(190 days)
The LeMaitre Irrigation Catheters are used to irrigate arteries after thrombo-embolectomy, veins after thrombectomy, and the biliary tree after intraductal stone removal.
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The provided document is a 510(k) clearance letter from the FDA for the LeMaitre Irrigation Catheter. It states the device's substantial equivalence to a legally marketed predicate device for its indicated uses. However, this type of regulatory document does not contain the detailed information required to answer your request about acceptance criteria and a study proving device performance.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Information on a test set (sample size, data provenance).
- Number or qualifications of experts for ground truth.
- Adjudication method.
- Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results from a standalone algorithm performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is solely a regulatory approval based on the comparison to a predicate device, not a performance study report. To obtain the kind of information you are looking for, one would typically need access to the technical documentation submitted to the FDA, such as preclinical or clinical study reports, which are not usually made public in this format.
§ 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).