The Compumedics Neuvo System is intended for measuring recording of the electrical activity of a patient's brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. The system is intended for the EEG and long/middle/short- latency EP registration in the research environment. The system is intended to be used by qualified/trained EEG technologists and/or physicians. The data acquired must be interpreted by a qualified physician.

Device Description

The Compumedics Neuvo System is intended for measuring of the electrical activity of a patient's brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. The system is intended for the EEG and long/middle/short-latency EP registration in the research environment. The system is intended to be used by qualified/traincd EEG technologists and/or physicians. The data acquired must be interpreted by a qualified physician.

The Neuvo Amplifier System is an EEG/ERP/EP amplifier and data acquisition system. The amplifier and data acquisition clectronics are housed in a small enclosure (Headbox) placed near the patient, and into which individual clectrodes, collections of electrodes, may be connected. Additionally a high density electrode cap connector is provided on the Headbox. The Headbox also contains a connector for the interconnect cable to the System Unit.

The System Unit is slightly larger than the Headbox and serves as an interface between up to four Headboxes and the host computer.

The system operates under the software control of a host computer over an Ethernet 100BaseT interface. Data flows from the Neuvo amplifier over this interface.

AI/ML Overview

Here's an analysis of the provided text regarding the Neuvo device's acceptance criteria and study, based on the information available in the 510(k) summary:

Unfortunately, the provided 510(k) summary for the Compumedics Neuvo (K081151) does not contain information about acceptance criteria or specific study results demonstrating performance for the device.

This document primarily serves as a submission for substantial equivalence to a predicate device (SynAmps2 510(k) # K023771) and focuses on describing the device, its intended use, and its classification. Performance data with acceptance criteria is typically detailed in separate sections of a 510(k) submission, such as a "Summary of Design Control Documentation" or "Performance Data," which are not present in the given excerpt.

Therefore, I cannot provide the requested information. The document focuses on:

Administrative details: Contact person, date prepared, proprietary and common names, classification, and predicate device.
Device description: Explanation of the Neuvo system components (amplifier, headbox, system unit, software control).
Intended Use/Indications for Use: What the device is designed to do (measure electrical activity of the brain to aid in monitoring and diagnosis for EEG, and for EP registration in research).
FDA correspondence: The letter confirming substantial equivalence.

Without further documentation from the 510(k) submission, it's impossible to answer the specific questions about acceptance criteria, study design, sample sizes, ground truth, or expert involvement.

Summary

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(K08115)

Page ① of 2

510(k) Summary

SEP - 8 2008

Safety and offectiveness information concerning this device is summarized below. Because this is not a Class III device, the special certification defined in this section is not required.

Submitted by:

David Graves Quality Engineer Compumedics USA Ltd 6605 West WT Harris Blvd, Suitc F Charlotte, NC, USA 28269 Ph : 704 749 3221 Fx : 704 749 3298 dgraves@compumedicsusa.com www.compumedics.com

Contact Person:

David Graves
Quality Engineer
Compumedics USA Ltd
6605 West WT Harris Blvd. Suite F
Charlotte, NC, USA 28269
Ph : 704 749 3221
Fx : 704 749 3298
dgraves@compumedicsusa.com
www.compumcdics.com

Date Prepared: 25 Feb 2008

Proprietary Namc: Neuvo

Common Name: Electroencephalograph (EEG)

Classification Name: GWQ, GWP, GWF, GWE, GWJ

Device Classification: Class II: 21 CFR § 882.1400 Electroencephalograph

Predicate Device: SynAmps2 510(k) # K023771

Description of the Device:

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Page (2) of 2

The System Unit is slightly larger than the Headbox and serves as an interface between up to four Headboxes and the host computer.

The system operates under the software control of a host computer over an Ethernet 100BaseT interface. Data flows from the Neuvo amplifier over this interface.

Image /page/1/Figure/4 description: This image shows a diagram of a medical device system. The system includes a display, a system unit, a network connection, a power connection, an external DC input module, a headbox, an LTM headbox, and an event button. The headbox is labeled as "up to 4 off."

NEUVO SYSTEM COMPONENTS

Figure 1-1 Illustration of the various Neuvo components.

Figure 1-1 illustrates the various components that can be used in a Neuvo system. Note that the cable management system is not shown.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three distinct lines forming its body and wings. The bird is positioned diagonally within the frame. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

Compumedics USA, Limited c/o Intertek Testing Services Mr. Daniel W. Lehtonen 2307 East Aurora Road, Unit B Twinsburg, Ohio 44087

Re: K081151

Trade/Device Name: Compumedics Neuvo Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ, GWF, GWJ, GWE Dated (Date on orig SE ltr): August 22, 2008 Received (Date on orig SE ltr): August 25, 2008

Dear Mr. Lehtonen:

This letter corrects our substantially equivalent letter of September 8, 2008.

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.

APP - 9 2012

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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/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/ReportaProblem/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,

Kesia Alexander

Image /page/3/Picture/7 description: The image shows a stylized signature. The signature appears to be handwritten in cursive. The letters are connected and flow together in a fluid manner.

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

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Attachment 2 - Statement of Indications for use

Applicant:	Compumedics USA, Ltd
510(K) Number:	K081151
Device Name:	Compumedics Neuvo
Indications For Use:	The Compumedics Neuvo System is intended for measuring recording of the electrical activity of a patient's brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. The system is intended for the EEG and long/middle/short- latency EP registration in the research environment. The system is intended to be used by qualified/trained EEG technologists and/or physicians. The data acquired must be interpreted by a qualified physician.

Prescription Use(Per 21 CFR 801 SubpartD)	✓	AND/OR	Over the Counter Use(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of device Evaluation (ODE)
Mark A. Miller
K081151

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

510(k) Number K08 115

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).