(179 days)
Not Found
No
The summary describes passive electrodes for recording and stimulating brain signals, with no mention of AI/ML processing of these signals.
No.
The device is described as being used with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain, supporting the definition of epileptogenic foci and brain mapping. This indicates a diagnostic or monitoring purpose rather than a direct therapeutic intervention.
Yes
The device is described as supporting "definition of the location of epileptogenic foci and brain mapping," which are diagnostic activities. It records electrical signals on the surface of the brain for monitoring and analysis to aid in diagnosis.
No
The device description explicitly states the device is "Subdural electrodes" which are physical, invasive components placed in contact with the brain. This is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Description: The description clearly states that these electrodes are "invasive as they are placed in contact with the brain." This means they are used inside the body.
- Intended Use: The intended use is for "recording, monitoring and stimulation of electrical signals on the surface of the brain." This is a direct interaction with the body's electrical activity, not an analysis of a sample taken from the body.
Therefore, the AD-TECH Subdural Electrodes are a medical device used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AD-TECH Subdural Electrodes (Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler) are intended for temporary (
§ 882.1310 Cortical electrode.
(a)
Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.(b)
Classification. Class II (performance standards).
0
MAY 30 2006
510(k) Summary
| 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: | Subdural Electrodes (Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler) | |
| Common Name: | Cortical Electrodes | |
| Classification Name: | 21 CFR 882.1310, Cortical Electrode | |
| Predicate Device(s): | 510(k) Number: | K970587, K923803 |
| | Manufacture: | AD-TECH Medical Instrument Corporation |
| | Trade Name: | Subdural Electrode |
| | 510(k) Number: | K021144 |
| | Manufacture: | Nicolet Biomedical Corporation |
| | Trade Name: | Subdural Strip Electrode |
1.0 Description of Electrodes
Subdural 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 the 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 subdural electrodes.
1
2.0 Intended Use of Electrodes
The AD-TECH Subdural Electrodes (Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler) are intended for temporary (