NICOLET WIRELESS EEG

K103140 · Carefusion 209, Inc. · GWL · Apr 8, 2011 · Neurology

Device Facts

• Record ID: K103140
• Device Name: NICOLET WIRELESS EEG
• Applicant: Carefusion 209, Inc.
• Product Code: GWL · Neurology
• Decision Date: Apr 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1835
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and transmit electrophysiological signals in a wired or wireless mode for the Nicolet Neurodiagnostic system.

Device Story

Nicolet Wireless EEG Amplifier is a portable, battery or AC-powered device for acquiring, storing, and transmitting electrophysiological signals (EEG, EKG, EMG, EP, temperature, blood pressure, pulse). Available in 32 or 64-channel models; units can be cascaded for higher channel counts. Operates in wired (Ethernet) or wireless (802.11b/g) modes; stores data locally for backup during out-of-range conditions. Used in clinical settings including OR, ICU, LTM, and ambulatory/home environments. Operated by clinicians to facilitate neurological and sleep diagnostics. Data is transmitted to a Nicolet Neurodiagnostic system for review, aiding clinical decision-making by providing continuous or mobile physiological monitoring.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation testing confirmed the device meets design inputs and user needs for an EEG amplifier. Testing included basic safety (IEC 60601-1), EMC (IEC 60601-1-2), usability (IEC 60601-6), risk management (ISO 14971), biocompatibility (ISO 10993-1), and FCC radiated energy/SAR standards.

Technological Characteristics

Portable amplifier (32/64 channels); wired (10/100baseT) or wireless (802.11b/g) connectivity; battery or 110/220VAC power. Local data storage for backup. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, and ISO 10993-1. IP addressable for network integration.

Indications for Use

Indicated for use as a front-end amplifier to acquire, store, and transmit electrophysiological signals (EEG, EKG, EMG, EP, temperature, blood pressure, pulse) for neurological and sleep testing in ambulatory, OR, LTM, EEG, and ICU settings.

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

• Nicoletone V32 Amplifier with Oximetry (K061908)
• Blackrock Neuroport Biopotential Signal Processing System (K090957)
• NeuroPort Instrument (K060523)
• gUSBamp (K060803)
• Sandman SD20 Amplifier (K040113)
• Nihon Kohden WEE-1000 Wireless Amplifier (K033475)
• Siesta Compumedics (K003175)

Submission Summary (Full Text)

{0}------------------------------------------------

K103140

## 510(k) SUMMARY

ー。

t

APR - 8 2011

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

| 1 | Submitter Information | | | | |
|----|--------------------------------------|--------------------------------------|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | Name | CareFusion 209, Inc. | | | |
| | Address | 1850 Deming Way, Middleton, WI 53562 | | | |
| | Phone number | 608-829-8655 | | | |
| | Fax number | 608-829-8769 | | | |
| | Establishment<br>Registration Number | 3008289288 | | | |
| | Name of contact<br>person | Robert J Burdge | | | |
| | Date prepared | | 6 April 2011 | | |
| 2 | Name of Device | | | | |
| | Trade or proprietary<br>name | Nicolet Wireless EEG Amplifier | | | |
| | Common or usual<br>name | Amplifier, Electroencephalograph | | | |
| | Classification name | Electroencephalograph | | | |
| | Classification Panel | Neurology | | | |
| | Device Class | Class II | | | |
| | Regulation | 21 CFR 882.1400 | | | |
| | Product Code(s) | GWQ, GWL | | | |
| ਤੇ | Legally marketed device(s) | 510(k) #: | Cleared on: | Name | Code: |
| | to which equivalence is<br>claimed | K061908 | 11/06/2006 | Nicoletone V32 Amplifier with Oximetry | GWQ |
| | | K090957 | 05/28/2009 | Blackrock Neuroport Biopotential Signal Processing System | GWL |
| | | K060523 | 03/28/2006 | NeuroPort Instrument | GWQ |
| | | K060803 | 05/02/2006 | gUSBamp | GWL |
| | | K040113<br>K033475 | 02/18/2004<br>01/07/2004 | Sandman SD20 Amplifier<br>Nihon Kohden WEE-1000 Wireless Amplifier | GWL<br>GWQ |
| | | K003175 | 12/27/2000 | Siesta Compumedics | GWQ |
| | | | | | |
| | Reason for 510(k)<br>submission | | NicoletOne base system<br>Battery or Mains power | The changes addressed in this submission include:<br>Addition of wireless communication capability between the amplifier and the<br>Increased channels and sampling rates | |
| 4 | Device Description | | | The Nicolet Wireless Amplifiers are used in a wide variety of EEG applications<br>including: Ambulatory (at home or in transit to home), OR, LTM, EEG, Sleep and<br>ICU. The proposed amplifiers are small portable devices that can run on main<br>electrical A/C power or use a portable battery pack. | |

