Entropy Module, E-ENTROPY-01

K150298 · Ge Healthcare Filand OY · OLW · Nov 12, 2015 · Neurology

Device Facts

• Record ID: K150298
• Device Name: Entropy Module, E-ENTROPY-01
• Applicant: Ge Healthcare Filand OY
• Product Code: OLW · Neurology
• Decision Date: Nov 12, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The GE Healthcare 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 Entropy algorithm in the host monitor calculates the spectral entropies, Response Entropy (RE) and State Entropy (SE), which 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 Story

The Entropy Module, E-ENTROPY-01 is a plug-in parameter module for GE Healthcare modular patient monitors. It acquires, amplifies, filters, and digitizes raw EEG and frontal EMG (FEMG) signals via a forehead sensor. The module performs electrode impedance measurements to ensure signal quality. The device does not calculate entropy values or trigger alarms; these functions reside in the host monitor. The host monitor uses the Entropy algorithm (Spectral Entropy) to calculate Response Entropy (RE) and State Entropy (SE). RE (0-100) measures EEG/FEMG (0.8-47 Hz) to indicate reaction to external stimuli; SE (0-91) measures EEG (0.8-32 Hz) to assess anesthetic drug effects. Qualified medical personnel use these outputs to titrate anesthetic drugs, potentially reducing anesthetic consumption and speeding patient emergence. The module is intended for hospital use.

Clinical Evidence

No clinical data. Bench testing only. Verification included risk analysis, design reviews, unit-level module verification, system integration testing, and usability validation per IEC 60601-1-6. Performance testing confirmed compliance with electrical safety and electromagnetic compatibility standards (IEC 60601-1, 60601-1-2, 60601-2-26).

Technological Characteristics

Plug-in parameter module for modular patient monitors. EEG/FEMG sensing via forehead electrodes. Defibrillation-proof (3000V). Sampling frequency 400 Hz (1600 Hz oversampling). Connectivity via proprietary host monitor interface. Software algorithm: Spectral Entropy (published). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, IEC 60601-1-4, IEC 60601-1-6.

Indications for Use

Indicated for adult and pediatric patients >2 years in hospital settings for monitoring brain state via EEG and frontal EMG signals. Used as an adjunct to other physiological parameters. In adults, aids in monitoring anesthetic agent effects to assist drug titration, potentially reducing anesthetic use and accelerating emergence.

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 S/5 Entropy Module, E-ENTROPY-00 (K061907)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other. The profiles are connected by flowing lines, creating a sense of unity and movement.

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

November 12, 2015

GE Healthcare Finland Oy % Joel Kent, M.S., RAC Manager, Quality and Regulatory Affairs GE Healthcare 86 Pilgrim Road Needham, MA 02492

Re: K150298

> Trade/Device Name: Entropy Module, E-ENTROPY-01 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLW, OMC, ORT Dated: September 28, 2015 Received: September 29, 2015

Dear Mr. 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. 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.

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

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

*Tejashri Purohit-Sheth, M.D.*

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known):

## Device Name: ENTROPY MODULE, E-ENTROPY-01

Indications for use:

The GE Healthcare 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 Entropy algorithm in the host monitor calculates the spectral entropies, Response Entropy (RE) and State Entropy (SE), which 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.

X Prescription Use Over-The-Counter Use 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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## 510(k) Summary

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

# Owner/Contact/Date (807.92(a)(1)):

| Date: | 5 October 2015 |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Healthcare Finland Oy<br>Kuortaneenkatu 2,<br>00510 Helsinki<br>Finland<br>Phone: [phone] |
| Primary Contact Person: | Joel Kent<br>Manager, Quality and Regulatory Affairs<br>GE Medical Systems Information Technologies, Inc<br>Telephone: [phone]<br>Fax at [phone]<br>E-mail: [e-mail] |
| Secondary Contact Person: | Rauno Ruoho<br>Regulatory Affairs Manager<br>GE Healthcare Finland Oy<br>Kuortaneenkatu 2,<br>00510 Helsinki<br>Finland<br>Phone: [phone]<br>E-mail: [e-mail] |
| Device names (807.92(a)(2)): | |
| Trade Name: | ENTROPY MODULE, E-ENTROPY-01 |
| Common/Usual Name: | Electroencephalograph |
| Classification Names: | 21 CFR 882.1400 Electroencephalograph |
| Classification Product<br>Code: | OLW, OMC, ORT |

