The GE EEG module, E-EEGX, the GE EEG headbox, N-EEGX, and accessories are intended to be used with the compatible CARESCAPE monitors for the monitoring of electroencephalograph (EEG), frontal electromyograph (FEMG), and auditory evoked potentials (AEP) of all hospital patients. The device is intended for use by qualified medical personnel only.

Device Description

The E-EEGX module is a single-width plug-in interface module to be used with CARESCAPE Bx50 V3 patient monitors. It is used with N-EEGX headbox and accessories for monitoring neurophysiological status of all hospital patients by measuring the electroencephalogram (EEG), frontal electromyogram (FEMG) and auditory evoked potentials (AEP).

The E-EEGX module is used with the N-EEGX headbox for monitoring of EEG. FEMG. to stimulate the brain with auditory stimuli, and to measure AEP. The E-EEGX module connects to a N-EEGX headbox which further connects to accessories that connect to the patient.

The EEG, FEMG and AEP measurements are performed by the N-EEGX headbox. The N-EEGX headbox measures the raw EEG waveform data from four real-time EEG waveform channels, FEMG from one channel and AEP from two channels. The N-EEGX headbox is connected to the patient with EEG accessories.

The E-EEGX module transfers the digitized EEG data received from the N-EEGX headbox to the host monitor. The module also generates the stimuli used in the AEP measurement and performs part of the AEP measurement data processing.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the E-EEGX module, N-EEGX headbox, and accessories, based on the provided FDA 510(k) summary:

The document does not detail specific quantitative acceptance criteria or a study designed to explicitly "prove" the device meets these criteria in the way a clinical trial would for a new therapeutic. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K051883 Datex-Ohmeda S/5 EEG Module, E-EEG and Headbox, N-EEG and Accessories) through non-clinical testing.

The "acceptance criteria" can be inferred from the comparison table and the list of standards the device complies with. The "reported device performance" is essentially that the new device's specifications are either identical or acceptably equivalent to the predicate, and that it meets relevant safety and performance standards.

1. Table of Acceptance Criteria and Reported Device Performance

Since specific "acceptance criteria" with numerical targets and a performance study against them aren't explicitly presented, I've constructed a table based on the comparative effectiveness information provided, which serves as the basis for demonstrating substantial equivalence. The "Acceptance Criteria" column reflects the predicate device's specifications (which the new device aims to match or improve within acceptable limits), and the "Reported Device Performance" column shows the new device's specifications.

