, pre-shape, and angled designs.
Acceptance Criteria and Study to Prove Device Meets Criteria for CHIKAI Nexus 014
The provided FDA 510(k) clearance letter and summary for the CHIKAI Nexus 014 detail performance testing to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating human reader performance with an AI device. The CHIKAI Nexus 014 is a catheter guide wire, a physical device, and not an AI/software as a medical device (SaMD) that would involve human readers or AI-assisted interpretation of images.
Therefore, many of the requested categories (e.g., number of experts, adjudication methods, MRMC study, standalone performance for an algorithm, ground truth for training/test sets for an AI) are not applicable to the information provided for this specific physical medical device.
The acceptance criteria and performance data provided relate to the physical and functional characteristics of the guide wire.
1. Table of Acceptance Criteria and Reported Device Performance
Device: CHIKAI Nexus 014 (Catheter Guide Wire)
| Test Category | Acceptance Criteria (Implicit from "All samples met the acceptance criteria" or "Results/Conclusion") | Reported Device Performance |
|---|---|---|
| Dimensional Verification | Measurements (overall length, outer diameters, coating lengths) within specified tolerances. | All samples met the acceptance criteria. |
| Simulated Use | Successful advancement and removal through a clinically relevant model according to IFU; proper and safe operation. | All samples met the acceptance criteria. |
| Visual Inspection | Absence of foreign matter, damage, or excessive droplet-like residue of coating liquid. | All samples met the acceptance criteria. |
| Tensile Strength | Withstand specified tensile forces without failure. | All samples met the acceptance criteria. |
| Torque Strength | Withstand specified torque forces without failure when distal end is stationary. | All samples met the acceptance criteria. |
| Torqueability | Achieve specified distal end rotation/response upon proximal end rotation through a rotational response model. | All samples met the acceptance criteria. |
| Coating Integrity | Coating adhesion and integrity maintained after winding around a test jig; no visual damage. | All samples met the acceptance criteria. |
| Coating Integrity/Particulate Evaluation | Comparable to predicate device in terms of particulate generation during simulated use in a glass vascular model. | The results were comparable to the predicate device. |
| Lubricity | Meet specified slipping resistance against a catheter. | All samples met the acceptance criteria. |
| Corrosion Resistance | No signs of corrosion after immersion in sodium chloride solution. | All samples met the acceptance criteria. |
| Kink Resistance | No damage (microscopic) after multiple bends of clinically relevant radii. | All samples met the acceptance criteria. |
| Tip Flexibility | Bending loads at various points of the distal end meet specified criteria. | All samples met the acceptance criteria. |
| Radiopacity | Distal end clearly visible under fluoroscopy. | All samples met the acceptance criteria. |
Study Proving Device Meets Acceptance Criteria
The study described is a series of non-clinical, bench-top performance tests, and biocompatibility assessments comparing the CHIKAI Nexus 014 to its predicate device, the ASAHI Neurovascular Guide Wire CHIKAI black (K141751), and other reference devices. The goal was to establish substantial equivalence for a physical medical device.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document repeatedly states "All samples met the acceptance criteria" or "The samples are visually inspected..." or "All samples are performed/tested..." indicating that multiple samples were used for each test, but the exact number of samples for each specific test is not explicitly quantified (e.g., "n=X").
- Data Provenance: The data are from laboratory bench testing and biocompatibility testing. Given "ASAHI INTECC CO., LTD." is based in "Aichi, Japan," it's highly probable the testing was conducted prospectively at their R&D facilities or authorized contract labs, likely in Japan or globally recognized testing centers.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
- N/A for this type of device. This device is a physical guidewire, not an AI or imaging device requiring expert interpretation for ground truth. "Ground truth" here refers to the measured physical and performance characteristics determined by established test methods and standards.
4. Adjudication Method for the Test Set:
- N/A. Adjudication methods like 2+1 or 3+1 are typical for subjective human assessments (e.g., in reading medical images) to establish a consensus ground truth. For objective physical device testing, results are typically quantitative measurements against predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This is a physical guidewire, not an AI-powered diagnostic or assistive tool for human readers. No human clinical performance study (like an MRMC) involving "human readers" or "AI assistance" was conducted as part of this 510(k) submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This applies to AI algorithms. The performance of this guide wire was evaluated through bench testing against established physical and mechanical properties.
7. The Type of Ground Truth Used:
- For performance testing: Objective engineering measurements and observations against predetermined specifications and widely accepted industry standards (e.g., "All samples met the acceptance criteria" implying specific numerical or qualitative thresholds were achieved). The FDA guidance document "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling," October 2019, served as a reference for the test methods, which implicitly defines the "ground truth" of what constitutes acceptable performance for such a device.
- For biocompatibility testing: Established laboratory test results compared against ISO 10993 series standards and control samples.
8. The Sample Size for the Training Set:
- N/A. This is not an AI/ML device that requires a training set. The "design" of the device is based on engineering principles and comparison to existing predicate devices, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established:
- N/A. As above, no training set or ground truth in the context of an AI/ML model was established for this 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.