Spencer Probe Depth Electrodes

• K Number: K223269
• Device Name: Spencer Probe Depth Electrodes
• Manufacturer: Ad-Tech Medical Instrument Corporation
• Date Cleared: 2023-05-18 ( 206 days)
• Product Code: GZL , REG
• Regulation Number: 882.1330
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: K163355

Intended Use

The AD-TECH Depth Electrodes (Spencer Probe Depth Electrodes) are intended for temporary (

Device Description

The Depth Electrodes (Spencer Probe Depth Electrode) are intended for recording, monitoring and stimulation at sub-surface levels of the brain. These electrodes are provided sterile, disposable and single patient use. The Depth Electrodes (Spencer Probe Depth Electrodes) provide the patient contact device. The Depth Electrodes (Spencer Probe Depth Electrodes) connect to an electrode cable that is applied to the user's equipment. The electrodes are used by physicians.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Spencer Probe Depth Electrodes, as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Hazard Addressed	Test Method Used	Acceptance Criterion	Reported Device Performance (Summary of Test Results)
Image Artifact	ASTM F2119-13	No Criteria, Descriptive Statement	1.5T: Adoption from 3.0T tests since 3.0T is the worst-case. 3.0T: Image distortion of 19 mm from the edge of the device.
Magnetically Induced Displacement Force	ASTM F2052-15

Regulation Number and Section

§ 882.1330 Depth electrode.

(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).