CEREBRALOGIK- AEEG

K131789 · Mennen Medical , Ltd. · OMA · Dec 27, 2013 · Neurology

Device Facts

• Record ID: K131789
• Device Name: CEREBRALOGIK- AEEG
• Applicant: Mennen Medical , Ltd.
• Product Code: OMA · Neurology
• Decision Date: Dec 27, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The intended use of the CerebraLogik is to monitor the state of the brain by acquisition of EEG signals and display the stored EEG in a compressed form of Amplitude Integrated EEG - aEEG and in conjunction with other clinical data.

Device Story

CerebraLogik is a dual-channel EEG amplifier module interfacing with Mennen Medical VitaLogik patient monitors. It acquires EEG signals via 5 electrode inputs; signals are filtered, rectified, and compressed into Amplitude Integrated EEG (aEEG). The system displays real-time EEG and aEEG history alongside standard vital signs (ECG, NIBP, SpO2, etc.) on the monitor screen. Used in hospital settings (ICU, OR, clinical research) by clinicians to monitor neurological status, manage anti-convulsive therapy, and assess hypoxic-ischemic events. Output allows clinicians to observe treatment effects on brain state. Benefits include synchronous monitoring of neurological data with standard physiological parameters, aiding in clinical decision-making and long-term patient management.

Clinical Evidence

No human clinical trials. Evidence consists of bench testing and an animal study. Bench testing compared amplifier characteristics (noise floor, impedance, CMRR, frequency response) and output using a Grass EEG Simulator, showing identical aEEG graphs. Animal study recorded EEG signals from anesthetized piglets in parallel on both subject and predicate devices for 3-7 hours, demonstrating identical aEEG patterns during variations in ventilation and anesthesia.

Technological Characteristics

Dual-channel EEG amplifier; 5 electrode inputs; 600 K Ohm input impedance (active); 110dB CMRR; 2-15 Hz frequency response. Interfaces with VitaLogik monitors via UIM input. Connectivity includes Ethernet (RJ-45), USB for data storage, and serial ports. Software-based signal processing (filtering, rectification, compression). Complies with IEC 60601-1, 60601-1-1, 60601-1-2, 60601-2-27, 60601-2-30, 60601-2-34, 60601-2-49, and 60601-2-26.

Indications for Use

Indicated for monitoring brain state via EEG acquisition and aEEG display in conjunction with other clinical data. Used in intensive care, operating rooms, and clinical research to monitor neurological status, assist in treatment management, predict neurological outcomes, monitor seizure frequency/intensity, and assess severity of hypoxic-ischemic encephalopathy in infants.

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

• Olympic CFM 6000 (K031149)

Submission Summary (Full Text)

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Date: Dec 25,2013

# Topic: K131789- CerebraLogik - Traditional 510K for addition of aEEG to the Monitors family

Establishment Name, Registration Number and Address:

| Name: | Mennen Mec |
|----------------------|---------------|
| Registration Number: | 9611022 |
| Operator Number: | 9069173 |
| Address: | 4 Hayarden S |
| Postal Address: | PO Box 102. |
| Tel: | +972-8-932- |
| Fax: | +972-8-932: |
| Contact person: | Ifat Shwarts. |

dical Ltd. Street, Yavne, 81228, Israel , Rehovot, 76100, Israel 3333 8210 , Regulatory Affairs

The following information is being submitted in conformance with 21 CFR 807.87:

- I. Classification Name Electroencephalograph 2. Classification Number: 21 CFR 882.1400 3. Common/Usual Name Electroencephalograph 4. Trade/Proprietary Name CerebraLogik 5. Part Number of CerebraLogik 681-138-010 6. Establishment Registration Number 9611022 7. FDA Classification Class II 8. Classification Product Code OMA, OMC 9. The Monitor Product Codes (VitaLogik) DSI23 10. Reviewing Panel Neurological 11. Performance Standards see page 8

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## Terminology

CerebraLogik aEEG - the monitor records EEG signals from two pairs of electrodes placed on the patient's head. The signal is filtered, rectified and compressed.

The CerebraLogik aEEG module will be interfaced to the VitaLogik monitor family, as below.

510(k) Marketing clearance for VitaLogik monitors:

VitaLogik 5000/5500 Patient Monitor = subject of this traditional 510(k). was approved for marketing by the FDA (K052288 - 20 Dec 2005)

VitaLogik 4000/4500 Patient Monitor = subject of this traditional 510(k). was approved for marketing by the FDA (K073140 - 21 Nov 2007)

VitaLogik 6000/6500 Patient Monitor = subject of this traditional 510(k). was approved for marketing by the FDA (K093766 - 7 May, 2010)

All monitors detailed above, belong to the same family, use the same menus and differ only in display size and packaging

All monitors detailed above, will be upgraded with the CerebraLogik module. The user will be able, in addition to existing capabilities, to also measure EEG signals and displays aEEG history.

