(89 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 Gaia (hereafter ASAHI Gaia), is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
The basic structure of ASAHI Gaia consists of a tapered core wire and coils. There are currently three models of the ASAHI Gaia:
- ASAHI Gaia First ●
- ASAHI Gaia Second ●
- . ASAHI Gaia Third
Each of these models share similar design characteristics and have the same maximum outside diameter. The models differ in the distal diameter.
The ASAHI Gaia consists of a tapered core wire and two distal coils: an inner and outer coil. The outer coil is radiopaque so as to be easily confirmed of its position under radioscopy. The distal part of the ASAHI Gaia is tapered. The distal tip of the ASAHI Gaia is available straight or pre-shaped.
In addition, coatings are applied on the surface of the product. The distal part is coated with hydrophilic polymer, and the proximal part is coated with PTFE.
The ASAHI PTCA Guide Wire ASAHI Gaia did not undergo a clinical study with human subjects to prove it meets acceptance criteria. Instead, substantial equivalence was demonstrated through non-clinical laboratory testing and comparison to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Assessment) | Reported Device Performance (ASAHI Gaia) |
|---|---|
| Tensile Strength | Performed. Assessed to be substantially equivalent to predicate devices. |
| Torque Strength | Performed. Assessed to be substantially equivalent to predicate devices. |
| Torqueability | Performed. Assessed to be substantially equivalent to predicate devices. |
| Tip Flexibility | Performed. Assessed to be substantially equivalent to predicate devices. |
| Coating Adhesion/Integrity | Performed. Assessed to be substantially equivalent to predicate devices. |
| Catheter Compatibility | Performed. Assessed to be substantially equivalent to predicate devices. |
| Coating Integrity and Acute Particulate Characterization | Performed. Assessed to be substantially equivalent to predicate devices. |
| Biocompatibility | Verified to be the same as predicate devices, based on similarities of materials. |
| Intended Use | Same as predicate devices. |
| Technological Characteristics (components, design, materials, sterilization, shelf life, operating principles) | Similar to predicate devices. Combines torqueability and crossability of two predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable as the studies were non-clinical laboratory tests, not clinical studies with human subjects. The document does not specify sample sizes for the non-clinical tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as there was no test set involving expert interpretation or ground truth establishment in a clinical context. The performance was assessed through laboratory testing against established specifications or comparison to predicate devices.
4. Adjudication Method for the Test Set
This information is not applicable as there was no test set requiring adjudication in a clinical context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable. The device is a PTCA Guide Wire, not an AI-assisted diagnostic or interpretative tool, and no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance was established through:
- Engineering specifications and standards: Non-clinical laboratory tests (Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Adhesion/Integrity, Catheter Compatibility, Coating Integrity and Acute Particulate Characterization) would have been performed against pre-defined engineering requirements and industry standards for guide wires.
- Comparison to predicate devices: The device's performance was directly compared to the established performance and safety profiles of the cited predicate devices (K101986 - ASAHI UltimateBros3 PTCA Guide Wire, K100578 - ASAHI SION PTCA Guide Wire, K122469 - ASAHI SION J PTCA Guide Wire, K041531 - ASAHI PTCA Guide Wire Confianza Pro, K043422 - ASAHI PTCA Guide Wire, J Shape series (ASAHI Confianza Pro J)). The "ground truth" for substantial equivalence was that the new device performs "as safe and effective as its predicates."
8. The Sample Size for the Training Set
This information is not applicable as there was no training set in the context of an AI/machine learning model. The device's validation was based on non-clinical testing and comparison to predicates.
9. How the Ground Truth for the Training Set Was Established
This information is not 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.