(174 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 Neurovascular Guide Wire is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 200 cm and 300 cm lengths. The extension wire 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 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 similar to the 510k cleared ASAHI SION PTCA guide wire with K100578. 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 proximal section of the guide wire for 300 cm wire is coated with PTFE.
The provided text describes a 510(k) summary for the ASAHI CHIKAI Neurovascular Guide Wire, outlining its technical characteristics, intended use, and performance data to demonstrate substantial equivalence to predicate devices. However, it does not contain information describing acceptance criteria or a study that establishes performance against those criteria in the way typically expected for an AI/ML device (e.g., sensitivity, specificity, or FROC analysis).
The document is for a medical device (a guide wire), not an AI/ML diagnostic or prognostic tool. Therefore, the questions regarding acceptance criteria in terms of accuracy metrics, sample sizes for test/training sets, expert consensus for ground truth, adjudication methods, or MRMC studies are not applicable in this context. The "performance data" referred to is related to the physical and biological properties of the guide wire itself.
Here's a breakdown of the available information based on the provided text, and where the requested AI/ML specific information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria or performance metrics in a table format that would typically be used for an AI/ML device. Instead, it lists various types of in vitro bench tests and biocompatibility evaluations that were conducted. The "acceptance criteria" here are implied to be successful completion of these tests, demonstrating the device performs as intended and is substantially equivalent to predicate devices.
| Test Category | Specific Test | Reported Device Performance |
|---|---|---|
| In vitro bench testing | Tensile Strength | Meets predetermined performance criteria; performs as intended. |
| Turns to Failure (Torque Strength) | Meets predetermined performance criteria; performs as intended. | |
| Torqueability (Torque Response) | Meets predetermined performance criteria; performs as intended. | |
| Tip Flexibility | Meets predetermined performance criteria; performs as intended. | |
| Coating Adhesion | Meets predetermined performance criteria; performs as intended. | |
| Catheter compatibility (Slipping Ability) | Meets predetermined performance criteria; performs as intended. | |
| Particulate testing | Meets predetermined performance criteria; performs as intended. | |
| Shelf life testing | Meets predetermined performance criteria; performs as intended. | |
| Biocompatibility/evaluation | Systemic Toxicity Study | Established by successful use of same materials and manufacturing process in 510(k) approved Asahi Guide Wire products. |
| In Vitro Hemolysis Study | Established by successful use of same materials and manufacturing process in 510(k) approved Asahi Guide Wire products. | |
| Intracutaneous Study | Established by successful use of same materials and manufacturing process in 510(k) approved Asahi Guide Wire products. | |
| Cytotoxicity Study | Established by successful use of same materials and manufacturing process in 510(k) approved Asahi Guide Wire products. | |
| Sensitization Study | Established by successful use of same materials and manufacturing process in 510(k) approved Asahi Guide Wire products. | |
| Pyrogen Study | Established by successful use of same materials and manufacturing process in 510(k) approved Asahi Guide Wire products. | |
| Plasma Recalcification Time | Established by successful use of same materials and manufacturing process in 510(k) approved Asahi Guide Wire products. | |
| Coagulation Study | Established by successful use of same materials and manufacturing process in 510(k) approved Asahi Guide Wire products. | |
| In Vivo Thromboresistance Study | Established by successful use of same materials and manufacturing process in 510(k) approved Asahi Guide Wire products. | |
| C3a Complement Activation Study | Established by successful use of same materials and manufacturing process in 510(k) approved Asahi Guide Wire products. | |
| SC5b-9 Complement Activation Study | Established by successful use of same materials and manufacturing process in 510(k) approved Asahi Guide Wire products. |
The document states: "Enclosed within this submission is performance data that demonstrates that the ASAHI CHIKAI Neurovascular Guide Wire meets all predetermined performance criteria." and "This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI CHIKAI Neurovascular Guide Wire performs as intended."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests mentioned are laboratory bench tests and biocompatibility studies, not clinical studies with 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. The "ground truth" for a physical medical device typically refers to engineering specifications and material science standards, not expert interpretations of medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a concept used in diagnostic studies (often for AI/ML) where expert disagreement needs to be resolved. It does not apply to the physical performance testing of a guide wire.
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 device is a physical medical instrument, not an AI/ML diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an AI/ML algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" is based on established engineering standards for mechanical properties and validated scientific methods for biocompatibility (e.g., ISO standards for tensile strength, cytotoxicity tests, etc.). No "expert consensus," "pathology," or "outcomes data" in the clinical sense is explicitly mentioned as ground truth for these performance tests.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
Not applicable. This device does not involve machine learning or a "training set."
Summary of Device and Study Type:
The provided document describes a 510(k) Premarket Notification for a physical medical device, a neurovascular guide wire. The "study" referenced is a series of in vitro bench tests and biocompatibility evaluations designed to demonstrate the device's physical performance, material safety, and substantial equivalence to existing predicate devices. It is not an AI/ML device, and therefore, many of the requested criteria related to AI/ML performance assessment are not present or applicable.
§ 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.