(110 days)
Not Found
No
The description focuses on the physical components and intended use of the EEG electrode array, with no mention of AI or ML for signal processing or interpretation.
No.
The device is used to record electrophysiological signals (EEG), which is a diagnostic function, not a therapeutic one.
Yes
The device enables recordings of electrophysiological signals (such as EEG) which are used for neuro-diagnostic or neuro-monitoring equipment. These recordings provide information that can be used to diagnose medical conditions related to brain activity.
No
The device description clearly outlines physical hardware components including electrodes, a flexible polyester substrate, foam, an interface cable, and connectors. It is not solely software.
Based on the provided information, the NEON EEG is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of disease or conditions.
- NEON EEG Function: The NEON EEG is applied directly to the patient's scalp to record electrophysiological signals (EEG). It is a device that interacts with the patient's body to measure electrical activity, not a device that analyzes samples taken from the body.
Therefore, the NEON EEG falls under the category of a medical device that is used in vivo (within the living body) to acquire physiological data.
N/A
Intended Use / Indications for Use
The NEON EEG is intended to be applied directly to the patient's scalp to enable recordings of electrophysiological signals (such as EEG) on infants from birth. The NEON EEG is indicated for single use only and should be replaced after 12 hours of use.
The NEON EEG is not indicated for use with electro stimulation equipment.
Product codes
GXY
Device Description
The NEON EEG consists of an array of pre-gelled electrodes that are sized to fit an infant's scalp. The electrodes utilize materials that are common in sensing technology: The electrodes are screen-printed in Ag/AgCl ink on a flexible polyester substrate. The electrodes are pre-gelled with industry-standard electrode paste that provides both the intimate electrical connection and the adhesion to the scalp. The electrode array substrate has a thin layer of inert foam to provide comfort to the patient whilst the device is being worn.
The electrode array connects to a monitoring machine by an interface cable that has medically-recognized safety end fittings ("touch proof" or "D type") that cannot be inserted into an AC outlet. The safety connector is connected to the electrically and patient-isolated pre-amplifier input of a neuro-diagnostic or neuro-monitoring equipment. All of the electrical safety features are provided by the neuro-diagnostic or neuro-monitoring equipment.
The NEON electrode array is sized to fit new-born infants and so has a reduced lead set of 5 pairs of electrodes, with each pair having an electrode on opposite sides of the head, plus a Ground and Reference. The positioning of the electrodes in the array is based upon the principles of the 10-20 placement system, with the individual electrodes labeled with their 10-20 nomenclature. The shape of the array is designed to allow as much access to the scalp as possible, so that the NEON EEG can co-exist with other monitoring requirements and to allow the free circulation of air to the infant's head and thus not contribute to cranial overheating.
An industry-standard EEG electrolyte qel is supplied in the device package to allow optional application on individual electrodes sites, should it be required to reduce the electrode impedance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's scalp
Indicated Patient Age Range
infants from birth
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The NEON EEG has been tested to the relevant parts of the following recognized performance standards:
- IEC60601-1-2:2007 Medical electrical equipment Part 1-2: General ● requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- AAMI EC12: 2005 - Disposable ECG electrodes
- IEEE 2010:2012 - IEEE Recommended Practice for Neurofeedback Systems
In all instances, the NEON EEG functioned as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 29, 2015
Incereb Ltd Paul Phillips QA/RA Manager Centre Of Applied Science For Health, Institute Of Technology Tallaght Dublin. IE DUBLIN24
Re: K151576
Trade/Device Name: Neon EEG Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: June 4, 2015 Received: June 17, 2015
Dear Paul Phillips:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Carlos L. Pena -S 同公
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151576
Device Name NEON EEG
Indications for Use (Describe)
The NEON EEG is intended to be applied directly to the patient's scalp to enable recordings of electrophysiological signals (such as EEG) on infants from birth. The NEON EEG is indicated for single use only and should be replaced after 12 hours of use.