Characteristic	Acceptance Criteria (Predicate: K051883)	Reported Device Performance (E-EEGX, N-EEGX)	Discussion of Differences & Acceptance Statement
Indications for Use	Monitoring of EEG, FEMG, and AEP of all hospital patients by qualified medical personnel.	Monitoring of EEG, FEMG, and AEP of all hospital patients with compatible CARESCAPE monitors by qualified medical personnel.	Equivalent. Minor text edits for clarity, company name update ("GE" instead of "Datex"), and reference to compatible monitors. No significant impact on safety/effectiveness.
Module Size (E-EEGX)	112 x 37 x 186 mm (0.3 kg)	112 x 37 x 187 mm (0.3 kg)	Equivalent. Negligible physical size difference (1mm depth).
Headbox Size (N-EEGX)	34 x 97 x 174 mm	34 x 97 x 174 mm	Identical.
Headbox Weight (N-EEGX)	0.44 kg (1.1 lb)	0.5 kg (1.1 lb)	Equivalent. Slightly changed due to new hardware design. No significant impact on safety/effectiveness.
Host Device Compatibility	S/5 AM, CAM, S/5 CCM, CARESCAPE B450, B650, B850 (ESP V1 or V2)	CARESCAPE Bx50 V3 patient monitors	Equivalent. New device compatible only with newer CARESCAPE Bx50 V3 monitors. Verified functionality remains equivalent. No significant impact on safety/effectiveness.
Measured Parameters	EEG, Auditory Evoked Potentials, EMG	EEG, Auditory Evoked Potentials, EMG	Identical.
Mode	Referential or Bipolar	Referential or Bipolar	Identical.
EEG Processing	Spectral analysis (SEF, Median frequency, Relative power in Delta, Theta, Alpha, Beta), Burst suppression, Total power	Spectral analysis (SEF, Median frequency, Relative power in Delta, Theta, Alpha, Beta), Burst suppression, Total power	Identical.
EEG Measurement Method	1, 2, 3 or 4 channels of EEG	1, 2, 3 or 4 channels of EEG	Identical.
EEG Range	$\pm$ 400 μV	$\pm$ 500 μV	Equivalent. Range expanded to meet IEC 60601-2-26:2012. Verified functionality remains equivalent. No significant impact on safety/effectiveness.
EEG Freq. Range	0.5 ... 30 Hz	0.5 ... 50 Hz	Equivalent. Range expanded to meet IEC 60601-2-26:2012. Verified functionality remains equivalent. No significant impact on safety/effectiveness.
AEP Evoked Potentials	Brain stem and mid-latency	Brain stem and mid-latency	Identical.
AEP Sampling Freq.	BAEP: 4800 Hz; MLAEP: 2400 Hz	BAEP: 4800 Hz; MLAEP: 2400 Hz	Identical.
AEP Frequency Range	0.5 Hz - 1000 Hz	0.5 Hz - 1000 Hz	Identical.
AEP Stimulation Type	Condensating click	Condensating click	Identical.
AEP Stimulation Freq.	1.1 to 9.1 Hz (1 Hz steps) @ 10 ms sweep; 1.1 to 8.1 Hz (1 Hz steps) @ 100 ms sweep	1.1 to 9.1 Hz (1 Hz steps) @ 10 ms sweep; 1.1 to 8.1 Hz (1 Hz steps) @ 100 ms sweep	Identical.
EMG Measurement Freq.	60 to 300 Hz	60 to 300 Hz	Identical.
Safety Standards	Compliance with relevant IEC standards (implied by predicate clearance)	ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012, IEC 60601-1-2: 2014, IEC 60601-2-26:2012, IEC 60601-2-40: 2016, IEC 60601-2-49: 2011	The device has undergone and passed safety testing in accordance with these standards, demonstrating compliance and substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe "test sets" or "data" in the context of clinical or performance data from patients. The evaluation performed was largely based on non-clinical testing (e.g., engineering verification, design validation, safety testing) and comparison of specifications to a predicate device. Therefore, no information on sample size, data provenance, or retrospective/prospective nature of a dataset is provided for this type of submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this 510(k) submission. No expert review of patient data to establish ground truth was conducted or reported, as the submission focused on non-clinical testing and substantial equivalence to a predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable to this 510(k) submission, as there was no test set involving expert adjudication of patient data.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable to this 510(k) submission. The device (E-EEGX module, N-EEGX headbox and accessories) is an electroencephalograph system, not an AI-assisted diagnostic tool that would typically undergo MRMC studies comparing human reader performance. The submission makes no mention of AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable to this 510(k) submission. The device is a hardware module and headbox for physiological measurement, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable to this 510(k) submission, as there was no patient outcome or diagnostic ground truth required for its submission based on substantial equivalence and non-clinical testing. The "ground truth" for showing substantial equivalence was the specifications and validated performance of the predicate device and compliance with recognized international standards (e.g., IEC 60601 series) for medical electrical equipment.

8. The sample size for the training set

This information is not applicable to this 510(k) submission. The device does not appear to involve machine learning or AI that would require a "training set."

9. How the ground truth for the training set was established

This information is not applicable to this 510(k) submission, as there was no training set for an AI/ML algorithm.

Summary

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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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

Joel Kent Senior Regulatory Affairs Manager GE Healthcare Finland Oy Kuortaneenkatu 2 00510 Helsinki, Finland

Re: K191322

Trade/Device Name: E-EEGX module, N-EEGX headbox and accessories Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLT, GWJ, MHX, MLD, OMC, ORT Dated: December 19, 2019 Received: December 23, 2019

Dear Joel Kent:

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 probibitions 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

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801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191322

Device Name

E-EEGX module, N-EEGX headbox and accessories

Indications for Use (Describe)

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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GE Healthcare Finland Oy Kuortaneenkatu 2, P.O. Box 900 00031 GE
Finland
T: +358 10 39411
F: +358 9 1463310