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Predicate Device(s) K061907 Datex-Ohmeda S/5™ Entropy Module, (807.92(a)(3): E-ENTROPY-00

Device Description GE Healthcare Entropy Module, E-ENTROPY is a single-(807.92(a)(4)): width plug-in parameter module for GE Healthcare modular monitoring systems. EEG signals reflect the underlying state of brain activity. As a person falls asleep or is anesthetized, the brain function (activity) starts to decrease and becomes more orderly and regular. EEG changes from irregular to more regular patterns when anesthesia deepens. Similarly, frontal EMG quiets down as the deeper parts of the brain are increasingly saturated with anesthetics. Entropy measurement is based on processing of raw EEG and FEMG signals by using the Entropy algorithm, a GE application of Spectral Entropy. The algorithm is published: Viertiö-Oja H et al. Description of the Entropy algorithm as applied in the Datex-Ohmeda S/5 Entropy Module. (Acta Anaesthesiologica Scandinavica 2004; Volume 48: Issue 2:154-161, 2004).

> Entropy measures irregularity of EEG and FEMG. The GE Entropy measurement devices are responsible for EEG and FEMG signal acquisition, amplification, filtering and digitization and electrode impedance measurement. The Entropy algorithm in the host monitor calculates the spectral entropies, Response Entropy (RE) and State Entropy (SE).

The Entropy Module, E-ENTROPY-01 uses the identical Entropy algorithm and accessories as the predicate device, S/5TM Entropy Module, E-ENTROPY-00 (K061907).

Parameters calculated by the Entropy algorithm are:

-Response Entropy, RE (range 0-100), is a fast reacting parameter, which measures EEG and FEMG in the frequency range 0.8 Hz to 47 Hz. Its reaction time is two seconds. It may give an indication of the patient's reaction to external stimuli, such as intubation and skin incision, if neuromuscular blocking agents are not used.

-State Entropy, SE (range 0-91), is a more stable and robust parameter, which measures EEG in the frequency range of 0.8 Hz to 32 Hz. Its reaction time is 15

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seconds. SE may be used to assess the effect of certain anesthetic drugs on the brain.

Burst Suppression Ratio, BSR (range 0-100%), is defined as the percentage of time of suppressed (isoelectric, flat line) EEG periods during the last minute of observation. Emergence of burst suppression pattern may indicate very deep anesthesia, hypothermia or ischemia.

The Entropy Module, E-ENTROPY measures the EEG and FEMG signals by using a sensor placed on patient's forehead.

The Entropy Module, E-ENTROPY acquires the EEG and FEMG signals from the sensor and communicates them to the host device.

The Entropy Module, E-ENTROPY is a plug-in module that can be used with Datex-Ohmeda S/5TM modular patient monitors and GE Healthcare's CARESCAPE™ modular patient monitors. GE Healthcare purchased Datex-Ohmeda in 2003 and while some of the legacy branding may remain the new Entropy Module, E-ENTROPY-01 and the predicate Datex-Ohmeda S/5TM Entropy Module, E-ENTROPY as well as monitors mentioned are all products of GE Healthcare.

The Entropy Module, E-ENTROPY performs electrode impedance measurement for all sensor leads at the same time in order to determine if they are functioning well enough to make the measurement. The electrode impedance is measured by applying a known current through the electrode and measuring the voltage drop over the electrode. This way the impedance of a single electrode can be determined.

The Entropy Module. E-ENTROPY does not calculate the entropy values itself. The Entropy algorithm resides in the host patient monitor.

The Entropy Module, E-ENTROPY does not trigger or issue any physiological or technical alarms by itself. All management of alarms is entirely performed by the host monitor based on calculated entropy values and status data received from the module, as well as on the alarm

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condition data stored in the host device.

The Entropy Module, E-ENTROPY is designed to be used with a host system. The module itself does not alarm or display data. The current hosts (all with separate 510(k) clearances) for the new Entropy Module, E-ENTROPY-01 are:

- · Datex-Ohmeda S/5™ Anesthesia Monitor (K092680)
· Datex-Ohmeda S/5TM Compact Anesthesia Monitor (K061185)

· GE Healthcare CARESCAPE™ B850 Patient monitor (K131414)

· GE Healthcare CARESCAPE™ B650 Patient monitor (K131223)

· GE Healthcare CARESCAPE™ B450 Patient monitor (K132533)

- · GE Healthcare B40 Patient monitor (K133576)
The GE Healthcare Entropy module, E-ENTROPY, and Intended Use (807.92(a)(5)): 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 Entropy algorithm in the host monitor calculates the spectral entropies, Response Entropy (RE) and State Entropy (SE), which 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

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### medical personnel only.

