(197 days)
The MiVi 6F Guide Catheter is indicated for use in facilitating the insertion and guidance of microcathers into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter.
The MiVi 6F Guide Catheter consists of a single lumen, braided, variable stiffness shaft designed for use in facilitating the insertion and guidance microcatheters into a selected blood vessel in the peripheral, coronary or neurovascular system. A radiopaque marker is included on the distal end for angiographic visualization. The catheter shaft has a hydrophilic coating to reduce friction during use. A luer hub on the proximal end allows attachments for flushing, insertion of catheters and aspiration. It is used in junction with a rotating hemostatic valve with side-arm adapter for flushing, catheter insertion and aspiration. The MiVi 6F Guide Catheter has a straight distal tip and is available in a 110 cm length and 6F diameter.
The provided text describes the MiVi 6F Guide Catheter and its substantial equivalence to predicate devices, focusing on design verification and biocompatibility testing rather than a study proving performance against acceptance criteria in the context of an AI/ML device.
Therefore, many of the requested data points (sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI/ML models) are Not Applicable (NA) as this is a traditional medical device submission (catheter), not an AI/ML device.
Here's the information that can be extracted and a clear indication of NA for the AI/ML specific criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Push/Track | Met established criteria | Met established criteria |
| Stent Crossing | Met established criteria | Met established criteria |
| Tip Stiffness | Met established criteria | Met established criteria |
| Torque Response | Met established criteria | Met established criteria |
| Kink Resistance | Met established criteria | Met established criteria |
| Tensile | Met established criteria | Met established criteria |
| Luer Leakage | Met established criteria | Met established criteria |
| Coating Adhesion | Met established criteria | Met established criteria |
| Coating Uniformity | Met established criteria | Met established criteria |
| Coating Thickness | Met established criteria | Met established criteria |
| Surface Integrity | Met established criteria | Met established criteria |
| Radiopacity | Met established criteria | Met established criteria |
| System Introduction | Met established criteria | Met established criteria |
| Device Compatibility | Met established criteria | Met established criteria |
| Packaging (Shipping) | Met established criteria | Met established criteria |
| Cytotoxicity (ISO MEM Elution Assay) | Non-cytotoxic (score '0') | Score '0' at 24, 48, and 72 hours |
| Irritation (Intracutaneous Reactivity Test) | Non-irritating | No abnormal clinical signs/significant dermal reactions |
| Hemolysis (ASTM Direct Contact & Extract) | Non-hemolytic (≤0.2% above control) | Direct: 0.1% above control; Extract: 0.0% above control |
| Thrombosis (4hr Thromboresistance Dogs) | Similar to predicate device | Similar thromboresistance to predicate device |
| Complement Activation (C3a and SC5b-9) | Not an activator and comparable to predicate | C3a: 1.0 (device), 3.2 (predicate); SC5b-9: 0.0 (device), 1.1 (predicate) |
| Pyrogenicity (LAL Limit Test) | Non-pyrogenic ( |
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).