(37 days)
Not Found
No
The device description explicitly states that all components are passive and intended exclusively for recording applications. There is no mention of any processing, analysis, or interpretation of the recorded data using AI/ML. The performance testing focuses on the physical and electrical properties of the electrode itself (impedance measurement).
No
The device is indicated for recording and monitoring brain electrical activity for diagnostic purposes, not for treating any condition.
Yes
The device is indicated for "recording and monitoring of brain electrical activity," and its description states it is used for "monitoring brain electrical activity, defining the location of the epileptogenic foci and brain mapping." These activities are performed to gain information about a patient's medical condition, which is the definition of a diagnostic device.
No
The device description explicitly states that the device consists of physical components, specifically high impedance electrodes on a silicon substrate, which are passive and provide patient contact. This indicates it 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 Function: The NeuroPort™ Electrode (SIROF) is described as a device that is implanted inside the brain to record electrical activity. It is a direct contact device used for monitoring and recording, not for analyzing samples taken from the body.
- Intended Use: The intended use is for "temporary (
N/A
Intended Use / Indications for Use
The NeuroPort™ Electrode (SIROF) 1.0 mm and 1.5 mm are indicated for temporary (
§ 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).
0
KIIoold
510(k) Summary NeuroPortTM Electrode (SIROF)
FEB 9 2011
1: SPONSOR/APPLICANT
Blackrock Microsystems, LLC 391 Chipeta Way, Suite G Salt Lake City, UT 84108
| Telephone: | 801-582-5533 |
|---|---|
| Facsimile: | 801-582-1509 |
Primary Contact: Jerry Alperin
2. ČONSULTANT/CONTACT
3. DEVICE NAME
NeuroPort™ Electrode (SIROF) (1.0mm) and NeuroPort™ Proprietary Name: Electrode (SIROF) (1.5mm) Common/Usual Name: Depth Electrode Depth Electrode Classification Name:
4. DEVICE CLASSIFICATION
A Depth Electrode has been classified by the Neurological Devices Panel as a Class II device per 21 CFR 882.1330, Product Code GZL. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.
1
5: PREDICATE DEVICES
The predicate device NeuroPort™ Electrode previously cleared August 3, 2007 under K070272.
6: DEVICE DESCRIPTION
The NeuroPort™ Electrode (SIROF) detects the electrical activity of cortical neurons during sub-chronic-monitoring procedures for less than thirty consecutive days. All of the components in the NeuroPort™ Electrode (SIROF) are passive and are intended exclusively for recording applications: monitoring brain electrical activity, defining the location of the epileptogenic foci and brain mapping.
The NeuroPort™ Electrode (SIROF) consists of high impedance electrodes. The NeuroPort™ Electrode (SIROF) has 100 electrode contacts on a silicon substrate of 4mm by 4mm.
The electrodes provide the patient contact device. The electrodes connect the users recording and monitoring equipment. The electrodes are used under the supervision of a physician. Physicians in the areas of biopotential recording and monitoring understand the use of depth electrodes.
7. INTENDED USE/INDICATIONS FOR USE
The NeuroPort™ Electrode (SIROF) 1.0 mm and 1.5 mm are indicated for temporary (