(137 days)
The Export Advance™ Aspiration Catheter is indicated for:
- -Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, and
- To sub selectively infuse/deliver diagnostics or therapeutics agents with or without vessel occlusion.
The Export Advance™ Aspiration Catheter is a dual lumen catheter used for the aspiration of thrombus and/or debris from a vascular site. The Export Advance™ may also be used for the infusion of diagnostic or therapeutic agents to a desired vascular site.
The provided text describes the Medtronic Export Advance Aspiration Catheter, which is indicated for the removal/aspiration of embolic material from vessels of the arterial system and for subselectively infusing/delivering diagnostic or therapeutic agents. This device is an aspiration catheter, not an AI/ML medical device. Therefore, the information requested in the prompt, such as acceptance criteria and studies related to AI/ML performance, is not applicable.
The document focuses on demonstrating substantial equivalence to a predicate device (Export AP Catheter) through non-clinical bench testing and biocompatibility testing. No clinical investigation was performed on the subject device.
Here's an overview of the non-clinical testing performed:
1. Acceptance Criteria and Reported Device Performance:
The document broadly states that the device "met the acceptance criteria and performance similar to the predicate device" based on design verification (bench) testing. Specific quantitative acceptance criteria or detailed device performance metrics for each test are not provided in this summary. Instead, it lists the types of tests performed.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Design Verification (Bench) Testing: | "met the acceptance criteria and performance similar to the predicate device." Specific quantitative values are not provided in this summary. |
| Profile Dimensions | Passed |
| Guide Wire Lumen ID | Passed |
| Working Length | Passed |
| Proximal Shaft Tensile | Passed |
| Microlumen Tear | Passed |
| Tip Tensile | Passed |
| Marker Band Tensile | Passed |
| Hub Tensile | Passed |
| Stylet Hub Tensile | Passed |
| Vacuum Integrity | Passed |
| Pressure Integrity | Passed |
| Air Aspiration | Passed |
| Proximal Shaft Crush | Passed |
| Proximal Shaft Buckle | Passed |
| Evacuation Flow Rate | Passed |
| Particle Retrieval | Passed |
| 2D Track and Lesion Cross | Passed |
| Lubricity & Durability | Passed |
| Proximal Shaft Stiffness Room Temp | Passed |
| Proximal Shaft Stiffness Body Temp | Passed |
| Torque Strength | Passed |
| Distal Kink | Passed |
| Particulate Generation | Passed |
| Biocompatibility Testing: | "concluded full biocompatibility testing". No new safety or effectiveness issues were raised. |
| Cytotoxicity | Passed |
| In vitro Hemolysis | Passed |
| Systemic Toxicity | Passed |
| Sensitization | Passed |
| C3a Complement Activation | Passed |
| Sc5b9 Complement Activation | Passed |
| ISO Intracutaneous Reactivity | Passed |
| USP Material Mediated Pyrogen Study | Passed |
| In vivo Thromboresistance | Passed |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify sample sizes for each of the design verification (bench) tests. The data provenance is described as "Design verification (bench) testing" and "Pre-clinical in vivo (non-GLP) studies," implying laboratory and animal testing, respectively. This data is retrospective from the perspective of the 510(k) submission, as the tests were completed before submission. The country of origin is not explicitly stated but can be inferred to be the US, given the submission to the FDA.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable, as this is not an AI/ML device requiring expert-established ground truth for a test set. The evaluation is based on engineering specifications and biological safety.
4. Adjudication Method:
Not applicable, as this is not an AI/ML device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable, as this is not an AI/ML device designed to assist human readers.
6. Standalone (Algorithm Only) Performance:
Not applicable, as this is a physical medical device, not a software algorithm.
7. Type of Ground Truth Used:
For design verification testing, the "ground truth" would be established by the engineering specifications and performance standards met by the predicate device and relevant industry standards. For biocompatibility testing, the ground truth is based on established biological safety standards (e.g., ISO 10993-1 and 21 CFR 58).
8. Sample Size for the Training Set:
Not applicable, as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as this is not an AI/ML device.
§ 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).