(374 days)
The Retriever II is indicated for use in the retrieval of intravascular occlusion coils misplaced during interventional radiological procedures in peripheral and neurovasculature.
The Retriever II (R-II) is a single use, disposable endovascular Snare. The R-II consists of a flexible core wire, radiopaque coils at the distal end of the corewire facilitate fluoroscopic visualization. Fiber strands are attached to the distal tip of the core wire. A platinum tip marker is attached at the distal end of the fibers to facilitate fluoroscopic visualization. The fibers, when manipulated, work to ensnare the misplaced coil.
No, the provided document does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested.
The document is a 510(k) summary and the FDA's clearance letter for the Retriever II Endovascular Snare Device. It states that:
- "TESTING in SUPPORT of SUBSTANTIAL EQUIVALENCE DETERMINATION: The results of bench testing (tensile, turns to failure, tip flexibility, fiber retention), animal studies, and Biocompatibility testing support the substantial equivalence claims of the R-II for its intended use."
- "Results of the bench testing, animal studies, and Biocompatibility testing in conjunction with the substantial equivalence claims as outlined in this premarket notification, effectively demonstrate that the R-II is substantially equivalent to the predicate device."
However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Information on any Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Details of a standalone (algorithm only) performance study (as this is a medical device, not an AI/algorithm-based device).
- Type of ground truth used (again, this is physical device testing).
- Sample size for training set (not applicable for this type of device submission).
- How ground truth for the training set was established (not applicable).
The document focuses on demonstrating substantial equivalence to a predicate device (Retriever-18) through general descriptions of bench testing, animal studies, and biocompatibility, rather than presenting a detailed performance study against specific acceptance criteria.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).