(145 days)
The Excipio® SV Aspiration Catheter and Tubing is indicated for the non-surgical removal of fresh, soft emboli and thrombi from peripheral blood vessels.
The Excipio SV Aspiration Catheter and Tubing consists of an aspiration catheter which is a single, large inner lumen catheter with a hydrophilic coating (20cm outside the distal end) designed to navigate through the peripheral vasculature and provide the maximum luminal area for aspiration. The aspiration catheter will be available in 7F and 8F sizes. Sterile, single use aspiration tubing will be distributed to facilitate a vacuum connection between the aspiration catheter and the collection canister of the vacuum pump.
Since the provided text describes a medical device (catheter and tubing) rather than an AI/ML powered device, the requested information (such as sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size, etc.) is not applicable or available in the document.
The document discusses the non-clinical testing performed to establish substantial equivalence of the Excipio SV Aspiration Catheter and Tubing to a predicate device.
Here's a summary of the available information based on the provided text, focusing on the acceptance criteria and performance data for this type of medical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests/Assessments | Reported Device Performance |
|---|---|---|
| Excipio SV Aspiration Catheter | Visual Inspection | Met all acceptance criteria |
| Dimensional Inspection | Met all acceptance criteria | |
| Kink Resistance (material property) | Met all acceptance criteria | |
| Torsional Strength | Met all acceptance criteria | |
| Tensile Testing | Met all acceptance criteria | |
| Functional Testing: Vacuum Collapse | Performed similarly to the predicate device, functioned as intended | |
| Functional Testing: Kink Resistance | Performed similarly to the predicate device, functioned as intended | |
| Functional Testing: Torque Testing | Performed similarly to the predicate device, functioned as intended | |
| Functional Testing: Tip Pull | Performed similarly to the predicate device, functioned as intended | |
| Functional Testing: Proximal Shaft to Luer | Performed similarly to the predicate device, functioned as intended | |
| Functional Testing: Coating Length | Performed similarly to the predicate device, functioned as intended | |
| Coating Integrity | Met all acceptance criteria | |
| Particulate Testing | Met all acceptance criteria | |
| Tubing | Dimensional Inspection | Met all acceptance criteria |
| Tensile Testing | Met all acceptance criteria | |
| Functional Testing: Vacuum Collapse | Performed similarly to the predicate device, functioned as intended | |
| Functional Testing: Kink Resistance | Performed similarly to the predicate device, functioned as intended | |
| System-level Testing | Simulated Use Testing | Performed similarly to the predicate device, functioned as intended |
| Visual Inspection | Met all acceptance criteria | |
| Tubing Testing | Met all acceptance criteria | |
| Packaging and Sterile Barrier Testing | Met all acceptance criteria | |
| Biocompatibility (Catheter) | Cytotoxicity, Sensitization, Irritation, Acute System Toxicity, Material Mediated Pyrogenicity, Hemolysis, Complement Activation, Thrombogenicity | Results showed the device to be biocompatible |
| Biocompatibility (Tubing) | Cytotoxicity, Sensitization, Irritation | Results showed the device to be biocompatible |
| GLP Animal Study (Porcine) | In vivo thrombogenicity, acute performance, and safety | Usable, non-thrombogenic, raised no new safety questions |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not specified for individual bench tests. The animal study was conducted using a "porcine model," but the number of animals is not provided.
- Data Provenance: The "non-clinical laboratory testing" and "in vitro bench tests" were performed, indicating laboratory-generated data. The "GLP animal study (porcine)" indicates live animal data. Countries of origin are not specified for these tests. The data appears to be prospective as it was performed to support the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not applicable and not provided. The testing described involves objective physical and biological measurements, not expert interpretation of outputs like in AI/ML performance evaluation.
4. Adjudication Method
- This information is not applicable and not provided. The testing described involves objective measurements against predefined criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to this medical device submission.
6. Standalone Performance
- The document describes "Non-Clinical Testing/Performance Data" and "in vitro bench tests" which evaluate the device's performance properties as a standalone product (i.e., algorithm only without human-in-the loop performance). The animal study also evaluated standalone performance in an in-vivo setting.
7. Type of Ground Truth Used
- The "ground truth" for this device type is established by:
- Engineering specifications and standards: For dimensional, strength, and functional tests (e.g., kink resistance, tensile strength, vacuum collapse).
- Validated biological assays: For biocompatibility tests (e.g., cytotoxicity, hemolysis).
- In-vivo observations and measurements: For the GLP animal study (e.g., thrombogenicity, acute performance, safety).
8. Sample Size for the Training Set
- This information is not applicable and not provided. There is no AI/ML component described, so no 'training set' is used.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable and not provided, as there is no AI/ML component or training set.
§ 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).