(167 days)
The ReFLOW Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary, carotid and peripheral vasculature.
The ReFLOW Aspiration Catheter is an embolectomy catheter comprised of a catheter shaft and hub. It is 150cm long and is available in 6F and 7F diameters.
The provided text describes the 510(k) summary for the ReFLOW Aspiration Catheter, which includes performance data derived from non-clinical testing. It does not contain information about acceptance criteria or a study with specific performance metrics such as sensitivity, specificity, or AUC, which are typically used for AI/ML-based device performance evaluations. The data provided focuses on physical and biological characteristics of the device, not a comparative clinical study or AI algorithm performance.
Therefore, many of the requested categories cannot be filled as the information is not present in the provided document.
Here's a breakdown of the available information and what's missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance |
|---|---|---|
| Non-clinical Device Testing | Not explicitly stated as acceptance criteria, but implied to meet "known standards or product specifications" | |
| Dimensional Verification | Successfully completed | |
| Visual Inspection | Successfully completed | |
| Particulate Evaluation | Successfully completed | |
| Tube to Stopcock Tensile Strength | Successfully completed | |
| Tube to Luer Tensile Strength | Successfully completed | |
| RX Notch Tensile Strength (if applicable) | Successfully completed | |
| Hub to Shaft Tensile Strength | Successfully completed | |
| Loading Tool Tensile Strength | Successfully completed | |
| Liquid Leak Pressure Test | Successfully completed | |
| Wall Integrity Test | Successfully completed | |
| Guidewire Loading Test | Successfully completed | |
| Torque Strength | Successfully completed | |
| Coating Adhesion Test | Successfully completed | |
| Kink Resistance | Successfully completed | |
| Liquid Aspiration Leak Test | Successfully completed | |
| Aspiration Flow Rate | Successfully completed | |
| Thromboemboli Aspiration Simulated Use Testing | Successfully completed | |
| Biocompatibility Testing | ||
| Cytotoxicity | Successfully completed | |
| Intracutaneous | Successfully completed | |
| Systemic Toxicity | Successfully completed | |
| Maximum Sensitization | Successfully completed | |
| Material Mediated Pyrogen | Successfully completed | |
| ASTM Hemolysis | Successfully completed | |
| In Vitro Hemolysis | Successfully completed | |
| C3a Complement Activation | Successfully completed | |
| SC5-b Complement Activation | Successfully completed | |
| Partial Thromboplastin Time | Successfully completed | |
| In vivo Thromboresistence | Successfully completed | |
| Limulus Amebocyte Lysate | Successfully completed |
2. Sample size used for the test set and the data provenance
The document describes non-clinical bench and biocompatibility testing. It does not refer to a "test set" in the context of clinical data, AI/ML performance evaluation, or patient-specific samples. The tests were performed on the device itself. Therefore, sample size and data provenance as requested are not applicable in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study that uses expert-established ground truth for a test set. The "ground truth" for the non-clinical tests would be the established scientific methods and pass/fail criteria for each specific test (e.g., a certain tensile strength must be achieved, or a certain level of cytotoxicity must not be exceeded).
4. Adjudication method for the test set
Not applicable. There is no test set in the clinical evaluation sense that would require adjudication.
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. This is not an AI/ML-based device and no MRMC study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML-based device.
7. The type of ground truth used
For the non-clinical and biocompatibility tests, the ground truth is based on established industry standards, scientific methodologies, and product specifications. For example, tensile strength tests have defined failure points, and biocompatibility tests have defined acceptable limits for various biological responses.
8. The sample size for the training set
Not applicable. There is no training set mentioned as this is not an AI/ML-based device.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned as this is not an AI/ML-based 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).