Predicate Devices

K061908, K090957, K060523, K060803, K040113, K033475, K003175

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the hardware and data acquisition capabilities of the amplifier, with no mention of AI or ML for signal processing or analysis.

Therapeutic

No
The device is described as an amplifier intended to acquire, store, and transmit electrophysiological signals, not to treat a disease or condition.

Diagnostic

Yes

The device is an amplifier designed to acquire, store, and transmit electrophysiological signals such as EEG, EKG, EMG, and EP, which are used in neurodiagnostic systems for various applications including LTM, EEG, Sleep, and ICU. The acquisition and processing of these signals are essential steps in the diagnosis of neurological and sleep disorders.

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components such as amplifiers, battery packs, wireless capability, and physical connections (Ethernet, AC power). The performance studies also include testing for hardware-related standards like electrical safety, EMC, and battery safety.

IVD (In Vitro Diagnostic)

Based on the provided information, the Nicolet Wireless EEG Amplifier is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is to "acquire, store, and transmit electrophysiological signals" from the human body (EEG, EKG, EMG, etc.). This is a measurement of physiological processes within a living organism.
Device Description: The device description reinforces this by detailing its use in various clinical settings for acquiring these types of signals.
Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Nicolet Wireless EEG Amplifier does not interact with or analyze such specimens.

Therefore, the device falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

GWQ, GWL

Device Description

The Nicolet Wireless Amplifiers are used in a wide variety of EEG applications including: Ambulatory (at home or in transit to home), OR, LTM, EEG, Sleep and ICU. The proposed amplifiers are small portable devices that can run on main electrical A/C power or use a portable battery pack. The proposed device consists of two models designated as the 32 channel and the 64 channel amplifier. These units can acquire from up to 32 or 64 channels, they can be grouped or "cascaded" together for more channels. The amplifiers are capable of acquiring a variety of electrophysiological signals at variable sampling frequencies. These signals include EEG, EKG, EMG, EP, temperature, blood pressure, pulse, and other signals standard to neurological and sleep testing. The amplifiers have wireless capability and a battery pack for mobile data acquisition. Wireless access points collect the wireless data transmissions. The amplifiers can be connected to the Ethernet by a cable and also to AC power. The amplifiers are IP addressable and can be connected directly to a network device. In all situations the amplifiers store a copy of the data locally to allow for data back-up. This amplifier provides storage and subsequent transmission of data that is not transferred live when the amplifier is in out of range situations.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Tests:

Basic safety: IEC 60601-1; The proposed device passes the applicable tests and standards.
Programmable Electrical Medical Systems: IEC 60601-4; The proposed device passes the applicable tests and standards.
Usability: IEC 60601-6; The proposed device passes the applicable tests and standards.
EMC Compatibility: IEC60601-1-2; The proposed device passes the applicable tests and standards.
Collateral Safety: IEC 60601-1-1; The proposed device passes the applicable tests and standards.
Electroencephalographs: IEC 60601-2-26; The proposed device passes the applicable tests and standards.
Risk Management: ISO 14971; The proposed device passes the applicable tests and standards.
Biocompatibility- non contact device: ISO 10993-1; The proposed device passes the applicable tests and standards.
FCC Specific Absorption Ratio (SAR): FCC Part 15C; FCC OET Bulletin 65, Supplement C; The proposed device passes the applicable tests and standards.
Battery safety: UN/DOT 38.3 Transportation testing 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 performance testing summary above. These standards address safety, biocompatibility, EMC compatibility, risk, usability, and radiated energy.

Clinical testing was not performed with this device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K061908, K090957, K060523, K060803, K040113, K033475, K003175

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 882.1835 Physiological signal amplifier.

(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).

