K Number

Device Name

DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES

Manufacturer

DATEX-OHMEDA

Date Cleared

2003-01-13

(90 days)

Product Code

OLW GXY OMC ORT

Regulation Number

882.1400

Intended Use

The Datex-Ohmeda Entropy module , M-ENTROPY and accessories are intended to be used with Datex-Ohmeda modular multiparameter monitoring the neurophysiological status of hospitalized patients. The Datex-Ohmeda Entropy Module is indicated for monitoring the state of the central nervous system (CNS) by data acquisition of electroencephalograph (EEG) and frontal electromyograph (FEMG) signals in the anesthesia environment. The spectral entropies, State Entropy (SE) and Response Entropy (RE), are processed EEG and FEMG variables, and may be used as an aid in monitoring the effects of certain anesthetic agents. The Entropy module is indicated for use by qualified medical personnel only.

Device Description

The Datex-Ohmeda Entropy module, M-ENTROPY is a single-width plug-in parameter module for a Datex-Ohmeda modular monitoring system. The Datex-Ohmeda Entropy module, M-ENTROPY can be used with the following Datex-Ohmeda modular monitors: S/5™ Anesthesia Monitor (AM) with main software L-ANE03(A).00 or newer version, and S/5TM Compact Anesthesia Monitor (CAM) with main software L-CANE03(A)..00 or newer version. Entropy is an innovative monitoring modality which is designed to provide information on the electrical activity of the CNS during general anesthesia. Entropy monitoring is based on acquisition, and processing of raw EEG and FEMG signals by using the Entropy algorithm. The entropy algorithm is a Datex-Ohmeda application of spectral entropy based on information theory. The Datex-Ohmeda Entropy Module for the Datex-Ohmeda S/57M Monitoring system may be used as an aid in monitoring the effects of certain anesthetic agents. The Datex-Olumeda Entropy sensor is a rectangular shaped, pre-gelled array of three (3) Zipprep® electrodes that is applied to the patient's skin to record electrophysiological (such as EEG) signals. It is a low impedance, single patient use, disposable sensor that is designed for application to the frontal / temporal area. The Datex-Ohmeda Entropy sensor is designed to provide ease of use and electrode placement accuracy. The sensor is used in conjunction with M-ENTROPY. The Datex-Ohmeda Entropy sensor cable connects the Entropy sensor to the M-ENTROPY module both mechanically and electrically. Calculated parameters are: - Response Entropy, RE (range 0-100), continuous processed variable for fast detection of activation of facial muscles, i.e. FFMG. - 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 past 60 seconds in which the EEG signal is considered suppressed. All the calculated parameters can be selected on the display, and trended. The raw EEG signal can be displayed from one of the two monitored channels. 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-Ohmeda S/S patient monitors. There are auditory and visual alarms and user adjustable limits for Entropy variables. The default is OFF, because the device does not provide information to be used for treatment or therapy.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K013389

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on signal processing using a specific "Entropy algorithm" based on spectral entropy and information theory, not AI/ML techniques. There is no mention of AI, ML, or related concepts like training or test sets.

Therapeutic

No
The device is described as aiding in monitoring the effects of anesthetic agents and does not provide information for treatment or therapy.

Diagnostic

Yes

The device monitors the state of the central nervous system by acquiring and processing electroencephalograph (EEG) and frontal electromyograph (FEMG) signals to aid in monitoring the effects of anesthetic agents, which fits the definition of a diagnostic device.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "single-width plug-in parameter module" and mentions a "sensor" and "sensor cable," indicating hardware components are integral to its function.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze samples taken from the body (in vitro), such as blood, urine, or tissue. The Datex-Ohmeda Entropy module analyzes electrical signals (EEG and FEMG) directly from the patient's body (in vivo) via electrodes placed on the skin.
The intended use and device description clearly state that it monitors neurophysiological status by acquiring and processing electrical signals from the brain and facial muscles. This is a form of physiological monitoring, not laboratory testing of biological samples.

Therefore, the Datex-Ohmeda Entropy module is a physiological monitoring device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Intended use: The Datex-Ohmeda Entropy module , M-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 is indicated for monitoring the state of the central nervous system (CNS) by data acquisition of electroencephalograph (EEG) and frontal electromyograph (FEMG) signals in the anesthesia environment. The spectral entropies, State Entropy (SE) and Response Entropy (RE), are processed EEG and FEMG variables, and may be used as an aid in monitoring the effects of certain anesthetic agents. The Entropy module is indicated for use by qualified medical personnel only.

Product codes (comma separated list FDA assigned to the subject device)

OLW, ORT, GXY, OMC

Device Description

Calculated parameters are:

Response Entropy, RE (range 0-100), continuous processed variable for fast detection of activation of facial muscles, i.e. FFMG.
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 past 60 seconds in which the EEG signal is considered suppressed.

