FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

Device Description

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.

AI/ML Overview

The acceptance criteria and study proving the device meets them are described in the provided text.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Test Method Summary	Acceptance Criteria	Conclusions (Reported Device Performance)
Simulated Use - Bench (AXS Vecta Aspiration System)	AXS Vecta Aspiration System underwent simulated use testing by a physician in a benchtop model.	Test samples must meet predetermined user needs.	AXS Vecta Aspiration System test samples met the acceptance criteria for Simulated Use - Bench to demonstrate that the AXS Vecta System is substantially equivalent to the predicate device.
Simulated Use Testing – Usability (AXS Vecta Aspiration System)	AXS Vecta Aspiration System underwent simulated use testing by a physician in a benchtop model.	Test samples must meet predetermined user needs.	AXS Vecta Aspiration System test samples met the acceptance criteria for Simulated Use - Usability to demonstrate that the AXS Vecta Aspiration System is substantially equivalent to the predicate device.
Vacuum Drop / Suction Connector Secure Attachment (Aspiration Tubing Set)	Vacuum pressure measured at source and tip to evaluate pressure difference.	Test sample results must meet or exceed existing pressure specifications.	AXS Vecta Aspiration System test samples met the acceptance criteria for Vacuum Drop to demonstrate that the AXS Vecta Aspiration System is substantially equivalent to the predicate device.
Lumen Patency (Aspiration Tubing Set)	Samples were evaluated for lumen collapse during aspiration.	Test sample results must meet or exceed existing lumen patency specifications.	AXS Vecta Aspiration System test samples met the acceptance criteria for Lumen Patency to demonstrate that the AXS Vecta Aspiration System is substantially equivalent to the predicate device.
Note: For Calculated Force at Tip (shown in a previous table within the document), the reported values for the Subject Device (AXS Vecta Aspiration System) are 0.025 kgf for 0.071 in ID and 0.027 kgf for 0.074 in ID. The original document does not explicitly state the acceptance criteria for force at tip, but compares it to values for the predicate and reference devices, implying that similar characteristics are acceptable.	Note: For Calculated Force at Tip (shown in a previous table within the document), the measurement method is not explicitly detailed but involves measuring Catheter Inner Diameter (ID) to calculate force.	Note: For Calculated Force at Tip, the document doesn't explicitly state numerical acceptance criteria. However, the comparison table implicitly suggests that the calculated forces for the subject device (0.025 kgf for 0.071 in ID and 0.027 kgf for 0.074 in ID) are considered acceptable because they are similar to or slightly higher than the predicate device (0.024 kgf for 0.071 in ID, 0.026 kgf for 0.074 in ID) which was already cleared. The text states: "a calculation of the force at the tip demonstrated that the pressure differences and forces exhibited on the product with the different pumps are minimal."	The calculated forces at the tip for the AXS Vecta Aspiration System (0.025 kgf for 0.071 in ID and 0.027 kgf for 0.074 in ID) are shown to be comparable to the predicate device, supporting substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document repeatedly refers to "test samples" for each test. However, the exact number of samples used for "Simulated Use - Bench," "Simulated Use – Usability," "Vacuum Drop / Suction Connector Secure Attachment," and "Lumen Patency" tests is not explicitly stated.
Data Provenance: The tests are described as "benchtop model" tests and "Animal testing previously conducted for the Zenith Flex System was used to support this change." This indicates:
- Bench Tests: Performed in a laboratory setting.
- Animal Testing: The previous animal testing for the predicate device (Zenith Flex System) was retrospectively leveraged. The original context of this animal testing (country of origin, etc.) is not detailed in this document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For "Simulated Use - Bench" and "Simulated Use – Usability," the testing was conducted "by a physician." The document specifies "a physician" (singular).
Qualifications of the physician: Not explicitly stated beyond "physician."

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method (e.g., 2+1, 3+1). The "Simulated Use" tests were conducted "by a physician," and the "test samples must meet predetermined user needs." It implies a direct assessment by the physician against predefined criteria rather than an adjudication process involving multiple reviewers of outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. The document explicitly states: "No clinical study was conducted as bench and animal testing was determined sufficient for verification and validation purposes."

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a medical aspiration system, not an AI algorithm. Therefore, a standalone (algorithm only) performance study would not be relevant.

7. Type of Ground Truth Used

Expert Assessment/Predicate Device Performance:
- For the "Simulated Use" tests, the ground truth was effectively whether the "test samples met predetermined user needs" as assessed by a physician.
- For the engineering tests (Vacuum Drop, Lumen Patency, Calculated Force at Tip), the ground truth was based on meeting "existing pressure specifications" or "existing lumen patency specifications," which are predefined technical performance standards, and comparison to the performance of the predicate device.
- For the animal testing (leveraged from the predicate), the ground truth would have been safety and efficacy outcomes observed in the animal model.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there is no training set for this type of device.

Summary

Regulation Number and Section

§ 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).