NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM

K042626 · Cyberkinetics, Inc. · GWQ · Mar 28, 2005 · Neurology

Device Facts

• Record ID: K042626
• Device Name: NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM
• Applicant: Cyberkinetics, Inc.
• Product Code: GWQ · Neurology
• Decision Date: Mar 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

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

Device Story

NeuroPort NSP System records and monitors brain electrical activity; supports up to 96 channels. Hardware includes patient cable, amplifier, CPU, and display monitor. Software performs acquisition, amplification, digitization, and display of neural signals. Used in clinical settings for routine brain activity monitoring, retrieval, and replay. Healthcare providers use the system to visualize neural data, facilitating clinical assessment of brain electrical activity.

Clinical Evidence

Bench testing only. The device conforms to safety standards including IEC 60601-2-26, IEC 60601-1-2, UL 2601-1, and CAN/CSA-C22.2 no. 601.1-M90.

Technological Characteristics

Supports up to 96 channels. Components: patient cable, amplifier, CPU, display monitor. Software-based acquisition, amplification, and digitization. Conforms to IEC 60601-2-26, IEC 60601-1-2, UL 2601-1, and CAN/CSA-C22.2 no. 601.1-M90 safety standards.

Indications for Use

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

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

• BMSI 5000 (Nicolet)
• Ceegraph (Bio-Logic)
• EMU 128 (XLTek)

Submission Summary (Full Text)

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K042626

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| 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: | Sept 24, 2004 |
| Device Trade Name: | NeuroPort™ NSP System |
| Device Common Name: | Neural Signal Amplifier |
| Predicate Devices: | BMSI 5000 (Nicolet), Ceegraph (Bio-Logic) and EMU 128<br>(XLTek) |
| Device Description: | The Neuroport Neural Signal Processing (NSP) System is<br>intended for recording and monitoring. Its functionality includes<br>routine brain activity recording, monitoring, retrieval and replay.<br>The Neuroport supports up to 96 channels of recording and is<br>comprised of the following hardware components: Patient Cable,<br>Amplifier, CPU and a Display monitor. The Neuroport System<br>also includes the following software functions: acquisition,<br>amplification and display. |
| Intended Use: | The NeuroPort™ NSP System is intended for temporary (<30<br>days) recording and monitoring of brain electrical activity. |
| Performance Data: | The NeuroPort™ NSP conforms to the relevant safety standards<br>for intra-operative and hospital monitoring settings: IEC 60601-<br>2-26, IEC 60601-1-2, UL 2601-1, CAN/CSA-C22.2 no. 601.1-<br>M90. |
| Conclusion: | The NeuroPort™ Neural Signal Processing (NSP) System has<br>similar indications statements as the predicate devices. All are<br>used for monitoring brain electrical activity. The functionality of<br>the Neuroport NSP System and predicate devices is identical and<br>includes routine brain activity recording, amplification,<br>digitization, monitoring, retrieval and display. Therefore the<br>Neuroport NSP is substantially equivalent to the predicate<br>devices. |

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

APF - y 2012

Re: K042626

Trade/Device Name: Neuroport™ Neural Signal Processor System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWO Dated (Date on orig SE ltr): February 8, 2005 Received (Date on orig SE ltr): February 9, 2005

Dear Ms. Murthy:

This letter corrects our substantially equivalent letter of March 28, 2005.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Ms. Murthy

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kesia Alexander

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Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K042626

Neuroport"™ Neural Signal Processor System Device Name:

Indications For Use:

The intended use of the Cyberkinetics, Inc. Neuropprt Neural Signal Processor System is I he mendou ass of also of all monitoring of brain electrical activity.

Prescription Use × (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)

Styck Clark

(Divisio Division of General, Restorative, and Neurological Devices

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