The Neuroscan Nuamps® system is intended for the measuring, recording and analysis 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 setting for EEG. The system is intended for the EEG and long/middle-latency EP registration in the research environment.

Device Description

The Neuroscan Nuamps® is a 40-channel EEG amplifier capable of direct current (DC) recording, including signal amplification, analog-to-digital conversion, and filtering. Nuamps® permits high-speed simultaneous sampling, acquisition and transfer of data host computer that controls, displays, and stores the acquired data. Nuamps®'s software routines separately control each channel and perform real-time digital filtering. Nuamps® software measures and analyzes EEG signals and performs analysis of complete data sets, calculates compressed spectrum arrays (CSA), and presents results as annotated signal plots or topographic/tomographic maps in real-time two or three-dimensional (2/3-D) context. Nuamps® is optically isolated and transformers are available for line voltages of 100, 120, 230, VAC.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Neuroscan Nuamps® device:

Based on the provided text, the device is an Electroencephalograph (EEG) system, and the submission is a 510(k) premarket notification. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through rigorous clinical trials with specific acceptance criteria in the same way a PMA device would.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to compliance with applicable standards and performance equivalent to the predicate device, demonstrated through non-clinical testing. The text does not describe a study involving human subjects, AI performance, or the establishment of ground truth in the traditional sense for diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Compliance/Equivalence)	Reported Device Performance
Compliance with IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for safety) and related collateral/particular standards.	"All tests were completed satisfactorily without adverse report."
Compliance with EN46001 / EN ISO9001:2000 (Quality systems - Medical devices)	"All tests were completed satisfactorily without adverse report."
Compliance with MDD 93/42/EEC (Medical Device Directive)	"All tests were completed satisfactorily without adverse report."
Compliance with AAMI EC53-1995 (Standard for Ambulatory Electrocardiographs) - Note: Though context is EEG, this standard is listed.	"All tests were completed satisfactorily without adverse report."
Compliance with CDRH Guidance Document on the "Performance Standard for Electrode Lead Wire and Patient Cables," March 9, 1998.	"All tests were completed satisfactorily without adverse report."
Functional equivalence to the predicate device, Neuroscan SCAN LT (K001564), in terms of safety and effectiveness for EEG measurement, recording, and analysis.	"The Neuroscan Nuamps® systems works in the same manner as the approved and predicate device," and "demonstrate that the performance of the system is equivalent to that of the predicate devices in the terms of safety and effectiveness."
Additional features (12-bit trigger board for timing information) provide utility and product performance exceeding the predicate device.	"additional features provide utility and product performance which exceed that of the predicate devices."
Electrical activity measurement, recording, and analysis for monitoring and diagnosis in clinical EEG settings.	"intended for the measuring, recording and analysis 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 setting for EEG."
EEG and long/middle-latency EP registration in the research environment.	"The system is intended for the EEG and long/middle-latency EP registration in the research environment."

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not describe a test set or data provenance in the context of diagnostic accuracy where a "sample size" of patient data would be relevant. The testing performed was related to engineering and regulatory compliance standards for electrical safety and functional equivalence, not a clinical study on a patient cohort.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable and not provided as the submission describes an EEG hardware and software system, not an AI or diagnostic algorithm requiring expert-established ground truth for a test set. The validation focused on technical performance and safety standards.

4. Adjudication Method for the Test Set

This information is not applicable and not provided for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. The document describes a 510(k) submission for an EEG device, focusing on its technical specifications, compliance with standards, and equivalence to a predicate device. It does not involve human readers interpreting cases or AI assistance to human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This information is not applicable as the device is an EEG system for measuring, recording, and analyzing electrical brain activity, not a standalone diagnostic algorithm that operates without human clinician involvement. While it has "software routines" that "measure and analyze EEG signals," this is part of a standard EEG system, not an AI algorithm designed to operate independently for diagnosis without human oversight or interpretation of the generated data.

7. The Type of Ground Truth Used

The concept of "ground truth" (e.g., pathology, outcomes data) as typically applied to diagnostic AI devices is not relevant or described in this 510(k) summary. The "truth" for this device's performance is compliance with electrical and medical device safety standards, and functional specifications equivalent to a predicate EEG device.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is an EEG hardware and software system, not a machine learning model that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided for the same reasons as point 8.

