(279 days)
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.
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).
Here's a breakdown of the acceptance criteria and study information for the GE Healthcare Entropy Module, E-ENTROPY-01, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" for performance in a quantitative way for the new device, other than demonstrating substantial equivalence to the predicate. Instead, it details the technical specifications of both the predicate and proposed device, and notes whether they are identical or equivalent. The "acceptance criteria" here are implicitly the specifications of the predicate device, or updated standards where applicable.
| Feature / Specification | Predicate Device (E-ENTROPY-00) Performance | Proposed Device (E-ENTROPY-01) Performance | Discussion of Differences / Acceptance Outcome |
|---|---|---|---|
| Indications for Use | Same as proposed device | Indicated for adult & pediatric patients > 2 years for EEG/FEMG monitoring as adjunct; aids in monitoring anesthetic effects in adults, potentially reducing anesthetic use & speeding emergence. Prescription use. | Equivalent (Clarification that algorithm resides in monitor, no impact on SE) |
| Patient Age Limit | Adult & pediatric patients > 2 years | Adult & pediatric patients > 2 years | Identical |
| General Safety Standards | IEC 60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995, EN 60601-1:1990 + A1:1993 + A2:1995 + A13:1996, CAN/CSA-C22.2 No. 601-M90 + S1:1194 + Amdt 2:1998, UL 2601-1:1997, IEC 60601-2-26:2002, EN 60601-2-26:2002, IEC 60601-1-2:2001, EN 60601-1-2:2001, IEC 60601-1-4:1996 + Amd 1:1999, EN 60601-1-4:1996 + A1:1999 | IEC 60601-1:1988 + Amdt 1:1991 + Amd 2:1995, EN 60601-1:1990 + A1:1993 + A2:1995 + A13:1996, CAN/CSA-C22.2 No. 601-M90 + S1:1194 + Amdt 2:1998, UL 60601-1:2003, IEC 60601-2-26:2002, EN 60601-2-26:2002, IEC 60601-1-2:2001 + A1:2004, EN 60601-1-2:2001 + A1:2006, IEC 60601-1-4:1996 + A1:1999, EN 60601-1-4:1996 + A1:1999 | Equivalent (Updated standards used for proposed device, no impact on SE) |
| Patient Monitor Compatibility | Datex-Ohmeda S/5™ Anesthesia Monitor (K092680), Datex-Ohmeda S/5™ Compact Anesthesia Monitor (K061185) | Datex-Ohmeda S/5™ Anesthesia Monitor (K092680), Datex-Ohmeda S/5™ 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) | Equivalent (New monitors added since predicate submission) |
| Number of EEG Channels | 1 channel of raw EEG | 1 channel of raw EEG | Identical |
| EEG Measurement Mode | Referential | Referential | Identical |
| Input Dynamic Range | ±400 uV | ±500 uV | Equivalent (Slightly larger range, no impact on SE) |
| Input Offset | ±300 mV | ±300 mV | Identical |
| Frequency Range | 0.5 to 118 Hz | 0.5 to > 100 Hz | Equivalent (Algorithm uses frequencies within both specifications, no impact on SE) |
| Noise | < 0.5 uV RMS | < 0.5 uV RMS | Identical |
| Noise (peak-to-peak) | Not specified | < 6 uV peak-to-peak | New specification (Required by IEC 60601-2-26 3rd ed, no impact on SE) |
| Input Impedance | > 1 MΩ at 10 Hz | > 400 KΩ @ 10 Hz | Substantially equivalent (Per IEC 60601-2-26:2012, 400 kΩ is still significantly higher than max skin-electrode impedance for reliable measurement, no impact on SE) |
| Common Mode Rejection Ratio | > 100 dB at 50 Hz | > 90 dB @ 50 Hz | Substantially equivalent (Harmonized with IEC 60601-2-26 3rd ed., no impact on SE) |
| 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 |
| Impedance Measurement Frequency | 75 Hz | 75 Hz | Identical |
| Impedance Measurement Range | 1 to 30 kΩ | 1 to 20 kΩ | Equivalent (Decision limit for "check sensor" is 7.5 kΩ, well within both specs, no impact on SE) |
| Impedance Measurement Resolution | 0.1 kΩ | 0.1 kΩ | Identical |
| Impedance Measurement 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 Patient Cable | GE Entropy Cable M1050784, K062580 | GE Entropy Cable M1050784, K062580 | Identical |
| Compatible Sensors | GE Entropy Sensor M1038681, K082540; Entropy EasyFit Sensor M1174413, K103129 | GE Entropy Sensor M1038681, K082540; Entropy EasyFit Sensor M1174413, K103129 | Identical |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "No additional clinical tests were performed for proposed ENTROPY MODULE, E-ENTROPY."
