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510(k) Data Aggregation
(85 days)
The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The Distal Access Catheter is also indicated for use as a conduit for retrieval devices.
The Distal Access Catheter is a sterile, single lumen, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The catheter comes in Straight (with no shaping of the catheter tip) and Curved (curved catheter tip) models based on the distal end. The catheter shaft has a hydrophilic coating on the distal end of the shaft to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end.
This document is a 510(k) summary for a medical device called the "Distal Access Catheter." It describes non-clinical performance testing and biocompatibility testing conducted to demonstrate that the device is substantially equivalent to a predicate device.
1. Table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria (Test Method / Applicable Standard) | Reported Device Performance |
|---|---|---|
| Dimensional Verification | Verify dimensions using specified measurement tool. | Pass |
| Tip Configuration | Visually inspect distal tip at 10x magnification. | Pass |
| Surface Integrity | Inspect catheter surface. ISO 10555-1:2013 | Pass |
| Tip Buckling | Use a testing apparatus to measure the maximum force required to cause a test sample to buckle at 5 mm, 10 mm and 20 mm from distal tip. | Pass |
| Luer Connector Tests | ISO 80369-7: 2021 | Pass |
| Flexural Fatigue | After ten runs of the Distal Access Catheter with the accessories in the simulated use model, remove the test sample and inspect the sample for kinks or damage. | Pass |
| Trackability | Test the peak tracking force and the compatibility with the ancillary devices during insertion and retraction of the catheter in the simulated use model. | Pass |
| Catheter Lubricity and Durability | Use friction tester to measure the frictional force of the test samples when pulled between two clamped pads. Record the peak frictional force over 5 cycles. | Pass |
| Particulate and Coating Integrity Test | Measure the size and number of particulates generated during simulated use and conduct visual inspection at 50x and 200x magnification of the outer surface of the catheter after simulated use. | Pass |
| Tensile Strength Test | ISO 10555-1:2013 | Pass |
| Air Leakage | ISO 10555-1:2013 | Pass |
| Liquid Leakage | ISO 10555-1:2013 | Pass |
| Torque Resistance | Fix the distal tip of the Distal Access Catheter and rotate the proximal end until the Distal Access Catheter shows kink or other signs of failure. | Pass |
| Kink Resistance Test | Visually inspect whether the Distal Access Catheter kinks or not when wrapped around mandrels with diameters 1 mm to 10 mm (in 1 mm increments). | Pass |
| Catheter Tip and Lumen Integrity | After simulated use, aspirate test sample for 10 sec using a 60 cc syringe during retrieval device withdrawal. Visually inspect the test sample to verify absence of tip or lumen collapse. | Pass |
| Corrosion Resistance Test | ISO 10555-1:2013 | Pass |
| Tip Flexibility Test | Use a mechanical force meter to push the tip from left to right at 5 mm, 10 mm, and 20 mm from the distal tip. | Pass |
| Radiopacity | ASTM F640-12 | Pass |
| Static Burst Pressure | ISO 10555-1:2013 | Pass |
| Compatibility Test | The compatibility of the Distal Access Catheter with a marketed introducer sheath, guide catheter, guidewire, micro guidewire, microcatheter, and stent-retriever is evaluated. | Pass |
| Flow Rate | Use a flow rate tester to measure the flow rate of the Distal Access Catheter. | Pass |
| Biocompatibility Tests | ||
| Cytotoxicity | Viability > 70% (ISO 10993-5: 2009, MTT Method) | Pass |
| Skin Sensitization | Magnusson & Kligman grades ) | Below 2.15 EU/device |
| Shelf-life | Device performs as intended to support the proposed 2-year shelf-life. | Demonstrates 2-year shelf-life |
2. Sample size used for the test set and the data provenance:
The document describes non-clinical (bench and in vitro) and biocompatibility testing. It does not mention a "test set" in the context of patient data or clinical images. Therefore, questions regarding data provenance (country of origin, retrospective/prospective) are not applicable here.
For the non-clinical and biocompatibility tests, the sample sizes are not explicitly stated for each individual test. The document generally states "test sample" or refers to the number of cycles/animals without specifying the exact number for statistical power. The tests are performed on the device itself or its extracted components, not on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a submission for a physical medical device (catheter) based on non-clinical and biocompatibility testing, not an AI/software device that requires expert-established ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. As noted above, there is no "test set" in the context of clinical data for expert adjudication.
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:
Not applicable. This is not an AI/software device, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an AI/software device. The performance reviewed here is the physical device's standalone performance under various bench and in vitro conditions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the non-clinical and biocompatibility tests are defined by the established industry standards and test methods (e.g., ISO 10555-1:2013, ISO 10993 series, ASTM F640-12). The acceptance criteria outlined within these standards serve as the "truth" against which the device's performance is measured. For example, for cytotoxicity, the ground truth is "Viability > 70%."
8. The sample size for the training set:
Not applicable. There is no training set as this is not an AI/software device.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of device.
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