(279 days)
No
The device description explicitly states that the Entropy measurement is based on processing raw EEG and FEMG signals using the "Entropy algorithm, a GE application of Spectral Entropy," and references a specific published paper describing this algorithm. There is no mention of AI, ML, or any learning-based approach.
No
The device is described as a monitoring device that aids in monitoring effects of certain anesthetic agents, not as a device that delivers therapy.
No
The device is described as an "adjunct to other physiological parameters" for monitoring the state of the brain and the effects of anesthetic agents, rather than providing a stand-alone diagnosis. It processes signals to aid in titration of drugs and potentially faster emergence, but doesn't diagnose a disease or condition.
No
The device description explicitly states that the GE Entropy measurement devices are responsible for "EEG and FEMG signal acquisition, amplification, filtering and digitization and electrode impedance measurement," which are hardware functions. The Entropy algorithm is software, but it processes data acquired by hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The GE Healthcare Entropy module acquires and processes electrical signals (EEG and FEMG) directly from the patient's forehead. It does not analyze samples taken from the body.
- Intended Use: The intended use is to monitor the state of the brain by acquiring and processing these electrical signals, not to diagnose a condition based on a biological sample.
Therefore, the GE Healthcare Entropy module falls under the category of a medical device that monitors physiological parameters in vivo (within the living body), rather than an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
OLW, OMC, ORT
Device Description
GE Healthcare Entropy Module, E-ENTROPY is a single-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 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 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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients older than 2 years
Intended User / Care Setting
qualified medical personnel only. within a hospital
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)
No additional clinical tests were performed for proposed ENTROPY MODULE, E-ENTROPY.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
3
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 |
| Kuortaneenkatu 2, | |
| 00510 Helsinki | |
| Finland | |
| Phone: +358-394-11 | |
| Primary Contact Person: | Joel Kent |
| Manager, Quality and Regulatory Affairs | |
| GE Medical Systems Information Technologies, Inc | |
| Telephone: +1 617 851 0943 | |
| Fax at +1 781 433-1344 | |
| E-mail: joel.kent@med.ge.com | |
| Secondary Contact Person: | Rauno Ruoho |
| Regulatory Affairs Manager | |
| GE Healthcare Finland Oy | |
| Kuortaneenkatu 2, | |
| 00510 Helsinki | |
| Finland | |
| Phone: +358-10-394 3624 | |
| E-mail: rauno.ruoho@med.ge.com | |
| 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 | |
| Code: | OLW, OMC, ORT |
4
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
5
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
6
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
7
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.
8
| Specification | Predicate Device | Proposed | Discussion of Differences |
|---|---|---|---|
| Datex-Ohmeda S/5 Entropy Module, E-ENTROPY-00 | |||
| 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. | ||
| 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. | 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. | Equivalent | ||
| 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 | ||
| Datex-Ohmeda S/5 Entropy | |||
| Module, E-ENTROPY-00 | |||
| K061907 | Proposed | ||
| Entropy module, | |||
| E-ENTROPY-01 | Discussion of | ||
| Differences | |||
| General safety standards | IEC 60601-1:1988 + Amdt. | ||
| 1:1991 + Amdt. 2:1995 | IEC 60601-1:1988 + Amdt | ||
| 1:1991 + Amd 2:1995 | Equivalent | ||
