(275 days)
The LMI Carotid Endarterectomy Shunt Catheter is intended for use during a carotid endarterectomy procedure to provide temporary carotid artery bypass (blood flow) for cerebral circulation.
The LMI Carotid Endarterectory Shunt Catheter consists of a multi-lumen, straight or tapered silicone tube with or without stainless steel wire reinforcement with one or more silicone balloons formed at either or both ends. Additional silicone tubes are attached at the approximate center and at approximately 90 degrees of the main tube for communicaton with the main central lumen as well as the smaller lumen used to inflate the balloons that are located on either or both ends. The proximal ends of the balloon inflation tubes are fitted with a female luer connector and may on some models incorporate a strain relief that is bonded to the silicone shaft. The proximal communicating tube is also fitted with a female luer connector and models incorporate a strain relief that is bonded to the silicone shaft. Stopcocks are attached to the female her connecting tubes. The ends of the main nulti-lumen tube are end formed to create a soft leading edge. The main multi-lumen tube may also be tapered in certain models to enchance blood tlow.
I am sorry, but the provided text from the 510(k) notification for the LMI Carotid Endarterectomy Shunt does not contain the detailed information required to fill out all the sections of your request. This document is a summary of the device for regulatory clearance, not a clinical study report.
Specifically, the text does not contain information about:
- Acceptance criteria and reported device performance in a table format. It states the device is "substantially equivalent" to predicate devices, but doesn't provide specific performance metrics or acceptance criteria that were met through a study.
- Sample size used for the test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human readers with/without AI assistance. (This is not applicable as it's a medical device, not an AI/software device).
- Whether a standalone (algorithm only) performance study was done. (Not applicable as it's a physical medical device).
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The document discusses the device's description, intended use, principle of operation, and its substantial equivalence to other legally marketed devices based on materials, construction, sterilization, and indicated use. The FDA letter confirms the substantial equivalence finding, allowing the device to be marketed.
To provide the information you're looking for, you would typically need a clinical study report or a more detailed technical file for the device, which would include performance data and the methodology of any testing conducted. This 510(k) summary focuses on regulatory clearance based on equivalence rather than detailed performance study results.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).