(58 days)
The Plato 17 Microcatheter is intended for the introduction of embolic coils and infusion of diagnostic agents, such as contrast media, 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 distal vasculature. The Plato 17 Microcatheter is supplied sterile and is for single use only. The Plato 17 Microcatheter is packaged with 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 intraluminal delivered embolic coils and contrast media: the distal exterior section of the catheter shaft is hydrophilic coated to reduce friction during manipulation in vessels. The working length of the catheter is 160 cm. The microcatheter includes two radiopague tip markers to facilitate fluoroscopic visualization and a clear hub with luer lock and a strain relief. The Plato 17 Microcatheter is compatible with 0.014 inch guidewires or embolic coils.
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 Scientia Vascular, LLC's Plato® 17 Microcatheter was evaluated through non-clinical performance tests, including biocompatibility and functional testing, to demonstrate substantial equivalence to the predicate device, the Excelsior™ SL-10 Pre-Shaped Microcatheter (K042568) and reference device Excelsior XT-17 Microcatheter (K142565).
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Attribute and Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing (ISO 10993-1:2018) | ||
| Cytotoxicity: MEM Elution | Cell culture was observed for cytotoxic reactivity. | Non-cytotoxic. |
| Sensitization | Study animals with subject device were observed for dermal sensitization. | No sensitization reaction. |
| Intracutaneous Reactivity- by extract | Study animals with subject device were observed for dermal reaction. | No significant dermal reactions at the injected site. |
| Acute Systemic Toxicity - by extract | Study animals with the subject device were observed for abnormal clinical signs indicative of toxicity during the 72-hour test period. | No signs of toxicity. |
| Material-Mediated Pyrogenicity | Study animals were observed for individual temperature rise. | Non-pyrogenic. |
| 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. | The difference in average clot time between the subject device and predicate was 7 seconds. The two samples are considered similar. |
| Complement activation of SC5b-9 | Comparison of the subject device SC5b-9 value to the predicate device for all exposure times was performed. | The subject device had similar or lower potential to activate the complement system when compared to the predicate. |
| Hemocompatibility In-vitro Blood Loop | The catheters are placed in an in-vitro blood loop for three runs. The thrombus score for the subject device and predicate device is observed. | The lab testing concluded that the subject device showed minimal thrombus formation and is considered thromboresistant. |
| Functional Testing | ||
| Visual and Dimensional Inspection | Visual inspection of the catheter effective length to be free from surface defects, surface extraneous matter, and coating droplets. Catheter to meet the dimensional specifications per the design specifications. | PASS |
| Tensile Strength | The minimum tensile force for all microcatheters must meet the tensile requirements of ISO 10555-1. | PASS |
| Tip Flexibility | Comparable to the tip flexibility of the predicate catheter. | PASS |
| Flexural Fatigue | Catheter shall withstand cyclic fatigue without catheter damage. | PASS |
| Flow Characterization and Power Injection | Characterize fluid (saline and contrast media) flow rate through the catheter. No leak or break in the catheter when subject to power injection. | PASS |
| Catheter Liquid Leak Under Pressure | No liquid leakage on the hub or catheter body. | PASS |
| Catheter Static Burst | Maximum catheter burst pressure > 300psi. | PASS |
| Torque Turns to Failure | Maintain catheter integrity after applied hub rotations with the distal end held stationary. | PASS |
| Particulate Generation During Simulated Use | The amount of particulate matter that comes off the hydrophilic coated shaft during simulated use testing shall be determined and compared to the competitive products. | PASS |
| Coating Lubricity, Durability and Integrity | After 15 cycles the coating must maintain a minimum lubricity and maintain a minimum surface coating coverage. | PASS |
| Negative Collapse Pressure and Air Ingress | No air ingress while under vacuum with a syringe held for 10 seconds. No catheter lumen collapse after applied vacuum with a syringe. | PASS |
| Kink Radius | The catheter must maintain lumen integrity while wrapped around an anatomically relevant bend radius. | PASS |
| Tip Shape and Shape Retention | Catheter tip meets defined tip dimensional tolerances and must maintain tip shape. | PASS |
| Catheter Elongation | Catheter shaft elongation at breakage should be comparable to the predicate. | PASS |
| Catheter Hub Luer Validation | Plato 17 Microcatheter hub will be compliant to requirements found in ISO 80369-7. | PASS |
| Simulated Use Model and Product Compatibility Evaluation | Simulated use testing of the microcatheter was performed with accessory devices in a neurovascular model. The microcatheter and interfacing devices were delivered through the model and evaluated for effectiveness of delivery and functionality. | PASS |
| Accessory Verification | The Peel-Away Introducer must facilitate introduction of catheter into a guide catheter. The tip shaping mandrel must facilitate steam shaping of the catheter tip and show no signs of corrosion. The ruler on the accessories card must meet design specifications. | PASS |
| Radiopacity | Catheter tip markers to be visible under X-Ray fluoroscopy within the neuro vasculature. | PASS |
| Catheter Usability Study | Physician evaluation of the microcatheter in a cadaver study demonstrates acceptable use when compared to current marketed devices. The microcatheter and interfacing devices were delivered through a representative procedure and evaluated for effectiveness of delivery and functionality. | PASS |
| Corrosion Resistance | No corrosion is visible on the catheter samples in compliance with ISO 10555-1. | PASS |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for each functional test performed. However, it mentions "study animals" for some biocompatibility tests (e.g., sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity) and "catheter samples" for corrosion resistance. For the Catheter Usability Study, it mentions a "cadaver study." The provenance of the data (country of origin, retrospective/prospective) is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
For the "Catheter Usability Study," it states "Physician evaluation of the microcatheter in a cadaver study." The number of physicians and their specific qualifications are not provided. For other functional and biocompatibility tests, "ground truth" is established by adherence to recognized standards and objective measurements, not necessarily expert consensus in the clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method for establishing ground truth, as most tests are bench-top or animal studies with objective pass/fail criteria or comparisons to predicate devices/standards. For the "Catheter Usability Study" involving physician evaluation, the method of aggregation or adjudication of physician opinions is not detailed.
5. 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
No MRMC comparative effectiveness study was done as this device is a microcatheter, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a physical medical device (microcatheter), not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For biocompatibility tests, the ground truth is based on the biological responses observed in study animals or in vitro tests, evaluated against established scientific principles and standards (ISO 10993-1:2018). For functional tests, the ground truth is based on physical measurements, mechanical performance, and adherence to engineering standards (ISO 80369-7, ISO 80369-20, ISO 10555-1), as well as comparison to the predicate device where applicable. For the usability study, "acceptable use" by physicians in a cadaver study serves as a form of expert assessment.
8. The sample size for the training set
This device is a physical microcatheter, not a machine learning or AI model. Therefore, the concept of a "training set" is not applicable.
9. How the ground truth for the training set was established
As described in point 8, the concept of a "training set" and its associated ground truth is not applicable to this device submission.
§ 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).