The Datex-Ohmeda S/5™ EEG module , E-EEG and the Datex-Ohmeda S/5™ EEG headbox, N-EEG and accessories are intended to be used with Datex-Ohmeda modular multiparameter monitors for monitoring neurophysiological status of hospitalized patients.

The Datex-Ohmeda S/5™ EEG module , E-EEG and the Datex-Ohmeda S/5™ EEG headbox, N-EEG and accessories are indicated for monitoring of electroencephalograph (EEG), frontal electromyograph (FEMG) and auditory evoked potentials (AEP) of all hospital patients. The device is indicated for use by qualified medical personnel only.

Device Description

The Datex-Ohmeda S/5M EEG module, E-EEG is a single-width plug-in parameter module for a a Datex-Ohmeda modular monitoring system. The Datex-Ohmeda EEG module, E-EEG is for controlling the EEG, FEMG and AEP measurements in the N-EEG. The Datex-Ohmeda EEG headbox, N-EEG is a separate preamplifier and measurement unit for EEG, FEMG and AEP measurements. N-EEG can measure up to 4 real-time EEG waveform channels and an FEMG measurement from one channel. It can also measure AEP from two channels. The N-EEG can only be used with the Datex-Ohmeda EEG module, E-EEG.

The Datex-Ohmeda EEG module, E-EEG can be used with the following Datex-Ohmeda modular monitors:

S/5TM Anesthesia Monitor (AM) with main software S-ANE99(A) or L-ARK99(A) or newer S/5™ Compact Anesthesia Monitor (CAM) with main software S-ANE99(A) or L-ARK99(A) or newer

S/5TM Critical Care Monitor (CCM) with main software L-ICU99(A) or newer.

S/57M Compact Critical Care Monitor (CCCM) with main software L-ICU99(A) or newer. The raw EEG signal is displayed from all the monitored channels. The waveform size, color and sweep speed can be adjusted. Spectral analysis is performed on all of the measured EEG channels. Total power is calculated, and several parameters are calculated based on the power spectrum of the signal. The burst suppression pattern is detected, and suppression ratio is calculated. All the calculated parameters can be selected on the display, and trended. For auditory evoked potentials, the stimulation intensity and frequency can be set, and the number of averaged responses can be determined. The averaged AEP can be stored and markers can be set manually. Six sets of AEP's can be stored and printed. One of the saved responses can be selected as a reference on screen. Electrode impedance is measured automatically, when the electrodes are attached, and during monitoring at user-defined intervals. There are no alarms associated with the measurement, except for a message and an auditory beep for leads off situations. To simplify the patient connections, a series of preconfigured lead sets for different EEG measurements are available. The lead wires are connected together by a plastic piece, which has labels indicating where to attach which lead. The lead wire goes through the plug so that the connectors of the wire are visible from the other side to be plugged into the headbox. The lead set has an identification pin by which the monitor can automatically select the correct montage. There are 8 different lead sets, of which 3 are preconfigured and 5 are empty ones, for the user's own montages. The length of the leads is 0.60 m. The headphones for AEP monitoring are connected to a standard 3.5 mm stereo female plug in the headbox. The headphones supplied by Datex-Ohmeda generate the sound wave in a speaker, from where the pulse is transmitted to the ear through plastic tubes. Standard safety pin EEG leads and commercial headphones can also be used with the device.

The accessories are the same for the E- EEG module and the predicate device, the M- EEG (K000892).

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Datex-Ohmeda S/5™ EEG Module, E-EEG and Headbox, N-EEG, and accessories. This submission is for a medical device seeking substantial equivalence to a predicate device, not for a new device requiring extensive clinical trials for performance validation. Therefore, the information typically requested regarding acceptance criteria, clinical study details, sample sizes, expert involvement, and ground truth establishment, as it pertains to AI/ML device performance, is not present in this type of regulatory document.

This document focuses on demonstrating that the new device is "substantially equivalent" to an already legally marketed device (the Datex-Ohmeda M-EEG Module, K000892) in terms of intended use, indications for use, fundamental technology, and safety/effectiveness, despite minor differences in physical appearance and electronic layout. The basis for substantial equivalence is primarily non-clinical testing against recognized standards.

Here's an analysis based on the information provided, highlighting why some requested details are absent:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria in the sense of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic output, nor does it report device performance against such metrics. Instead, the "acceptance criteria" are implied by the comprehensive list of national and international standards against which the device was evaluated for safety and effectiveness.