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Owner/Contact/Date(807.92(a)(1):
Date:	January 16, 2020
Owner/Submitter:	GE Healthcare Finland Oy.Kuortaneenkatu 200510 HelsinkiFINLANDPhone: +358 10 39411
Primary Contact Person:	Joel KentSenior Regulatory Affairs ManagerGE HealthcarePhone: 617-851-0943E-mail: joel.kent@ge.com
Secondary Contact Person:	Anna PehrssonRegulatory Affairs LeaderGE Healthcare Finland OyKuortaneenkatu 200510 HelsinkiFinlandPhone: + 358 40 569 5108E-mail: anna.pehrsson@ge.com
Device names (807.92(a)(2)):
Trade Name:	E-EEGX module, N-EEGX headbox and accessories
Common/Usual Name:	EEG measurement module, headbox and accessories
Classification Name:	21 CFR 882.1400 electroencephalograph

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Product Code OLT

Subsequent Product Codes: GWJ, MHX, MLD, OMC, ORT

Predicate Device(s) K051883 Datex-Ohmeda S/5 EEG Module, E-EEG and Datex-(807.92(a)(3): Ohmeda S/5 EEG Headbox, N-EEG and Accessories
The E-EEGX module is a single-width plug-in interface module Device Description (807.92(a)(4)): to be used with CARESCAPE Bx50 V3 patient monitors. It is used with N-EEGX headbox and accessories for monitoring neurophysiological status of all hospital patients by measuring the electroencephalogram (EEG), frontal electromyogram (FEMG) and auditory evoked potentials (AEP).

Intended Use: (807.92(a)(5): The GE EEG module, E-EEGX, the GE EEG headbox, N-EEGX, and accessories are intended to be used with the compatible CARESCAPE monitors for the monitoring of electroencephalograph (EEG), frontal electromyograph (FEMG), and auditory evoked potentials (AEP) of all hospital patients. The device is intended for use by qualified medical personnel only.

The E-EEGX module is used with the N-EEGX headbox for Technology (807.92(a)(6)): monitoring of EEG. FEMG. to stimulate the brain with auditory stimuli, and to measure AEP. The E-EEGX module connects to a N-EEGX headbox which further connects to accessories that connect to the patient.

The EEG, FEMG and AEP measurements are performed by the N-EEGX headbox. The N-EEGX headbox measures the raw EEG waveform data from four real-time EEG waveform channels, FEMG from one channel and AEP from two channels. The N-EEGX headbox is connected to the patient with EEG accessories.

The fundamental function and operation of the device remains unchanged compared to the predicate. A summary of the main changes compared to the predicate is listed below.

