The Datex-Ohmeda Entropy Module, E-Entropy and accessories are indicated for adult and pediatric patients older than 2 years within a hospital for monitoring the state of the brain by data acquisition of electroencephalograph (EEG) and frontal electromyograph (FEMG) signals. The spectral entropies, Response Entropy (RE) and State Entropy (SE), are processed EEG and FEMG variables. The Entropy measurement is to be used as an adjunct to other physiological parameters.

In adult patients, Response Entropy (RE) and State Entropy (SE) may be used as an aid in monitoring the effects of certain anesthetic agents, which may help the user titrate anesthetic drugs according to the individual needs of adult patients. Furthermore in adults, the use of Entropy parameters may be associated with a reduction of anesthetic use and faster emergence from anesthesia.

The Entropy module is indicated for use by qualified medical personnel only.

Device Description

The Entropy Module, E-ENTROPY, is a single-width plug-in parameter module for Datex-Ohmeda modular perioperative monitors, the S/5 AM. E-ENTROPY is a module used to calculate parameters from electroencephalograph (EEG) and frontal electromyograph (FEMG) signals. The E-ENTROPY module provides two spectral entropy parameters State Entropy (SE) and Response Entropy (RE). The E-ENTROPY module uses the identical Entropy algorithm and accessories as the predicate device, E-ENTROPY (K050835). Entropy monitoring is based on acquisition of raw EEG and FEMG signals and processing them by using the Entropy algorithm - a Datex-Ohmeda application of spectral entropy based on information theory. Calculated parameters are: Response Entropy, RE (range 0-100), continuous processed variable for fast detection of activation of facial muscles, i.e. FEMG. State Entropy, SE (range 0-91), continuous processed variable calculated from the EEG. SE is designed to be sensitive to the hypnotic effect of anesthetic drugs in the brain. Burst Suppression Ratio, BSR (range -0-100%), the percentage of epochs in the pass 60 seconds in which the EEG signal is considered suppressed.

AI/ML Overview

The provided document, a 510(k) premarket notification summary, primarily focuses on demonstrating substantial equivalence to a predicate device for updated indications for use, rather than presenting a detailed study supporting specific device performance acceptance criteria. The submission states that the proposed modifications to the indications for use do not involve changes to the module's hardware, software, or accessories, and that the device uses the identical Entropy algorithm as the predicate device (K050835). Therefore, the information typically found in a study demonstrating performance against acceptance criteria for a new device is largely absent.

However, based on the information provided, we can infer some details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define acceptance criteria or present a table of reported device performance in the way a clinical study report would. Instead, it justifies the expanded indications for use based on the existing device's proven technology and scientific literature.

Acceptance Criteria (Inferred from context): The implicit acceptance criteria are that the device, with its unchanged hardware/software, continues to perform as safely and effectively as the predicate device (K050835) for the expanded indications (pediatric patients > 2 years, aiding in titrating anesthetic drugs, reducing anesthetic use, and enabling faster emergence from anesthesia in adults).
Reported Device Performance: The document states that the Datex-Ohmeda S/5™ Entropy Module, E-ENTROPY uses the identical Entropy algorithm and accessories as the predicate device, E-ENTROPY (K050835). The calculated parameters are:
- Response Entropy (RE): range 0-100, continuous processed variable for fast detection of activation of facial muscles (FEMG).
- State Entropy (SE): range 0-91, continuous processed variable calculated from the EEG, sensitive to the hypnotic effect of anesthetic drugs.
- Burst Suppression Ratio (BSR): range 0-100%, percentage of epochs in the past 60 seconds where the EEG signal is suppressed.
  The document asserts that the updated indications are "based on independent, peer-reviewed and published scientific articles in medical journals, as well as studies made internally at GE Healthcare." This implies that external research and internal studies provided the evidence for the efficacy related to the new claims, but the details of these studies are not provided in this 510(k) summary.

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

This information is not explicitly stated in the provided 510(k) summary. The submission refers to "independent, peer-reviewed and published scientific articles in medical journals, as well as studies made internally at GE Healthcare" for the scientific justifications. The specific sample sizes, study designs (retrospective/prospective), and data provenance (e.g., country of origin) for these underlying studies are not detailed here.

