BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM

K090957 · I2s Micro Implantable Systems, LLC · GWL · May 28, 2009 · Neurology

Device Facts

• Record ID: K090957
• Device Name: BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM
• Applicant: I2s Micro Implantable Systems, LLC
• Product Code: GWL · Neurology
• Decision Date: May 28, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.1835
• Device Class: Class 2

Intended Use

The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP).

Device Story

System acquires, processes, and displays biopotential signals (ECoG, EEG, EMG, ECG, EOG, EP) from user-supplied electrodes or NeuroPort Array. High input impedance amplifier (1000 Megohm) captures signals; 16-bit A/D conversion at sampling rates up to 30,000 Hz. Device supports up to 128 channels (256 via cascading). Used in clinical/research settings by clinicians/researchers. Output displayed on PC for interpretation; no physiologic alarms provided. Passive signal splitter allows simultaneous connection to user equipment. System facilitates signal analysis via third-party software (e.g., Persyst Insight, NeuroPlex, Matlab, Spike 2). Benefits include flexible, high-channel-count signal acquisition for neurophysiological monitoring and research.

Clinical Evidence

Bench testing only. Documentation included software testing, system testing, and standards compliance (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26) to demonstrate substantial equivalence.

Technological Characteristics

Physiologic signal amplifier; 1000 Megohm input impedance; 16-bit A/D conversion; up to 30,000 Hz sampling rate; >90 dB CMRR. Connectivity via interface cables and passive signal splitter. Supports cascading for 256 channels. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-26. Power: 110 VAC.

Indications for Use

Indicated for recording, processing, and display of biopotential signals (ECoG, EEG, EMG, ECG, EOG, EP) in research institutions, clinics, hospitals, operating rooms, and epilepsy evaluation environments using user-supplied electrodes or the NeuroPort Array.

Regulatory Classification

Identification

A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).

Predicate Devices

• NeuroPort Neural Signal Processing (NSP) System (K042626)
• g.USBamp (K060803)
• Sandman SD20 Amplifier (K040113)

Reference Devices

• NeuroPort Electrode Array (K042384)
• X-CEL TEK device

Submission Summary (Full Text)

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# 510(k) Summary

Device Name: Blackrock NeuroPort Biopotential Signal Processing System

510(k) Sponsor: I2S Micro Implantable Systems, LLC, d/b/a Blackrock Microsystems 391 Chipeta Way, Suite G Salt Lake City, UT 84108

510(k) Contact: Chris DeCaria Director of Product Development Blackrock Microsystems 391 Chipeta Way, Suite G Salt Lake City, UT 84108

Summary Date: May 15, 2009

Trade Name: Blackrock NeuroPort Biopotential Signal Processing System

Common Name: Bio-potential Signal Acquisition System

Classification Name: CFR 882.1835 Physiologic Signal Amplifier, Product Code: GWL CFR 882.1845 Physiological Signal Conditioners, Product Code: GWK

Predicate Devices:

510{k) Number: K042626

Trade Name: NeuroPort™ Neural Signal Processing (NSP) System

510(k) Number: K060803 Trade Name: g.USBamp

510(k) Number: K040113 Trade Name: Sandman SD20 Amplifier

#### 1.0 Description of Device

The Blackrock NeuroPort Biopotential Signal Processing System (System), when connected to customer supplier bio-potential electrodes or the NeuroPort Electrode Array (K042384), supports recording and display of bio-potential signals. Bio-potential signals that can be recorded by the System include:

- 1. Electrooculography (EOG),
- Electrocorticography (ECoG), 2.

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- electroencephalography (EEG), 3.
- 4. electromyography (EMG),
- న్న electroencephalography (ECG) and
- evoked potential (EP). 6.

The System is not a monitoring system. No physiologic alarms are provided. The acquisition and display of bio-potential signals is for the interpretation and use of the clinician.

#### 1.2 Clinical Application

The System is used in research institution, clinic, hospital, operating room and epilepsy evaluation environments to acquire (record) bio-potential signals from user supplied electrodes or the NeuroPort Array. All of these electrodes require a high input impedance amplifier to acquire and display the bio-potential signal from the human body the electrodes contact.

## 2.0 Intended use of Device

The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP).

### 3.0 Technological Characteristics

The only hardware modifications to the predicated NeuroPort System are:

- 1. The addition of interface cables to support connection of user supplied electrodes to the amplifier. These interface cables are verified by the continuity of the single pathway, commercial electrode input connector to the amplifier output connector.
- 2. A passive signal splitter box allows the user supplied electrodes to connect to the System Amplifier and the user's own equipment. This passive box will be verified by continuity of the signal pathways between the user supplied electrode input connector and the two signal connector outputs (System Amplifier output connector and User defined equipment connector).
- Sync to an external EEG instrument, such as the X-CEL TEK device is addressed in 3. the software testing, see Section 6.0.

