(30 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 CHIKAI X 014 soft (hereafter "CHIKAI X 014 soft") is a steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 200cm length. The extension wire is connected to the end of the guide wire outside the body for 200cm wire. The guide wire is constructed from a stainless steel core wire with a 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 distal end of the guide wire has a radiopaque tip to achieve visibility, and is available in a straight configuration and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. The coil assembly construction is similar to the 510(K) cleared ASAHI Neurovascular Guide Wire CHIKAI with K110584.
This document is a 510(k) Premarket Notification for a medical device called the "ASAHI Neurovascular Guide Wire (CHIKAI X 014 soft)". It describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to previously cleared predicate devices.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a summary table of non-clinical bench testing. The acceptance criteria for each test were established by prior comparative testing with predicate devices, ASAHI's established guide wire specifications, and clinical experience. The reported device performance indicates that all tested articles met these criteria.
| Test | Test Method Summary | Acceptance Criteria Basis | Reported Device Performance (Results / Conclusions) |
|---|---|---|---|
| Tensile Strength | To determine maximum allowable tensile load between connections, guide wire is fixed in the Tensile Testing Machine and pulled until failure. | Determined by evaluation of predicate devices and ASAHI's established tensile strength specifications. | All test articles met established acceptance criteria. |
| Torque Strength | To determine torque strength, distal end is inserted and advanced through simulated model. Distal tip is held stationary while proximal end is rotated until failure. | Determined by evaluation of predicate devices and ASAHI's established torque strength specifications. | All test articles met established acceptance criteria. |
| Torqueability | To determine torque response, guidewire is inserted through catheter and into Rotational Response model. Proximal end is rotated from 0° to 720°. Torque response at distal end is measured at each 90° angle. | Determined by evaluation of predicate devices and ASAHI's established torqueability specifications. | All test articles met the acceptance criteria. |
| Tip Flexibility | To determine flexibility of the distal end, the force to deflect the guide wire 45° and 90° at 5, 10, and 20mm from distal tip is measure by a force analyzer attached to a load cell. | Determined by evaluation of predicate devices and ASAHI's established tip flexibility specifications. | All test articles met established Tip Flexibility acceptance criteria. |
| Coating Adherence | Integrity of coated outer coil and core wire is determined before, and after, pretreatment and manipulation in excess of that expected in clinical use. | (Implicitly, the coating should remain intact and adherent after simulated use. No explicit numerical criteria provided, but the conclusion confirms integrity.) | Test results confirmed the integrity of the coating was maintained during simulated clinical use in all test articles. |
| Catheter Compatibility | Catheter compatibility is evaluated by measuring the force to withdraw the guide wire that has been inserted through the test catheter. | (Implicitly, the resistance should be similar to or better than the predicate. No explicit numerical criteria provided.) | All test articles met the acceptance criteria. Resistance to catheter withdrawal is similar or better than predicate. |
| Bench Testing | To simulate clinical use, guidewire is inserted through guide catheter placed in simulated model and advanced to target area. Microcatheter is inserted over guidewire and advanced to target cerebral artery multiple times. | (Implicitly, the guidewire should reach the target area and allow successful advancement of the interventional catheter. No explicit numerical criteria beyond functional success.) | Test results on all test articles confirmed guidewire performance. Guidewire reached target area and interventional catheter was successfully advanced over guide wire to target site. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify an exact numerical sample size for each test. It uses phrases like "All test articles" or refers to "multiple times" for the bench testing. This typically implies a statistically relevant number of units were tested to ensure consistency and reliability, but the precise numbers are not disclosed.
- Data Provenance: The tests are described as non-clinical bench testing which are performed in a controlled laboratory environment. There is no mention of human subject data, country of origin related to human data, or whether it was retrospective or prospective, as it's a device performance study, not a clinical study.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- This information is not applicable to this type of device clearance. The "ground truth" here is the physical performance criteria and specifications of the device, which are established through engineering design, industry standards, and comparison to predicate devices, not through expert human readings or interpretations.
4. Adjudication Method for the Test Set:
- Not applicable. As stated above, this involves physical bench testing against predefined engineering specifications and predicate performance, not human adjudication of observations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was not done. This device is a physical medical instrument (guide wire), not an AI/imaging diagnostic tool that would typically undergo an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device, not a software algorithm.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's performance evaluation is based on:
- Prior comparative testing with predicate devices: Directly comparing the new device's performance to that of legally marketed and accepted similar devices.
- ASAHI's established guide wire specifications: Internal engineering and design specifications for their devices.
- Clinical experience: Implicitly, the understanding of performance requirements derived from the real-world use of similar guide wires.
8. The Sample Size for the Training Set:
- Not applicable. This is a physical medical device, not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As above, no training set for an AI model is involved.
§ 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.