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The Aventus Clot Management System is indicated for use with the Aventus Thrombectomy System for autologous blood transfusion.

The Aventus Clot Management System accessory allows for autologous injection of aspirated blood from the Aventus Thrombectomy System embolectomy procedure. The sterile, single-use Aventus Clot Management System is comprised of the following two components:

• Aspiration Syringe
• . Clot Canister
  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.
  The Clot Canister connects to the Aspiration Syringe via quick disconnect connector at the inlet port on the side of the Canister. The aspirant from the Aventus Thrombectomy System procedure is injected into the Clot Canister. The blood passes through the Clot Canister dual layer nominal 40u/200u polyester screen filter, filling a syringe pre-connected to the female luer lock that is positioned below the filter assembly. The clinician can then return the filtered blood back to the patient via a standard sterile syringe with a required suitable blood transfusion filter (not provided).
  The Clot Canister also has a flush port with a standard 3-way stopcock positioned above the filter assembly where an additional syringe can be attached to inject saline or air to assist in clot visualization without removing the lid.

The provided text describes a 510(k) premarket notification for the Aventus Clot Management System. The document focuses on regulatory approval and substantial equivalence to a predicate device, rather than detailed performance study results with specific acceptance criteria and performance metrics for an AI/ML component.

Therefore, I cannot provide the information requested in the format of acceptance criteria and reported device performance, sample sizes for test and training sets, expert qualifications, or details about MRMC studies. The device is a physical medical device (Autotransfusion apparatus), not an AI/ML-driven device, so many of the requested technical details are not applicable or present in this regulatory document.

However, I can extract the general performance testing categories that were conducted.

The document indicates that Inquis Medical performed comprehensive non-clinical bench testing to demonstrate that the device met all required specifications and performs as intended.

Here's what information I can glean from the provided text regarding performance testing, even without specific acceptance criteria and numerical results:

General Performance Testing Categories

The following categories of performance data were provided in support of the substantial equivalence determination:

• Biocompatibility Testing:

  • Tests Conducted: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemocompatibility (Hemolysis, Complement Activation, Thrombogenicity).
  • Guidance: Conducted in accordance with FDA Guidance Document for the Use of International Standard ISO 10993-1.
  • Conclusion: Demonstrated that the materials do not pose a risk of negative interaction with patients.

• Sterilization:

  • Tests Conducted: Sterilization testing and Bacterial Endotoxins Test (BET)/Limulus amebocyte lysate (LAL) testing.
  • Guidance/Standard: ISO 14937:2009 for sterilization, USP and AAMI ST72 for BET.
  • Conclusion: Demonstrated an SAL of 10^-6 and confirmed the system meets established pyrogen limit specifications.

• Distribution, Packaging, and Shelf-Life Testing:

  • Tests Conducted: Distribution testing and accelerated aging.
  • Conclusion: Successfully tested demonstrating integrity of the sterile barrier and preservation of properties through the labeled shelf-life.

• Performance Testing – Bench:

  • Tests Conducted: Visual and Dimensional Inspection, Tensile Strength, Pressure/Leak Integrity, Clot Burden Removal Validation, Vacuum Test, Leak Test, Compatibility Testing, Simulated-Use Particulate Testing, Hematocrit Testing, Mechanical Hemolysis Testing, Filtration Efficiency.
  • Conclusion: Design verification testing demonstrated that physical and functional requirements were met.

• Performance Testing – Non-Clinical (Animal Study):

  • Type of Study: GLP animal study (chronic large animal GLP study).
  • Guidance: Complied with GLP regulation (21 CFR Part 58) and FDA Guidance: General Considerations for Animal Studies for Cardiovascular Devices (July 2010), and FDA Guidance: General Considerations for Animal Studies Intended to Evaluate Medical devices (March 2023).
  • Conclusion: Demonstrated that the device was able to be used safely to return aspirated blood and met all pre-defined study endpoints.

Note: The document does not contain specific quantitative acceptance criteria or numerical results for any of these tests, nor does it refer to an AI/ML component or associated studies like MRMC or standalone algorithm performance. The focus is on the substantial equivalence of the physical device to a predicate device.

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