(29 days)
Not Found
No
The description focuses on hardware and software changes for automated impedance testing, with no mention of AI or ML for data analysis or interpretation.
No.
The device is used for recording and monitoring brain electrical activity, which is diagnostic, not therapeutic. The description focuses on its use for data acquisition from the brain (local field potentials and extra cellular spikes) and undergoing modifications related to impedance testing, further indicating its role in monitoring rather than treating conditions.
Yes
The device records and monitors brain electrical activity, which is a key function of diagnostic devices in identifying and assessing medical conditions.
No
The device description explicitly mentions hardware changes (addition of an impedance test switch to the Patient Cable, hardware change to support automated impedance testing) and hardware verification testing, indicating it is not solely software.
Based on the provided information, the Cyberkinetics Neurotechnology Systems, Inc. NeuroPort System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- NeuroPort System Function: The NeuroPort System is described as a device for "temporary (
N/A
Intended Use / Indications for Use
The intended use of the Cyberkinetics Neurotechnology Systems, Inc. NeuroPort System is for temporary (
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the text 'K060523' with a box around it, 'MAR 28 2006', and the word 'Cyberkinetics Neurotechnology Systems, inc.'. The text 'MAR 28 2006' appears to be a date. The image appears to be a document or label.
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Foxborough, MA 02035 508.549.9981 F. 508.549.9985 w cyberkineticsinc com _______________________________________________________________________________________________________________________________________________________
510(k) Summary
| Company Name: | Cyberkinetics Neurotechnology Systems, Inc. |
|---|---|
| Device Name: | NeuroPort System |
| 510(k) Sponsor: | Cyberkinetics, Inc. |
| A/k/a Cyberkinetics Neurotechnology Systems, Inc. | |
| F/k/a Trafalgar Ventures, Inc. | |
| 100 Foxborough Blvd., Suite 240 | |
| Foxborough, MA 02035 | |
| 510(k) Contact: | Jon Joseph |
| Vice President R+D and Applications Development | |
| Cyberkinetics Neurotechnology Systems, Inc. | |
| 391 Chipeta Way, Suite G | |
| Salt Lake City, UT 84108 | |
| Phone: (801) 582-5533 | |
| Fax: (801) 582-1509 | |
| Summary Date: | March 23, 2006 |
| Trade Name: | NeuroPort System |
| Common Name: | Electroencephalograph |
| Classification Name: | Electroencephalograph, CFR 882.1400, Product Code: GWQ, Class II |
| Predicate Device: | NeuroPort System, 510(k) K042626 |
Description of Device 1.0
The NeuroPort System, when connected to the NeuroPort Array Electrode, supports recording and display of local field potentials and extra cellular spikes from the brain. The NeuroPort Array is not modified by this 510(k) submission.
The NeuroPort Electrode Array has 100 electrode contacts on a substrate of 4mm. The NeuroPort Electrode array is implanted in the cortex of the brain for less than 30 days. The NeuroPort Electrode Array passes neural activity of the brain cortex to the NeuroPort System through a Patient Cable assembly.
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The modification described within this 510(k) submission is summarized as:
- a) the addition of an impedance test switch to the Patient Cable,
- b) a hardware change to support automated impedance testing of the NeuroPort Electrode Array, and
- c) a software change to support automated impedance testing of the NeuroPort Electrode Array.
1.2 Clinical Application
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 System.
By the automated impedance test option, the user is provided the feature of an impedance test of the NeuroPort Electrode Array.
2.0 Intended use of Device
The intended use of the modified NeuroPort System is the same as the unmodified NeuroPort System:
The intended use of the Cyberkinetics Neurotechnology Systems, Inc. NeuroPort System is for temporary (