(29 days)
The Pounce™ Thrombectomy System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature.
The Surmodics Pounce™ Thrombectomy System is a percutaneous catheter system designed to facilitate mechanical thrombus removal in the peripheral arterial vasculature. The system is comprised of three separate components: a Delivery Catheter, a Basket Wire with a preloaded loading tool, and the Funnel Catheter. The system contains radiopaque components to conduct the procedure and is intended to be introduced through a minimum 7Fr guide sheath.
The Delivery Catheter is a flexible 5Fr catheter designed to deliver the Basket Wire to the location of the thrombus. Incorporated in the catheter is a radiopaque marker band located at the distal tip.
The Basket Wire is comprised of two distal self-expanding baskets mounted a core wire for capturing thrombus. The distal capture baskets have integral radiopaque markers mounted on the struts of the basket for basket visibility under fluoroscopy.
The Funnel Catheter is used for thrombus collection and retrieval in conjunction with the Basket Wire. The Funnel Catheter is comprised of an inner funnel catheter and an outer delivery catheter. The two catheters work together to allow unsheathing and sheathing of the funnel using the slider button on the integrated handle.
This document is a 510(k) premarket notification for the Surmodics Pounce™ Thrombectomy System. It outlines the device's description, indications for use, and a comparison to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative format, nor does it present device performance against specific targets for efficacy. Instead, it describes a series of bench tests conducted to demonstrate substantial equivalence to the predicate device after modifications. The reported performance is a qualitative statement of meeting these testing requirements.
| Acceptance Criterion (Implicit) | Reported Device Performance (Qualitative) |
|---|---|
| Maintain specified dimensions | Evaluated through dimensional testing. |
| Withstand tensile forces | Evaluated through tensile strength testing. |
| Prevent air and liquid leakage | Evaluated through air and liquid leak testing. |
| Maintain handle integrity under specified force | Evaluated through handle split force testing. |
| Maintain components in place under specified force | Evaluated through retention force testing. |
| Present atraumatic surfaces | Evaluated through atraumatic surfaces testing. |
| Function as intended when assembled | Evaluated through assembled functionality testing. |
| Withstand rotational forces | Evaluated through torque strength testing. |
| Achieve specified lock and unlock forces | Evaluated through lock and unlock force testing. |
| Maintain tensile strength of components | Evaluated through tensile strength testing (listed twice, suggesting different components or aspects). |
| Maintain integrity during packaging and distribution | Evaluated through packaging/distribution testing. |
| Exhibit biocompatibility | Evaluated through biocompatibility testing. |
| Substantial equivalence to predicate device (K211492) | "Changes to the predicate device that have led to the submission of this new 510(k) are ergonomic and branding in nature... All characteristics that were not identical...were verified through performance bench and biocompatibility testing and determined to be substantially equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the bench tests. The tests are described as "design verification" and "biocompatibility testing." These are typically laboratory-based engineering tests, not clinical studies involving human or animal subjects. Therefore, the concept of "data provenance" (country of origin, retrospective/prospective) as it applies to clinical data is not relevant here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This report details bench testing, not a study requiring expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication in this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement
No. The document explicitly states: "No clinical studies were required for the Pounce Thrombectomy System." Therefore, no MRMC study was conducted.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a medical instrument (thrombectomy system), not an AI algorithm, so standalone performance in that context is not relevant.
7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the bench testing, the "ground truth" would be the engineering specifications and established standards for performance and biocompatibility for medical devices. The device was tested against these predefined criteria to ensure it met the necessary performance characteristics and was safe for its intended use, demonstrating substantial equivalence to its predicate.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. 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).