(133 days)
These guidewires are intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.
The PVS 1400 Guidewire is a 0.014" outside diameter, single-use guidewire, which is used to gain intravascular access to and to facilitate the positioning and exchange of catheters in small diameter, tortuous vasculature for coronary and peripheral diagnostic or interventional procedures. The wire can be torqued to facilitate navigation through the vasculature. The proximal wire material is stainless steel. The guidewire is coated to provide lubricity. The tip material of the guidewire is nitinol.
Here's an analysis of the provided text regarding the PVS 1400 Guidewire, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes performance criteria for various physical characteristics of the guidewire. Acceptance for these criteria is demonstrated by achieving "similar," "better," or meeting specific numerical thresholds compared to predicate devices.
| Acceptance Criteria (Characteristic) | Reported Device Performance (PVS 1400 Guidewire) |
|---|---|
| Tip Flexibility | Similar values compared to three predicate devices; similar to two predicates but less flexible than one. |
| Tensile Strength | Similar values compared to two predicate devices; similar to one predicate device and lower tensile strength than the other. |
| Torqueability | Much better torqueability (much less difference between proximal input angle and distal tip output angle in a simulated tortuous anatomy) than the predicate device against which it was compared. |
| Torsional Stiffness | Approximately 7.5 times higher than the ACS predicate device. Higher than Microvena UltraSelect® Standard Tip and Boston Scientific/Medi-Tech Target Stubbie® predicate devices. |
| Torsional Strength | Approximately 3 times higher than the ACS predicate device. Higher than Microvena UltraSelect® Standard Tip and Boston Scientific/Medi-Tech Target Stubbie® predicate devices. |
| Turns to Failure (Torsional) | Approximately the same or more turns to failure as Microvena UltraSelect® Standard Tip and Boston Scientific/Medi-Tech Target Stubbie® predicate devices. |
| Catheter Compatibility | Similar to that of the three predicate devices against which it was compared. |
| Coating Flake Resistance | Similar to that of the predicate device against which it was compared. |
| Biocompatibility (Cytotoxicity, Systemic Toxicity, Intracutaneous Reactivity, Sensitization, Hemocompatibility) | Established as biocompatible based on testing per FDA guidance for an external communicating device in contact with circulating blood for less than 24 hours. |
| Sterilization (Ethylene Oxide Residuals) | Ethylene Oxide: ≤ 25 ppm |
| Ethylene Chlorohydrin: ≤ 25 ppm | |
| Ethylene Glycol: ≤ 250 ppm |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the sample size for each performance test. It refers to "testing" that was performed on the PVS 1400 Guidewire, implying a set of units were tested.
- Data Provenance: The data appears to be prospective in nature, as it describes tests specifically conducted on the PVS 1400 Guidewire to compare it to predicate devices. The country of origin for the data is not specified, but the submission is to the US FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. This device, being a guidewire, relies on objective physical performance tests rather than expert opinion for its "ground truth" or performance evaluation. The "experts" would be the engineers and technicians conducting the physical tests according to established protocols.
4. Adjudication Method for the Test Set:
Not applicable. The performance evaluation is based on objective measurements and comparisons to predicate devices, not on expert adjudication of subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This type of study (MRMC) is typically used for diagnostic devices (e.g., imaging AI) where human readers interpret cases. The PVS 1400 Guidewire is a physical medical device (guidewire) whose performance is evaluated through bench testing.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done:
Yes, in essence. The performance data presented (tip flexibility, tensile strength, torqueability, etc.) are all standalone evaluations of the PVS 1400 Guidewire's physical characteristics, often compared to predicate devices. There is no "algorithm" in the sense of a software-based AI, but the device's inherent performance is tested independently of human intervention during its function in the context of these tests.
7. The Type of Ground Truth Used:
The ground truth used for performance validation is primarily objective physical measurements and comparisons to established predicate devices. For biocompatibility, the ground truth is established by standardized biological tests and their respective pass/fail criteria. For sterilization, the ground truth is the measured residual levels of sterilants compared to specified limits.
8. The Sample Size for the Training Set:
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. Its design and manufacturing process are refined based on engineering principles and material science, not data training.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the reasons stated above (no training set for a physical device). The "ground truth" for the device's fundamental design aspects would come from engineering specifications, material properties, and clinical requirements for guidewires.
§ 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.