NICOLETONE SYSTEM V32 AMPLIFIER

K061908 · Viasys Neuro Care · GWQ · Nov 6, 2006 · Neurology

Device Facts

• Record ID: K061908
• Device Name: NICOLETONE SYSTEM V32 AMPLIFIER
• Applicant: Viasys Neuro Care
• Product Code: GWQ · Neurology
• Decision Date: Nov 6, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The NicoletOne System V32 Amplifier is a stand alone electroencephalography (EEG) amplifier for the recording of electrical signals from the brain. An optional feature of pulse oximetery (SpO2) is available.

Device Story

NicoletOne System V32 Amplifier is a standalone EEG amplifier supporting 32 channels of patient input. Device records electrical brain signals; optional NONIN XPOD pulse oximeter module and 8000X Series sensor provide SpO2 signal input. System includes integral headbox; optional HB3 external headbox available. Device connects to NicoletOne System computer via Ethernet. Used in hospitals, neurology clinics, and sleep labs by clinicians to support EEG diagnosis. Provides system evaluation/calibration signal and electrode impedance monitoring. No physiologic alarms supported. Output displayed on computer for clinical review to assist in diagnostic decision-making.

Clinical Evidence

Bench testing only. No clinical data presented. Evidence consists of software verification and validation, hardware/system verification of conformance to specifications, and declaration of compliance with safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, ISO 9919).

Technological Characteristics

32-channel EEG amplifier; Ethernet connectivity; filter bandwidth 0.053 to 500 Hz; common mode rejection >110dB at 50/60 Hz; DC input tolerance +350mV; continuous/user-selected electrode impedance testing. Optional external HB3 headbox. OEM pulse oximetry integration (NONIN XPOD). Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, and ISO 9919.

Indications for Use

Indicated for use in hospitals and clinical environments, such as neurology clinics and sleep labs, for the recording and monitoring of electroencephalograph (EEG) signals and pulse oximetry (SpO2) to support EEG diagnosis.

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

• DG Nervus (K964280)
• Digital EEG and Sleep Acquisition System with or Without Pulse Oximetery Feature (Waratah and Cardinal Digital EEG/Sleep Acquisition System) (K990522)

Submission Summary (Full Text)

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# 510(k) Summary K061908

| 510(k) Summary K061908 | | NOV - 6 2006 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Company Name: | VIASYS NeuroCare, Inc. | |
| Device Name: | NicoletOne System V32 Amplifier with Oximetery | |
| 510(k) Sponsor, Contact: | VIASYS NeuroCare, Inc.<br>5225 Verona Road<br>Madison, WI 53711<br>Glen Hermanson<br>Mange of Global Quality<br>Phone: [phone]<br>Fax: [phone] | |
| Summary Date: | September 29, 2006 | |
| Common Name: | Electroencephalograph | |
| Classification Name: | Electroencephalograph, CFR 882.1400, Product Code: GWQ, Class II | |
| Predicate Device(s): | K964280 DG Nervus | |
| | K990522 Digital EEG and Sleep Acquisition System with or<br>Without Pulse Oximetery Feature (Waratah and Cardinal<br>Digital EEG/Sleep Acquisition System) | |

## 1.0 Description of Device

The NicoletOne System V32 Amplifier is a stand alone EEG amplifier embodiment. The V32 Amplifier supports 32 channels of patient input. The EEG electrode interface (headbox) is integral to the amplifier. The NicoletOne System V32 Amplifier provides an electrophysiological amplifier variation for use with the NicoletOne System.

An optional external passive headbox, the HB3, is available for use with the V32 Amplifier. An optional Original Equipment Manufacturer (OEM) supplied pulse oximeter can be provided as a signal input from the patient. The optional OEM pulse oximeter feature is supported by a NONIN XPOD pulse oximeter module and NONIN Pure light 8000X Series Pulse Oximeter Sensor.

510(k) Summary

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The V32 Amplifier has a system evaluation signal (calibration signal) to verify system signal pathways, electrode impedance display on the amplifier and uses an Ethernet connection to communicate to the NicoletOne System computer. No physiologic alarms are supported by the V32 Amplifier.