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- 4. The syncing of two Systems to be capable of recording up to 256 input channels is supported in the software testing, see Section 6.
## 3.1 Comparison to Predicates

| Feature | System<br>Under Review | Predicate<br>NeuroPort<br>Instrument<br>(K060523) | Predicate<br>g.USBamp<br>(K060803) | Predicate<br>Sandman SD20<br>Amplifier<br>(K0040113) | Comments |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use,<br>Indications<br>for Use | The Blackrock NeuroPort<br>Biopotential Signal<br>Processing System<br>supports recording,<br>processing and display of<br>biopotential signals from<br>user supplied electrodes.<br>Biopotential signals<br>include, but are not limited<br>to: Electrocorticography<br>(ECOG),<br>electroencephalography<br>(EEG), electromyography<br>(EMG),<br>electrocardiography<br>(ECG), electrooculography<br>(EOG) and Evoked<br>Potential (EP). | The intended use of<br>the Cyberkinetics<br>Neurotechnology<br>Systems, Inc.<br>NeuroPort Neural<br>Signal Processor<br>System is for<br>temporary (< 30<br>days) recording and<br>monitoring of brain<br>electrical activity. | Measuring,<br>recording and<br>analysis of<br>electrical activity of<br>the brain and/or<br>through the<br>attachment of<br>multiple electrodes<br>at various locations<br>to aid in morning<br>and diagnosis as<br>routinely found in<br>clinical settings of<br>EEG. | The SD20<br>Amplifier is<br>intended to be use<br>by or under the<br>directions of a<br>physician for<br>acquisition of EEG,<br>polygraphy and<br>polysomnography<br>signals and<br>transmission of<br>these signals to a<br>PC during<br>recording of<br>neurophysiology<br>examinations. | Equivalent<br>The Blackrock<br>NeuroPort<br>Biopotential<br>Signal<br>Processing<br>System under<br>review acquires,<br>conditions and<br>supports analysis<br>of the same types<br>of biopotential<br>signals as the<br>predicate<br>devices.<br>Polygraphy and<br>polysmnography<br>includes EEG,<br>EMG, ECG,<br>EOG,<br>biopotential<br>signals. |
| Typical<br>Biopotential<br>Signals<br>Recorded | Electroencephalography<br>(EEG)<br>Electrocorticography<br>(ECOG)<br>Electrocardiography (ECG)<br>Electromyography (EMG)<br>Electrooculography (EOG)<br>Evoked potential (EP) | EEG | EEG<br>ECoG<br>ECG<br>EMG<br>EOG | EEG<br>ECG<br>EMG<br>EOG<br>EP | Equivalent |
| Number of<br>Signal<br>Recording<br>Channels | Up to 128 with one<br>device;<br>Up to 256 by cascading<br>two devices | 96 | Up to 128 | Up to 128 | Equivalent |
| Amplifier<br>Input<br>Impedance | 1000 Megohm | 1000 Megohm | > 100 Megohm | Unknown | Same as<br>predicate<br>NeuroPort<br>Instrument. |
| A/D<br>Conversion | 16 Bit | 16 Bit | 24 Bit | 16 Bit | Equivalent |
| Sampling<br>Rate | Up to 30,000 Hz | Up to 30,000 Hz | Up to 38,400 Hz | Up to 32,000 Hz | Equivalent |
| CMRR | > 90 dB | > 90 dB | > 100 dB | > 100 dB | Equivalent |

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| Feature | System<br>Under Review | Predicate<br>NeuroPort<br>Instrument<br>(K060523) | Predicate<br>g.USBamp<br>(K060803) | Predicate<br>Sandman SD20<br>Amplifier<br>(K0040113) | Comments |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analysis<br>Software | Embedded, commercially<br>available and user<br>defined.<br>Examples:<br>Persyst Insight™<br>NeuroPlex™<br>Matlab™<br>Spike 2™<br>and others. | Embedded,<br>commercially<br>available and user<br>defined.<br>Examples:<br>Persyst Insight™<br>NeuroPlex™<br>Matlab™<br>Spike 2™<br>and others. | Embedded and<br>commercially<br>available.<br>Examples:<br>Matlab™<br>and others. | Embedded and<br>commercially<br>available | Equivalent<br>The<br>physician/clinician<br>may apply their<br>own analysis<br>software as a<br>research tool or<br>other<br>commercially<br>available<br>software<br>supporting<br>analysis. |
| Power | 110 VAC | 110 VAC | USB Port | Unknown | Safety of the<br>power source is<br>verified by<br>standards<br>compliance. |
| Alarms | No | No | No | Unknown | Same |
| Safety<br>Standards<br>Compliance | IEC 60601-1:1998<br>IEC 60601-1-2:2001<br>IEC 60601-2-26 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-26 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-26 | IEC 60601-1<br>IEC 60601-1-2 | Same |

## 4.0 Data Summary

Software documentation, system testing and standards compliance were provided to support the substantial equivalence, safety and effectiveness of the System.

## 5.0 Conclusions

The modifications to the Predicate NeuroPort System to create the Blackrock NeuroPort Biopotential Signal Processing System were evaluated and raise no new questions of safety or effectiveness.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with stylized lines forming the wings and body.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

I2S Micro Implantable Systems, LLC c/o Gary Syring, Principal Consultant Quality & Regulatory Associates, Inc. 800 Levanger Lane Stoughton, WI 53589

MAY 2 8 2009

Re: K090957

Trade/Device Name: Blackrock NeuroPort Biopotential Signal Processing System Regulation Number: 21 CFR 882.1835 Regulation Name: Physiologic Signal Amplifier Regulatory Class: II Product code: GWL (and GWK) Dated: April 2, 2009

Received: April 6, 2009

# 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 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); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/industry/support/index.html.

Sincerely yours.

Malvina B. Eglehnus, mD.

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

Enclosure

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# 690957

Indications for Use

510(k) Number (if known):

Device Name: Blackrock NeuroPort Biopotential Signal Processing System

Indications for Use:

The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP).

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)

E.K. Rhm

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices

510(k) Number K090957

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