(56 days)
ASAHI 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 10 Neurovascular Guide Wire is a steerable guide wire with a maximum diameter of 0.010 inches (0.26mm) and available in 200 cm and 300 cm maximall attimorer or one is connected to the end of the guide wire outside the body for 200 cm wire. The guide wire is constructed from a stainless steel core wire with for 200 on will be handstainless steel coils. The coil assembly consists of an inner coil and pratinan monor che coil assembly is soldered to the core wire. The coil assembly an outer outli, and the 510k cleared ASAHI CHIKAI Neurovascular Guide Wire with K110584. The distal end of the guide wire has a radiopaque tip to achieve visibility, and is available The distar end of the galas into has a made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the quide wire. The proximal section of the guide wire for 300 cm wire is coated with PTFE.
The provided document is a 510(k) Pre-Market Notification for a medical device, specifically a guide wire. It focuses on demonstrating substantial equivalence to predicate devices rather than proving novel diagnostic accuracy or clinical effectiveness for an AI/ML powered device. Therefore, many of the requested categories for AI/ML device studies (such as MRMC studies, training set details, and expert qualifications for ground truth establishment) are not applicable or not present in this type of document.
However, I can extract the acceptance criteria and performance data for the device's physical performance as tested in this submission.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical targets for each performance test. Instead, it states that "ASAHI CHIKAI 10 Neurovascular Guide Wire meets all predetermined performance criteria" and that it "performs as intended." The overall conclusion is that the device is "substantially equivalent" to predicate devices, inferring that its performance matches or is comparable to those predicate devices.
The performance areas evaluated are listed. I will present the evaluated performance aspects and the general statement of conformity.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain Tensile Strength | Meets predetermined performance criteria; Performs as intended; Substantially equivalent to predicate devices. |
| Maintain Turns to Failure (Torque Strength) | Meets predetermined performance criteria; Performs as intended; Substantially equivalent to predicate devices. |
| Maintain Torqueability (Torque Response) | Meets predetermined performance criteria; Performs as intended; Substantially equivalent to predicate devices. |
| Maintain Tip Flexibility | Meets predetermined performance criteria; Performs as intended; Substantially equivalent to predicate devices. |
| Maintain Coating Adhesion | Meets predetermined performance criteria; Performs as intended; Substantially equivalent to predicate devices. |
| Maintain Slipping Ability of Guide Wire with Microcatheter | Meets predetermined performance criteria; Performs as intended; Substantially equivalent to predicate devices. |
| Absence of excessive particulates (Particulate Testing) | Meets predetermined performance criteria; Performs as intended; Substantially equivalent to predicate devices. |
| Biocompatibility (various studies: Systemic Toxicity, Hemolysis, etc.) | Established by successful use of same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products; Meets performance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of guide wires or samples used for each in vitro bench test (tensile strength, torque strength, etc.). It generally states that "performance data" was enclosed and that tests "were conducted."
- Data Provenance: The tests are described as "In vitro bench testing," indicating they were conducted in a laboratory setting. The origin of the data is from the manufacturer, Asahi Intecc Co., Ltd. (Japan), as part of their submission to the FDA. The data is prospective in the sense that these tests were specifically conducted for this 510(k) submission to demonstrate device performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to this type of device submission. The "ground truth" for a medical device's physical and mechanical properties is typically established through standardized engineering and material science testing methods, not by expert consensus on observational data as would be done for an AI/ML diagnostic device.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review of cases to establish ground truth in diagnostic studies, which is not what was performed for this guide wire submission.
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
This question is not applicable. This submission is for a physical medical device (guide wire), not an AI-powered diagnostic tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. As stated above, this is not an AI/ML algorithm. The performance tests are for the physical device itself.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- Engineering Standards and Specifications: Tests like tensile strength, torque, and flexibility are measured against defined engineering limits and performance requirements relevant to the intended use.
- Biocompatibility Standards: Biocompatibility is assessed against established ISO standards and material safety profiles for medical devices.
- Comparison to Predicate Devices: Performance is benchmarked against the known characteristics and established safety/effectiveness of legally marketed predicate devices.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of an AI/ML model for this type of physical medical device submission.
9. How the Ground Truth for the Training Set was Established
This question is not applicable due to the absence of a training set for an AI/ML model.
§ 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.