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.

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 .

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the nëo Monitor System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific performance metrics against pre-defined acceptance criteria for the entire device. Instead, it compares the technological characteristics of the nëo Monitor System to its predicate, the Olympic Brainz Monitor.

The table below summarizes the technical specifications compared, which implicitly serve as acceptance criteria for functionality. It also includes the performance for the burst suppression detection software, which is a key differentiating feature with its own implicit performance.

Feature	Acceptance Criteria (based on Predicate/Standard)	nëo™ Monitor System Reported Performance
Reduced montage EEG	Yes (comparable to predicate)	Yes
Amplitude integrated electroencephalograph	Yes (comparable to predicate)	Yes
Burst suppression detection software	Indication of burst suppression detection capability (compared to another predicate, Background Pattern Classification software (BPc) by Natus Medical (K152301), and the Olympic Brainz Monitor which does not have this feature)	Burst suppression ratio (BSR) Inter burst Interval (IBI)
Target population	Neonates	Neonates
Use environment	Neonatal care areas / NICU/research	neonatal care areas
Number of channels	3 max (Predicate)	8 max
Sampling rate	2000 Hz (Predicate)	512 Hz
Sampling resolution	16 bits @2000 Hz (Predicate)	24 bit
Input impedance	>50MΩ (Predicate)	>1 GΩ
Bandwidth	0.5Hz ~ 450Hz (Predicate)	0Hz -128Hz
Noise in bandwidth	< 1 µV (RMS) (@450Hz bandwidth) (Predicate)	< 1.4µVrms for a bandwidth of 0Hz - 128Hz
aEEG filter specification	Defined frequency response profile (Predicate)	Expected aEEG values for sine wave input signals of 100µVpp:- 2Hz: 23µV - 10Hz: 100µV - 14Hz: 100µV - 25Hz: 14µV
Signal reliability parameters	Continuous Impedance values/trace (Predicate)	Notification messages for high impedance (>100kOhm) and non-physiological data (saturated channel, strong drift, and strong hum noise)
Basic Safety & Essential Performance	Compliance with IEC 60601-1, IEC 60601-2-26	Device has been developed and tested to IEC 60601-1, IEC 60601-2-26, IEC 60601-1-2, IEC 62304, ISO 14971. (This implies performance meets the requirements of these standards, though specific data is not detailed in this summary).

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not detail a clinical study with a specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective data for clinical validation). The submission relies on non-clinical testing against recognized standards and a comparison of technological characteristics to a predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Since a clinical test set for performance validation (beyond technical specifications) is not described, there is no information on:

The number of experts used.
The qualifications of those experts.

4. Adjudication Method for the Test Set

As no specific clinical test set for performance evaluation is described, there is no information on any adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study is mentioned in the provided document. The focus is on demonstrating substantial equivalence based on technical specifications and non-clinical testing, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

For the specific functions like aEEG signal processing and burst suppression detection, the document describes the algorithms and their technical specifications (e.g., aEEG filter specification, presence of BSR/IBI). The fact that these are listed as device features implies standalone algorithm functionality. However, a formal "standalone performance study" with specific metrics (e.g., sensitivity, specificity for burst detection against a human-annotated ground truth) is not detailed in this document. The comparison is largely at a functional and technical specification level.

7. The Type of Ground Truth Used

For the technical specifications, the ground truth is implicitly defined by:

Engineering specifications and test methodologies for electrical performance (e.g., sampling rate, resolution, noise, impedance).
Standardized test signals (e.g., sine wave inputs for aEEG filter specification).
Reference standards like IEC 60601-1, IEC 60601-2-26, etc. for safety and essential performance.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for a clinical validation study in this summary.

8. The Sample Size for the Training Set

The document does not mention any training set size as it concerns hardware/software specifications and regulatory compliance rather than an AI/machine learning model whose performance on classification/detection tasks is being clinically validated against a dataset. While the burst suppression detection software might involve algorithms, the document doesn't delve into its development data.

9. How the Ground Truth for the Training Set Was Established

Since no training set is described, no information is provided on how its ground truth might have been established.

Summary

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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

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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)

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

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510(k) Submission nëo™ system

the user.

Description of device:

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 integratedelectroencephalograph(code OMA)	Yes	Yes
Burst suppression detectionsoftware (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	< 1.4µVrms for a bandwidthof 0Hz - 128Hz	< 1 µV (RMS) (@450Hz bandwidth)
Secondary parameters	None	None
Signal reliabilityparameters	Notification messages forhigh impedance (>100kOhm)and non-physiological data(saturated channel, strongdrift, 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, dateof birth, time of birth and ID
Event marking	Yes, User can insert defaultor user- defined markersduring the recording	Yes. User can mark areas ofinterest.
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 andsynchronized aEEGand raw EEG display	Yes	Yes
ShowsImpedance measurements	Yes	Yes
aEEG signal processingalgorithm	Filtered by aEEG filter,rectified and semilogarithmically compressed	Filtered by aEEG filter, rectifiedand semi logarithmicallycompressed
aEEG filterspecification	Expected aEEG values forsine wave input signals of100µVpp:Frequency (Hz)-------------------- aEEG value µV--------------------2Hz 23µV10Hz 100µV14Hz 100µV25Hz 14µV	Up to 2 Hz: Rising by 60 dB/decade2 Hz - 12 Hz: Rising by 12dB/decade12 Hz - 16 Hz: 1 dB above 10 Hzlevel16 Hz - 30 Hz: cut off slope 120dB/decade50 Hz and above: 60 dB down on10 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 + 1reference + 1 patientground	4 active electrodes + 1 •reference

Summary of technological characteristics compared to predicate devices:

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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:

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. 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.

Regulation Number and Section

§ 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).