(93 days)
The FETCH™ Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
The FETCH Aspiration Catheter is a rapid exchange, low-profile tip, dual lumen catheter that uses a 0.014" (0.36 mm) guide wire to track to the target site. It is used for aspiration of fresh, soft emboli and thrombi. Its outer diameter 0.052" (1.33 mm) or 4F allows advancement to the target site through a 6F (0.070" I.D.) guiding catheter. A radiopaque marker is located about 2 mm from the distal tip. FETCH is provided with an extension line, 30 cc syringe, one-way stopcock and a 40 micron collection basket. This basket can be used to filter aspirated blood for laboratory analysis of collected thrombus.
The provided text is related to an FDA 510(k) premarket notification for the "FETCH Aspiration Catheter." It details the regulatory approval process and includes a brief device description and indications for use. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or detailed performance studies.
The document states: "Preclinical animal testing supported the substantial equivalency of the FETCH Aspiration Catheter to the predicate device for the indicated use." This indicates that animal testing was performed, but no details of the study design, acceptance criteria, or results are provided. The FDA 510(k) clearance process often relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical efficacy studies for many Class II devices.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance: Not available.
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method for the test set: Not available.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not available.
- If a standalone performance study was done: "Preclinical animal testing" was mentioned, but no study details are provided to assess if it was a standalone performance study in the context of your request (e.g., in a human clinical setting or with detailed metrics).
- The type of ground truth used: Not available beyond the mention of "preclinical animal testing."
- The sample size for the training set: Not applicable/available, as this appears to be a medical device clearance, not an AI/algorithm-based device in the context of your question about training sets.
- How the ground truth for the training set was established: Not applicable/available.
§ 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).