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 Description

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. 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.

AI/ML Overview

This document describes the NicoletOne System V32 Amplifier with Oximetery, an electroencephalograph (EEG) amplifier. The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel acceptance criteria.

Therefore, the specific information requested about acceptance criteria, study design for proving device meets criteria, sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not explicitly provided in this 510(k) summary.

The document details the technical characteristics and intended use of the device, and states that safety and effectiveness were demonstrated through compliance with the VIASYS NeuroCare Design Control process, including software verification and validation, and hardware and system verification to specifications.

Here's an attempt to extract and synthesize the requested information based on the provided text, acknowledging where information is not present:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present "acceptance criteria" in a quantitative, measurable format with corresponding "reported device performance" in the way one might expect from a clinical trial or algorithm validation study. Instead, it compares the technical specifications of the V32 Amplifier to a predicate U32 Amplifier to demonstrate substantial equivalence.

Amplifier Feature	Predicate U32 Amplifier (Reference)	V32 Amplifier (Performance)	Implied "Acceptance Criteria" (Equivalent or better than predicate)
Number of Channels	40: 32 Differential, 8 Bipolar	32	Sufficient number of channels for intended EEG recording (implied by predicate)
Interface with XPod Pulse Oximetery	Yes	Yes	Presence of pulse oximetry interface
Computer Interface	USB	Ethernet	Functional computer interface (different but acceptable technology)
Filter Bandwidth	0.16 to 500Hz	0.053 to 500 Hz	Broad enough bandwidth for EEG signals
Common Mode Rejection	>110dB at 0.16Hz to 70Hz	>110dB at 50/60 Hz	High common mode rejection for signal quality
Common Mode Input Impedance	> 100 MegOhm	> 100 MegOhm	High input impedance for accurate signal measurement
DC Input Tolerance	+250m V	+350m V	Adequate DC input tolerance
Electrode Impedance Test	Yes (Continuous)	Yes (Continuous and as selected by the user)	Ability to test electrode impedance
Impedance Indicator	Yes	Yes	Presence of impedance indicator
Optional External Headbox	No	Yes (HB3)	(New feature)
Patient Event Input	Yes	Yes	Presence of patient event input
Alarms	No	No	No physiological alarms (consistent with predicate)
Safety Standards Compliance	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26	IEC 60601-1, IEC 60601-1-2, IFC 60601-2-26, ISO 9919	Compliance with relevant safety standards (V32 adds ISO 9919)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not explicitly stated. The document mentions "Hardware and system verification of conformance to specifications." This typically refers to engineering bench testing of the device hardware and software, not clinical testing with patient data or a "test set" in the context of an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable / Not stated. This device is an EEG amplifier; its performance is typically evaluated against engineering specifications and regulatory standards, not against "ground truth" derived from expert interpretation of images or signals in a clinical study. The device provides raw data for human interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable / Not stated. As described above, there is no mention of a "test set" in the context of expert review or adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI-assisted device. It is a medical device for acquiring physiological signals.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable for this type of device. The NicoletOne System V32 Amplifier is a hardware device for signal acquisition, not an algorithm that performs interpretations.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable / Not stated. The "ground truth" for this device's performance would be the accurate measurement and transmission of electrical signals according to its engineering specifications and relevant industry standards.

8. The sample size for the training set

Not applicable / Not stated. This device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not applicable / Not stated. No training set is mentioned for this device.

Study Proving Device Meets Acceptance Criteria:

The document states: "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 3. Declaration of safety standard compliance prior to commercial distribution."

This "study" (or rather, set of tests) refers to the internal verification and validation activities conducted by the manufacturer, VIASYS NeuroCare, Inc., as part of their design control process to ensure the device met its design specifications and complied with relevant safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, and ISO 9919). This is the standard procedure for demonstrating substantial equivalence for hardware medical devices in a 510(k) submission. No specific details about the methodology, results, or "acceptance criteria" for these internal tests are provided in this summary, as they are typically kept by the manufacturer and are not required to be detailed in the 510(k) summary itself.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for VIASYS Healthcare. The logo is in black and white and features the word "VIASYS" in large, bold letters. Below the word "VIASYS" is the word "HEALTHCARE" in smaller letters. The logo is simple and clean, and it is likely used to represent the company's brand.

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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.5225 Verona RoadMadison, WI 53711Glen HermansonMange of Global QualityPhone: (608) 441-2065Fax: (608) 441-2007
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 orWithout Pulse Oximetery Feature (Waratah and CardinalDigital EEG/Sleep Acquisition System)

1.0 Description of Device

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(Continuous)	Yes(Continuous and as selected bythe user)
Impedance Indicator	Yes	Yes
Optional External Headbox	No	Yes (HB3)
Patient Event Input	Yes	. Yes
Alarms	No	No
Safety Standards Compliance	IEC 60601-1IEC 60601-1-2IEC 60601-2-26	IEC 60601-1IEC 60601-1-2IFC 60601-2-26ISO 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,
1. 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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
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.(b)
Classification. Class II (performance standards).