(155 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 product, ASAHI PTCA Guide Wire ASAHI RG3 (hereinafter ASAHI RG3 and ASAHI RG3 Soft), is intended to facilitate the insertion of an inflatable balloon catheter and other devices for treating narrowing and obstruction of the blood vessels.
The basic structure of the ASAHI RG3 and ASAHI RG3 Soft consists of a taper core wire and a coil. The taper core wire and the coil are soldered. The coil is radiopaque in part length so its position can be easily confirmed under radioscopy. In addition to this, coatings are applied on the surface of the product. The distal end of ASAHI RG3 and ASAHI RG3 Soft are coated with hydrophilic polymer. On the other hand, the proximal end of the taper core of ASAHI RG3 and ASAHI RG3 Soft wire is coated with silicone oil.
This document is a 510(k) premarket notification for the ASAHI PTCA Guidewire System, ASAHI RG3. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a diagnostic device's performance study is not applicable to this submission. This document describes a medical device, a guidewire, and the testing conducted is for its physical and biocompatibility properties, not diagnostic accuracy.
However, I can extract the relevant information regarding the non-clinical testing performed to establish substantial equivalence:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" alongside specific "reported device performance values" in a table format as would be typical for a diagnostic algorithm. Instead, it lists the types of non-clinical tests performed to demonstrate that the device functions as intended and is as safe and effective as predicate devices. The implicit acceptance criterion for these tests is that the device performs comparably to the predicate devices or within established engineering specifications for guidewires.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Tensile Strength | Performed, demonstrated substantial equivalence. |
| Torque Strength | Performed, demonstrated substantial equivalence. |
| Torqueability | Performed, demonstrated substantial equivalence. |
| Tip Flexibility | Performed, demonstrated substantial equivalence. |
| Coating Adhesion/Integrity | Performed, demonstrated substantial equivalence. |
| Catheter Compatibility | Performed, demonstrated substantial equivalence. |
| Biocompatibility | Verified to be the same as predicate devices based on material similarities. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each non-clinical test. The tests were performed on "the ASAHI RG3." As it's a physical device performance test, the "data provenance" would be a laboratory setting, not related to patient data or country of origin in the context of diagnostic performance. These would be prospective laboratory tests on the manufactured guidewires.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical device performance and safety study, not a diagnostic study requiring expert ground truth for interpretation.
4. Adjudication method for the test set
Not applicable. This is a non-clinical device performance and safety study.
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 is a non-clinical device performance and safety study for a guidewire, not a diagnostic AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a non-clinical device performance and safety study for a guidewire, not a diagnostic algorithm.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" would be the established engineering specifications for guidewire performance and safety, and direct measurement of the physical properties (e.g., tensile strength, torque, flexibility) of the ASAHI RG3 guidewire, compared against those of the predicate devices.
8. The sample size for the training set
Not applicable. This is a non-clinical device performance and safety study, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. This is a non-clinical device performance and safety study, not a machine learning 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.