(169 days)
The Endura guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature.
The Endura guidewire is a straight tip guidewire with a maximum outer diameter of 0.014" available in 190 cm and 300 cm lengths. The Endura guidewire consists of a bi-metal stainless steel and nitinol core wire covered on the distal end by a radiopaque coil at the distal end of the Endura guidewire has a hydrophilic coating (HPC) and the proximal end is coated with polytetrafluoroethylene (PTFE). The 190 cm length model is compatible with a guidewire extension.
The Endura Guidewire is a medical device intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature. The acceptance criteria and the study proving the device meets these criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Strength | Not explicitly stated, but implicitly passes performance testing | Passed |
| Torque Strength | Not explicitly stated, but implicitly passes performance testing | Passed |
| Torque Response (Torqueability) | Not explicitly stated, but implicitly passes performance testing | Passed |
| Guidewire Support Profile | Not explicitly stated, but implicitly passes performance testing | Passed |
| Tip Load (Tip Flexibility) | Not explicitly stated, but implicitly passes performance testing | Passed |
| Fracture Resistance | Not explicitly stated, but implicitly passes performance testing | Passed |
| Flex Resistance | Not explicitly stated, but implicitly passes performance testing | Passed |
| Hydrophilic Coating Particulate (Coating Adherence/Integrity) | Not explicitly stated, but implicitly passes performance testing | Passed |
| PTFE Coating Adhesion (Coating Adherence/Integrity) | Not explicitly stated, but implicitly passes performance testing | Passed |
| Corrosion Resistance | Not explicitly stated, but implicitly passes performance testing | Passed |
| Track Force | Not explicitly stated, but implicitly passes performance testing | Passed |
| Friction Force (HPC and PTFE) | Not explicitly stated, but implicitly passes performance testing | Passed |
| Fluoroscopy Visualization | Not explicitly stated, but implicitly passes performance testing | Passed |
| Length Extension | Not explicitly stated, but implicitly passes performance testing | Passed |
| Cytotoxicity (Biocompatibility) | In accordance with ISO 10993-1, implicitly passes acceptable bio-response | Passed |
| Sensitization (Biocompatibility) | In accordance with ISO 10993-1, implicitly passes acceptable bio-response | Passed |
| Irritation/Intracutaneous Reactivity (Biocompatibility) | In accordance with ISO 10993-1, implicitly passes acceptable bio-response | Passed |
| Systemic Toxicity (Biocompatibility) | In accordance with ISO 10993-1, implicitly passes acceptable bio-response | Passed |
| Pyrogenicity (Biocompatibility) | In accordance with ISO 10993-1, implicitly passes acceptable bio-response | Passed |
| Hemocompatibility (Biocompatibility) | In accordance with ISO 10993-1, implicitly passes acceptable bio-response | Passed |
| Sterility | Sterility Assurance Level (SAL) 10-6 via Ethylene Oxide (EO) sterilization | Achieved SAL 10-6 |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes used for each individual performance test or biocompatibility test. It mentions that "device samples" passed the biocompatibility tests and that the design was "verified through the following tests." The data provenance can be inferred as originating from Vascular Solutions, Inc., USA, the manufacturer of the device, through prospective testing conducted to demonstrate the device's performance and safety.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This section is not applicable as the Endura Guidewire is a physical medical device. The "ground truth" for its performance and safety is established through laboratory and bench testing, as well as biocompatibility assessments, rather than expert interpretation of data or images.
4. Adjudication Method for the Test Set:
This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments, which is not the case for the pre-market testing of this device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This section is not applicable. An MRMC study is relevant for AI algorithms or diagnostic tools where human reader performance is being evaluated with and without AI assistance. The Endura Guidewire is a physical interventional device, not a diagnostic or AI-powered system.
6. Standalone (Algorithm Only) Performance:
This section is not applicable. The Endura Guidewire is a physical medical device, not an algorithm, so the concept of "standalone algorithm performance" does not apply.
7. Type of Ground Truth Used:
The ground truth for the Endura Guidewire's performance is based on:
- Engineering specifications and test methodologies: Each performance test (e.g., tensile strength, torque response, flexibility, coating adherence) has predefined engineering benchmarks and standards that the device must meet.
- Biocompatibility standards: Compliance with ISO 10993-1 guidelines for biological evaluation of medical devices.
- Sterilization standards: Achieving a Sterility Assurance Level (SAL) of 10-6.
8. Sample Size for the Training Set:
This section is not applicable. The Endura Guidewire is a physical medical device and does not involve AI or machine learning, therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
This section is not applicable as there is no training set for this device.
§ 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.