Acceptance Criteria (Implied): Compliance with the following standards (among others listed):
- COUNCIL DIRECTIVE 93/42/EEC (Medical Devices)
- FDA/DCRND Reviewer Guidance for Premarket Notification Submissions, November 1993
- IEC 60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995 (General requirements for safety)
- EN 60601-1:1990+ A1:1993 + A13:1996 + A2:1995 (identical to IEC60601-1)
- CAN/CSA C22.2 No. 601.1-M90 + S1:1994 (Canadian deviations to IEC 60601-1)
- IEC 60601-1-2:2001 (Electromagnetic compatibility Requirements and tests)
- AAMI ESI-1993 (Safe current limits for electromedical apparatus)
- Electroencephalograph Devices Guidance for 510(k) Content, Draft Document Version 1.0, November 3, 1997
- FDA/ODE Guidance for Content of Premarket Submission for Software Contained in Medical Devices. (May 11, 2005)
- IEC 60601-2-26 Medical electrical equipment. Part 2: Particular requirements for the safety of electroencephalographs, 2002.
- ISO 14971 Ed. I: Medical devices Application of risk management to medical devices
- FDA Performance standard, 21 CFR Part 898.12
Reported Device Performance: The document states: "The device has been thoroughly tested through validation and verification of specifications." It concludes that the device is "substantially equivalent in safety and effectiveness" to the predicate device and that "there are no new questions of safety and effectiveness." Specific performance metrics are not provided.

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

This information is not provided as this submission is based on non-clinical engineering and regulatory compliance testing rather than clinical study data with a "test set" of patient cases for performance evaluation. The testing involved compliance with electrical safety, EMC, software, and general medical device standards.

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/not provided. The "ground truth" for this type of device, which is an EEG measurement module, would relate to accurate signal acquisition and processing capabilities, not interpretive diagnostic outputs requiring expert consensus. The validation focused on meeting technical specifications and regulatory standards.

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

This information is not applicable/not provided for the reasons stated above.

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/not provided. This device is not an AI-assisted diagnostic tool. It is a measurement module for physiological signals (EEG, FEMG, AEP). Therefore, an MRMC study or AI-related effectiveness metrics are irrelevant to this submission.

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

This information is not applicable/not provided. This device is hardware and associated software for signal measurement and display. It is used by "qualified medical personnel" for monitoring neurophysiological status. It is not a standalone algorithm performing a diagnostic task.

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

The concept of "ground truth" as it applies to diagnostic accuracy from expert interpretation is not relevant here. The ground truth for this device's validation would be the accurate measurement of electrical signals and adherence to technical specifications and safety standards. This would be established through engineering verification and validation, calibration, and standardized test procedures comparing device outputs to known inputs or reference standards.

8. The sample size for the training set

This information is not applicable/not provided. As this is not an AI/ML device, there is no "training set" in the context of machine learning model development.

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

This information is not applicable/not provided for the same reason as point 8.

Summary

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AUG 5 - 2005

Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5™ EEG Module, E-EEG and Datex-Ohmeda S/5™ EEG Headbox, N-EEG and Accessories

GENERAL COMPANY INFORMATION as required by 807.92(a)(1)

COMPANY NAME/ADDRESS/PHONE/FAX;

GE Healthcare 86 Pilgrim Road Needham, MA 02492 USA Tel: 781-449-8685 Fax: 781-433-1344

NAME OF CONTACT:

Mr. Joel Kent

DATE:

July 9, 2005

DEVICE NAME as required by 807.92(a)(2)

TRADE NAME:

Datex-Ohmeda S/5™ EEG Module, E-EEG and Datex-Ohmeda S/5TM EEG Headbox, N-EEG and Accessories.

COMMON NAME:

EEG Measurement Module, Headbox, and Accessories

CLASSIFICATION NAME:

The following Class II classification appears applicable:

Product Code	Classification Name	CFR Section
GWQ	Electroencephalograph	882.1400
GWJ	Stimulator, Auditory, Evoked response	882.1900

GWS	Electroencephalogram (EEG) signal spectrum analyzer	882.1420
The following Class I classification appears applicable:

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NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3)

(051883

The Datex-Ohmeda S/S™ EEG Module, E-EEG and Datex-Ohmeda S/5™ EEG Headbox, N-EEG and accessories is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M- EEG Module (K000892).

DEVICE DESCRIPTION as required by 807.92(a)(4)

The Datex-Ohmeda EEG module, E-EEG can be used with the following Datex-Ohmeda modular monitors:

S/5TM Anesthesia Monitor (AM) with main software S-ANE99(A) or L-ARK99(A) or newer S/5™ Compact Anesthesia Monitor (CAM) with main software S-ANE99(A) or L-ARK99(A) or newer

S/5TM Critical Care Monitor (CCM) with main software L-ICU99(A) or newer.

