NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM

K042384 · Cyberkinetics, Inc. (Cki) · GZL · Mar 29, 2005 · Neurology

Device Facts

• Record ID: K042384
• Device Name: NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM
• Applicant: Cyberkinetics, Inc. (Cki)
• Product Code: GZL · Neurology
• Decision Date: Mar 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1330
• Device Class: Class 2

Intended Use

The NeuroPort™ Array System (Neuroport Electrode) is intended for temporary (<30 days) recording and monitoring of brain electrical activity.

Device Story

NeuroPort™ Cortical Microelectrode Array System consists of 4 mm x 4 mm base with 100 microelectrodes, each 1 mm long; connects to percutaneous pedestal connector. Device records brain electrical activity; intended for temporary (<30 days) use. Operated by clinical staff in a medical setting. Output provides electrical signals for monitoring purposes, assisting clinicians in assessing brain activity. Benefits include localized, high-density neural signal acquisition.

Clinical Evidence

Bench testing only; device deemed biocompatible and capable of recording brain electrical activity.

Technological Characteristics

100-microelectrode array (1 mm length each) on 4 mm x 4 mm base; percutaneous pedestal connector. Biocompatible materials. Depth electrode classification (21 CFR 882.1330).

Indications for Use

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

Regulatory Classification

Identification

A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.

Predicate Devices

• Ad-Tech Spencer® Depth Electrode

Submission Summary (Full Text)

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K042384

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## MAR 2 9 2005

## 510(K) SUMMARY NeuroPort™ Cortical Microelectrode Array System (Neuroport Electrode)

| Submitter Name: | Cyberkinetics, Inc. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 100 Foxborough Boulevard, Suite 240<br>Foxboro, MA 02035 |
| Contact Person: | Nandini Murthy, V.P. Regulatory Affairs and Quality Systems |
| Phone Number: | [phone], Extn 103 |
| Fax Number: | [phone] |
| Date Prepared: | Aug 30, 2004 |
| Device Trade Name: | NeuroPort™ Cortical Microelectrode Array System (Neuroport<br>Electrode) |
| Device Common Name: | Depth electrode |
| Predicate Devices: | Ad-Tech Spencer® Depth Electrode |
| Device Description: | The NeuroPort™ Array System (Neuroport Electrode) is<br>comprised of a base approximately 4 mm x 4 mm dimensionally<br>with 100 microelectrodes. Each microelectrode is approximately<br>1 mm long. The lead connects the microelectrode array to the<br>percutaneous pedestal connector. |
| Intended Use: | The NeuroPort™ Array System (Neuroport Electrode) is<br>intended for temporary (<30 days) recording and monitoring of<br>brain electrical activity. |
| Performance Data: | Results of non-clinical testing indicate that the NeuroPort™<br>Array System is deemed biocompatible for its proposed intended<br>use and that the NeuroPort™ Array System records brain<br>electrical activity. |
| Conclusion: | The NeuroPort™ Array System has the same intended use as<br>compared to the predicate device. Based on the supporting<br>performance data, the NeuroPort™ Array System is capable of<br>recording brain electrical activity and is therefore substantially<br>equivalent to the predicate device technologically. |

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MAR 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Nandini Murthy Mis. Nancident, Vice President Regulatory Affairs and Quality Systems Cyberkinetics, Inc. 100 Foxborough Boulevard, Suite 240 Foxborough, Massachusetts 02035

Re: K042384

K042364
Trade/Device Name: Neuroport™ Cortical Microelectrode Array System (Neuroport™ Electrode) Regulation Number: 21 CFR 882.1330, 21 CFR 882.1835 Regulation Name: Depth electrode; Physiological signal amplifier Regulatory Class: II Product Code: GZL and GWL Dated: February 8, 2005 Received: February 9, 2005

Dear Ms. Murthy:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector. D're() personalially 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 conninered processified in accordance with the provisions of the Federal Food. Drug. de nees that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r our may, diererere, mains of the Act include requirements for annual registration, listing of general controls provisions 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 If your device is classified (600 a0070) vols. Existing major regulations affecting your device can thay be subject to back as a 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 I that FDA has made a determination that your device complies with other requirements of the Act that I Drederal statutes and regulations administered by other Federal agencies. You must of any i ederal statutes and regisements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY an 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and n your a FDA finding of substantial equivalence of your device to a legally prematicated predicated. The 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 desire 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 other general miletimational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Stpt. Rlurdu

Miriam C. Provost, Ph.D. Acting 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): K042384

Neuroport™ Microelectrode Array System (Neuroport Device Name: Electrode)

Indications For Use:

The intended use of the Cyberkinetics, Inc. Neuroport Microelectrode Array System is The monded ase of the Oyour-ling and monitoring of brain electrical activity

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hust Rhodes

(Divisi Division of General, Restorative. and Neurological Devices

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510(k) Number___ ko42384