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CES Pushable Coils may be used to reduce or block the rate of blood flow in vessels of the neurovasculature for the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas and other vascular lesions of the brain, spinal cord and spine.

The CES Vascular Occlusion System consists of straight and shaped CES Pushable Coils (made from platinum alloy and synthetic fibers) and the CES Coil Pusher (with two radiopaque tip markers). The pushable coils are designed for use under fluoroscopy with microcatheters having a minimum 0.21" I.D.

I am unable to provide a description of the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided text from the 510(k) summary for the CES Vascular Occlusion System does not contain information about specific performance acceptance criteria or details of a study designed to demonstrate meeting those criteria.

The document primarily focuses on establishing substantial equivalence to predicate devices based on design, materials, sterilization, and indications for use. It lists predicate devices and their 510(k) numbers, and indicates that "All applicable biocompatibility tests were successfully performed on the CES Pushable Coils." However, it does not state what the acceptance criteria for these tests were, nor does it provide any quantitative performance data from a specific study that would demonstrate the device meets any defined acceptance criteria for effectiveness or safety beyond biocompatibility.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert involvement, or comparative effectiveness.

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CES Occlusion Devices may be used to reduce or block the rate of blood flow in small or tapering vessels. They are indicated for use in the interventional radiologic management of arteriovenous malformations and other vascular lesions of the brain, spinal cord and spine when devascularization prior to definitive surgical resection is desired.

CES Vascular Occlusion System (occlusion device and coil pusher)

This document is a Premarket Notification 510(k) for the Cordis Corporation CES Vascular Occlusion System, submitted in 1997. It is a regulatory submission for a medical device and does not contain information about acceptance criteria or a study proving device performance against such criteria.

The document focuses on:

• General provisions (common/proprietary names, classification).
• Identification of predicate devices for substantial equivalence.
• Intended use and device description.
• Biocompatibility testing (stated as successfully performed, but no details of the tests or results are provided).
• Summary of substantial equivalence to predicate devices based on design, construction, indication for use, and performance characteristics (again, without detailed performance studies).

Therefore, I cannot provide the requested information in the table format because the source document does not contain any of the following:

• 1. A table of acceptance criteria and the reported device performance: This document is a summary of safety and effectiveness based on substantial equivalence to predicate devices, not a report of a specific clinical performance study with predefined acceptance criteria.
• 2. Sample sized used for the test set and the data provenance: No performance test set is described.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable.
• 4. Adjudication method: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not performed or reported in this document.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
• 7. The type of ground truth used: Not applicable as no detailed performance study is presented.
• 8. The sample size for the training set: Not applicable as no machine learning algorithm is involved.
• 9. How the ground truth for the training set was established: Not applicable.

The document states that "All appropriate biocompatibility tests were successfully performed on the CES Occlusion System," but it does not detail these tests, their acceptance criteria, or the specific results. The basis for clearance is "Summary of Substantial Equivalence," meaning the device is considered as safe and effective as previously cleared predicate devices, rather than through a new, specific performance study against defined criteria.

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