### 1.1 Clinical Application

The V32 amplifier is used in hospitals and clinical environments such as Neurology clinics and Sleep Labs to support clinical measurement and monitoring of electroencephalograph signals (EEG), pulse oximetery and other physiologic signals. The V32 Amplifier does not support any user alarins with regard to pulse oximeter limits. The pulse oximeter feature is applied to support EEG diagnosis.

### Intended use of Device 2.0

The intended use of the NicoletOne System V32 Amplifier with Oximetery is:

The NicoletOne System V32 Amplifier is a stand alone electroencephalography (EEG) amplifier for the recording of electrical signals from the brain. An optional feature of pulse oximetery (SpO2) is available.

## Technological Characteristics 3.0

Significant technical characteristics of the V32 amplifier are equivalent to those of the predicate amplifier. The features and specifications that are not identical, such as DC Input Tolerance, EEG Bandwidth and Calibration Waveform (system evaluation signal), do not raise new questions of safety or effectiveness.

510(k) Summary

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| Amplifier Feature | Predicate U32 Amplifier | V32 Amplifier |
|-------------------------------------|------------------------------------------------|------------------------------------------------------------|
| Number of Channels | 40: 32 Differential, 8 Bipolar | 32 |
| Interface with XPod Pulse Oximetery | Yes | Yes |
| Computer Interface | USB | Lthernet |
| Filter Bandwidth | 0.16 to 500Hz. | 0.053 to 500 Hz |
| Common Mode Rejection | >110dB at 0.16Hz to 70Hz | >110dB at 50/60 Hz |
| Common Mode Input Impedance | > 100 MegOhm | > 100 MegOhm |
| DC Input Tolerance | +250m V | +350m V |
| Flectrode Impedance Test | Yes<br>(Continuous) | Yes<br>(Continuous and as selected by<br>the user) |
| Impedance Indicator | Yes | Yes |
| Optional External Headbox | No | Yes (HB3) |
| Patient Event Input | Yes | . Yes |
| Alarms | No | No |
| Safety Standards Compliance | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-26 | IEC 60601-1<br>IEC 60601-1-2<br>IFC 60601-2-26<br>ISO 9919 |

#### 4.0 Data Summary

Testing of the NicoletOne System V32 Amplifier with Oximetery was performed in compliance with the VIASYS NeuroCare, Inc. design control process. Testing included:

- 1. Software verification and validation,
- 2. Hardware and system verification of conformance to specifications, and
- Declaration of safety standard compliance prior to commercial distribution. 2.

#### Conclusions 5.0

The safety and effectiveness of the NicoletOne System V32 Amplifier with Oximetery was demonstrated by testing in compliance with the VIASYS NeuroCare Design Control process. The intended use and technology of the NicoletOne System V32 Amplifier with Oximetery is the same as the predicate device. No new questions of safety or effectiveness are raised.

> 510(k) Summary Page 3 of 3

File name: Tornado 510(k) Reply to questions 9-28-2006

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Viasys Neurocare, Inc. C/o Gary Syring, Principal Consultant Quality and Regulatory Associates, LLC 800 Levanger Lane Stoughton, WI 53589

NOV - 6 2006

Re: K061908

Trade/Device Name: NicoletOne System V-32 Amplifier Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalogram - Neurology Regulatory Class: Class II Product Code: GWO Dated: September 29, 2006 Received: October 4, 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 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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Page 2 - Mr. Gary Syring

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. 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 contact 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/industry/support/index.html.

Sincerely yours,

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

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Page 3 – Mr. Gary Syring

Enclosure

:

cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ- 410 DGRND D.O.

f/t: DXV: 11- 02 - 06

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Indications for Use 510(k) Number (if known): K061908

Device Name: NicoletOne System V32 Amplifier with Oximetery Indications for Use:

> NicoletOne System V32 Amplifier is a stand alone electroencephalography (EEG) amplifier for the recording of electrical signals from the brain. An optional feature of pulse oximetery (SpO2) is available.

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)

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(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K061908