Therefore, there is no distinct "test set" or data provenance information provided from new clinical studies for this submission, as the device's substantial equivalence relies on its technical specifications matching or being equivalent to the predicate device and compliance with recognized standards. The study that "proves the device meets the acceptance criteria" is primarily the non-clinical testing detailed below, demonstrating the device's adherence to relevant standards and its technical similarity to the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable, as no new clinical or comparative performance studies with human readers and ground truth were conducted for this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable, as no new clinical or comparative performance studies were conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an Electroencephalograph (EEG) module that processes signals to derive "Entropy" values (Response Entropy and State Entropy). It is not an AI-assisted diagnostic tool that human readers would use in a comparative effectiveness study in the typical sense of MRMC. The device provides physiological parameters to aid medical personnel.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The device is an "Entropy Module" which acquires EEG/FEMG signals. The "Entropy algorithm in the host monitor calculates the spectral entropies." While the algorithm itself operates "standalone" in calculating the Entropy values, the overall system is designed for use by "qualified medical personnel" as an adjunct to other physiological parameters. The document doesn't describe an isolated performance study of just the algorithm's output quality against a gold standard without the full device hardware context or human interpretation, beyond validating its technical specifications. The provided document doesn't detail a standalone study of the algorithm's diagnostic accuracy or effectiveness.
7. The Type of Ground Truth Used
For the purpose of this 510(k), the "ground truth" for the algorithm's performance is implicitly established by its equivalence to the predicate device's algorithm, which is published (Viertiö-Oja H et al., Acta Anaesthesiologica Scandinavica 2004). The "ground truth" for the device's safety and effectiveness is its adherence to recognized medical device standards (IEC, EN, UL, CAN/CSA) and its equivalence to a legally marketed predicate device.
8. The Sample Size for the Training Set
Not applicable, as this is primarily a hardware device with an established algorithm (from the predicate). The document does not describe the development or training of a new AI algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no new training set or new AI algorithm development is described in this submission. The algorithm itself is stated to be identical to the predicate: "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)." The algorithm's prior validation and publication (Viertiö-Oja H et al.) serves as its original basis.
Summary of Device Meeting Acceptance Criteria:
The GE Healthcare Entropy Module, E-ENTROPY-01, meets its acceptance criteria primarily through:
- Substantial Equivalence: Demonstrating that it is "as safe, as effective, and performance is substantially equivalent to the predicate device" (Datex-Ohmeda S/5™ Entropy Module, E-ENTROPY-00, K061907) based on technical specification comparison.
- Adherence to Standards: Compliance with numerous national and international medical electrical equipment safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, etc.).
- Non-Clinical Testing: In-house system testing, usability validation, and software testing (DOC1221813 In-House Verification Report, DOC1208044 Usability Validation Plan, DOC1261218 Usability Testing Report, DOC1223430 E-ENTROPY-01 Verification Report) confirmed compliance with defined acceptance criteria in the verification plan (DOC1019758).
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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 (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
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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 OyKuortaneenkatu 2,00510 HelsinkiFinlandPhone: +358-394-11 |
| Primary Contact Person: | Joel KentManager, Quality and Regulatory AffairsGE Medical Systems Information Technologies, IncTelephone: +1 617 851 0943Fax at +1 781 433-1344E-mail: joel.kent@med.ge.com |
| Secondary Contact Person: | Rauno RuohoRegulatory Affairs ManagerGE Healthcare Finland OyKuortaneenkatu 2,00510 HelsinkiFinlandPhone: +358-10-394 3624E-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 ProductCode: | 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-00K061907 | 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. | EquivalentThere 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 DeviceDatex-Ohmeda S/5 EntropyModule, E-ENTROPY-00K061907 | ProposedEntropy module,E-ENTROPY-01 | Discussion ofDifferences |