The accessories are the same for the E- EEG module and the predicate device, the M- EEG (K000892).

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KO51883

INTENDED USE as required by 807.92(a)(5)

Intended Use:

Intended use:

The Datex-Ohmeda S/5M EEG module , E-EEG and the Datex-Ohmeda S/5TM EEG headbox, N-EEG are intended to be used with Datex-Ohmeda modular multiparameter monitors for monitoring neurophysiological status of hospitalized patients.

Indications for use:

SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)

The Datex-Ohmeda S/5TM EEG Module, E-EEG and Datex-Ohmeda S/5TM EEG Headbox, N-EEG and accessories is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M- EEG Module (K000892).

The E- EEG module has the following similarities compared to the predicate M- EEG (K000892):

identical intended use and indications for use �
. identical fundamental scientific technology
identical electronic measurement board .
same module software ●
same EEG-specific monitor software .
use the same operating principle .
identical accessories and headbox N-EEG .
have the same user interface at the monitor and alarms (can be used with the same . monitor software)
the Customer and parameter specifications are the same ●
have the same safety and effectiveness .
are manufactured using the same processes

The main differences between the new E-EEG and the predicate M-EEG (K000892) is primarily due to fact that the new E-EEG module has the following changes:

new color, shape, and size and thus differing mechanics .
The front panel and labeling have changed .
New layout of electronic input board between module connector and measurement board .

Based on the analysis and other documentation included in this 510(k) notification and attachments it is evident that the main features and indications for use of the Datex-Ohmeda S/5™ EEG Module, E-EEG are substantially equivalent to the predicate Datex-Ohmeda M- EEG Module (K000892).

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KOSI883

SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)

The Datex-Ohmeda S/5™ EEG Module, E-EEG is substantially equivalent in safety and cffectiveness to the legally marketed (predicate) Datex-Ohmeda M- EEG Module (K000892) have been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications.

COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices .
FDA/DCRND Reviewer Guidance for Premarket Notification Submissions, November 1993 ●
IEC 60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995 (Part 1: General requirements for safety) ●
EN 60601-1:1990+ A1:1993 + A13:1996 + A2:1995 (identical to IEC60601-1:1988 + Amdt. ● 1:1991 + Amdt. 2:1995)
CAN/CSA C22.2 No. 601.1-M90 + S1:1994 (Canadian deviations to IEC 60601-1:1988 + Amdt. ● 1:1991) + S2:1998 (=IEC Amdt 2:1995)
IEC 60601-1-2:2001 (Electromagnetic compatibility Requirements and tests) .
AAMI ESI-1993 (Safe current limits for electromedical apparatus) .
Electroencephalograph Devices Guidance for 510(k) Content, Draft Document Version 1.0 . November 3, 1997
FDA/ODE Guidance for Content of Premarket Submission for Software Contained in Medical ● Devices. (May 11, 2005)
IEC 60601-2-26 Medical electrical equipment. Part 2: Particular requirements for the safety of ● electroencephalographs, 2002.
ISO 14971 Ed. I: Medical devices Application of risk management to medical devices .
FDA Performance standard, 21 CFR Part 898.12 .

CONCLUSION:

The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda S/5TM EEG Module, E-EEG is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohineda M- EEG Module (K000892).

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

GE Healthcare c/o Mr. Joel C. Kent Manager, Quality and Regulatory Affairs 86 Pilgrim Road Needham, MA 02492

APR - 9 2012

Re: K051883

Trade/Device Name: Datex-Ohmeda S/5"14 EEG Module, E-EEG and Datex-Ohmeda S/57M EEG Headbox, N-EEG and Accessories Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLT, GWJ, OMC, MHX, MLD, ORT Dated (Date on orig SE ltr): July 10, 2005 Received (Date on orig SE ltr): July 12, 2005

Dear Mr. Kent:

This letter corrects our substantially equivalent letter of August 5, 2005.

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 (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.

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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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 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/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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Alexander

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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Indications for Use

510(k) Number (if known): _KOS1883

Device Name: Datex-Ohmeda S/5™ EEG Module, E-EEG and Datex-Ohmeda S/5™ EEG Headbox, N-EEG and Accessories.

Indications for Use:

The device is indicated for use by qualified medical personnel only.

Over-The-Counter Use Prescription Use __ X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

127-017

Page I of _ !

Division of General, Restorative, and Neurological Devices

510(k) Number_KOS1883

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).