DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES

K050835 · GE Healthcare · OLW · May 6, 2005 · Neurology

Device Facts

• Record ID: K050835
• Device Name: DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
• Applicant: GE Healthcare
• Product Code: OLW · Neurology
• Decision Date: May 6, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

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

Device Story

The E-ENTROPY module is a plug-in parameter module for Datex-Ohmeda modular anesthesia monitors. It acquires raw EEG and FEMG signals via a disposable, pre-gelled 3-electrode array (Zipprep) applied to the patient's frontal/temporal area. The device processes these signals using a spectral entropy algorithm based on information theory to calculate three variables: Response Entropy (RE, 0-100) for facial muscle activation; State Entropy (SE, 0-91) for hypnotic drug effects; and Burst Suppression Ratio (BSR, 0-100%). Output is displayed on the host monitor as real-time waveforms and trended variables. Used in clinical anesthesia environments by qualified medical personnel, the device provides physiological data to assist in assessing anesthesia adequacy alongside standard monitoring (HR, BP, NMT, MAC). It does not provide automated treatment or therapy.

Clinical Evidence

Bench testing only. The device underwent thorough validation and verification of specifications against recognized standards, including IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and IEC 60601-2-26 (electroencephalographs). No clinical study data was required or presented for this modification.

Technological Characteristics

Plug-in parameter module for modular monitors. Uses spectral entropy algorithm (information theory). Inputs: EEG/FEMG via 3-electrode disposable array. Connectivity: Proprietary interface for Datex-Ohmeda S/5 and Compact Anesthesia Monitors. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, AAMI ES1-1993. Software: Version 1.4 (updated from 1.2).

Indications for Use

Indicated for monitoring the central nervous system (CNS) state in hospitalized patients undergoing anesthesia. Uses EEG and frontal EMG (FEMG) signals to derive State Entropy (SE) and Response Entropy (RE) as an aid in monitoring anesthetic agent effects. For use by qualified medical personnel only.

Regulatory Classification

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.

Predicate Devices

• Datex-Ohmeda M-ENTROPY Module (K023459)

Submission Summary (Full Text)

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MAY - 6 2005

K050835

# 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 NAME/ADDRESS/PHONE/FAX:

GE Healthcare 86 Pilgrim Road Needham, MA 02492 USA Tel: [phone] Fax: [phone]

### NAME OF CONTACT:

Mr. Joel Kent

DATE:

March 30, 2005

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

#### TRADE NAME:

Datex-Ohmeda S/5TM Entropy Module, E-ENTROPY and accessories

#### COMMON NAME:

Electroencephalograph

### CLASSIFICATION NAME:

The following Class II classifications appear applicable:

21 CFR 882.1400 Electroencephalograph GWQ

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

The Datex-Ohmeda S/5TM Entropy Module, E-ENTROPY and accessories are substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M-ENTROPY Module (K023459)

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

The fundamental scientific technology is identical to the predicate device. ب The intended use for the modified device is the same as for the predicate, Datex-Ohmeda M-S ENTROPY module and accessories (K023459) The indications for use are also the same. > The Datex-Ohmeda S/5TM Entropy Module, E-ENTROPY is used for acquiring and processing of raw EEG and FEMG signals. The Entropy algorithm processes the collected signals and yields two Entropy variables - state entropy (SE) and response entropy (RE) - and burst suppression ratio, in addition to one real-time EEG waveform channel. The variables may be used as an aid in monitoring the effects of certain anesthetic agents. Entropy is thus used to assess the adequacy of anesthesia status in relation to other standard physiological signs and monitoring modalities (HR, blood pressure, NMT, MAC etc.).

There has been no change to the basic technology from the predicate. The E ENTROPY module is a facelifted version of the predicate M-ENTROPY module. The module cover and mechanics have changed, but the software and measurement hardware are the same as those of the predicate device (K023459).

The Datex-Ohmeda Entropy module, E-ENTROPY is a single-width plug-in parameter module for a Datex-Ohmeda modular monitoring system. The Datex-Ohmeda Entropy module, E-ENTROPY can be used with the following Datex-Ohmeda modular monitors:

S/5TM Anesthesia Monitor (AM) with main software L-ANE03(A)..00 (K030812) or newer version

S/5™ Compact Anesthesia Monitor (CAM) with main software L-CANE03(A).00 (K041790) or newer version.

The E-ENTROPY module uses the same Entropy algorithm and accessories as the predicate device, M-ENTROPY (K023459).

Entropy is an innovative monitoring modality which is designed to provide information on the electrical activity of the Central Nervous System during general anesthesia. 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. The E-Entropy Module may be used as an aid in monitoring the effects of certain anesthetic agents. 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 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/5 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.

