Search Results

The Aventus Thrombectomy System is indicated for:

· The non-surgical removal of emboli and thrombi from blood vessels.

· Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The Aventus Thrombectomy System is intended for use in the peripheral vasculature.

The Aventus Thrombectomy System is a catheter-based manual aspiration system designed for minimally invasive removal of emboli and thrombi from the peripheral vasculature and/or infusing fluids into the peripheral vasculature. The System is comprised of the following major components:

• Aventus Aspiration Catheter II .
• . Clot Management System consisting of:
  • . Aspiration Syringe
  • . Clot Canister

The System is compatible with a standard 24-French (24F) introducer sheath, 4-French (4F) Support Catheters and is to be used with 0.035" guidewires. The System is provided sterile and is intended for single use only.

The Aventus Aspiration Catheter II includes an atraumatic radiopaque Distal Tip with embedded sensors, and an angled aspiration orifice for directional aspiration and navigation without a dilator. A dedicated navigation catheter lumen for use with an off-the-shelf 4F Navigation Catheter, and dedicated infusion lumen for injection of fluids is also included in the shaft. The Catheter Handle assists the clinician in navigating within the vasculature and also includes a Sensing Indicator and houses the Sensing electronics. The Aspiration Catheter shaft incorporates a metallic reinforcement layer made of stainless steel, an inner liner and polymeric outer jacket having variable stiffness.

The System is provided with a 60-cc dual action manual syringe which allows for directional flow control and directs aspirated blood and clot into the Clot Canister.

This document is a 510(k) summary for the Inquis Medical Aventus Thrombectomy System (IM-2001/IM-0002). It describes the device, its intended use, and the performance data provided to demonstrate substantial equivalence to a predicate device.

Based on the provided text, the device in question is a medical device (Aventus Thrombectomy System), not an AI/software device. Therefore, the questions regarding acceptance criteria for AI/software, MRMC studies, standalone performance, ground truth for training/test sets, and sample sizes for training/test sets related to AI/software are not applicable.

The performance data section (VII. PERFORMANCE DATA) describes various tests conducted to support the substantial equivalence claim. Here's a breakdown of the relevant information provided:

1. A table of acceptance criteria and the reported device performance: This document does not present a formal table of "acceptance criteria" for the device's performance in the way one might expect for a software or AI model's accuracy. Instead, it lists various performance tests and states that the device "successfully met" or "complied with requirements" or "demonstrated that the physical and functional requirements were met."

   Performance Testing	Reported Device Performance and "Acceptance"
   Biocompatibility Testing	"...do not pose a risk of negative interaction with patients." (Leveraged from predicate)
   Sterilization	"demonstrated an SAL of 10-6." and "meets established pyrogen limit specifications." (Leveraged from predicate)
   Distribution, Packaging & Shelf-Life	"successfully tested demonstrating integrity of the sterile barrier and preservation of the System's properties." (Accelerated aging for 6-month shelf life leveraged from predicate)
   Software Testing	"successful software verification and validation testing, was provided as recommended by FDA Guidance..."
   Electrical Safety / EMC Testing	"complies with the requirements of IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6 and IEC 62366-1."
   Performance Testing - Bench	"demonstrated that the physical and functional requirements were met." This includes: Visual and Dimensional Inspection, Tensile Strength, Pressure/Leak Integrity, Clot Burden Removal Validation, Vacuum Test, Leak Test, Compatibility Testing, Torque Transmission Testing, Kink Testing, Simulated-Use Verification and Validation of Sensing. (Kink and Torque to Failure leveraged from predicate).
   Performance Testing - Non-Clinical	"demonstrated that the System was able to be used safely in a chronic large animal GLP study and met all pre-defined study endpoints." (Leveraged from predicate)

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The document does not specify exact sample sizes for each bench test (e.g., number of catheters tested for tensile strength).
   • For the non-clinical (animal) study, it mentions "a chronic large animal GLP study." It does not specify the number of animals or data provenance (country of origin), nor whether it was retrospective or prospective, though GLP (Good Laboratory Practice) studies are typically prospective.

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 is not applicable as the document describes performance testing of a physical medical device, not a diagnostic AI system requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable for the type of device and testing described.

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 as this is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. The device includes "disposable powered electronics and embedded software" for sensing (as stated in Section IV and VII), and "Software documentation, including successful software verification and validation testing, was provided." However, the description refers to V&V for the software functions of the device, not a standalone AI diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the physical and functional performance tests (bench testing), the "ground truth" would be established engineering specifications and physical measurements, rather than clinical consensus or pathology.
   • For the non-clinical animal study, the "ground truth" would be observed safety and performance metrics in the animal model, as defined by the study protocol and endpoints.

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set in the typical sense. The software mentioned is "embedded software" likely controlling device functions, not a learning algorithm trained on data.

9. How the ground truth for the training set was established:

   • Not applicable.

Ask a specific question about this device