(186 days)
No
The description focuses on the hardware (electrode array and inserter) and its function of recording and displaying brain electrical activity. There is no mention of any software or algorithms that process this data using AI or ML techniques. The modification is purely a change in the physical dimensions of the array.
No.
The device is used for temporary recording and monitoring of brain electrical activity, which is a diagnostic function, not a therapeutic one.
Yes
This device is intended for temporary recording and monitoring of brain electrical activity, which is a diagnostic function used to understand the state of the brain.
No
The device description clearly details a physical implantable component (NeuroPort Array) and associated hardware (Inserter Wand, Patient Cable, NeuroPort System). The modification described is a change in the length of the physical array and the inserter wand, not a software change.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary (
N/A
Intended Use / Indications for Use
The intended use of the Cyberkinetics Neurotechnology Systems. Inc. NeuroPort Microelectrode Array System is 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
Image /page/0/Picture/0 description: The image shows the logo for Cyberkinetics Neurotechnology Systems, Inc. The logo features a silhouette of a head with a series of dots arching over it. The text "Cyberkinetics" is written in a stylized font, with "Neurotechnology Systems, Inc." written in a smaller font underneath.
AUG - 3 2007
100 Foxborough Blvd. Suite 240 Foxborough, MA 02035 508.549.9981 F. 508.549.9985 www.cyberkineticsinc.com
510(k) Summary
| Company Name: | Cyberkinetics Neurotechnology Systems, Inc. |
|---|---|
| Device Name: | NeuroPortTM Microelectrode Array System (NeuroPort Array) |
| 510(k) Sponsor: | Cyberkinetics Neurotechnology Systems, Inc. |
| A/k/a Cyberkinetics, Inc. | |
| F/k/a Trafalgar Ventures, Inc. | |
| 100 Foxborough Blvd., Suite 240 | |
| Foxborough, MA 02035 | |
| 510(k) Contact: | Timothy Surgenor, President and Chief Executive Officer |
| Cyberkinetics Neurotechnology Systems, Inc. | |
| 391 Chipeta Way, Suite G | |
| Salt Lake City, UT 84108 | |
| Phone: (801) 582-5533 | |
| Fax: (801) 582-1509 | |
| Summary Date: | January 22, 2007 |
| Trade Name: | NeuroPort Array |
| Common Name: | Depth Electrode |
| Classification Name: | Depth Electrode, CFR 882.1330, Product Code: GZL, Class II |
| Predicate Device: | NeuroPortTM Microelectrode Array System (NeuroPort Array) |
| K042384 |
1.0 Description of Device
The NeuroPort Array connects to the NeuroPort System (510(k) K042626 and K060523). This combination of devices supports recording and display of local field potentials and extra cellular spikes from the brain. The NeuroPort System is not modified by this 510(k) submission.
The NeuroPort Array has 100 electrode contacts on a silicon substrate of 4 mm by 4 mm. The NeuroPort Array is implanted in the cortex of the brain for less than 30 days. The NeuroPort Array passes neural activity of the brain cortex to the NeuroPort System through the Patient Cable.
File: 1-5 mm Array 510k 1-23-2007
1
The NeuroPort Array consists of high impedance electrodes. The NeuroPort Array impedance is in the range of 0.1 to 1.0 Meg ohms per electrode.
The modification described within this 510(k) submission is summarized as providing a 1.5 mm length NeuroPort Array option in addition to the cleared to market 1,0 mm NeuroPort Array option. The 1,5 mm length variation has the following features and properties in common with the 1.0 mm NeuroPort Array:
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- Same materials.
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- Same manufacturing processes.
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- Same insertion technique,
- Same package and terminal sterilization process. 4.
Along with the longer NeuroPort Array, the Inserter Wand applied to place the NeuroPort Array is modified to support a variation with the 0.5 mm additional insertion depth.
1.2 Clinical Application
The NeuroPort Array, with the NeuroPort System, is used in clinical, operating room and epilepsy monitoring unit environments. This 510(k) does not affect the environment of use of the NeuroPort Array and NeuroPort System.
The NeuroPort Array is placed in brain tissue to support recording of cell potentials. Placement of the NeuroPort Array is accomplished by an Inserter Wand. The Inserter Wand is a pneumatic device that supports placement of the NeuroPort Array to the desired depth. The Inserter Wand is modified to two variations, a 1.0 mm and a 1.5 mm variation. The 1.0 mm Inserter Wand is cleared to market with the 1.0 mm NeuroPort Array, 510(k) K042384.
The 1.0 mm Inserter Wand variation is modified to allow the inserter to travel an additional 0.5 mm to support insertion of the 1.5 mm NeuroPort Array. Section 7.0 explains the Inserter Wand changes and evaluation of conformance.
With the 1.5 mm electrode length option, the user is given the opportunity to acquire signals from a deeper level of the brain than the 1.0 mm NeuroPort Array. The selection of NeuroPort Array variation is at the discretion of the user.
File: 1-5 mm Array 510k 1-23-2007
2
2.0 Intended use of Device
The intended use of the modified NeuroPort Array is the same as the unmodified NeuroPort Array:
The intended use of the Cyberkinetics Neurotechnology Systems. Inc. NeuroPort Microelectrode Array System is for temporary (