Summary

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V. 510(k) Summary

Safety and effectiveness 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:	Neuroscan7850 Paseo Del Norte, Suite 101El Paso, TX 79912Phone: 915-845-5600 ext 217Fax: 915-845-2965	JAN 1 5 2003
Contact Person:	Elvira Garcia
Date Prepared:	October 9, 2002
Proprietary Name:	Nuamps®
Common Name:	Electroencephalograph (EEG)
Classification Name:	Electroencephalograph (GWQ), OLT
Device ClassificationClass II:	21 CFR § 882.1400 Electroencephalograph
Predicate Device:	SCAN LT510(k) # K001564

Description of the Device: The Neuroscan Nuamps® is a 40-channel EEG amplifier capable of direct current (DC) recording, including signal amplification, analog-to-digital conversion, and filtering. Nuamps® permits high-speed simultaneous sampling, acquisition and transfer of data host computer that controls, displays, and stores the acquired data. Nuamps®'s software routines separately control each channel and perform real-time digital filtering. Nuamps® software measures and analyzes EEG signals and performs analysis of complete data sets, calculates compressed spectrum arrays (CSA), and presents results as annotated signal plots or topographic/tomographic maps in real-time two or threedimensional (2/3-D) context. Nuamps® is optically isolated and transformers are available for line voltages of 100, 120, 230, VAC.

The Neuroscan Nuamps® systems works in the same manner as the approved and predicate device, and:

permits 1 to 40 channels configuration, and .
simplifies the acquisition, recording and analysis of the data generated in . high-resolution

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The Neuroscan SCAN LT was slightly modified to make the Neuroscan Nuamps. The modification does not affect the safety or effectiveness of the device. The modification consisted of a hardware change. We added a 12-bit trigger board that adds timing information on stimulus presentation to the EEG data collected by the amplifier.

Statement of Indications For Use:

Patient Population: Adults, children and infants

510(k) Summary of Non-Clinical Testing

The following is a list of test performed on the Neuroscan Nuamps® system. These tests demonstrate that the performance of the system is equivalent to that of the predicate devices in the terms of safety and effectiveness, and that the additional features provide utility and product performance which exceed that of the predicate devices. All tests were completed satisfactorily without adverse report.

The Neuroscan Nuamps® system was designed and is manufactured to comply with:

IEC-60601-1 ●
IEC-60601-1-1 ●
IEC-60601-1-1-2
IEC-60601-1-1-4 .
IEC-60601-1-2-26 .
EN46001 ●
EN ISO9001:2000 ●
MDD 93/42/EEC .
AAMI EC53-1995 ●
CDRH Guidance Document on the "Performance Standard for Electrode ● Lead Wire and Patient Cables," March 9, 1998

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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 consists of a stylized eagle with three stripes forming its wing and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

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

Neuroscan Elvira Garcia Quality Assurance Manager 7850 Paseo del Norte, Suite 101 El Paso, Texas 79912

Re: K023536

Trade/Device Name: NuAmps Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLT, GWQ Dated (Date on orig SE ltr): October 9, 2002 Received (Date on orig SE ltr): October 21, 2002

APR - 9 2012

Dear Ms. Garcia:

This letter corrects our substantially equivalent letter of January 15, 2003.

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.

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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/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/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

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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Statement of Indications for Use IV.

Applicant:	Neuroscan7850 Paseo Del Norte, Suite 101El Paso, TX 79912Phone: 915-845-5600 ext. 217Fax: 915-845-2965
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51(k) Number: Ko23536

Neuroscan Nuamps® Device Name:

Indications For Use: The Neuroscan Nuamps® system is intended for the measuring recording and analysis 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-latency EP registration in the research environment

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of device Evaluation (ODE)

R. Mark N. Melkman

(Division Sign-Off) Division of Coneral, Res rative and Neurological Devices

:10(k) Number K 023536
K023536 mnr

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Nuamps 510(k) Application

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).