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

This information is not explicitly stated in the provided document. As the submission relies on existing scientific literature and internal studies, the details of expert involvement in establishing ground truth for those studies are not available here.

4. Adjudication Method for the Test Set

This information is not explicitly stated in the provided document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done (and effect size)

This information is not explicitly stated in the provided document. The submission focuses on the device's technical characteristics being identical to the predicate and the justification for expanded indications based on existing literature.

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

The device itself is an "algorithm only" component (an Entropy module calculating parameters from EEG/FEMG signals). The document states, "The F-F.NTROPY module uses the identical Entropy algorithm... as the predicate device." It describes the module's function to "calculate parameters" (RE, SE, BSR). Therefore, the device operates in a standalone manner to generate these parameters. However, the application of these parameters is "to be used as an adjunct to other physiological parameters" and "by qualified medical personnel only," implying a human-in-the-loop for interpretation and clinical decision-making. No separate "standalone performance study" of the algorithm independent of a human is detailed, as its core function is the calculation itself, which is already established by the predicate device.

7. The Type of Ground Truth Used

Based on the nature of the device (monitoring neurophysiological status and effects of anesthetic agents), the ground truth for the "scientific justifications" would likely involve:

Clinical Outcomes/Physiological Correlates: For claims like "titrate anesthetic drugs according to the individual needs," "reduce the amount of certain hypnotic drugs," and "enable faster emergence from anesthesia," the ground truth would be established through clinical outcomes (e.g., patient awakening times, actual drug dosages administered, clinical assessment of depth of anesthesia) correlated with Entropy parameter readings.
Expert Clinical Assessment/Consensus: The determination of "state of the brain" or "effects of certain anesthetic agents" would typically involve an expert's clinical judgment, potentially supported by other physiological monitors and patient responses.
Pathology/Biomarkers: Unlikely to be the primary ground truth for this type of device, but could potentially be part of broader research into anesthetic mechanisms.

The document states these justifications come from "independent, peer-reviewed and published scientific articles in medical journals, as well as studies made internally at GE Healthcare," suggesting that the ground truth methods used in these underlying studies would be diverse and appropriate for clinical research in anesthesiology.

8. The Sample Size for the Training Set

This information is not applicable or not provided.

It's "not applicable" in the context of this submission because the device's algorithm is identical to the predicate. The algorithm itself was already developed and validated with a "training set" for the predicate device (K050835). This submission is for expanded indications, not a new algorithm.
If we consider the original development of the Entropy algorithm, the details of its training set would reside in the documentation for the predicate device (K050835), or the external peer-reviewed literature and internal GE Healthcare studies referenced. These specifics are not provided in this document.

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

Similar to point 8, this information is not applicable or not provided in this specific 510(k) submission. The ground truth for the original algorithm development (i.e., for the predicate device) would have been established through clinical trials and expert correlation of EEG/FEMG signals with anesthetic depth and patient state. The precise methods would be detailed in the documentation for K050835 or the scientific literature that informed its development.

Summary

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Page 1 of 4

K061907

MAR 2 7 2008

Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5TM Entropy Module, E-ENTROPY and accessories

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

COMPANY NAMF/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:

March 27, 2008

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

TRADE NAME:

Datex-Ohmeda S/S™ Entropy Module, F .- F.NTROPY and accessories

COMMON NAME:

Electroencephalograph

CLASSIFICATION NAME:

The following Class II classifications appear upplicable:

Product Code

Classification Name Electroencephalograph ONA OK 7

CFR Section 882.1400

NAME OF LEGALLY MARKETED DI:VICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADL: as required by 807.92(a)(3)

The Datex-Ohmeda S/51M Intropy Module, I -- ENTROPY is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda E- ENTROPY Module (K050835).

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

The purpose of this submission is to add new marketing claims to the Entropy module, without changing anything in the module's hardware, software or accessories. Scientific justifications for the proposed modifications to the indications for use are provided. The updated indications of use of the module shall be expanded to cover pediatric patients 2 years or older.

Furthermore, we propose to add new claims in adult. Response Entropy (RE) and State Entropy (St.) may be used as an aid in monitoring the effects of certain anesthetic agents, which may help the user to titrate anesthelic drugs according to the individual needs of adult patients. Furthermore in adults, the use of lintropy parameters may help the user to reduce the amount of certain hypnotic drugs and chable faster emergence from anesthesia.

