(85 days)
The Cosgrove Depth Electrode Kit (CDEK) allows the user to place and secure epilepsy electrodes via a lateral orthogonal surgical approach or stereotactically using Radionics CRW and BRW Stereotactic Arc Systems which have been cleared through the FDA.
The CDEK Cosgrove Depth Electrode Kit addressed in this premarket notification has similar intended use and technological characteristics as accessories provided in the commercially available Radionics Todd-Wells Stereotaxic Guide (a pre-amendment device), the Radionics CRW and BRW Stereotactic Arc Systems, and Radionics Bipolar Forceps (a pre-amendment device).
The provided text describes a medical device, the Cosgrove Depth Electrode Kit (CDEK), and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets said criteria in the way you've outlined for an AI/CAD system.
The document is a "Summary of Safety and Effectiveness" for a traditional medical device (a kit for electrode placement), focusing on its substantial equivalence to predicate devices and general safety instructions. It doesn't involve performance metrics like sensitivity, specificity, or reader studies that would be typical for an AI-powered diagnostic device.
Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided input. The document discusses regulatory aspects and device characteristics, not performance evaluation data as would be generated for a software or AI-driven system.
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AUG - 7 1996
Cosgrove Depth Electrode Kit (CDEK)
Summary of Safety and Effectiveness APPENDIX 1: General Information I.
| Device: | Depth Electrode Placement Kit |
|---|---|
| Device Trade Name: | Cosgrove Depth Electrode Kit (CDEK) |
| Classification: | Class II |
| Intended Uses: | The Cosgrove Depth Electrode Kit (CDEK) allows theuser to place and secure epilepsy electrodes via a lateralorthogonal surgical approach or stereotactically usingRadionics CRW and BRW Stereotactic Arc Systemswhich have been cleared through the FDA. |
| Predicate Device | Todd-Wells Stereotaxic Guide and Accessories, (pre-amendment); manufactured by RadionicsRadionics CRW Stereotactic Arc System (K944463);Radionics BRW Stereotactic Arc System (K811452);Radionics Bipolar Forceps, (pre-amendment) |
| Establishment Name and Address: | Radionics, Inc.22 Terry Ave.Burlington, MA 01803 |
| Performance Standard: | None established under Section 514 of the Food, Drugand Cosmetic Act. |
| Establishment registration number: | 1219140 |
| Contact Name and Phone: | Amy J. LaForte, Ph.D. (617) 272-1233 |
II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination
A summary of the information contained in this premarket notification that addresses safety and effectiveness follows.
General Safety and Effectiveness Concerns
Radionics CDEK labeling contains instructions for the proper use of these devices when placing and securing epilepsy electrodes. It includes a description of the product, directions for use, and applicable safety information. These instructions ensure safe and effective use of the device when followed by the physician.
Description of the Device and Basis for Substantial Equivalence
The CDEK Cosgrove Depth Electrode Kit addressed in this premarket notification has similar intended use and technological characteristics as accessories provided in the commercially available Radionics Todd-Wells Stereotaxic Guide (a pre-amendment device), the Radionics CRW and BRW Stereotactic Arc Systems, and Radionics Bipolar Forceps (a pre-amendment device).
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).