No
The summary describes a standard EEG acquisition and display system. There is no mention of AI, ML, or any algorithms that would interpret or analyze the EEG data beyond basic filtering and display (aEEG). The device explicitly states it does not provide diagnostic conclusions.
No
The device is described as an electroencephalograph (EEG) for monitoring brain status, which involves recording and displaying signals. It explicitly states, "The device does not provide any diagnostic conclusion about the patient's condition to the user." There is no mention of treating or preventing a condition, only monitoring.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The device does not provide any diagnostic conclusion about the patient's condition to the user." It is intended for monitoring the brain status by recording and displaying EEG and aEEG signals.
No
The device description explicitly states that the system, as delivered, includes hardware components such as a Panel PC and an amplifier, in addition to the software.
Based on the provided text, this device 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.
- Device Function: The neo monitor acquires and displays electroencephalograph (EEG) and amplitude-integrated electroencephalograph (aEEG) signals. This involves placing electrodes on the patient's head to measure electrical activity directly from the brain. It does not analyze samples taken from the body.
- Intended Use: The intended use is to "record and display EEG and aEEG signals for monitoring the brain status of neonatal patients." This is a monitoring function, not a diagnostic test performed on a biological sample.
- Lack of Diagnostic Conclusion: The text explicitly states, "The device does not provide any diagnostic conclusion about the patient's condition to the user." IVDs are typically used to aid in diagnosis.
Therefore, the neo monitor falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The neo monitor is an 8-channel electroencephalograph (EEG) acquisition software. The device is intended to record and display EEG and aEEG signals for monitoring the brain status of neonatal patients (defined as from birth to 28 days postdelivery, and corresponding to a postconceptual age of 24 to 46 weeks). The device is to be used in a hospital environment by qualified clinical practitioners. The device does not provide any diagnostic conclusion about the patient's condition to the user.
Product codes (comma separated list FDA assigned to the subject device)
OMA, ORT, OMC
Device Description
The nëo™ system is a reduced montage neonatal electroencephalograph device that acquires, displays, stores, and archives electroencephalographic signals from the brain. By application of electrodes at specific location on the cranium,using up to 10 surface electrodes placed at specific locations the system functions to measure and record electrical activity of the brain by acquisition of electroencephalograph data and amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).
The neo System is an electromedical device incorporating software. The device itself has no patient contact, but is intended for use with FDA-cleared ECG electrodes. nëo™ Monitor software, which, when installed into a compatible touchscreen PC and paired with a physiological signal amplifier (eego model EE-411) forms the nëo™ Monitor System. The system is a compact and easy-to-use and can be set on a bedside table, pole-mounted, or on a cart in the neonatal care areas.
The system, as-delivered to the customer, is comprised of:
- nëo Monitor software (pre-installed) ●
- 15" Panel PC ●
- eego EE-411 model amplifier ●
- Mounting plate ●
- nëo User Manual .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain
Indicated Patient Age Range
neonatal patients (defined as from birth to 28 days post-delivery, and corresponding to a postconceptual age of 24 to 46 weeks)
Intended User / Care Setting
hospital environment by qualified clinical practitioners.
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)
Non-Clinical Testing:
The nëo has been developed and tested to the following standards:
- . IEC 60601-1: Medical Electrical Equipment - PART 1: General Requirements for Basic Safety and Essential Performance
- . IEC 60601-2-26: Medical electrical equipment – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
- IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for basic . safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- IEC 62304 Medical Device Software Software Life Cycle Processes ●
- . ISO 14971 - Medical Devices - Application of Risk Management to Medical Devices
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
eemagine Medical Imaging Solutions GmbH % Mr. Steve Hesler Consultant S. Hesler Compliance Engineering 2602 5th Avenue West Linn, Oregon 97068
Re: K192889
Trade/Device Name: nëo Monitor System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMA, ORT, OMC Dated: November 11, 2019 Received: November 13, 2019
Dear Mr. Steve Hesler:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical. Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192889
Device Name nëo™ Monitor System
Indications for Use (Describe)
The neo monitor is an 8-channel electroencephalograph (EEG) acquisition software. The device is intended to record and display EEG and aEEG signals for monitoring the brain status of neonatal patients (defined as from birth to 28 days postdelivery, and corresponding to a postconceptual age of 24 to 46 weeks). The device is to be used in a hospital environment by qualified clinical practitioners. The device does not provide any diagnostic conclusion about the patient's condition to the user.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary (per 21 CFR 807.92)
Date prepared:
January 19, 2020
Submitter:
eemaqine Medical Imaging Solutions GmbH Gubener Str. 47, D-10243 Berlin. Germany Phone: +49 (0)30 2904 8404 E-Mail: support@eemagine.com
Contact person:
Steve Hesler 503 260 8221 heslers@yahoo.com
Proprietary name:
nëo™ Monitor System
Common name:
Electroencephalograph
Classified name:
Reduced- Montage Standard Electroencephalograph CFR 882.1400 Product code: OMC Class 2
Amplitude-Integrated Electroencephalograph CFR 882.1400 Product code: OMA Class 2
Burst Suppression Detection Software for Electroencephalograph CFR 882.1400 Product code: ORT Class 2
Indications for use:
The nëo™ monitor is an 8-channel electroencephalograph (EEG) acquisition software. The device is intended to record and display EEG and aEEG signals for monitoring the brain status of neonatal patients (defined as from birth to 28 days post-delivery, and corresponding to a postconceptual age of 24 to 46 weeks). The device is to be used in a hospital environment by qualified clinical practitioners. The device does not provide any diagnostic conclusion about the patient's condition to
4
510(k) Submission nëo™ system
the user.
