MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
Device Facts
| Record ID | K061907 |
|---|---|
| Device Name | MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES |
| Applicant | GE Healthcare |
| Product Code | OLW · Neurology |
| Decision Date | Mar 27, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence, Pediatric |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K061907 · Mar 27, 2008 | MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES | GE Healthcare | Peer-reviewed published scientific literature | The sponsor utilized published clinical literature to support the expansion of indications for use, specifically for pediatric patients (2 years or older) and to support new claims regarding the titration of anesthetic agents and faster emergence from anesthesia in adult patients. | Literature review; Anesthetic titration; Pediatric use; Clinical outcomes |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Independent, peer-reviewed and published scientific articles; Literature review of clinical studies | Adult and pediatric patients (2 years or older) | Not applicable for this study | Monitoring effects of anesthetic agents, reduction of anesthetic use, emergence time from anesthesia |
Indications for Use
The Datex-Ohmeda Entropy module , E-ENTROPY and accessories are intended to be used with Datex-Ohmeda modular multiparameter monitoring the neurophysiological status of hospitalized patients.
Device Story
The E-ENTROPY module is a plug-in component for Datex-Ohmeda S/5 perioperative monitors. It acquires raw EEG and frontal EMG (FEMG) signals from patients. Using a spectral entropy algorithm based on information theory, it processes these signals to calculate three parameters: Response Entropy (RE), State Entropy (SE), and Burst Suppression Ratio (BSR). These parameters are displayed on the host monitor, where clinicians can view trends and set auditory/visual alarms. The device serves as an adjunct to other physiological parameters; it is not intended as the sole basis for treatment. By providing real-time data on the hypnotic effect of anesthetic drugs, the device assists clinicians in titrating anesthesia, which may reduce drug consumption and facilitate faster patient emergence. It is intended for use by qualified medical personnel in hospital environments.
Clinical Evidence
No new clinical trials were conducted for this submission. The expanded indications for use are supported by independent, peer-reviewed scientific literature and internal studies previously evaluated by the manufacturer.
Technological Characteristics
Single-width plug-in module for S/5 monitors. Sensing principle: spectral entropy analysis of EEG and frontal EMG signals. Parameters: RE (0-100), SE (0-91), BSR (0-100%). Connectivity: proprietary interface for Datex-Ohmeda S/5 modular monitors. Software: identical to predicate (K050835).
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, RE and SE may aid in monitoring anesthetic agent effects to assist titration, potentially reducing hypnotic drug use and enabling faster emergence from anesthesia. 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 E-ENTROPY Module (K050835)
Submission Summary (Full Text)
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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 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.
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)
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Jautor
(Division Sigil off.
Division of General, Restorative,
and Neurological Devices
Neurological Devices
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