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510(k) Data Aggregation
(258 days)
AXS Vecta Aspiration Catheter
The AXS Vecta Intermediate 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 AXS Vecta Intermediate Catheter is also indicated for use as a conduit for retrieval devices.
The AXS Vecta Intermediate Catheter is a single lumen, flexible stiffness catheter. It has a radiopaque marker band on the distal end and a Luer hub at the proximal end. The AXS Vecta Intermediate Catheter shaft has a lubricious hydrophilic coating at the distal end (distal 25cm) to reduce friction during use. It is packaged with one Scout Introducer, one hemostasis valve, and two peel-away introducers.
The Scout Introducer may be used in conjunction with the AXS Vecta Intermediate Catheter to facilitate in the introduction of the AXS Vecta Intermediate Catheter into distal vasculature and aid in navigation to distal anatomy. The Scout Introducer has a lubricious hydrophilic coating at the distal end to reduce friction during use. The inner lumen of the AXS Vecta Intermediate Catheter is compatible with the Scout Introducer, guide wires and microcatheters. The inner lumen of the Scout Introducer is compatible wires and microcatheters of an outer diameter of less than 0.044in.
The AXS Vecta Intermediate Catheter's acceptance criteria and the studies proving it meets them are described below. The device is not an AI/ML device, so certain categories will be marked as "Not Applicable".
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Design Verification Testing | ||
| Particulate Characterization | Particulate generated during simulated use must be acceptable. | Particulate generation was acceptable. |
| Design Validation Testing | ||
| Simulated Use (Torque, ID, Product Compatibility) | Test catheters must meet applicable user needs: introduction of interventional devices into the peripheral and neuro vasculature. | All test samples met the applicable user needs and design specifications. |
| Shelf Life Testing | Must meet established acceptance criteria (specific criteria not detailed in the provided text). | Results met the established acceptance criteria. |
| Sterilization Testing | Must meet established acceptance criteria (specific criteria not detailed in the provided text) and achieve a sterility assurance level (SAL) of 10-6. | Results met the established acceptance criteria. A SAL of 10-6 has been demonstrated. |
| Biocompatibility | Must be in accordance with EN ISO 10993-1 for an externally communicating medical device with circulating blood contact for less than 24 hours. | Testing for the identical catheter component in the Reference device (K172167 and K181354) supports the biocompatibility of the subject device. |
2. Sample Size Used for the Test Set and Data Provenance:
The document primarily refers to "test samples" for bench testing and does not explicitly state the numerical sample size for each bench test. For the "Simulated Use" test, it mentions "All test samples," implying N > 1, but the exact number isn't provided.
- Particulate Characterization: Not explicitly stated.
- Simulated Use: Not explicitly stated.
- Shelf Life Testing: Not explicitly stated.
- Sterilization Testing: Not explicitly stated.
- Biocompatibility: Not explicitly stated for specific tests, but based on the Reference device.
Data Provenance: The studies were conducted by Stryker Neurovascular ("Stryker Neurovascular has demonstrated...") and are retrospective for most tests as they leverage previous device submissions (K172167 and K181354). The animal study, for instance, was also performed to support previously cleared devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This device is a physical medical catheter, and the evaluation involves engineering and performance testing, not analysis of medical images or data requiring expert interpretation for ground truth.
4. Adjudication Method:
Not applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This is a physical medical device (catheter), not an AI/ML system that would involve human readers.
6. Standalone (Algorithm Only) Performance:
No. This is a physical medical device.
7. Type of Ground Truth Used:
For the performance tests, the "ground truth" is defined by compliance with established engineering design specifications, international standards (e.g., EN ISO 10993-1), and acceptable performance in simulated use models. For example:
- Particulate Characterization: Acceptable levels of particulates.
- Simulated Use: Meeting applicable user needs and design specifications in an in vitro neurovascular model.
- Shelf Life/Sterilization: Meeting established acceptance criteria for shelf life and achieving a specific sterility assurance level.
- Biocompatibility: Compliance with EN ISO 10993-1.
8. Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI/ML system requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. See point 8.
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