(266 days)
The Plato 17 Microcatheter is intended for the introduction of therapeutic devices, infusion of diagnostic agents, such as contrast media, and delivery of embolization materials to the peripheral and neuro vasculature systems. The Plato 17 Microcatheter is not intended for use in the coronary vasculature.
Scientia Vascular's Plato® 17 Microcatheter is a single lumen, open-ended catheter designed to be flexible and axially stable, to aid the physician in the accessing of the distal neuro and peripheral vasculature. The Plato® 17 Microcatheter is supplied sterile and is for single use only. The Plato® 17 Microcatheter is supplied in various tip configurations, including straight and pre-shaped (45° and 90°). The microcatheter shaft design includes nitinol, polymers of varying durometer, and an internal liner providing lubricity for therapeutic device, diagnostic agent, and embolization material delivery. The distal exterior section of the catheter shaft is hydrophilic coated to reduce friction during manipulation in vessels. The microcatheter includes two radiopaque tip markers to facilitate fluoroscopic visualization and a clear hub with luer lock and a strain relief.
The microcatheter is provided with a steam shaping mandrel, peel-away introducer, and a ruler. The shaping mandrel, peel-away introducer, and ruler are accessories included to facilitate use of the microcatheter and are not intended to contact the patient's body.
The provided document is a 510(k) summary for the Scientia Vascular, Inc. Plato® 17 Microcatheter. It does not contain information about studies related to AI/ML device performance, human reader improvement with AI assistance, or standalone algorithm performance. The device described is a microcatheter, a physical medical device, not a diagnostic imaging or AI-powered solution.
Therefore, I cannot populate the table or provide information for points 2 through 9 as they are specific to AI/ML device evaluations.
Here is the acceptance criteria and the (non-AI/ML related) study details as provided in the document:
1. A table of acceptance criteria and the reported device performance
| Test Name | Attribute and Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity: MEM Elution | Cell culture was observed for cytotoxic reactivity. | Non-cytotoxic. |
| Direct Contact and Extract method Hemolysis Test | The difference between the hemolytic indexes of the subject device and the negative control was evaluated. | Non-hemolytic. |
| Partial Thromboplastin Time (PTT) Test | The clotting time was observed for both the subject device and the predicate. | Non-activator. |
| Platelet Leukocyte Counts | The concentration of platelets and leukocytes were determined on an automated hematology analyzer. | Non-activator. |
| Functional Testing | ||
| Accessory Verification | The Peel-Away Introducer must facilitate introduction of catheter into a guide catheter. | PASS |
| Therapeutic Device Compatibility and Simulated Use | The Plato® 17 Microcatheter can successfully deliver representative therapeutic devices, including stent, in a tortuous neurovascular model. The Plato® 17 Microcatheter was evaluated for delivery to target location and functionality post therapeutic device delivery. | PASS |
| Embolization Material Compatibility | Visual inspection, lumen check, liquid leakage, static burst, tensile and force to withdraw testing was conducted for the Plato® 17 Microcatheter using representative embolization materials in a tortuous neurovascular model. | PASS |
Since the provided document is for a physical medical device (microcatheter) and not an AI/ML-powered device, the following points are not applicable and cannot be answered from the given text:
- Sample size used for the test set and the data provenance: Not applicable for a physical medical device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a physical medical device.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical medical device.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable as this is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI-powered algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a physical medical device; ground truth refers to labels/diagnoses in AI/ML performance evaluation. For this device, "ground truth" would relate to confirming physical properties and functional performance against standards.
- The sample size for the training set: Not applicable as this is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable as this is not an AI/ML device that requires a training set.
§ 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).