| EN 60601-1:1990 + A1:1993 |
- A2:1995 + A13:1996 | EN 60601-1:1990 + A1: 1993
- A2: 1995 + A13:1996 | UL 2601-1:1997 has
been superseded by
UL60601-1:2003 |
| | CAN/CSA-C22.2 No. 601-
M90 + S1:1194 + Amdt
2:1998 | CAN/CSA-C22.2 No. 601-
M90 + S1:1194 + Amdt
2:1998 | IEC 60601-1-2 has
a new amendment
A1:2004. EN
60601-1-2 has a
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 +
A1:2004 | |
| | EN 60601-1-2:2001 | EN 60601-1-2:2001 +
A1:2006 | |
| | IaEC 60601-1-4:1996 + Amd
1:1999 | IEC 60601-1-4:1996 +
A1:1999 | |
| | EN 60601-1-4:1996 +
A1:1999 | EN 60601-1-4:1996 +
A1:1999 | |
| Patient Monitor
compatibility | Datex-Ohmeda S/5TM
Anesthesia Monitor
(K092680) | Datex-Ohmeda S/5TM
Anesthesia Monitor
(K092680) | Equivalent |
| | Datex-Ohmeda S/5TM
Compact Anesthesia Monitor
(K061185) | Datex-Ohmeda S/5TM
Compact Anesthesia Monitor
(K061185) | New patient
Monitors supporting
Entropy have been
introduced since
Model E-
ENTROPY-00
submission |
| | | GE Healthcare
CARESCAPETM B850 Patient
monitor (K131414) | |
| | | GE Healthcare
CARESCAPETM B650 Patient
monitor (K131223) | |
| | | GE Healthcare
CARESCAPETM B450 Patient
monitor (K132533) | |
| | | GE Healthcare B40 Patient
monitor (K133576) | |
| Technical specifications | | | |
| Number of EEG
channels | 1 channel of raw EEG | 1 channel of raw EEG | Identical |
| Specification | Predicate Device
Datex-Ohmeda S/5 Entropy
Module, E-ENTROPY-00
K061907 | Proposed
Entropy module,
E-ENTROPY-01 | Discussion of
Differences |
| EEG measurement mode | Referential | Referential | Identical |
| Input dynamic range | ±400 uV | ±500 uV | Equivalent
Model E-ENTROPY-01 has
a slightly larger
dynamic range but
this has no impact
on substantial
equivalence as
compared to the
predicate. . |
| Input offset | ±300 mV | ±300 mV | Identical |
| Frequency range | 0.5 to 118 Hz | 0.5 to > 100 Hz | Equivalent
The algorithm used
to calculate
Entropy values,
Response Entropy
and State Entropy,
uses EEG
frequencies which
are within
specification of
both module
models. This has
no impact on
substantial
equivalence as
compared to the
predicate. |
| Noise | 1 ΜΩ$ at 10 Hz | $> 400 ΚΩ$ @10Hz | Substantially
equivalent
Essential
Performance
requirements from
IEC 60601-2-
26:2012 have been
integrated to
Model E-
ENTROPY-01
Product
Specifications. All
Essential
Performance
requirements are
fulfilled
demonstrating
EEG measurement
performance.
Input impedance
specification
change does not
cause unwanted
measurement error
in EEG signal
amplitude as 400
kΩ input
impedance is
significantly
higher than the
maximum allowed
skin-electrode
contact impedance
(7.5kΩ) for
Entropy
measurement,
This change has no
impact on
substantial
equivalence as
|
| Specification | Predicate Device
Datex-Ohmeda S/5 Entropy
Module, E-ENTROPY-00
K061907 | Proposed
Entropy module,
E-ENTROPY-01 | Discussion of
Differences |
| Common mode rejection
ratio | > 100 dB at 50 Hz | > 90 dB @ 50 Hz | Substantially
equivalent
The requirement
and measurement
method in the
proposed device
has been
harmonized with
IEC 60601-2-26
3rd edition section
201.12.1.101.5 and
this slight change
has no impact on
substantial
equivalence as
compared to the
predicate. |
| Defibrillation protection | 3000V | 3000V | Identical |
| Sampling frequency | 400 Hz (1600 Hz with
oversampling) | 400 Hz (1600 Hz with
oversampling) | Identical |
| Degree of protection
against electrical shock | CF, defibrillation-proof | CF, defibrillation-proof | Identical |
| Electrode impedance measurement specifications | | | |
| Measurement frequency | 75 Hz | 75 Hz | Identical |
| Specification | Predicate Device | Proposed | Discussion of |
| | Datex-Ohmeda S/5 Entropy | Entropy module, | Differences |
| | Module, E-ENTROPY-00 | E-ENTROPY-01 | |
| | K061907 | | |
| Range | 1 to 30 kΩ | 1 to 20 kΩ | Equivalent
Electrode
impedance
measurement
values are not
displayed to the
end user. Internally
the result is used to
evaluate if the
electrode
impedance is low
enough for reliable
Entropy
measurement.
