(416 days)
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Unknown
The summary mentions "automated event marking function" for seizure and spike detection, which could potentially utilize AI/ML, but the document does not explicitly state the use of these technologies. The lack of information on training/test sets and performance metrics further contributes to the uncertainty.
No
The device is EEG software for display, analysis, and review of physiological signals, and it explicitly states it "does not provide any diagnostic conclusion about the patient's condition to the user." It assists in assessment but does not treat.
No
The "Intended Use / Indications for Use" section explicitly states, "This device does not provide any diagnostic conclusion about the patient's condition to the user." While it assists in assessing EEG traces and marking potential seizures or spikes, this assistance is to "help the user to monitor and analyze" and "assist qualified clinical practitioners in the assessment," not to provide a definitive diagnosis itself.
Yes
The device description explicitly states "The Neuroworks is EEG software that displays physiological signals," and the entire summary focuses on the software's functionalities for processing and displaying EEG data. There is no mention of accompanying hardware components included with the device.
Based on the provided information, the Neuroworks device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The definition of an IVD typically involves the examination of specimens such as blood, urine, tissue, etc., in vitro (outside the body).
- Neuroworks analyzes physiological signals obtained from the body. The input is Electroencephalography (EEG) recordings, which are electrical signals measured from the scalp. This is a measurement of a physiological process happening in vivo (within the body), not an analysis of a sample taken from the body.
- The intended use is to assist in the assessment of EEG traces. The software helps qualified medical practitioners review and analyze EEG data, but it doesn't perform tests on biological samples to provide diagnostic information.
While the software assists in the diagnostic process by highlighting potential areas of interest (seizures, spikes), it does so by analyzing electrical signals from the brain, not by testing a biological sample.
N/A
Intended Use / Indications for Use
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.
Product codes
OMB, OMA, OLT
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
brain
Indicated Patient Age Range
adult (greater than or equal to 18 years)
Intended User / Care Setting
qualified medical practitioner trained in Electroencephalography
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
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.
1
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 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.
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