### Predicate Device

Olympic CFM 6000-K031149, cleared May, 14, 2003

#### 1. Device Description: CerebraLogik

The CerebraLogik consists of a dual channel EEG amplifier that is put near the monitored patient. The amplifier is connected, using an interface cable, to a Mennen Medical patient monitor via the UIM input of the monitor

The monitor has display options for both real time EEG and history of Amplitude Integrated EEG - aEEG.

The monitor stores both EEG and aEEG signals for the duration of the EEG monitoring

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## Functional Description of the Monitors family

The patient monitors measure vital signs such as ECG/Heart rate, NIBP, SpO2, Temperature, Invasive pressures, Cardiac output and EtCO2 as an option.

The only change to the monitors is the modification of the software to allow the monitors to interface to the CerebraLogik aEEG modules to measure and display aEEG.

### Substantial Equivalence: Comparison: CerebraLogik- aEEG with OLYMPIC CFM 2. 6000

## Comparison between the intended use and indication for use:

| Intended/i | OLYMPIC CFM 6000 | CerebraLogik- aEEG |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ndication<br>for use | K031149 | K131789 |
| Intended<br>for use | The Olympic CFM 6000 is intended to<br>monitor the state of the brain by acquisition<br>of EEG signals in the intensive care unit,<br>operating room, and for clinical research. | CerebraLogik - aEEG<br>The intended use of the<br>CerebraLogik is to<br>monitor the state of the<br>brain by acquisition of<br>EEG signals and display<br>the stored EEG in a<br>compressed form of<br>Amplitude Integrated<br>EEG - aEEG and in<br>conjunction with other<br>clinical data |
| Indication<br>for use | The Olympic CFM 6000is intended to be used<br>by a variety of clinicians to acquire and utilize<br>SSG signals, when used in conjunction with<br>other clinical data, in intensive car areas,<br>Operating Room, Emergency Room, and<br>clinical research lab:<br>- to monitor the state of the brain<br>- for determination of, and long-term<br>- monitoring of, the neurological status of<br>patients that may have suffered an<br>hypoxic-ischemic event.<br>- For monitoring of neurological status to<br>- assist in the clinical management and<br>treatment of the patient by observing<br>how the treatment affects the<br>neurological status as shown by the | The Intended Use is same<br>as the Indications For Us |

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Food and Drug Administration

Traditional 510(k) K131789 for CerebraLogik - addition of aEEG to the monitors family

| CFM | |
|-----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | - To assist in the predication of<br>neurological outcome<br>- To monitor and record frequency and<br>intensity of seizures in management of<br>anti-convulsive therapy.<br>- To assist in the prediction of severity of<br>Hypoxic-Ischemic Encephalopathy and<br>long-term outcome in infants who have<br>suffered an hypoxic-ischemic event. |

Note: The term aEEG used by Mennen Medical is equivalent to the term CFM used by the Olympic CFM 6000

We have preferred to use the term aEEG to describe the Amplitude Integrated EEG since this is the generic term.

## Conclusion of comparison of intended/indication for use:

The indication for use of both the CerebraLogik and the Olympic CFM 6000 (the predicate device) are not identical but have a similar content. Both devices intend to monitor the state of the brain by acquisition of EEG signals by acquisition of EEG signals and display the stored EEG in a compressed form of Amplitude Integrated EEG - aEEG and in conjunction with other clinical data.

The following table compares the major elements in the CerebraLogik- aEEG vs. the OLYMPIC CFM 6000 (predicate device):

