(30 days)
The XL extraction catheter is indicated for:
- the removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial . system
- the removal/aspiration of embolic material (thrombus/debris) from vessels of the deep . venous system
- to infuse/deliver diagnostic or therapeutic agents .
The XL extraction catheter is an over-the-wire embolectomy catheter that has a working length of 120 cm (straight tip model 5090) or 122.5 cm (pigtail tip model 5091 when tip is straightened). The device is delivered over a 0.035 inch guidewire and through a 14F or larger introducer sheath. Proximal to the tip, the catheter has an extraction lumen opening supported by nitinol and has radiopaque marker bands on each side of the opening. The catheter lumen is constructed with a PTFE liner, stainless steel braid, and various durometers of Pebax® (polyether block amide) resin loaded with barium sulfate. This construction creates a radiopaque shaft transitioning from a stiff proximal region to a more-flexible distal region. A silicone oil wipe is applied to the distal end of the catheter as a lubricant to enhance deliverability.
The proximal end of the catheter has a strain relief and hemostatic Y-junction hub. One branch of the hub is for the guidewire and the other for the attached extension line with roller clamp. The proximal end of the extension line has a custom luer fitting designed to be compatible with the custom luer tip of the supplied 60 mL vacuum-locking syringes. The supplied filter baskets can be used to filter blood aspirated during the procedure for laboratory analysis of any thrombus.
This document is a 510(k) summary for the XL Extraction Catheter, indicating its substantial equivalence to a predicate device. It explicitly states that clinical studies were not performed to support this submission. Instead, the determination of substantial equivalence is based on non-clinical testing. Therefore, many of the requested criteria related to clinical studies and human reader performance cannot be provided.
Here is the information that can be extracted from the provided text regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of acceptance criteria with specific numerical values or directly reported performance values for each criterion. It generally states that "Results of non-clinical testing met the specified acceptance criteria."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional verifications | Met specified criteria |
| Visual inspections | Met specified criteria |
| Simulated anatomy/concomitant device use | Met specified criteria |
| Thrombus aspiration | Met specified criteria |
| Extraction rate | Met specified criteria (≥1 mL/second shared characteristic with predicate) |
| Kink testing | Met specified criteria |
| Torque testing | Met specified criteria |
| Air aspiration | Met specified criteria |
| Liquid leak and flush | Met specified criteria |
| Tensile | Met specified criteria |
| Radiopacity | Met specified criteria |
| Biocompatibility: Cytotoxicity | Met specified criteria |
| Biocompatibility: Sensitization | Met specified criteria |
| Biocompatibility: Irritation/intracutaneous reactivity | Met specified criteria |
| Biocompatibility: Acute systemic toxicity | Met specified criteria |
| Biocompatibility: Material-mediated pyrogens | Met specified criteria |
| Biocompatibility: Hemolysis | Met specified criteria |
| Biocompatibility: Coagulation | Met specified criteria |
| Biocompatibility: Prothrombin time | Met specified criteria |
| Biocompatibility: Hematological parameters | Met specified criteria |
| Biocompatibility: Complement activation | Met specified criteria |
| Biocompatibility: Thrombogenicity | Met specified criteria |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for any of the non-clinical tests.
- Data Provenance: Non-clinical testing, presumably conducted by Vascular Solutions, Inc. or contractors. No information on country of origin. Retrospective/Prospective is not applicable as these are laboratory/bench tests, not clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable as this was a non-clinical study for device substantial equivalence, not a clinical study requiring expert ground truth for interpretation of imaging or clinical outcomes.
4. Adjudication Method for the Test Set
- Not applicable for non-clinical testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document explicitly states that the determination of substantial equivalence is based on non-clinical testing. No clinical studies, and therefore no MRMC studies, were performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This is a medical device (catheter), not an algorithm or AI. The tests performed are for the physical properties and functionality of the catheter.
7. Type of Ground Truth Used
- For the non-clinical tests, the "ground truth" would be established by the defined test standards and specifications for each physical and material characteristic (e.g., tensile strength required, specific aspiration rate, absence of leakage). These are objective measurements rather than expert consensus, pathology, or outcomes data, which are typically associated with clinical ground truth.
8. Sample Size for the Training Set
- Not applicable. This is not an AI/algorithm device requiring a training set. The device design and manufacturing processes are validated through the non-clinical tests mentioned.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
§ 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).