(88 days)
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Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe functionalities typically associated with AI/ML in medical devices (like image analysis or complex pattern recognition beyond basic signal processing).
No
The device is intended to "record and process EEG signals" and signals from other transducers, which makes it a diagnostic or monitoring device, not one that directly treats a condition.
No
The device records and processes EEG signals but does not state that it is used to diagnose a medical condition.
No
The device description is "Not Found," but the intended use explicitly states it records and processes EEG signals from "third party transducer such as ECG, EMG, Oxygen Saturation or Respiration." This indicates the device relies on external hardware transducers to acquire physiological data, making it not solely software.
Based on the provided information, the Nervus Monitor system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Nervus Monitor Function: The description states the Nervus Monitor records and processes physiological signals like EEG, ECG, EMG, Oxygen Saturation, and Respiration. These are signals measured from the body, not tests performed on samples taken from the body.
Therefore, the Nervus Monitor falls under the category of a medical device that monitors physiological parameters, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Nervus Monitor system is intended to record and process EEG signals from third party transducer such as ECG, EMG, Oxygen Saturation or Respiration, from adult to pediatric patients.
The Nervus Monitor is intended for use only by medically trained and qualified personnel, within a hospital or medical environment.
Product codes
OLV, GWQ
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
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Indicated Patient Age Range
Adult to pediatric patients.
Intended User / Care Setting
Medically trained and qualified personnel, within a hospital or medical environment.
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.
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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
Image /page/0/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Taugagreining HF E. J. Smith Smith Associates P.O. Box 4341 Crofton, Maryland 21114-4341
Re: K021185 Trade/Device Name: Nervus Monitor Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV, GWQ Dated (Date on orig SE ltr): April 15, 2002 Received (Date on orig SE Itr): April 15, 2002
- g 2012 APA
Dear Mr. Smith:
This letter corrects our substantially equivalent letter of July 12, 2002.
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 - Mr. E. J. Smith
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 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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Image /page/1/Picture/8 description: The image shows a stylized signature in black ink on a white background. The signature appears to be a cursive "fa" or a similar combination of letters, with a flowing, elongated "f" that curves downward and then loops back up to form the "a". The lines are thin and delicate, giving the signature an elegant and artistic appearance. The signature is positioned vertically in the image.
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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× 021188 ( K 0 21185 510(k) Number:
Device Name: Nervus Monitor
Classification Panel: GWQ
Indications for Use:
The Nervus Monitor system is intended to record and process EEG signals from third party transducer such as ECG, EMG, Oxygen Saturation or Respiration, from adult to pediatric patients.
The Nervus Monitor is intended for use only by medically trained and qualified personnel, within a hospital or medical environment.
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number -
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: _ U
Over-the-Counter Use: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Styet Rurle
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K021185