The proposed device in this document is the Entropy Technology (807.92(a)(6)): module, E-ENTROPY-01. The Entropy Module, E-ENTROPY together with a compatible host monitor forms a system for measuring patient entropy. The predicate device is the previously cleared Datex-Ohmeda S/5™ Entropy Module, E-ENTROPY-00, (K061907).

See comparison table in this section.

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| Specification | Predicate Device | Proposed | Discussion of Differences |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Datex-Ohmeda S/5 Entropy Module, E-ENTROPY-00<br>K061907 | Entropy module, E-ENTROPY-01 | |
| | Intended Use Statements | | |
| Indications for use | 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.<br>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.<br>The Entropy module is indicated for use by qualified medical personnel only. | The GE Healthcare 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 Entropy algorithm in the host monitor calculates the spectral entropies, Response Entropy (RE) and State Entropy (SE), which are processed EEG and FEMG variables. The Entropy measurement is to be used as an adjunct to other physiological parameters.<br>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.<br>The Entropy module is indicated for use by qualified medical personnel only. | Equivalent<br>There are no actual changes compared to the predicate but just clarification that the Entropy algorithm resides in the monitor. This has no impact on substantial equivalence as compared to the predicate. |
| Patient age limit | The device is intended for adult and pediatric patients up from 2 years. | The device is intended for adult and pediatric patients up from 2 years. | Identical |
| Specification | Predicate Device<br>Datex-Ohmeda S/5 Entropy<br>Module, E-ENTROPY-00<br>K061907 | Proposed<br>Entropy module,<br>E-ENTROPY-01 | Discussion of<br>Differences |
| General safety standards | IEC 60601-1:1988 + Amdt.<br>1:1991 + Amdt. 2:1995 | IEC 60601-1:1988 + Amdt<br>1:1991 + Amd 2:1995 | Equivalent |
| | EN 60601-1:1990 + A1:1993<br>+ A2:1995 + A13:1996 | EN 60601-1:1990 + A1: 1993<br>+ A2: 1995 + A13:1996 | UL 2601-1:1997 has<br>been superseded by<br>UL60601-1:2003 |
| | CAN/CSA-C22.2 No. 601-<br>M90 + S1:1194 + Amdt<br>2:1998 | CAN/CSA-C22.2 No. 601-<br>M90 + S1:1194 + Amdt<br>2:1998 | IEC 60601-1-2 has<br>a new amendment<br>A1:2004. EN<br>60601-1-2 has a<br>new amendment |
| | UL 2601-1:1997 | UL 60601-1:2003 | A1:2006 |
| | IEC 60601-2-26:2002 | IEC 60601-2-26:2002 | |
| | EN 60601-2-26:2002 | EN 60601-2-26:2002 | |
| | IEC 60601-1-2:2001 | IEC 60601-1-2:2001 +<br>A1:2004 | |
| | EN 60601-1-2:2001 | EN 60601-1-2:2001 +<br>A1:2006 | |
| | IaEC 60601-1-4:1996 + Amd<br>1:1999 | IEC 60601-1-4:1996 +<br>A1:1999 | |
| | EN 60601-1-4:1996 +<br>A1:1999 | EN 60601-1-4:1996 +<br>A1:1999 | |
| Patient Monitor<br>compatibility | Datex-Ohmeda S/5TM<br>Anesthesia Monitor<br>(K092680) | Datex-Ohmeda S/5TM<br>Anesthesia Monitor<br>(K092680) | Equivalent |
| | Datex-Ohmeda S/5TM<br>Compact Anesthesia Monitor<br>(K061185) | Datex-Ohmeda S/5TM<br>Compact Anesthesia Monitor<br>(K061185) | New patient<br>Monitors supporting<br>Entropy have been<br>introduced since<br>Model E-<br>ENTROPY-00<br>submission |
| | | GE Healthcare<br>CARESCAPETM B850 Patient<br>monitor (K131414) | |
| | | GE Healthcare<br>CARESCAPETM B650 Patient<br>monitor (K131223) | |
| | | GE Healthcare<br>CARESCAPETM B450 Patient<br>monitor (K132533) | |
| | | GE Healthcare B40 Patient<br>monitor (K133576) | |
| Technical specifications | | | |
| Number of EEG<br>channels | 1 channel of raw EEG…