{1}------------------------------------------------

| Device Description (cont) | | The proposed device consists of two models designated as the 32 channel and the<br>64 channel amplifier.<br><br>These units can acquire from up to 32 or 64 channels, they can be grouped or<br>"cascaded" together for more channels. The amplifiers are capable of acquiring a<br>variety of electrophysiological signals at variable sampling frequencies. These<br>signals include EEG, EKG, EMG, EP, temperature, blood pressure, pulse, and<br>other signals standard to neurological and sleep testing.<br><br>The amplifiers have wireless capability and a battery pack for mobile data<br>acquisition. Wireless access points collect the wireless data transmissions. The<br>amplifiers can be connected to the Ethernet by a cable and also to AC power. The<br>amplifiers are IP addressable and can be connected directly to a network device.<br>In all situations the amplifiers store a copy of the data locally to allow for data<br>back-up.<br><br>This amplifier provides storage and subsequent transmission of data that is not<br>transferred live when the amplifier is in out of range situations. | |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5 | Intended use of the device | The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier<br>to acquire, store, and transmit electrophysiological signals in a wired or wireless<br>mode for the Nicolet Neurodiagnostic system. | |
| 6 | Summary of the technological characteristics of the device compared to the predicate device | | |
| | Characteristic | New Device<br>Nicolet Wireless EEG Amplifier | Predicate [Device Name]<br>[510(k) number] |
| | Interface to Amplifier | Wired Ethernet (10/100baseT) or<br>Wireless Ethernet (802.11b/g) | Wired Ethernet (10/100baseT)or Wireless<br>Ethernet (802.11b)<br>Substantially equivalent to the Nihon Kohden<br>WEE-1000 Wireless Amplifier (K033475) |
| | Power | Battery or 110/220VAC | 110 VAC, Battery and USB Port<br>Substantially equivalent to the Nihon Kohden<br>WEE-1000 Wireless Amplifier (K033475) |
| | System components | Patient Cable, Amplifier, CPU and a<br>Display Monitor; Telemetry unit and<br>access point | System components comprised of telemetry<br>unit, Electrode junction box and access point<br>to operate with the current NK commercially<br>available EEG devices<br>Substantially equivalent to the Nihon Kohden<br>WEE-1000 Wireless Amplifier (K033475) |
| | Number of Signal Recording<br>Channels | Up to 32 or 64 channels | 32 and up to 128 with one device; Up to 256<br>by cascading two devices |
| PERFORMANCE DATA | | | |
| 7 | SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL<br>EQUIVALENCE | | |
| | Performance Test Summary-New Device | | |
| | Characteristic | Standard/Test/FDA Guidance | Results Summary |
| | 1. Basic safety | IEC 60601-1 | The proposed device passes the applicable tests and standards. |
| | 2. Programmable Electrical<br>Medical Systems | IEC 60601-4 | The proposed device passes the applicable tests and standards. |
| | 3. Usability | IEC 60601-6 | The proposed device passes the applicable tests and standards. |
| | 4. EMC Compatibility | IEC60601-1-2 | The proposed device passes the applicable tests and standards. |
| | 5. Collateral Safety | IEC 60601-1-1 | The proposed device passes the applicable tests and standards. |
| | 6. Electroencephalographs | IEC 60601-2-26 | The proposed device passes the applicable tests and standards. |
| | 7. Risk Management | ISO 14971 | The proposed device passes the applicable tests and standards. |
| | 8. Biocompatibility- non contact<br>device | ISO 10993-1 | The proposed device passes the applicable tests and standards. |
| | 9. FCC Specific Absorption<br>Ratio (SAR) | FCC Part 15C; FCC OET Bulletin 65,<br>Supplement C | The proposed device passes the applicable tests and standards. |
| | 10. Battery safety | UN/DOT 38.3 Transportation testing<br>for lithium batteries | The proposed device passes the applicable tests and standards. |
| | Summary Discussion of Bench Performance Data | | |
| | The Nicolet EEG Wireless Amplifier device passed all specified test requirements. | | |
| | The validation and verification testing confirmed this device meets user needs and design inputs for an EEG amplifier. | | |
| | Testing also confirmed physical attributes and device performance meet the requirements of the standards listed in the<br>performance testing summary above. These standards address safety, biocompatibility, EMC compatibility, risk,<br>usability, and radiated energy. | | |
| 8 | SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL | | |

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

{2}------------------------------------------------

ノ

i

{3}------------------------------------------------

| | EQUIVALENCE AND/OR OF CLINICAL INFORMATION |
|---|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Clinical Performance Data/Information<br>Clinical testing was not performed with this device. |
| 9 | CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA |
| | The Nicolet Wireless EEG Amplifiers meet the functional claims and intended use as described in the product labeling.<br>The safety and effectiveness are substantially equivalent to The K061908- NicoletOne V32 Amplifier with Oximetry, the<br>K090957 Blackrock Neuroport Biopotential Signal Processing System, the K060523 NeuroPort Instrument, the<br>K060803 gUSBamp, the K040113 Sandman SD20 Amplifier, the K033475-Nihon Kohden WEE-1000 Wireless<br>Amplifier and the K003175 Siesta Compumedics described in the submission. |

..

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three overlapping wings or feathers.

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

Carefusion 209. Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25" Street, NW Buffalo, MN 55313

Re: K103140

APR - 8 2011

Trade/Device Name: Nicolet Wireless EEG Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWL and GWO Dated: January 20, 2011 Received: January 21, 2011

Dear Mr. Job:

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.

{5}------------------------------------------------

Page 2 - Mr. Mark Job

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/ReportalProblem/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.

signature

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

{6}------------------------------------------------

## Indications for Use

510(k) Number (if known): __K103140_

Device Name: Nicolet Wireless EEG Amplifier

The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and transmit electrophysiological signals in a wired or wireless mode for the Nicolet Neurodiagnostic system.

Prescription Use _ XXX_ (Part 21 CFR 801 Subpart D)

.

:

AND/OR

Over-The-Counter use_ (21 CFR Part 801 Subpart C)

(PLEASE DO NO WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Quynh Hoang

(Division S Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K103140