(80 days)
The VP Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).
The FlowCardia VP Wire is a steerable guide wire with an outer diameter of 0.014" and The FlowCardia VI Wire is a steerable gatus ATS y are constructed from a stainless steel available in 105 cm of 500 on overall rengths for each design. The proximal end of the core wire is coated with polytetrfluoroethylene (PTFE). A short radiopaque coil tip is soldered to the distal end of the core wire.
The provided text describes a 510(k) submission for the FlowCardia VP Wires. This submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing novel safety and effectiveness through extensive clinical trials or complex performance criteria with specific numerical thresholds.
Here's an analysis based on the information provided, specifically addressing your numbered points:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of predefined numerical acceptance criteria typically seen for diagnostic AI/ML devices, this submission for a medical device (guidewire) focuses on similarity to predicate devices and functional performance. The acceptance criteria are implicit in meeting established technical and biocompatibility standards for guidewires.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material Composition | Constructed from the same materials as predicate devices. |
| Dimensions | Offered in the same diameters and overall lengths as predicate devices. |
| Intended Use | Same intended use: facilitate placement of balloon dilatation catheters during PTCA and/or PTA. |
| Functional Performance | Met acceptance criteria for: Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Radiopacity, Biocompatibility, and Catheter Compatibility. |
| Safety & Effectiveness | No new safety or effectiveness issues raised during testing. Performed similarly to predicate devices. |
| Regulatory Compliance | Substantially equivalent to claimed predicate devices and other currently marketed PTCA Guide Wires. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state sample sizes for specific functional tests (e.g., number of guidewires tested for tensile strength).
The data provenance is industrial testing (bench and animal testing), not human clinical data from specific countries or prospective/retrospective sets.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and not provided. The ground truth for this type of device (guidewire) is established through standardized engineering specifications, material science, and relevant (non-clinical) performance tests, not through expert consensus on medical images or diagnoses.
4. Adjudication Method
This is not applicable and not provided. Adjudication methods like 2+1 or 3+1 typically refer to expert review of clinical cases for diagnostic accuracy, which is not the nature of this device's evaluation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) might be assisted by AI. This device is a physical guidewire, and its evaluation does not involve human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
No standalone algorithm performance study was done. This term is specific to AI/ML devices. The FlowCardia VP Wire is a physical medical device.
7. Type of Ground Truth Used
The "ground truth" for this device, in the context of its 510(k) submission, is based on:
- Engineering Specifications: Adherence to design requirements for dimensions, materials, and physical properties.
- Standardized Bench Testing: Results from tests like Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Radiopacity, and Catheter Compatibility, which have established methods and expected performance ranges.
- Biocompatibility Testing: Compliance with ISO 10993 standards to ensure the device is safe for biological contact.
- Comparison to Predicate Devices: Performance being "similar" to legally marketed devices.
8. Sample Size for the Training Set
This is not applicable and not provided. This device is not an AI/ML product, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable and not provided. As there is no AI/ML component, there is no training set and therefore no ground truth established for it.
§ 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.