(64 days)
The Neuro-Fiberscope is indicated for use in viewing the ventricles and cavities of the brain.
The KSEA Neuro-Fiberscope is a manually operated surgical devices. The KSEA Neuro-Fiberscope is a flexible fiberoptic telescope which utilizes fiber-optic technology. The body contact portions of the KSEA Neuro-Fiberscope are composed of medical grade polyurethane.
The provided text is a 510(k) summary for the Karl Storz Neuro-Fiberscope, which is a medical device. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets them. It does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, data provenance, number of experts, adjudication methods, or MRMC studies.
- Information about standalone algorithm performance, types of ground truth, or details on training sets.
Instead, the submission states:
- Substantial Equivalence: "The KSEA Neuro-Fiberscope is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA Neuro-Fiberscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices."
This means that the device was approved based on its similarity to existing, legally marketed devices, and no new clinical performance study demonstrating specific acceptance criteria was required for this 510(k) submission.
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).