(22 days)
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 cerebral blood vessel.
The Asahi PTCA Guide Wires are steerable guide wires with a maximum diameter of 0.014" and available in 180 cm and 300 cm length. The extension wire is connected to the end of the guide wire outside the body. The wire is constructed from a stainless steel core wire. The core wire and coil are soldered except tip which uses welding, The distal end of the guide wire has a radiopaque tip that is available straight and is made soft to easily bend with the vessel curve. The coating (hydrophilic and silicone) is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with PTFE.
This document describes the performance testing for the Asahi PTCA Guide Wires, which aims to demonstrate its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document states that "Bench and biocompatibility testing were conducted according to the recommendations from relevant FDA guidance to demonstrate that the Asahi PTCA Guide Wires met the acceptance criteria and performed similarly to the predicate devices." However, it does not explicitly list specific acceptance criteria values or detailed performance metrics for each test. Instead, it offers a general statement of compliance.
Summary of Reported Performance:
| Test Type | Acceptance Criteria (Not explicitly stated with values) | Reported Device Performance |
|---|---|---|
| Bench Testing | Acceptance criteria were based on recommendations from relevant FDA guidance and aimed to demonstrate similar performance to predicate devices. (Specific quantitative criteria are not detailed in the provided text.) | "Asahi PTCA Guide Wires met the acceptance criteria and performed similarly to the predicate devices." (No specific quantitative results or direct comparison values are provided in this summary.) |
| Biocompatibility | Acceptance criteria were based on recommendations from relevant FDA guidance. (Specific quantitative criteria are not detailed in the provided text.) | "Asahi PTCA Guide Wires met the acceptance criteria..." (No specific quantitative results or direct comparison values are provided in this summary.) |
| Overall Safety and Effectiveness | No new safety or effectiveness issues raised. | "No new safety or effectiveness issues were raised during the testing." This implies the device was deemed safe and effective for its intended use, comparable to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Bench and biocompatibility testing" but does not specify the sample size used for these tests. It also does not elaborate on the data provenance in terms of country of origin or whether the studies were retrospective or prospective. Given the nature of manufacturing quality control and device testing for 510(k) submissions, these would typically be controlled laboratory tests performed on newly manufactured devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This entire document pertains to a 510(k) submission for a physical medical device (guide wire) and does not involve a diagnostic AI/ML device that requires human expert ground truth establishment for a test set. Therefore, this section is not applicable. The "ground truth" for this device would be established through engineering specifications, material standards, and in-vitro or in-vivo biological responses as measured by standard laboratory tests.
4. Adjudication Method for the Test Set:
As mentioned above, this filing concerns a physical medical device, not a diagnostic imaging or AI device. Therefore, the concept of an adjudication method for a test set based on expert consensus is not applicable. Performance is evaluated against pre-defined engineering and biological standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is typically conducted for diagnostic devices (especially those involving image interpretation or clinical decision support) to assess how a device affects human reader performance. This type of study was not done for the Asahi PTCA Guide Wire, as it is a physical medical device and not a diagnostic or AI-assisted system. No effect size of human readers improving with AI assistance is reported because AI assistance is not part of this device's function or evaluation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
This question is related to AI/ML device performance. Since the Asahi PTCA Guide Wire is a physical medical device, and not an algorithm or AI system, a standalone performance evaluation (without human-in-the-loop) in the context of AI is not applicable. The performance of the guide wire is inherent to its physical and material properties and its function in facilitating catheter placement, not to an algorithm's output.
7. The Type of Ground Truth Used:
For this type of physical medical device, the "ground truth" is established through:
- Engineering specifications and material standards: Adherence to established industry standards for material composition, dimensions, and mechanical properties.
- Performance benchmarks: Comparison to predicate devices through various bench tests (e.g., tensile strength, kink resistance, pushability, trackability, torque response).
- Biocompatibility testing results: Compliance with ISO 10993 standards for biological safety, demonstrating that the device does not elicit adverse biological responses.
- Functional performance in simulated environments: Testing the device's ability to navigate through simulated anatomy or perform its intended function in a controlled, non-clinical setting.
8. The Sample Size for the Training Set:
This question is relevant to AI/ML models. Since this submission is for a physical medical device and not an AI/ML system, the concept of a "training set" in this context is not applicable. The device's design and manufacturing rely on engineering principles and quality control processes rather than machine learning training data.
9. How the Ground Truth for the Training Set was Established:
As the concept of a "training set" does not apply to this physical medical device, this question 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.