(33 days)
The Aventus Thrombectomy System is indicated for:
- The non-surgical removal of emboli and thrombi from blood vessels.
- Iniection, 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 svstem 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 Thrombectomy Catheter
- Clot Management System consisting of:
- Aspiration Syringe
- Clot Canister
The System is compatible with a standard 24-French (24F) introducer sheath, 4F or 5F Navigation Catheters (based on Aventus Thrombectomy Catheter model) and is to be used with 0.035" guidewires. The System is provided sterile and is intended for single use only.
The Aventus Thrombectomy Catheter includes an atraumatic radiopaque Distal Tip with embedded sensors, and an angled aspiration orifice for directional aspiration and navigation without a dilator. The Catheter Handle assists the clinician in navigating within the vasculature and 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.
The provided document is a 510(k) summary for the Aventus Thrombectomy System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive details on a de novo clinical study with specific acceptance criteria and detailed performance of an AI algorithm.
Therefore, the requested information regarding acceptance criteria, specific device performance metrics in a clinical context (like sensitivity, specificity, accuracy), sample sizes for test sets, expert qualifications, and ground truth establishment, is not present in this document. The document primarily addresses engineering and safety performance data, often leveraged from the predicate device, to support the claim of substantial equivalence.
Here's an analysis based on the information available in the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for clinical performance (e.g., sensitivity, specificity, or success rates for thrombus removal in a clinical setting) or reported device performance against such metrics. Instead, it lists various engineering and safety performance tests and states that the "physical and functional requirements were met" and that the device "demonstrated that the System was able to be used safely ... and met all pre-defined study endpoints" in an animal study.
| Performance Testing Type | Criteria (Implicit from "met," "demonstrated," "complies") | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | No risk of negative interaction with patients | Materials do not pose a risk of negative interaction with patients. |
| Sterilization | SAL of 10^-6, meets pyrogen limit specifications | Achieved SAL of 10^-6, confirmed to meet pyrogen limit specifications. |
| Distribution, Packaging, Shelf-Life | Integrity of sterile barrier, preservation of properties | Demonstrated integrity of sterile barrier and preservation for 6-month shelf-life. |
| Software Testing | Complies with FDA Guidance | Documentation leveraged from predicate, as recommended by guidance. |
| Electrical Safety / EMC | Complies with IEC 60601-1, -1-2, -1-6, IEC 62366-1 | Complies with relevant IEC standards; electrical leak testing repeated on subject device. |
| Bench Performance Testing | Physical and functional requirements met | Physical and functional requirements were met (e.g., tensile strength, leak integrity, clot removal validation, vacuum, kink, simulated use, sensing verification). |
| Non-Clinical (GLP Animal Testing) | Safe usage in chronic large animal study; met pre-defined study endpoints | System was able to be used safely and met all pre-defined study endpoints in GLP animal study. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any clinical or human-use test set. The animal study mentions a "chronic large animal GLP study," but an N is not given.
- Data Provenance: Not specified for any clinical or human-use data. The animal study was conducted in compliance with GLP regulation (21 CFR Part 58), which implies a controlled, prospective study design, but the location is not mentioned.
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 information is not available in the document. The submission focuses on substantial equivalence based on material, engineering, and safety testing, not on a clinical performance study requiring expert ground truth establishment for diagnostic or treatment effectiveness.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the document, as there is no described clinical test set requiring expert adjudication for ground truth.
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
There is no mention of an MRMC study or AI assistance in this document. The device is a physical thrombectomy system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an AI algorithm. It's a medical device system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the safety and performance tests described:
- Biocompatibility: Ground truth is established by standardized testing protocols (ISO 10993-1:2018) and the observation of biological responses to the materials.
- Sterilization: Ground truth is established by demonstrating a Sterility Assurance Level (SAL) and meeting pyrogen limits.
- Bench Performance: Ground truth is against predefined engineering specifications and physical properties (e.g., tensile strength values, leak rates, clot removal efficiency in a model).
- Non-Clinical (GLP Animal Testing): Ground truth is established by pre-defined study endpoints focusing on safety and functional performance in an animal model, observed by veterinary and research staff.
Ultimately, the ground truth for this submission is that the device is substantially equivalent to its predicate based on the provided engineering, safety, and non-clinical data.
8. The sample size for the training set
This information is not applicable as the device is not an AI algorithm.
9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI algorithm.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).