(29 days)
The AXS Vecta Aspiration Catheter, as part of the AXS Vecta Aspiration System, is indicated in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - MI and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.
The Stryker AXS Vecta Aspiration System includes an aspiration catheter and its accessories, including the Scout Introducer, the Peel-Away Introducers, the Hemostasis Valve, the AXS Universal Aspiration Tubing, the Medela Dominant Flex Pump, and the AXS Universal Liner Set.
This document is a 510(k) summary for the AXS Vecta Aspiration System, which is a percutaneous catheter used for revascularization in patients with acute ischemic stroke. The submission seeks to demonstrate substantial equivalence to a previously cleared predicate device (K190212).
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document provides a "Performance Testing Summary" table (Table 2) which includes the "Test" conducted and the "Conclusion". While it states "All units met the acceptance criteria and passed," the specific acceptance criteria values for each test are not explicitly listed in this document. The table implicitly states that the device met the unlisted criteria.
| Test | Reported Device Performance (Conclusion) | Explicit Acceptance Criteria |
|---|---|---|
| Visual Inspection (Packaging: Pouch Visual) | All units met the acceptance criteria and passed Packaging Visual Inspection. | Not explicitly stated |
| Visual Inspection (Packaging: Undamaged Product) | All units met the acceptance criteria and passed Packaging Visual Inspection. | Not explicitly stated |
| Tensile Strength | All units met the acceptance criteria and passed Tensile Strength testing. | Not explicitly stated |
| PTFE Delamination | All units met the acceptance criteria and passed PTFE Delamination testing. | Not explicitly stated |
| Torque Strength | All samples met acceptance criteria and passed Torque Strength testing. | Not explicitly stated |
| Catheter Burst | All samples met acceptance criteria and passed Catheter Burst testing. | Not explicitly stated |
| Leak (Liquid) | ||
| Leak (Air) | All samples met acceptance criteria and passed the Air and Liquid Leakage testing. | Not explicitly stated |
| Dimensional (ID, OD, & Working Length) | All samples met acceptance criteria and passed Dimensional testing. | Not explicitly stated |
| Kink Resistance | All samples met acceptance criteria and passed Kink Resistance testing. | Not explicitly stated |
| Visual Inspection (Transition & Tip) | All samples met acceptance criteria and passed both the transition and tip visual inspections. | Not explicitly stated |
| Lumen Patency | All samples met acceptance criteria and passed Lumen Patency testing. | Not explicitly stated |
| Vacuum Drop | All samples met acceptance criteria and passed Vacuum Drop testing. | Not explicitly stated |
| Tip Flexibility | All samples met acceptance criteria and passed Tip Flexibility testing. | Not explicitly stated |
| Friction Force | All samples met acceptance criteria and passed Friction Force testing. | Not explicitly stated |
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 states, "All units met the acceptance criteria" or "All samples met acceptance criteria" for each test, implying that the acceptance criteria were met by all tested units/samples. However, the specific number of samples used for each non-clinical bench test is not explicitly mentioned.
No animal or clinical studies were performed for the current submission. The document states that animal testing previously conducted for the AXS Vecta Aspiration System was leveraged (from K190212, K172167, and K181354). The provenance of this leveraged animal data (country of origin, retrospective/prospective) is not specified in this 510(k) summary.
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)
This 510(k) summary primarily relies on non-clinical bench testing. Therefore, there are no human experts establishing ground truth in the context of diagnostic performance or clinical outcomes. The "ground truth" for bench tests is defined by engineering specifications and test protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since no clinical or human-reader studies were conducted for this submission, an adjudication method for a test set is not applicable.
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 is a medical device (catheter) and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an algorithm's performance without human interaction. This is not applicable as the device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical bench tests (e.g., tensile strength, burst pressure, dimensions), the ground truth is based on engineering specifications and established test methods that define what constitutes acceptable performance for a medical device of this type.
8. The sample size for the training set
This is not applicable as the device is a physical medical device (catheter) and not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
§ 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).