COSGROVE DEPTH ELECTRODE KIT(CDEK)

K961858 · Radionics, Inc. · HAW · Aug 7, 1996 · Neurology

Device Facts

• Record ID: K961858
• Device Name: COSGROVE DEPTH ELECTRODE KIT(CDEK)
• Applicant: Radionics, Inc.
• Product Code: HAW · Neurology
• Decision Date: Aug 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Indications for Use

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.

Device Story

Kit facilitates placement and securing of epilepsy electrodes; utilizes lateral orthogonal surgical approach or stereotactic guidance via Radionics CRW/BRW Arc Systems. Used in surgical settings by physicians. Provides mechanical guidance and fixation for electrodes; assists in precise intracranial positioning for epilepsy monitoring. Benefits patient by enabling accurate electrode placement for diagnostic evaluation.

Clinical Evidence

No clinical data provided; device relies on established technological characteristics and equivalence to predicate surgical guidance systems.

Technological Characteristics

Mechanical surgical kit for electrode placement and fixation. Compatible with Radionics CRW and BRW Stereotactic Arc Systems. Non-powered, manual surgical instrumentation.

Indications for Use

Indicated for patients requiring epilepsy electrode placement via lateral orthogonal surgical approach or stereotactic guidance.

Regulatory Classification

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.

Predicate Devices

• Todd-Wells Stereotaxic Guide and Accessories (pre-amendment)
• Radionics CRW Stereotactic Arc System (K944463)
• Radionics BRW Stereotactic Arc System (K811452)
• Radionics Bipolar Forceps (pre-amendment)

Submission Summary (Full Text)

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K96/858

AUG - 7 1996

Cosgrove Depth Electrode Kit (CDEK)

# APPENDIX 1: Summary of Safety and Effectiveness

## I. General Information

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 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.

Predicate Device: Todd-Wells Stereotaxic Guide and Accessories, (pre-amendment); manufactured by Radionics Radionics 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, Drug and Cosmetic Act.

Establishment registration number: 1219140

Contact Name and Phone: Amy J. LaForte, Ph.D. [phone]

## 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).

May 13, 1996