(267 days)
The Ad-Tech Subdural Electrodes (Strip/Intraoperative Strip, Grid/Intraoperative Grid, Dual-Sided Interhemissheric, Multi-Strip and Split Grid, Intraoperative Mapping Grid) are intended for temporary (
The device under review is a family of Subdural Electrodes. These electrodes provide surface brain contact to support recording, monitoring and stimulation from user supplied equipment.
The family of Subdural Electrodes under review are used under the direction of neurosurgeons and other skilled physicians to support their clinical needs for subdural electrodes on the brain. Based upon the needs of their clinical practice and particular patients, various 2-dimensional geometric shapes (length and width) resulting in variations of Subdural Electrode body shapes and orientation configurations are necessary.
All variations of Subdural Electrodes under review consist of the same materials and fundamental design as the predicate Subdural Electrodes. Either round discs or rectangular electrode contact material are sandwiched between two layers of silicone substrate electrode body material. The brain contacting side of the silicone substrate body has material removed to expose an amount of electrode contact surface area. The subdural electrode wires between the electrode contact and connector contacts at the most distal end of the subdural electrode tail pass through a tube for interface with the user's equipment.
Here's a breakdown of the acceptance criteria and study information for the Ad-Tech Subdural Electrodes based on the provided document:
This document is a 510(k) summary for a medical device, which typically aims to demonstrate substantial equivalence to a predicate device rather than providing extensive clinical study data that would be found in a PMA (Premarket Approval) application. Therefore, you will find information related to design and performance verification rather than large-scale clinical trials.
1. Table of Acceptance Criteria and Reported Device Performance
Device: Ad-Tech Subdural Electrodes (Strip/Intraoperative Strip, Grid/Intraoperative Grid, Dual-Sided Interhemispheric, Multi-Strip and Split Grid, Intraoperative Mapping Grid)
| Acceptance Criteria / Performance Requirement | Reported Device Performance |
|---|---|
| Electrical Resistance: Measure electrical resistance from the electrode contact to connector. Verification of electrical resistance from electrode contact to connector meet specification, no electrical contact or connector cross connects to another electrode contact or connector. | Pass: Verification of electrical resistance from electrode contact to connector meet specification, no electrical contact or connector cross connects to another electrode contact or connector. (The specific resistance values/specifications are not provided in this summary but are implied to be met). |
| Dimensional Characteristics: Dimensional requirements are met by manufacturing. Verification of the dimensional characteristics, electrode contact placement is confirmed using the same manufacturing methods and processes as the predicate electrodes. | Pass: Verification of the dimensional characteristics, electrode contact placement is confirmed using the same manufacturing methods and processes as the predicate electrodes. (The specific dimensional requirements are not provided, but the document mentions modifications like range of contact spacing (1-20mm) and range of round electrode contact diameters (1.96-6.35mm), and exposed surface area (1.08-19.6 mm²), all confirmed through manufacturing methods.) |
| Stimulation Effect: Stimulation at 30 µC/cm² does not affect the electrodes. Verification that under the anticipated duration of electrical stimulation at the maximum limit does not affect the electrode resistance. | Pass: Verification that under the anticipated duration of electrical stimulation at the maximum limit does not affect the electrode resistance. (Confirmed that charge density limits of |
§ 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).