NATUS NEUROWORKS, MODEL 104196 by NATUS MEDICAL, INC.

The Neuroworks is EEG software that displays physiological signals. The intended user of this product is a qualified medical practitioner trained in Electroencephalography. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.

The Neuroworks EEG software allows acquisition, display, archive, review and analysis . of physiological signals.
The Seizure Detection component of Neuroworks is intended to mark previously . acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system.
The Spike Detection component of Neuroworks is intended to mark previously acquired l sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp nontage according to the standard 10/20 system.
The aEEG functionality included in Neuroworks is intended to monitor the state of the 포 brain. The automated event marking function of Neuroworks is not applicable to aFEG.
Neuroworks also includes the display of a quantitative EEG plot, Compressed Spectrum 1 Array (CSA), which is intended to help the user to monitor and analyze the EEG waveform. The automated event marking function of Neuroworks is not applicalle to CSA.
This device does not provide any diagnostic conclusion about the patient's condition to the user.

Device Description

The Neuroworks is EEG software that displays physiological signals.

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for the Natus Neuroworks, Model 104196. It details the device's indications for use but does not contain information about the acceptance criteria, specific study details, or performance results that would typically be reported for an AI/ML medical device.

The device, Natus Neuroworks, is referred to as "EEG software" with components for "Seizure Detection" and "Spike Detection." However, the letter predates the widespread acceptance and specific regulatory pathways for AI/ML performance evaluation in medical devices. At the time of this letter (2010), the focus was primarily on substantial equivalence to predicate devices under the general controls provisions of the Act.

Therefore, I cannot provide the requested information from the provided text for the following reasons:

No Acceptance Criteria or Device Performance: The document does not list any quantitative acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, AUC) for the Seizure Detection or Spike Detection components.
No Study Details: There is no description of a study design, sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
No AI/ML Specific Evaluations: The document does not mention multi-reader multi-case (MRMC) studies, standalone algorithm performance, or training set details, which are standard for evaluating AI/ML models. While the device has "automated event marking functions," the regulatory review in 2010 did not necessitate the level of detail now expected for AI/ML performance studies.

In summary, the provided document confirms the substantial equivalence of the Natus Neuroworks device to a predicate device based on its indications for use, but it does not include the detailed performance study information required to answer your specific questions about acceptance criteria and how a study proved the device meets them.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Natus Medical, Inc. Excel-Tech Ltd. % Ms. Goldy Singh Director of Quality and Regulatory 2568 Bristol Circle Oakville, Ontario Canada, L6H 5S1

FEB 2 2 2010

Re: K090019

Trade Name: Natus Neuroworks, Model 104196 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMB, OMA, OLT Dated: September 9, 2009 Received: September 28, 2009

Dear Ms. Singh:

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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Page 2 - Ms. Goldy Singh

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/AboutFD/VCentersOffices/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,

Mark N. Melkerson

Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement - Supplement 6

510(k) Number: K090019

Device Name: Natus Neuroworks, Model 104196

Indications for Use:

The Neuroworks EEG software allows acquisition, display, archive, review and analysis . of physiological signals.
The Seizure Detection component of Neuroworks is intended to mark previously . acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system.
The Spike Detection component of Neuroworks is intended to mark previously acquired l sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp nontage according to the standard 10/20 system.
The aEEG functionality included in Neuroworks is intended to monitor the state of the 포 brain. The automated event marking function of Neuroworks is not applicable to aFEG.
Neuroworks also includes the display of a quantitative EEG plot, Compressed Spectrum 1 Array (CSA), which is intended to help the user to monitor and analyze the EEG waveform. The automated event marking function of Neuroworks is not applicalle to CSA.

This device does not provide any diagnostic conclusion about the patient's condition to the user.

Prescription Use x (Per 21 CFR 801.109) og

Over-The Counter Use ___________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR M. ME be optional Format 1-2-96) (Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090019

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).