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Specification	Datex-Ohmeda S/5 EEG Module, E-EEG andDatex-Ohmeda S/5 EEG Headbox, N-EEG andAccessories (K051883)	E-EEG X module, N-EEGX headbox and EEGaccessories	Discussion of differences
Indications for use	The Datex-Ohmeda EEG module, E-EEG and theDatex-Ohmeda EEG headbox, N-EEG andaccessories are indicated for monitoring ofelectroencephalograph (EEG), frontalelectromyograph (FEMG) and auditory evokedpotentials (AEP) of all hospital patients.The device is indicated for use by qualifiedmedical personnel only.	The GE EEG module, E-EEGX, the GE EEGheadbox, N-EEGX, and accessories are intendedto be used with the compatible CARESCAPEmonitors for the monitoring ofelectroencephalograph (EEG), frontalelectromyograph (FEMG), and auditory evokedpotentials (AEP) of all hospital patients. Thedevice is intended for use by qualified medicalpersonnel only.	EquivalentThe changes from previously clearedindications are:Company name "Datex" has beenreplaced by "GE".The indications refer to compatiblemonitors.Some minor text edits and changesfor added clarity.The changes have been made toimprove clarity of labeling.Therefore, they do not significantlyaffect safety and/or effectiveness.
Physical PropertiesModule Size(H x W xD)Module Weight	E-EEG module112 x 37 x 186 mm(4.4 x 1.5 x 7.3 in)0.3 kg (0.7 lb)N-EEG headbox34 x 97 x 174 mm(1.3 x 3.8 x 6.8 in)0.44 kg (1.1 lb)	E-EEGX module112 x 37 x 187 mm(4.4 x 1.5 x 7.3 in)0.3 kg (0.7 lb)N-EEGX headbox34 x 97 x 174 mm(1.3 x 3.8 x 6.8 in)0.5 kg (1.1 lb)	EquivalentThe N-EEGX headbox weight hasslightly changed due to a newhardware design.This change does not significantlyaffect safety and/or effectiveness.
Host devicecompatibility	E-EEG module is compatible with S/5 AM,CAM, S/5 CCM, CARESCAPE B450 Monitorwith software ESP V1 or V2, CARESCAPEMonitor B650 with software ESP V1 or V2 andCARESCAPE Monitor B850 with software ESPV1 or V2	E-EEGX module and N-EEGX headbox arecompatible with the CARESCAPE Bx50 V3patient monitors	EquivalentThe E-EEGX module and N-EEGXheadbox are only compatible withCARESCAPE Bx50 V3 patientmonitors.This change has been verified and theoverall functionality remainsequivalent.This change does not significantlyaffect safety and/or effectiveness.
Parameter Specifications
Measured parameters	EEG, Auditory Evoked Potentials, EMG	EEG, Auditory Evoked Potentials, EMG	Identical
Mode	Referential or Bipolar	Referential or Bipolar	Identical
Processing of the EEG	Spectral analysis: Spectral Edge Frequency(SEF), Median frequency, Relative power inDelta, Theta, Alpha and Beta bandsBurst suppression detectionTotal power	Spectral analysis: Spectral Edge Frequency(SEF), Median frequency, Relative power inDelta, Theta, Alpha and Beta bandsBurst suppression detectionTotal power	Identical
EEG parameter specifications
EEG Measurementmethod	1, 2, 3 or 4 channels of EEG	1, 2, 3 or 4 channels of EEG	Identical
Range	$\pm$ 400 μV	$\pm$ 500 μV	EquivalentRange has been expanded to meet therequirements of IEC 60601-2-26:2012.This change has been verified and theoverall functionality remainsequivalent.This change does not significantlyaffect safety and/or effectiveness.
Measurement rangefrequency	0.5 ... 30 Hz	0.5 ... 50 Hz	EquivalentRange has been expanded to meet therequirements of IEC 60601-2-26:2012.This change has been verified and theoverall functionality remainsequivalent.This change does not significantlyaffect safety and/or effectiveness.
AEP parameter specifications
Evoked potentials	Auditory evoked potentials: brain stem and mid-latency	Auditory evoked potentials: brain stem and mid-latency	Identical
Measurement Samplingfrequency	Brainstem Auditory Evoked Potentials (BAEP):4800 HzMiddle Latency Auditory Evoked Potential(MLAEP): 2400 Hz	Brainstem Auditory Evoked Potentials (BAEP):4800 HzMiddle Latency Auditory Evoked Potential(MLAEP): 2400 Hz	Identical
Frequency range	0.5 Hz - 1000 hz	0.5 Hz - 1000 Hz	Identical
Stimulation type	Condensating click	Condensating click	Identical
Stimulation frequency	1.1 to 9.1 Hz(1 Hz steps) @ 10 ms sweep1.1 to 8.1 Hz(1 Hz steps) @ 100 ms sweep	1.1 to 9.1 Hz(1 Hz steps) @ 10 ms sweep1.1 to 8.1 Hz(1 Hz steps) @ 100 ms sweep	Identical
EMG parameter specifications
EMG measurementfrequency range	60 to 300 Hz	60 to 300 Hz	Identical

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Determination of Substantial Equivalence (807.92(b)(1))

Summary of Non-Clinical Tests:

For the E-EEGX module, N-EEGX headbox and accessories the following quality assurance measures were applied to the development of the system.

1. Risk Analysis
1. Requirements Reviews
1. Design Reviews
1. Testing on unit level (Module verification)
1. Integration testing (System verification)
1. Final acceptance testing (Validation)
1. Performance testing (Verification)
Safety testing (Verification) 8.
1. The following list contains applicable standards regarding performance testing related to E-EEGX module, N-EEGX headbox and accessories:
- ANSI/AAMI ES60601-1:2005/(R)2012 and ● A1:2012: Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1: 2012)
- . IEC 60601-1-2: 2014: Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- IEC 60601-2-26:2012: Medical electrical equipment Part 2-26: Particular requirements for

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the safety and essential performance of electroencephalographs

IEC 60601-2-40: 2016: Medical Electrical ● Equipment Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
IEC 60601-2-49: 2011: Medical electrical ● equipment Part 2-49: Particular requirements for the safety essential performance of multifunction patient monitoring equipment

Clinical (807.92(b)(2)): Summary of Clinical Tests:

The subject of this premarket submission, the E-EEGX module, N-EEGX headbox and accessories did not require clinical studies to support substantial equivalence.

Conclusion (807.92(b)(3)): GE Healthcare considers the E-EEGX module, N-EEGX headbox and accessories to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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).