All the calculated parameters can be selected on the display, and trended. The raw EEG signal can be displayed from one of the two monitored channels. 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-Ohmeda S/S patient monitors. There are auditory and visual alarms and user adjustable limits for Entropy variables. The default is OFF, because the device does not provide information to be used for treatment or therapy.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

central nervous system (CNS), frontal / temporal area

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified medical personnel, hospitalized patients

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)

The device has been thoroughly tested including electrical safety, electromagnetic compatibility, mechanical and environmental tolerance, software validation and verifications. Verifications. Verification of compliance with the following mandatory and voluntary standards has been made:

· IEC 60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995 (Part 1: General requirements for safety) · EN 60601-1:1990+ A1:1993 + A2:1996 + 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)

• UL 2601-1, October 24, 1997 (U.S. deviations to IEC 60601-1:1988 + Amdt. 1:1991+ Amdt. 2:1995)

· AAMI ES1-1993 (Safe current limits for electromedical apparatus)

· Electroencephalograph Devices Guidance for 510( k) Draft Document Version 1.0 November 3, 1997 • IEC 601-2-26 Medical electrical equipment. Part 2: Particular requirements for the safety of electroencephalographs 04/01/94

· ISO 14971 Ed. 1: Medical devices - Application of risk management to medical devices

· FDA Performance standard, 21 CFR Part 898.12 - PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES

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.

K013389

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.

Not Found

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

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).

Summary

Image /page/0/Picture/0 description: The image is a black and white logo. The logo consists of a large circle with a white letter "D" inside. There is a small square in the upper right corner of the circle.

JAN 1 3 2003

K02345-9

Page 1 of 3

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

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

COMPANY NAME/ADDRESS/PHONF/FAX:

Datex-Ohmeda 86 Pilgrim Road Needham, MA 02492 USA Tcl: 781-449-8685 Fax: 781-433-1344

NAME OF CONTACT:

Mr. Joel Kent

DATE:

October 11, 2002

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

TRADE NAME:

Datex-Ohmeda S/5 Entropy Module, M-ENTROPY and Accessories

COMMON NAME:

EEG and FEMG Measurement Module with Entropy variables

CLASSIFICATION NAME:

The following Class II classifications appear applicable:

Electroencephalograph 882.1400 OLSN, ORT, GXY, OMC

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

The Datex-Ohmeda Entropy Module, M-ENTROPY and accessories is substantially equivalent in safety and effectiveness to the legally marketed predicate Datex-Ohmeda S/5™ BIS module M-BIS (K013389).

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

Calculated parameters are:

Response Entropy, RE (range 0-100), continuous processed variable for fast detection of activation of facial muscles, i.e. FFMG.
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 past 60 seconds in which the EEG signal is considered suppressed.

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

Intended use:

The Datex-Ohmeda Entropy module , M-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 is indicated for monitoring the state of the central nervous system (CNS) by data acquisition of electroencephalograph (EEG) and frontal electromyograph (FEMG) signals in the anesthesia environment. The spectral entropies, State Entropy (SE) and Response Entropy (RE), are processed EEG and FEMG variables, and may be used as an aid in monitoring the effects of certain anesthetic agents. The Entropy module is indicated for use by qualified medical personnel only.

SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807,92(a)(6)

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

The Datex-Ohmeda Entropy Module, M-ENTROPY and accessories complies with the safety standards below and is therefore safe and effective for the intended use. The device has been thoroughly tested including electrical safety, electromagnetic compatibility, mechanical and environmental tolerance, software validation and verifications. Verifications. Verification of compliance with the following mandatory and voluntary standards has been made:

· IEC 60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995 (Part 1: General requirements for safety) · EN 60601-1:1990+ A1:1993 + A2:1996 + 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)

• UL 2601-1, October 24, 1997 (U.S. deviations to IEC 60601-1:1988 + Amdt. 1:1991+ Amdt. 2:1995)

· AAMI ES1-1993 (Safe current limits for electromedical apparatus)

· ISO 14971 Ed. 1: Medical devices - Application of risk management to medical devices

· 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 safety and effectiveness for the Datex-Ohmeda Entropy Module, M-ENTROPY and accessories as compared to the predicate device.

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.

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

Datex-Ohmeda Joel Kent Manager, Quality and Regulatory Affairs 86 Pilgrim Road Needham, Massachusetts 02492

Re: K023459

APR - 9 2012

Trade/Device Name: Datex-Ohmeda S/5 Entropy Module, M-Entropy and Accessories Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLW, ORT, GXY, OMC Dated (Date on orig SE ltr): October 11, 2002 Received (Date on orig SE ltr): October 15, 2002

Dear Mr. Kent:

This letter corrects our substantially equivalent letter of January 13, 2003.

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.

Page 2 - Mr. Joel 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 vours.

Kesia Alexander

Image /page/4/Picture/8 description: The image shows a close-up of a document with some text. The text includes the name "Malvina B", followed by the word "Director". The text also includes the phrases "Division of" and "Office of". The text appears to be part of a formal document, possibly related to an organization or institution.

Malvina B. Eydelman, M.D. Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

510(k) Number (if known):	4023451
---------------------------	---------

Device Name: Datex-Ohmeda S/5130 Entropy Module (M-ENTROPY) and accessories

The Datex-Ohmeda Entropy Module is indicated for monitoring the state of the central nervous system (CNS) by data acquisition of electroencephalograph (EEG) and frontal electromyograph (FEMG) signals in the anesthesia environment. The spectral entropies, State Entropy (SE) and Response Entropy (RE), are processed EEG and FEMC variables, and may be used as an aid in monitoring the effects of certain anesthetic agents. The Entropy module is indicated for use by qualified medical personnel only.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)	OR	Over-The-Counter Use (Optional Format 1-2-96)
for	(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number	K023459