(90 days)
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.
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).