Description of device:
The nëo™ system is a reduced montage neonatal electroencephalograph device that acquires, displays, stores, and archives electroencephalographic signals from the brain. By application of electrodes at specific location on the cranium,using up to 10 surface electrodes placed at specific locations the system functions to measure and record electrical activity of the brain by acquisition of electroencephalograph data and amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).
The neo System is an electromedical device incorporating software. The device itself has no patient contact, but is intended for use with FDA-cleared ECG electrodes. nëo™ Monitor software, which, when installed into a compatible touchscreen PC and paired with a physiological signal amplifier (eego model EE-411) forms the nëo™ Monitor System. The system is a compact and easy-to-use and can be set on a bedside table, pole-mounted, or on a cart in the neonatal care areas.
The system, as-delivered to the customer, is comprised of:
- nëo Monitor software (pre-installed) ●
- 15" Panel PC ●
- eego EE-411 model amplifier ●
- Mounting plate ●
- nëo User Manual .
Substantial equivalence:
The nëo™ system is substantially equivalent to the Olympic Brainz Monitor (K093949, June 16. 2010).
| Device Feature | nëo TM | Olympic Brainz Monitor |
|---|---|---|
| Reduced montage EEG | ||
| (code OMC) | Yes | Yes |
| Amplitude integrated | ||
| electroencephalograph | ||
| (code OMA) | Yes | Yes |
| Burst suppression detection | ||
| software (code ORT) | Burst suppression ratio | |
| (BSR) | ||
| Inter burst Interval (IBI) | No | |
| Target population | Neonates | Neonates |
| Use environment | neonatal care areas | NICU/research |
| Access | Roll-pole mount, cart mount | Roll-pole |
| Power Supply | 100-240V /50/60 Hz | 100 - 240 VAC, 50/60 Hz |
| Display/user interface | 15" touchscreen | 15" touchscreen |
| Mount | Vesa 100 interface | Vesa interface |
| Number of channels | 8 max | 3 max |
| Sampling rate | 512 Hz | 2000 Hz |
| Sampling resolution | 24 bit | 16 bits @2000 Hz |
| Input impedence | >1 GΩ | >50MΩ |
| Bandwidth: | 0Hz -128Hz | 0.5Hz ~ 450Hz |
| Noise in bandwidth | 100kOhm) | |
| and non-physiological data | ||
| (saturated channel, strong | ||
| drift, and strong hum noise) | Continuous Impedance values/trace | |
| Patient identification data | Shows Patient name, ID, | |
| Date of birth, Gender, | ||
| Gestational age at birth | Shows patient name, date | |
| of birth, time of birth and ID | ||
| Event marking | Yes, User can insert default | |
| or user- defined markers | ||
| during the recording | Yes. User can mark areas of | |
| interest. | ||
| Recorded file reviewing. | Yes | Yes |
| Working memory | 8 GB | 2 GB |
| Data export / storage: | via USB port | via USB port |
| Software upgrades: | via USB port | CD ROM drive |
| Simultaneous and | ||
| synchronized aEEG | ||
| and raw EEG display | Yes | Yes |
| Shows | ||
| Impedance measurements | Yes | Yes |
| aEEG signal processing | ||
| algorithm | Filtered by aEEG filter, | |
| rectified and semi | ||
| logarithmically compressed | Filtered by aEEG filter, rectified | |
| and semi logarithmically | ||
| compressed | ||
| aEEG filter | ||
| specification | Expected aEEG values for | |
| sine wave input signals of | ||
| 100µVpp: | ||
| Frequency (Hz) |
aEEG value µV
2Hz 23µV
10Hz 100µV
14Hz 100µV
25Hz 14µV | Up to 2 Hz: Rising by 60 dB/decade
2 Hz - 12 Hz: Rising by 12
dB/decade
12 Hz - 16 Hz: 1 dB above 10 Hz
level
16 Hz - 30 Hz: cut off slope 120
dB/decade
50 Hz and above: 60 dB down on
10 Hz response |
| aEEG display | Semi logarithmic scale from | Semi logarithmic scale |
| scale | 0 to 100 micro Volts | from 0 to 100 micro Volts. |
| Number of electrodes | 8 active electrodes + 1
reference + 1 patient
ground | 4 active electrodes + 1 •
reference |
Summary of technological characteristics compared to predicate devices:
5
nëo™monitor software is also compared with the Background Pattern Classification software (BPc) released by Natus Medical (K152301). Both software packages employ burst suppression algorithms.
Non-Clinical Testing:
The nëo has been developed and tested to the following standards:
6
- . IEC 60601-1: Medical Electrical Equipment - PART 1: General Requirements for Basic Safety and Essential Performance
- . IEC 60601-2-26: Medical electrical equipment – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
- IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for basic . safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- IEC 62304 Medical Device Software Software Life Cycle Processes ●
- . ISO 14971 - Medical Devices - Application of Risk Management to Medical Devices
Conclusion:
Based on the above comparison it is determined that the nëo™ system is substantially equivalent to the predicate Olympic Brainz Monitor.