DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES

• K Number: K053358
• Device Name: DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES
• Manufacturer: AD-TECH MEDICAL INSTRUMENT CORP.
• Date Cleared: 2006-05-25 ( 174 days)
• Product Code: GZL
• Regulation Number: 882.1330

Intended Use

The AD-TECH Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Maero Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.

Device Description

Depth electrodes described in this application are single patient use, disposable, sterile and non-sterile devices. The electrodes are invasive as they are placed in contact with nerve tissue (brain). The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and stimulation/response equipment. The electrodes are used under the supervision of a physician.

Predicate Devices

K891920, K964644, K990788, K041604, K861031, K042384

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a passive electrode device for recording and stimulating electrical signals, with no mention of AI/ML processing of these signals.

Therapeutic

No
The device is strictly for recording, monitoring, and stimulation of electrical signals for diagnostic purposes (defining epileptogenic foci and brain mapping), not for treating a condition.

Diagnostic

Yes
The device is used for "recording, monitoring and stimulation of electrical signals at the subsurface level of the brain" and "The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping," which are diagnostic activities.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the device is a physical electrode intended for invasive placement in the brain, connecting to recording, monitoring, and stimulation equipment. It is a hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body).
• This device is described as being placed in contact with nerve tissue (brain), which is an in vivo (inside the body) application.
• The intended use is for recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain, directly interacting with the patient's body.

Therefore, the AD-TECH Depth Electrodes are considered an invasive medical device used for neurological monitoring and stimulation, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The AD-TECH Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Maero Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (

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).

Summary

0

053358

510(k) Summary

MAY 2 5 2006

| Company Name: | AD-TECH Medical Instrument Corporation
1901 William Street
Racine, WI 53404 1876 | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Contact: | John Ziobro, Chief Operating Officer | |
| Phone: | 262 367-9200, ext. 101 | |
| Fax: | 262 367-9149 | |
| Summary Date: | November 22, 2005 | |
| Trade Name: | Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes,
Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler
Sphenoidal Depth Electrodes) | |
| Common Name: | Depth Electrodes | |
| Classification Name: | 21 CFR 882.1330, Depth Electrode | |
| Predicate Device(s): | | |
| | 510(k) Number:
Manufacture:
Trade Name: | K891920, K964644
AD-TECH Medical Instrument Corporation
Depth Electrode |
| | 510(k) Number:
Manufacture:
Trade Name: | K990788
AD-TECH Medical Instrument Corporation
Foramen Ovale Depth Electrode |
| | 510(k) Number:
Manufacture:
Trade Name: | K041604
AD-TECH Medical Instrument Corporation
Macro-Micro Depth Electrode |
| | 510(k) Number:
Manufacture:
Trade Name: | K861031
AD-TECH Medical Instrument Corporation
Wyler Sphenoidal Depth Electrode |
| | 510(k) Number:
Manufacture:
Trade Name: | K042384
Cyberkinetics, Inc.
NeuroPortTM Cortical Microelectrode Array System (Neuroport
Electrode) |

1

1.0 Description of Electrodes

Depth electrodes described in this application are single patient use, disposable, sterile and non-sterile devices. The electrodes are invasive as they are placed in contact with nerve tissue (brain).

The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and stimulation/response equipment. The electrodes are used under the supervision of a physician. Physicians in the areas of biopotential recording, monitoring and stimulation/response studies understand the use of depth electrodes.

2.0 Intended Use of Electrodes

The AD-TECH Depth Electrodes (Depth Electrode, Foramen Ovale Depth Electrode, Macro Micro Depth Electrode, Spencer Probe Depth Electrode, Wyler Sphenoidal Depth Electrode) are intended for temporary (