(97 days)
The Prodigy™ Thrombectomy System is intended for the removal and thrombi and thrombi from vessels of the peripheral arterial and venous systems.
Not for use in the coronaries, pulmonary vasculature, or the neurovasculature
The Prodigy™ Thrombectomy System is designed to remove thrombus from the vasculature using aspiration. The Prodigy™ Thrombectomy System is comprised of several components including:
- . Prodigy™ Catheter
- . Prodigy™ Twist
- . Prodigy™ Hotshot™ Controller
- TRUVIC Generator
- TRUVIC Canister
- . TRUVIC Tubeset
The single-lumen Prodigy™ Catheter targets aspiration from the TRUVIC Generator directly to the thrombus. The wire-based Prodigy™ Twist utilizes a soft, flexible polymeric tip to facilitate thrombus removal through the Prodigy™ Catheter as needed. The Prodigy™ Catheter is available in multiple diameters and both the Prodigy™ Catheter and Prodigy™ Twists are available in multiple effective lengths and are visible under fluoroscopy via radiopaque marker bands.
The Prodigy™ Hotshot™ Controller connects the Prodigy™ Catheter to the TRUVIC Generator and provides the user with the ability to control aspiration flow and visualize the extracted thrombus.
The provided text does not contain information about acceptance criteria and the study that proves a device meets those criteria in the context of a medical device cleared through a 510(k) submission.
The document is an FDA 510(k) clearance letter for the Prodigy™ Thrombectomy System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study proving the device meets them in the way one might expect for a de novo submission or a clinical trial for a novel device.
The "Non-Clinical testing / Performance Data" section (page 5) lists various tests performed, such as "Visual and Dimensional Verification," "Kink / Bend / Flex Verification," and "Simulated Use Performance Validation." It states, "The in vitro bench tests demonstrated that the Prodigy™ Thrombectomy System met all acceptance criteria and performed similarly to the predicate device." However, it does not explicitly state what those acceptance criteria were (e.g., a specific tensile strength value or a kink angle). It only broadly claims they were met.
Similarly, the "IN-VIVO GLP PRE-CLINICAL TESTING / PERFORMANCE DATA" section (page 6) mentions an animal study where "All acceptance criteria passed." Again, the specific acceptance criteria are not detailed.
Therefore, I cannot provide the requested table or answer most of the numbered questions because the specific acceptance criteria and detailed study results demonstrating their fulfillment are not present in this document.
To clarify, if the document had included a table like:
| Criterion | Acceptance Value | Reported Performance | Result |
|---|---|---|---|
| Tensile Strength Luer Lock | > 20 N | 25 N | Pass |
| Burst Pressure Catheter | > 500 psi | 550 psi | Pass |
...and then described the study (e.g., "A total of 10 samples were tested in a controlled lab environment according to ASTM FXXXX standard..."), I would be able to populate the requested information. However, this level of detail is absent.
§ 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).