The NEON EEG is not indicated for use with electro stimulation equipment.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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V. 510(K) SUMMARY
510(k) SUMMARY
Incereb Ltd's NEON EEG
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Incereb Ltd Centre of Applied Science for Health Institute of Technology, Tallaght Dublin 24 IRELAND
Phone: +353 1 685 2245 EMail: pphillips@incereb.com
Contact Person: Paul Phillips
Date Prepared: 4th June 2015
Name of Device
NEON EEG
Common or Usual Name
Cutaneous Electrode
Classification Name/Product Code/CFR Reference
Class II, Cutaneous Electrode, Product code: GXY, 21 CFR 882.1320,
Predicate Devices
Primary Predicate: Aspect Medical Systems' BIS Bilateral Sensor (K062692) Secondary Predicate: Aspect Medical Systems' BIS Pediatric Sensor (K041670)
Intended Use / Indications for Use
The NEON EEG is intended to be applied directly to the patient's scalp to enable recordings of electrophysiological signals (such as EEG) on infants from birth.
The NEON EEG is indicated for single use only and should be replaced after 12 hours of use.
The NEON EEG is not indicated for use with electro stimulation equipment
4
Technological Characteristics
The NEON EEG consists of an array of pre-gelled electrodes that are sized to fit an infant's scalp. The electrodes utilize materials that are common in sensing technology: The electrodes are screen-printed in Ag/AgCl ink on a flexible polyester substrate. The electrodes are pre-gelled with industry-standard electrode paste that provides both the intimate electrical connection and the adhesion to the scalp. The electrode array substrate has a thin layer of inert foam to provide comfort to the patient whilst the device is being worn.
The electrode array connects to a monitoring machine by an interface cable that has medically-recognized safety end fittings ("touch proof" or "D type") that cannot be inserted into an AC outlet. The safety connector is connected to the electrically and patient-isolated pre-amplifier input of a neuro-diagnostic or neuro-monitoring equipment. All of the electrical safety features are provided by the neuro-diagnostic or neuro-monitoring equipment.
The NEON electrode array is sized to fit new-born infants and so has a reduced lead set of 5 pairs of electrodes, with each pair having an electrode on opposite sides of the head, plus a Ground and Reference. The positioning of the electrodes in the array is based upon the principles of the 10-20 placement system, with the individual electrodes labeled with their 10-20 nomenclature. The shape of the array is designed to allow as much access to the scalp as possible, so that the NEON EEG can co-exist with other monitoring requirements and to allow the free circulation of air to the infant's head and thus not contribute to cranial overheating.
An industry-standard EEG electrolyte qel is supplied in the device package to allow optional application on individual electrodes sites, should it be required to reduce the electrode impedance.
Performance Standards
The NEON EEG has been tested to the relevant parts of the following recognized performance standards:
- IEC60601-1-2:2007 Medical electrical equipment Part 1-2: General ● requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- AAMI EC12: 2005 - Disposable ECG electrodes
- . IEEE 2010:2012 - IEEE Recommended Practice for Neurofeedback Systems
In all instances, the NEON EEG functioned as intended.
5
Substantial Equivalence
The NEON EEG is as safe and effective as the Aspect Medical Systems' BIS Bilateral Sensor (K062692). The NEON EEG has the same intended use, main technological characteristics, and principles of operation as its predicate device. The indications for use of the primary predicate device do not indicate that it is only for adult patients, though the device sizing implies it as it would be too large for a new-born. The secondary predicate (K041670) is of the same technology as both the primary predicate and the NEON, it has just 4 electrodes in its array, to allow it to be applied to a pediatric scalp. The secondary predicate's indications for use do specifically cite pediatric use.
The NEON and the two predicate devices all share the same technology, they just differ in minor technical implementations and in the number of electrodes in their electrode array, which is a feature to enable the devices to suit the size of the scalp of the patients in their intended use/indications for use. These minor differences between the NEON EEG and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the NEON EEG is safe and effective in use. Thus, the NEON EEG is substantially equivalent.