Summary

0

K103140

510(k) SUMMARY

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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
Registration Number	3008289288
	Name of contact
person	Robert J Burdge
	Date prepared		6 April 2011
2	Name of Device
	Trade or proprietary
name	Nicolet Wireless EEG Amplifier
	Common or usual
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
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
K033475	02/18/2004
01/07/2004	Sandman SD20 Amplifier
Nihon Kohden WEE-1000 Wireless Amplifier	GWL
GWQ
		K003175	12/27/2000	Siesta Compumedics	GWQ

	Reason for 510(k)
submission		NicoletOne base system
Battery or Mains power	The changes addressed in this submission include:
Addition of wireless communication capability between the amplifier and the
Increased channels and sampling rates
4	Device Description			The Nicolet Wireless Amplifiers are used in a wide variety of EEG applications
including: Ambulatory (at home or in transit to home), OR, LTM, EEG, Sleep and
ICU. The proposed amplifiers are small portable devices that can run on main
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
64 channel amplifier.

These units can acquire from up to 32 or 64 channels, they can be grouped or
"cascaded" together for more channels. The amplifiers are capable of acquiring a
variety of electrophysiological signals at variable sampling frequencies. These
signals include EEG, EKG, EMG, EP, temperature, blood pressure, pulse, and
other signals standard to neurological and sleep testing.

The amplifiers have wireless capability and a battery pack for mobile data
acquisition. Wireless access points collect the wireless data transmissions. The
amplifiers can be connected to the Ethernet by a cable and also to AC power. The
amplifiers are IP addressable and can be connected directly to a network device.
In all situations the amplifiers store a copy of the data locally to allow for data
back-up.

This amplifier provides storage and subsequent transmission of data that is not
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
to acquire, store, and transmit electrophysiological signals in a wired or wireless
mode for the Nicolet Neurodiagnostic system. | |
| 6 | Summary of the technological characteristics of the device compared to the predicate device | | |
| | Characteristic | New Device
Nicolet Wireless EEG Amplifier | Predicate [Device Name]
[510(k) number] |
| | Interface to Amplifier | Wired Ethernet (10/100baseT) or
Wireless Ethernet (802.11b/g) | Wired Ethernet (10/100baseT)or Wireless
Ethernet (802.11b)
Substantially equivalent to the Nihon Kohden
WEE-1000 Wireless Amplifier (K033475) |
| | Power | Battery or 110/220VAC | 110 VAC, Battery and USB Port
Substantially equivalent to the Nihon Kohden
WEE-1000 Wireless Amplifier (K033475) |
| | System components | Patient Cable, Amplifier, CPU and a
Display Monitor; Telemetry unit and
access point | System components comprised of telemetry
unit, Electrode junction box and access point
to operate with the current NK commercially
available EEG devices
Substantially equivalent to the Nihon Kohden
WEE-1000 Wireless Amplifier (K033475) |
| | Number of Signal Recording
Channels | Up to 32 or 64 channels | 32 and up to 128 with one device; Up to 256
by cascading two devices |
| PERFORMANCE DATA | | | |
| 7 | SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL
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
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
device | ISO 10993-1 | The proposed device passes the applicable tests and standards. |
| | 9. FCC Specific Absorption
Ratio (SAR) | FCC Part 15C; FCC OET Bulletin 65,
Supplement C | The proposed device passes the applicable tests and standards. |
| | 10. Battery safety | UN/DOT 38.3 Transportation testing
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
performance testing summary above. These standards address safety, biocompatibility, EMC compatibility, risk,
usability, and radiated energy. | | |
| 8 | SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL | | |

2

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i

3

	EQUIVALENCE AND/OR OF CLINICAL INFORMATION
	Clinical Performance Data/Information
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.
The safety and effectiveness are substantially equivalent to The K061908- NicoletOne V32 Amplifier with Oximetry, the
K090957 Blackrock Neuroport Biopotential Signal Processing System, the K060523 NeuroPort Instrument, the
K060803 gUSBamp, the K040113 Sandman SD20 Amplifier, the K033475-Nihon Kohden WEE-1000 Wireless
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 (800) 638-2041 or (301) 796-7100 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