| General safety standards | IEC 60601-1:1988 + Amdt.1:1991 + Amdt. 2:1995 | IEC 60601-1:1988 + Amdt1:1991 + 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 hasbeen superseded byUL60601-1:2003 | |
| CAN/CSA-C22.2 No. 601-M90 + S1:1194 + Amdt2:1998 | CAN/CSA-C22.2 No. 601-M90 + S1:1194 + Amdt2:1998 | IEC 60601-1-2 hasa new amendmentA1:2004. EN60601-1-2 has anew 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 + Amd1:1999 | IEC 60601-1-4:1996 +A1:1999 | ||
| EN 60601-1-4:1996 +A1:1999 | EN 60601-1-4:1996 +A1:1999 | ||
| Patient Monitorcompatibility | Datex-Ohmeda S/5TMAnesthesia Monitor(K092680) | Datex-Ohmeda S/5TMAnesthesia Monitor(K092680) | Equivalent |
| Datex-Ohmeda S/5TMCompact Anesthesia Monitor(K061185) | Datex-Ohmeda S/5TMCompact Anesthesia Monitor(K061185) | New patientMonitors supportingEntropy have beenintroduced sinceModel E-ENTROPY-00submission | |
| GE HealthcareCARESCAPETM B850 Patientmonitor (K131414) | |||
| GE HealthcareCARESCAPETM B650 Patientmonitor (K131223) | |||
| GE HealthcareCARESCAPETM B450 Patientmonitor (K132533) | |||
| GE Healthcare B40 Patientmonitor (K133576) | |||
| Technical specifications | |||
| Number of EEGchannels | 1 channel of raw EEG | 1 channel of raw EEG | Identical |
| Specification | Predicate DeviceDatex-Ohmeda S/5 EntropyModule, E-ENTROPY-00K061907 | ProposedEntropy module,E-ENTROPY-01 | Discussion ofDifferences |
| EEG measurement mode | Referential | Referential | Identical |
| Input dynamic range | ±400 uV | ±500 uV | EquivalentModel E-ENTROPY-01 hasa slightly largerdynamic range butthis has no impacton substantialequivalence ascompared to thepredicate. . |
| Input offset | ±300 mV | ±300 mV | Identical |
| Frequency range | 0.5 to 118 Hz | 0.5 to > 100 Hz | EquivalentThe algorithm usedto calculateEntropy values,Response Entropyand State Entropy,uses EEGfrequencies whichare withinspecification ofboth modulemodels. This hasno impact onsubstantialequivalence ascompared to thepredicate. |
| Noise | < 0.5 uV RMS | < 0.5 uV RMS | Identical |
| Specification | Predicate DeviceDatex-Ohmeda S/5 EntropyModule, E-ENTROPY-00K061907 | ProposedEntropy module,E-ENTROPY-01 | Discussion ofDifferences |
| Noise (peak-to-peak) | Not specified | < 6 uV peak-to-peak | New specificationadded for ModelE-ENTROPY-01for peak-to-peaknoise as requiredby IEC 60601-2-263rd edition section201.12.1.101.3Adding additionalspecifications hasno impact onsubstantialequivalence ascompared to thepredicate. . |
| Specification | Predicate DeviceDatex-Ohmeda S/5 EntropyModule, E-ENTROPY-00K061907 | ProposedEntropy module,E-ENTROPY-01 | Discussion ofDifferences |
| Input impedance | $> 1 ΜΩ$ at 10 Hz | $> 400 ΚΩ$ @10Hz | SubstantiallyequivalentEssentialPerformancerequirements fromIEC 60601-2-26:2012 have beenintegrated toModel E-ENTROPY-01ProductSpecifications. AllEssentialPerformancerequirements arefulfilleddemonstratingEEG measurementperformance.Input impedancespecificationchange does notcause unwantedmeasurement errorin EEG signalamplitude as 400kΩ inputimpedance issignificantlyhigher than themaximum allowedskin-electrodecontact impedance(7.5kΩ) forEntropymeasurement,This change has noimpact onsubstantialequivalence as |
| Specification | Predicate DeviceDatex-Ohmeda S/5 EntropyModule, E-ENTROPY-00K061907 | ProposedEntropy module,E-ENTROPY-01 | Discussion ofDifferences |
| Common mode rejectionratio | > 100 dB at 50 Hz | > 90 dB @ 50 Hz | SubstantiallyequivalentThe requirementand measurementmethod in theproposed devicehas beenharmonized withIEC 60601-2-263rd edition section201.12.1.101.5 andthis slight changehas no impact onsubstantialequivalence ascompared to thepredicate. |
| Defibrillation protection | 3000V | 3000V | Identical |
| Sampling frequency | 400 Hz (1600 Hz withoversampling) | 400 Hz (1600 Hz withoversampling) | Identical |
| Degree of protectionagainst 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 | EquivalentElectrodeimpedancemeasurementvalues are notdisplayed to theend user. Internallythe result is used toevaluate if theelectrodeimpedance is lowenough for reliableEntropymeasurement.Limit in Entropymeasurement is 7.5kΩ. If theimpedance isabove that limit, a"check sensor"message isdisplayed andmeasurement isstopped. Thisdecision limit (7.5kΩ) is well withinthe specificationsof both Entropymodule modelsand this change toa 20 kΩ has noimpact onsubstantialequivalence ascompared to thepredicate. |
| 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 impedancemeasurement | 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 DeviceDatex-Ohmeda S/5 EntropyModule, E-ENTROPY-00K061907 | ProposedEntropy module,E-ENTROPY-01 | Discussion ofDifferences |
| Sensors | GE Entropy SensorM1038681, 510(k) NumberK082540Entropy EasyFit SensorM1174413, 510(k) NumberK103129 | GE Entropy SensorM1038681, 510(k) NumberK082540Entropy EasyFit SensorM1174413, 510(k) NumberK103129 | Identical |
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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 proposedClinical (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.
§ 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).