NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM

K060523 · Cyberkinetics, Inc. · OMC · Mar 28, 2006 · Neurology

Device Facts

• Record ID: K060523
• Device Name: NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM
• Applicant: Cyberkinetics, Inc.
• Product Code: OMC · Neurology
• Decision Date: Mar 28, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The intended use of the Cyberkinetics Neurotechnology Systems, Inc. NeuroPort System is for temporary (< 30 days) recording and monitoring of brain electrical activity.

Device Story

NeuroPort System records/displays local field potentials and extracellular spikes from brain cortex; utilizes implanted NeuroPort Array Electrode (100 contacts on 4mm substrate). Modification adds impedance test switch to patient cable and hardware/software support for automated impedance testing of electrode array. Used in clinical, operating room, and epilepsy monitoring unit environments by healthcare professionals. Automated impedance test feature allows user to verify electrode array integrity. System facilitates neural activity monitoring; aids clinical decision-making regarding patient neurological status.

Clinical Evidence

Bench testing only. Software verification and validation and hardware verification of design output meeting design input requirements were performed.

Technological Characteristics

100-electrode array on 4mm substrate; implanted < 30 days. System includes patient cable assembly for signal transmission. Modification adds impedance test switch and automated impedance testing hardware/software. Class II electroencephalograph (21 CFR 882.1400).

Indications for Use

Indicated for temporary (< 30 days) recording and monitoring of brain electrical activity in patients requiring such monitoring.

Regulatory Classification

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.

Predicate Devices

• NeuroPort System (K042626)

Submission Summary (Full Text)

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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.<br>A/k/a Cyberkinetics Neurotechnology Systems, Inc.<br>F/k/a Trafalgar Ventures, Inc.<br>100 Foxborough Blvd., Suite 240<br>Foxborough, MA 02035 |
| 510(k) Contact: | Jon Joseph<br>Vice President R+D and Applications Development<br>Cyberkinetics Neurotechnology Systems, Inc.<br>391 Chipeta Way, Suite G<br>Salt Lake City, UT 84108<br>Phone: [phone]<br>Fax: [phone] |
| 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 (< 30 days) recording and monitoring of brain electrical activity.

#### 3.0 Technological Characteristics

The technical characteristics of the modified NeuroPort System are the same as those of the unmodified NeuroPort System.

#### 4.0 Data Summary

Testing of the automated impedance test of the NeuroPort Electrode Array modification was performed in compliance with the Cyberkinetics, Inc. design control process. Testing included:

- 1. Software verification and validation,
- 2. Hardware verification of design output meeting design input requirements.

Testing is completed. No safety or effectiveness concerns remain.

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# 5.0 Conclusions

The safety and effectiveness of the modified NeuroPort System was demonstrated by testing in compliance with the Design Control process. The intended use and technology of the modified NeuroPort System is the same as the unmodified NeuroPort System. No new questions of safety or effectiveness are raised.

File: NeuroPort Impedance Test 510k Reply 3-23-2006

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Public Health Service

MAR 2 8 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cyberkinetics Inc. c/o Quality & Regulatory Associates, I.LC Mr. Gary Syring 800 Levanger Lane Stoughton, Wisconsin 53589

Re: K060523

Trade/Device Name: Modified NeuroPort System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ Dated: February 17, 2006 Received: February 27, 2006

Dear Mr. Syring:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 – Mr. Gary Syring

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. production of the manation begin marketing your device as described in your Section 510(k) I mo letter will and hy a the FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please n you a the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Hubert Lenoir

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): KU60523

Device Name: Modificd NeuroPort System

Indications for Use:

The intended use of the Cyberkinetics Neurotechnology Systems, Inc. NeuroPort System is for temporary (< 30 days) recording and monitoring of brain electrical activity.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kb60523

Helen Lewis

(Division Sig Division of General, Restorative, and Neurological Devices

510(k) Number_

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