(85 days)
No
The summary describes a kit for placing electrodes using stereotactic systems and does not mention any AI/ML components or functions.
No
The device is described as a kit for placing and securing epilepsy electrodes, implying it is an accessory used during a procedure, not a device that directly treats a condition.
No
Explanation: The device is used to place and secure epilepsy electrodes, which are then used for diagnosis, but the device itself is an accessory for placement and not directly performing a diagnostic function.
No
The device description explicitly refers to a "Kit" and "accessories" used for placing and securing electrodes, which are physical components, not software.
Based on the provided information, the Cosgrove Depth Electrode Kit (CDEK) is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as allowing the user to place and secure epilepsy electrodes via a surgical approach. This is an in vivo procedure, meaning it is performed within a living organism (the patient).
- Device Description: The description focuses on the device's use in conjunction with stereotactic systems and forceps, all of which are used in surgical procedures on the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health.
IVD devices are specifically designed to be used in vitro (outside the body) to diagnose, monitor, or screen for diseases or conditions. The CDEK's function is directly related to a surgical procedure performed in vivo.
N/A
Intended Use / 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.
Product codes
Not Found
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Todd-Wells Stereotaxic Guide and Accessories, Radionics CRW Stereotactic Arc System (K944463), Radionics BRW Stereotactic Arc System (K811452), Radionics Bipolar Forceps
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 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. (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).