The Entropy Module, E-ENTROPY, is a single-width plug-in parameter module for Datex-Ohmeda modular perioperative monitors, the S/5 AM. The parameter and customer specifications or the compatibility with Datex . Ohmeda S/5 monitoring products are not affected by the updated indications for use.

E-ENTROPY is a module used to calculate parameters from electroencephalograph (EEG) and frontal electromyograph (I'LMC) signals. The !:- ENTROPY module provides two spectral entropy parameters State Entropy (SE) and Response Entropy (RE).

The F-F.NTROPY module uses the identical Entropy algorithm and accessories as the predicate device, E-EN7ROPY (K050835). I:ntropy monitoring is based on acquisition of raw EEG and FEMG signals and processing them by using the Entropy algorithm . a Datex-Ohmeda application of spectral entropy based on information theory.

Calculated parameters are:

Response Entropy, RE (range 0-100), continuous processed variable for fast detection of activation of facial muscles, i.e. FT:MG.
State Entropy. SE (range 0-91), continuous processed variable calculated from the EEG. SE is designed to be sensitive to the hypnotic effect of anesthetic drugs in the brain.
Burst Suppression Ratio, BSR (range -0-100%), the percentage of epochs in the pass 60 seconds in which the FFG signal is considered suppressed.

All the calculated parameters can be selected on the display, and trended. The waveform size, color and sweep speed can be adjusted. Alarms for Entropy are taken care of by the host monitor and follow the user interface for alarms in Datex-()hmeda S/S patient monitors. There are auditory and visual alarms and user adjustable limits for lintropy variables. The default is OFF, because the device is not to be used as the sole basis for treatment or therapy but rather as an adjunct to other paramelers.

The accessories are the same for the E-ENTROPY module and the predicate device, the E-ENTROPY (K050835).

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

Intended Use:

The Datex-Ohmeda Entropy module , F-ENTROPY and accessories are intended to be used with Datex-Ohmeda modular multiparameter monitoring the neurophysiological status of hospitalized patients.

Indications for use:

The Datex-Ohmeda Entropy Module, I -Entropy and accessories are indicated for adult and pediative patients older than 2 years within a hospital for monitoring the state of the brain by data acquisition of electroencephalograph (Lt:G) and frontal electromyograph (FEMG) signals. The spectral entropies, Response Intropy (RE) and State Entropy (SE), are processed EEG and FEMG variables. The Entropy measurement is to be used as an adjunct to other physiological parameters.

In adult patients, Response Entropy (RE) and State Fintropy (SE) may be used as an aid in monitoring the effects of certain anesthetic agents, which the user titrate anesthetic drugs according to the individual needs of adult patients. Furthermore in adults, the use of Entropy parameters may be associated with a reduction of anesthetic use and faster emergence from anesthesia.

The Entropy module is indicated for use by qualified medical personnel only.

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

The Datex-Ohmeda S/51M Entropy Module, E-F.N. ROPY is substantially conivalent in safety and effectiveness to the legally marketed (prodicate) Datex-Ohmeda E- ENTROPY Module (K050835). The only difference between the new !- F.NTROPY and the predicate E-ENTROPY (K050835) is the updated indications for use of the Datex-Ohmeda S/5™ E-ENTROPY Module and accessories. The same module with accessories is used as the predicate device (K050835). The purpose is to add new marketing claims to the lintropy module, without changing anything in the module's hardware, software or accessories. Currently, the Datex-Ohmeda S/5M E-ENTROPY Module (KU50835) is intended for use with Datex-Ohmeda modular multiparameter monitors for monitoring the neurophysiological status of hospitalized patients. RE and SE parameters can be used as an aid in montoring the effects of certain anesthetic agents.

The purpose of this submission is to add new marketing claims to the Entropy module, without changing anything in the module is hardware, software or accessories. Scientific justifications for the proposed modifications to the indications for use are provided. The updated indications of use of the module shall be expanded to cover pediatic patients 2 years or older. Furthermore, we propose to add new claims in adult. Response I:ntropy (RE) and State Entropy (SE) may be used as an and in montoring the effects of certain anesthetic agents, which may help the user to titrate anesthetic drugs according to the individual needs of adult patients. Furthermore in adults, the use of Entropy parameters may help the user to reduce the amount of certain hypnotic drugs and enable faster emergence from anesthesia. The updated indications for use are based on independent, pect-reviewed and published scientific articles in medical journals, as well as studies made internally at Git Healtheare. Based on the analysis and other documentation included in this 510(k) notification and attachments it is evident that the Datex-Ohmeda S/57M Entropy Module, f .-ENTROPY are substantially equivalent to the predicate Datex-Ohmeda E-ENTROPY Module (K050835).

