(28 days)
The guidewires are intended to facilitate the placement and exchange of balloon catheters or other interventional devices within the peripheral vasculature during Percutaneous Transluminal Angioplasty (PTA) or other intravascular interventional procedures.
The Victory Guidewire range are a disposable medical device designed for single use only. The device is intended to facilitate the placement of percutaneous devices during Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature. The family consists of a PTFE coated 195cm or 300cm, 0.014" or 0.018" diameter stainless steel core wire, one end of which is reduced in diameter in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness and can be varied to produce 6 various levels of support.
The provided document is a 510(k) summary for the Victory Guidewire. It describes the device, its intended use, and the non-clinical performance testing conducted to demonstrate its substantial equivalence to predicate devices. However, this document does not describe a study involving an AI/Machine Learning device or its acceptance criteria and performance against those criteria. Instead, it describes:
- Acceptance Criteria and Reported Device Performance: This section outlines the in-vitro bench tests performed and states that the results met the defined acceptance criteria and performed comparably to predicate devices. The acceptance criteria themselves are not explicitly detailed with specific numerical thresholds but are implied to be part of the "product specification."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Defined in product specification based on FDA guidance | Met the acceptance criteria defined in the product specification |
| Performed comparably to predicate devices in specified tests | Performed comparably to the predicate device(s) in specified tests |
| Biological safety established through biological risk assessment | Biological safety established through biological risk assessment |
| Biocompatibility testing in compliance with ISO 10993-1 | Biocompatibility testing carried out in compliance with ISO 10993-1 |
- Sample size used for the test set and the data provenance: The document details "In vitro bench tests" for the device, which are performed on physical samples of the guidewire. It does not refer to a "test set" in the context of data for an AI/ML model. The sample sizes for these bench tests are not explicitly stated.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as the study involves physical product testing, not human-interpreted data for establishing ground truth for an AI/ML model.
- Adjudication method: Not applicable for this type of device testing.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an AI/ML device, and no MRMC study was performed.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
- The type of ground truth used: The "ground truth" for the bench tests would be the established engineering specifications and performance characteristics of the predicate devices and the industry standards (e.g., FDA guidance, ISO 10993-1).
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
Study Description:
The study described is a series of in vitro bench tests conducted to demonstrate the substantial equivalence of the Victory Guidewire to predicate devices. The tests were performed with reference to the FDA's guidance document "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995".
The specific bench tests performed include:
- Tensile Strength
- Torque Strength
- Outer Diameter & Length Measurement
- Torque Response
- Catheter Compatibility
- Coating Adherence/Coating Integrity
- Particulate Testing
- Tip Flexibility
In addition to these mechanical and physical tests, biological safety was established through biological risk assessment, chemical characterization, and biocompatibility testing in compliance with ISO 10993-1.
The conclusion of the study was that the Victory Guidewire met the predefined acceptance criteria and performed comparably to its predicate devices, thus demonstrating substantial equivalence.
§ 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.