(505 days)
The Recording and stimulating for Central Nervous System electrodes (Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid) are intended for limited (≤24 hours) use with recording, monitoring, and stimulation equipment for electrical stimulation, monitoring of the signals on the surface of the brain for intraoperative monitoring, brain mapping and location of epileptogenic foci.
The Recording and stimulating for Central Nervous System electrodes are used for electrical stimulation, monitoring and recording of the signals on the surface of the brain for intraoperative monitoring, brain mapping and location of epileptogenic foci. The electrodes are multipole arrays of electrodes that are positioned on the surface of the brain. The electrode must be designed to follow the complex anatomy and they can assume different conformations in relation to the requests of clinical needs. The neurosurgeon is the person recommended for electrode placement. The electrodes have to be used under the direction of the neurosurgeon and other skilled physicians to support their clinical needs.
The provided text describes the acceptance criteria and the results of various performance tests for the Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid (hereinafter referred to as "the device").
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|
| Cytotoxicity | Reactivity grade of 0 (none reactivity) | Test sample results to have a reactivity grade of 0 (=none reactivity) | NON-CYTOTOXIC. No test extract does not show any reactivity. |
| Skin Irritation | Final test sample score of 1.0 or less | The final test sample score is 1.0. Very slight erythema (barely perceptible). | NON-IRRITATING. The test item satisfied the requirements of the test. |
| Skin Sensitization | % sensitising treated guinea pigs equal to 0% (no visible change) | The results show a % sensitising treated guinea pigs equal to 0% (=no visible change). | NON-SENSITIZING. The tested item is considered not sensitizing. |
| Systemic Toxicity | No weight loss, mortality, or toxic signs/symptoms in treated and control animals | Weight increase: no weight loss was recorded in any treated and control animals. Mortality: in none of the treated and control animals mortality was observed. Clinical symptoms: in none of the treated and control animals toxic signs or symptoms were observed. | DO NOT CAUSE TOXIC SYMPTOMS. The tested item doesn't cause toxic symptoms and satisfies the requirements of the test. |
| Pyrogenicity Test | Sum of individual temperature rises 30N | All the tensile strength evaluates results to be greater than 30N (average 41.35 N). | The device demonstrates very high strength during pull-out tests, ensuring manufacturing process safety and strength of use. |
| Impedance Test and Dielectric Strength | Impedance |
§ 882.1310 Cortical electrode.
(a)
Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.(b)
Classification. Class II (performance standards).