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

The Entropy module E-1:NI ROPY and accessories are used in a Datex-Ohmeda S/5 monitoring system. The E-ENTROPY module is not a life -supporting device.

The Datex-Ohmeda Entropy module. I -- INTROPY, and accessories have taken into account general electrical salety requirements in the design. The hardware and software and accessories for the E-Entropy module and accessories with extended indications are identical to the predicate E-Fintropy module and accessories (K050835). (The details of compliance can be found in the predicate 510(k) submission (K050835) or on file at GF: Healthcare Finland Oy).

The following safety standards have been followed:

, A COUNCIL DIRECTIVE 93/42/F.IFC of 14 June 1993 concerning medical devices
FIDA/DCRNI) Reviewer Guidance for Premarket Notification Submissions, November ﻨﺰ 1993
ﺮ ﻟ 11:( 60601-1:1988 · Amdt. 1:1991 · Amdt. 2:1995 (Part 1: General requirements for safety)
, ﻟ EN 60601-1:1990+ A1:1993 · A13:1996 · A2:1995 (identical to IEC60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995)
ﺎ ﺗﻌ CAN/CSA C22.2 No. 601.1-M90 . SI:1994 (Canadian deviations to IEC 60601-1:1988 + Amdt. 1:1991) + S2:1998 ( "Il:C Amdt 2:1995)
ﺮ ﻟ Ul. 2601-1. October 24, 1997 (U.S. deviations to IEC 60601-1:1988 + Amd. 1:1991 + Amdt. 2:1995)
ﻣﻤﻠ 11:C 60601-1-2:2001 (Electromagnetic compatibility - Requirements and tests)
, ﻟ AAMI EST-1993 (Safe current limits for clectronical apparatus)
-1:1ectroencephalograph Devices Guidance for 5101 k) Content, Draft Document Version 1.0 November 3, 1997
ﻣﻤﻠﻜﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ I DA/OD): Guidance for Content of Premarket Submission for Software Contained in Medical Devices. Version 1.0. (May, 29, 1998)
ﯩﺰ 11:4 60601-2-26 Medical electrical equipment. Part 2: Particular requirements for the safety of electroencephalographs. 2002.
ﻣﺨ ISO 14971 Ed. 1: Medical devices - Application of risk management to medical devices
. A FDA Performance standard, 21 CFR Part 898.12 - PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES

CONCLUSION:

The summary above shows that there are no new questions of salety and effectiveness for the Datex-Ohmeda S/5™ Entropy Module, 1:- INTROPY and accessories compared to the legally marketed (predicate) Datex-Ohmeda S/5/M I:ntropy Module, F:-ENTROPY and accessories (KUS0835).

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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 stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper half of the circle.

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

GE Healthcare c/o Mr. Joel Kent 86 Pilgrim Road Needham, MA 02492

APR - 9 2012

Re: K061907 Trade/Device Name: Datex-Ohmeda S/5"M Entropy Module, E-ENTROPY and accessories Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLW, OMC, ORT Dated (Date on orig SE ltr): December 27, 2007 Received (Date on orig SE ltr): December 28, 2007

Dear Mr. Kent:

This letter corrects our substantially equivalent letter of March 27, 2008.

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.

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Page 2 - Mr. Kent

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

Image /page/5/Picture/8 description: The image shows a handwritten word "for" in cursive. The word is written in black ink on a white background. The letters are connected and flow smoothly together.

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): ______ K061907__

Device Name: Datex-Ohmeda S/5 Entropy Module, E-Entropy and Accessories.

Indications for Use:

The Entropy module is indicated for use by qualified medical personnel only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page ___of ____

Jautor
(Division Sigil off.
Division of General, Restorative,
and Neurological Devices

Neurological Devices

510(k) : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : | 902

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).