The accessories are the same for the E-ENTROPY module and the predicate device, the M-ENTROPY (K023459). The Datex-Ohmeda 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 electrode 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 only with M-ENTROPY and E ENTROPY modules. The Datex-Ohmeda Entropy sensor cable connects the Entropy sensor to the ENTROPY module both mechanically and electrically.

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

Intended use:

The Datex-Ohmeda Entropy module , E-ENTROPY and accessories are intended to be used with Datex-Ohmeda modular multiparameter monitors for 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)

The Datex-Ohmeda S/5™ Entropy Module, E-ENTROPY is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M- ENTROPY Module (K023459).

The E-ENTROPY module has the following similarities compared to the predicate M ENTROPY (K023459):

- identical intended use and indications for use .
- identical fundamental scientific technology .
- the same (improved) electronic measurement board .
- same (improved) module software (version changed from 1.2 to 1.4) .
- same entropy calculation algorithm, with one additional enhancement for demonstrations . with awake test persons
- use the same operating principle .
- identical accessories .
- 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-ENTROPY and the predicate M-ENTROPY (K023459) is primarily due to fact that the new E-ENTROPY module has the following changes:

- New color, shape, and size and thus differing mechanics .
- The front panel and labeling have changed .
- Minor improvements to the electronic measurement board .
- Minor improvements to the module software .
- An improvement to the entropy algorithm in the monitor software for demonstration . situations with awake test persons.

Based on the analysis and other documentation included in this 510(k) notification and Dasco on the unaryon and other main features and indications for use of the Datex-Ohmeda S/5TM Entropy Module, E-ENTROPY are substantially equivalent to the predicate Datex-Ohmeda M-ENTROPY Module (K023459).

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

The Datex-Ohmeda S/5™ Entropy Module, E-ENTROPY and accessories have been assessed I he Datox Onlined Liber. The device has been thoroughly tested through validation and verification of specifications.

- 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)
- UL 2601-1, October 24, 1997 (U.S. deviations to IEC 60601-1:1988 + Amdt. 1:1991+ Amdt. . 2:1995)
- IEC 60601-1-2:2001 (Electromagnetic compatibility Requirements and tests) .
- AAMI ES1-1993 (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. Version 1.0. (May, 29, 1998)
- IEC 60601-2-26 Medical electrical equipment. Part 2: Particular requirements for the safety of . electroencephalographs, 2002.
- 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 The Datex-Ohmeda S/5™ Entropy Module, E-ENTROPY and accessories as compared to the predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and a circular border. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged around the upper portion of the circle.

MAY - 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Joel C. Kent Manager, Quality and Regulatory Affairs GE Healthcare 86 Pilgrim Road Needham, Massachusetts 02492

Re: K050835

Trade/Device Name: Datex-Ohmeda S/5™ Entropy Module, E-ENTROPY and accessories Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ Dated: March 31, 2005 Received: April 1, 2005

Dear Mr. Kent:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) pension is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally namestical Device Amendments, or to commerce prior to May 26, 1976, the enaounce with the provisions of the Federal Food, Drug, devices that have been recassified in assee approval of a premarket approval application (PMA). alle Cosment Act (71ct) mar do not require apperal controls provisions of the Act. The r ou may, dicierore, market the act include requirements for annual registration, listing of general controls provisions of the free labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (660 ace re) arols. Existing major regulations affecting your device and i It may be subject to saon additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Court of Feachs, concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issualles or wouldevice complies with other requirements of the Act that I DA has made a determination administered by other Federal agencies. You must of any I ederal statutes and regarations and limited to: registration and listing (21 comply with an the Act 3 requirements, news and acturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (QD) regulantial (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Joel C. Kent

This letter will allow you to begin marketing your device as described in your Section 510(k) i his letter will anow you to oegin maxeting your maxeting of your device to a legally premarket notification. "The I DIT Intering of our device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you ucsile specific advice for Jour access in the regulation of the regulation entitled, Colliation of Compullion as (21 to the end (21 transmit (21CFR Part 807.97). You may obtain Misoraliung by reference to premainter to premainter the Act from the Division of Small other general information on your responsions and its toll-free number [phone] or Manufacturers, internet and Consultive risoner risoners and consisted with industry/support/index.html.

Sincerely yours,

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): 4050835

Device Name: Datex-Ohmeda S/5™ Entropy Module, E-ENTROPY and accessories

Indications for Use:

The Datex-Ohmeda Entropy Module, E-ENTRQPY and accessories are 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, Response Entropy (RE) and State Entropy (SE), 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.

Prescription Use __ Over-The-Counter 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)

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