Limit in Entropy
measurement is 7.5
kΩ. If the
impedance is
above that limit, a
"check sensor"
message is
displayed and
measurement is
stopped. This
decision limit (7.5
kΩ) is well within
the specifications
of both Entropy
module models
and this change to
a 20 kΩ has no
impact on
substantial
equivalence as
compared to the
predicate. |
| Resolution | 0.1 kΩ | 0.1 kΩ | Identical |
| Accuracy | ±1 kΩ or ±10% | ±1 kΩ or ±10% | Identical |
| Leads of detection | Continuous | Continuous | Identical |
| Start of impedance
measurement | Manual / Automatic | Manual / Automatic | Identical |
| Compatible accessories | | | |
| Patient cable | GE Entropy Cable M1050784,
510(k) Number K062580 | GE Entropy Cable M1050784,
510(k) Number K062580 | Identical |
| Specification | Predicate Device
Datex-Ohmeda S/5 Entropy
Module, E-ENTROPY-00
K061907 | Proposed
Entropy module,
E-ENTROPY-01 | Discussion of
Differences |
| Sensors | GE Entropy Sensor
M1038681, 510(k) Number
K082540
Entropy EasyFit Sensor
M1174413, 510(k) Number
K103129 | GE Entropy Sensor
M1038681, 510(k) Number
K082540
Entropy EasyFit Sensor
M1174413, 510(k) Number
K103129 | Identical |
9
10
11
12
13
14
15
Determination of Summary of Non-Clinical Tests: Substantial Equivalence
(807.92(b)(1):
- The ENTROPY MODULE, E-ENTROPY complies with voluntary standards as detailed below. The following quality assurance measures were applied in the development of the system:
- Risk Analysis
- Requirements Reviews
- · Design Reviews
- · Testing on unit level (Module verification)
- · Integration testing (System verification)
- · Final acceptance testing (Validation)
- · Performance testing (Verification)
- ●
The ENTROPY MODULE, E-ENTROPY was designed and tested for compliance to the following standards:
- . IEC 60601-1:1988 + A1:1991 + A2:1995, Medical Electrical Equipment Part General Requirements for Safety
- . IEC 60601-1-2:2001 Medical electrical equipment = = Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-1-2:2007, Medical electrical equipment ● - Part 1-2: General requirements for basic safety
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and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-1-4:2000 Consol. Ed. 1.1 (IEC 60601-1-4:1996 + + A1:1999), Medical electrical equipment - Part 1-4: General requirements for safety -- Collateral standard: Programmable electrical medical systems, edition 1.1. (General)
- IEC60601-1-6:2006, Medical electrical equipment ● - Part 1-6: General requirements for basic safety and essential performance - collateral Standard: Usability
- IEC60601-1-26:2002、 ● Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs
Except for the following clause:
- Clause 17h: Defibrillation voltage 3kV is o allowed to be used instead of 5kV in the differential mode test when testing the E-ENTROPY module.
- The voltages between the electrodes of the o sensor placed on the forehead can be assumed to be below 3kV (see Annex AA.1 in IEC 60601-2-26:2002).
- EN 980:2008, Symbols for use in the labeling of ● medical devices
- EN1041:2008, Information supplied by the ● manufacturer of medical devices
In addition to standards testing the ENTROPY MODULE, E-ENTROPY was also verified in other bench tests:
- The results of In-House system testing are summarized in ● test report DOC1221813 In-House Verification Report for E-Entropy-01 Module. Conclusion of the In-House system testing is: "All the verification activities planned in E-Entropy-01 program verification plan have been completed and the defect from the E-Entropy-01 database in ClearQuest have been verified and reviewed in DRB by the LSD and OA. Verification has PASSED."
- usability validation performed according ● The to DOC1208044 E-ENTROPY-01 Usability Validation Plan demonstrates that the usability and ergonomic design of
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the Entropy Module, E-ENTROPY is acceptable to the intended users and therefore supports IEC 60601-1-6:2006 Medical electrical equipment. Part 1-6: General requirements for safety - Collateral standard: Usability. The results of usability testing are captured in DOC1261218 E-ENTROPY-01
- Software testing is described is described in the ● DOC1223430 E-ENTROPY-01 Verification Report
- Overall, a summary of the verification testing for the Entropy Module, E-ENTROPY is described in the DOC1223430 E-ENTROPY-01 Verification Report enclosed in the appendix. The conclusion is that satisfactory completion of the verification activity for the Entropy Module, E-ENTROPY has been achieved. The verification has passed based on the summary of results from the verification reports and the acceptance criteria defined in DOC1019758 E-Entropy-01 Verification Plan.
Summary of Clinical Tests:
| No additional clinical tests were performed for proposed
| Clinical (807.92(b)(2)): ENTROPY MODULE, E-ENTROPY. |
|---|
Conclusion (807.92(b)(3)): GE Healthcare considers the proposed ENTROPY MODULE, E-ENTROPY to be as safe, as effective, and performance is substantially equivalent to the predicate device.