(137 days)
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No
The summary describes a device for acquiring, digitizing, storing, and transmitting physiological signals, which are standard functions of an electroencephalograph. There is no mention of AI, ML, or any advanced analytical capabilities beyond basic signal processing. The emphasis is on data acquisition and transmission for interpretation by trained professionals.
No
The device is described as an electroencephalograph that acquires, digitizes, stores, and transmits physiological signals for EEG studies. It is used for diagnosis and monitoring, not for treating a condition.
Yes
The device is described as an "electroencephalograph" that is "used to acquire, digitize, store and transmit physiological signals (such as EEG, pulse and oximetry signals) for EEG studies in research and clinical environments." It also states that its "output must be reviewed and interpreted by trained medical professionals who will exercise professional judgment in using this information," implying that the information gathered is used for diagnostic purposes.
No
The device description explicitly states "The EMU40 Headbox is an electroencephalograph" and describes its function as acquiring, digitizing, storing, and transmitting physiological signals, indicating it is a hardware device. While it works in conjunction with software, it is not solely software.
Based on the provided information, the EMU40 Headbox is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- EMU40 Function: The EMU40 Headbox acquires, digitizes, stores, and transmits physiological signals directly from the body (EEG, pulse, oximetry). It does not analyze specimens taken from the body.
- Intended Use: The intended use describes the device as an electroencephalograph for EEG studies, which involves measuring electrical activity in the brain directly from the patient.
Therefore, the EMU40 Headbox falls under the category of a medical device used for physiological monitoring, not an IVD.
N/A
Intended Use / Indications for Use
The EMU40 Headbox is an electroencephalograph that works in conjunction with XLTEK NeuroWorks software {FDA 510(k) #K980214}.
The EMU40 Headbox is used to acquire, digitize, store and transmit physiological signals (such as EEG, pulse and oximetry signals) for EEG studies in research and clinical environments.
The EMU40 Headbox requires competent user input, and its output must be reviewed and interpreted by trained medical professionals who will exercise professional judgment in using this information.
Product codes
GWO
Device Description
The EMU40 Headbox is an electroencephalograph. It is used to acquire, digitize, store and transmit physiological signals (such as EEG, pulse and oximetry signals).
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
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Indicated Patient Age Range
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Intended User / Care Setting
competent user input, and its output must be reviewed and interpreted by trained medical professionals who will exercise professional judgment in using this information.
research and clinical environments.
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.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Image /page/0/Picture/1 description: The image shows a logo with a circular border containing text, surrounding a stylized symbol. The symbol consists of three curved lines that resemble human profiles facing to the right. The logo is simple and monochromatic, with a focus on the symbol's abstract representation of people.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2006
Excel-Tech. Ltd c/o Ms. Nicole Landreville, Eng. RAC Director, Quality and Regulatory 258 Bristol Circle Oakville, Ontario Canada L6H 5S1
Re: K053386
Trade/Device Name: XLTEK EMU40 EEG Headbox Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWO Dated: March 21, 2006 Received: March 23, 2006
Dear Mr. Landreville:
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 vour 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
1
Page 2 - Ms. Nicole Landreville, Eng. RAC
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. 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) 276-0115. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours
elmdl
Mark N. Melkerson
Director
Division of General, Restorative
and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Statement of Indications for Use
510(k) Number (if known): KoS 3386
Device Name: XLTEK EMU40 EEG Headbox
Indications for Use:
The EMU40 Headbox is an electroencephalograph that works in conjunction with XLTEK NeuroWorks software {FDA 510(k) #K980214}.
The EMU40 Headbox is used to acquire, digitize, store and transmit physiological signals (such as EEG, pulse and oximetry signals) for EEG studies in research and clinical environments.
The EMU40 Headbox requires competent user input, and its output must be reviewed and interpreted by trained medical professionals who will exercise professional judgment in using this information.
Prescription Use × (Per 21 CFR 801.109)
OR
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)
QmDQ
(Division Sign Off)
Division of General, Restorative,
and Neurological Devices
510(k) N
(Optional Format 1-2-96)