(114 days)
ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.
The ASAHI® PTCA Guide Wire ASAHI Gladius Mongo consists of a one-piece core wire and a distal coil assembly. The coil assembly consists of an inner coil and an outer coil, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of the ASAHI® PTCA Guide Wire ASAHI Mongo. The coil and distal portion of the quide wire are coated with polyurethane and then covered with hydrophilic coating. The proximal portion of the guide wire is coated with PTFE only. The ASAHI® PTCA Guide Wire ASAHI Mongo is available in various lengths. The shorter length device is designed for use with a commercially available ASAHI INTECC extension, wire.
The provided text describes the 510(k) premarket notification for the "ASAHI® PTCA Guide Wire ASAHI Gladius Mongo 14 and ASAHI Gladius Mongo 14 ES." This document pertains to a medical device (a guide wire), not an AI algorithm or a diagnostic tool. Therefore, the questions regarding acceptance criteria and studies for an AI/ML powered device, specifically those requiring information on human readers, ground truth establishment for AI training/test sets, and expert adjudication, are not applicable to this document.
The document focuses on demonstrating substantial equivalence of the new guide wire to a legally marketed predicate device (ASAHI® Fielder XT-A). It primarily relies on non-clinical testing/performance data to show that the new device functions as intended and has a similar safety and effectiveness profile.
Here's a breakdown of the relevant information provided, responding to the spirit of the request where applicable to a traditional medical device:
1. A table of acceptance criteria and the reported device performance:
The document lists the following non-clinical tests performed, implying that internal acceptance criteria were met. However, the specific quantitative acceptance criteria and the exact reported performance results (e.g., specific tensile strength values or torque strength ranges) are not detailed within this public summary. The statement is qualitative: "met all acceptance criteria and performed similarly to the predicate device."
| Test Performed | Implied Acceptance Criteria (Qualitative) | Reported Device Performance (Qualitative) |
|---|---|---|
| Tensile Strength | Met predefined strength requirements | Performed similarly to predicate |
| Torque Strength | Met predefined torque requirements | Performed similarly to predicate |
| Torqueability | Met predefined torqueability standards | Performed similarly to predicate |
| Tip Flexibility | Met predefined flexibility standards | Performed similarly to predicate |
| Coating Adhesion | Met predefined adhesion standards | Performed similarly to predicate |
| Catheter Compatibility | Compatible with standard catheters | Performed similarly to predicate |
| Particulate Testing/ Coating Integrity | Met predefined particulate limits and coating integrity standards | Performed similarly to predicate |
| Lubricity Testing | Met predefined lubricity standards | Performed similarly to predicate |
| Biocompatibility | Materials are biocompatible (similar to predicate/reference devices) | Verified to be the same as predicate/reference devices based on material similarity |
Regarding the other questions, they are not directly applicable to this type of device submission:
- 2. Sample sized used for the test set and the data provenance: This refers to data for an AI model. For this physical device, "sample size" would refer to the number of devices tested for each non-clinical test. This specific number is not provided in the summary. Data provenance is not relevant for a physical device's bench testing.
- 3. Number of experts used to establish the ground truth... and qualifications: This is for AI performance evaluation. Not applicable.
- 4. Adjudication method... for the test set: This is for AI performance evaluation. Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: This is for AI performance evaluation. Not applicable.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is for AI algorithm performance. Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This is for AI ground truth. For this device, "ground truth" would be established by validated test methods and engineering specifications.
- 8. The sample size for the training set: This is for AI model training. Not applicable.
- 9. How the ground truth for the training set was established: This is for AI model training. Not applicable.
In summary, the provided document is a 510(k) summary for a physical medical device (a guide wire), and the questions posed are primarily designed for the evaluation of AI/ML-powered medical devices. Therefore, most of the specific details requested regarding AI acceptance criteria, ground truth, and study design are not found within this document. The core of this submission is demonstrating substantial equivalence through a comparison of technological characteristics and non-clinical bench testing.
§ 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.