| Component | OLYMPIC CFM 6000 | CerebraLogik- aEEG |
|------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Principle of<br>Operation | Recording of EEG and<br>storage and display of<br>Amplitude integrated<br>EEG | Same:<br>Recording of EEG and storage and<br>display of Amplitude integrated EEG |
| Number of<br>channels | Single channel EEG &<br>aEEG | Dual channel EEG & aEEG |
| Number of<br>electrode inputs | 3 | 5 |
| Display size | 10" | 12" on VitaLogik 4000/4500<br>15" on VitaLogik 6000/6500<br>17" on VitaLogik 5000/5500 |
| aEEG Display area | 180 x 50 mm | On VitaLogik 4000/4500 |
| | | Single channel 180 x 50 mm |
| | | Dual Channel 180 x 35 mm |
| GUI | EEG + CFM {aEEG) | EEG + aEEG + VitaLogik Vital Signs |
| LAN | No | Yes |
| Touch screen | Yes (only) | Yes (optional) |
| Electrode quality | Resistance | Quality |
| Data storage | 20,000 hours of data | 3 patient , 7 days per patient |
| Output Storage<br>Device | CD-RW drive | USB (Data Storage Device) |
| Recorder | Built-in | Built-in (option) |
| | RS-232 I/O port | |
| Ethernet port | RJ-45 (10/100) Ethernet<br>port | RJ-45 (10/100) Ethernet port |
| Serial port | PS2 standard keyboard<br>serial port (service only) | PS2 standard keyboard serial port |
| Serial port | PS2 standard mouse<br>serial port (service only) | PS2 standard mouse serial port |
| Marker | Yes | Yes |
| Section selection | No | Yes |
| Amplifier** | | |
| EEG Noise floor | 1.5 micro Volt peak to<br>peak | 1.5 micro Volt peak to peak |
| aEEG Noise floor | 1.0-1.5 micro Volt peak to<br>peak | 0.5-1 micro Volt peak to peak |
| Input Impedance<br>active electrodes | 25 K Ohm | 600 K Ohm |
| Input Impedance<br>active electrodes to<br>reference | 200 K Ohm | 250 K Ohm |
| CMRR | 120DB | 110DB |
| Frequency<br>response | 2-15 Hz | Same, within + / - 2 dB |

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Note: These values are measured values from bench testing of the subject and predicate devices

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### Summary of comparison tests

### Bench test

Two types of bench testing of the subject and predicate device was performed. The first type compared amplifier characteristics of the devices. These tests included measurement and comparison of noise floors, input impedances, CMRR, and frequency responses. The second type of bench testing compared the output of the devices in a simulated use. In this test, EEG signal from Grass EEG Simulator model EEG SIM was inserted in parallel to both Olympic CFM 6000 and the CrebraLogik for periods of 3 hours. Both devices showed same aEEG graphs.

### Animal Study

EEG signals of anesthetized piglets were recorded in parallel on Olympic CFM 6000 and the CerebraLogik for periods of 3 and 7 hours. EEG and aEEG recording changes caused by variation in ventilation and anesthesia during the test were compared and showed same aEEG pattern

The results confirm that the device under test, the CerebraLogik, is accurate and gave same results as the predicate device.

We consider the CerebraLogik- aEEG to be substantially equivalent to the OLYMPIC CFM 6000 and we submit that any differences between the two systems

· do not raise any new issues of safety and effectiveness

## Reasons for change of Monitors family

Mennen Medical made the changes to the monitors' family for the following reasons:

- . As part of continuous improvement and innovation and in order to comply with market's requirements, Mennen Medical added the aEG parameter to its patient monitors family,
- The benefit of the incorporation of EEG and aEEG to the patient monitors is in the . synchronous monitoring, and storage, of the standard vital signs with the EEG waveform.

### 3. Detailed description of the changes made to the VitaLogik monitors to incorporate CerebraLogik

### GUI

No changes were made to the GUI in the display or monitoring of standard vital signs.

For the display of EEG and aEEG an EEG menu was added, and display panels for single or dual channel EEG and aEEG real time and history were added.

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### Software

Software versions are the same for all VitaLogik monitors to ensure compatibility of all system components along the history of the system.

The change is limited to the addition of the CerebraLogik dual channel EEG amplifier, and use of algorithm for display of Amplitude Integrated EEG - aEEG

### 4. Verification, Validation and Testing

The CerebraLogik was tested in bench test and in animals by connecting in parallel the inputs of the Olympic CFM 6000 and the CerebraLogik.

Similar waveforms of both EEG and aEEG were received in these tests.

Internal tests called STD (Software Test Descriptions) were also performed on the CerebraLogik's software to ensure its verification and validation. The tests ensure the CerebraLogik aEEG monitor interfaces properly with the monitors and perform according its specifications.

### ട. Proposed Labeling

The system will be called CerebraLogik and will be added to the VitaLogik monitors.

We have assigned a new Part Number to the CerebraLogik P/N 681-138-010

User Manuals of each of the monitors will have a chapter describing the use of the CrebraLogik.

Page 1-1 of the introduction to the VitaLogik (6000&4X00) User Manuals contains the following Prescription Notice: "Caution: Federal law restricts this device to sale by or on the order of qualified medical personnel only."

The following symbols appear on page 2-5 of the User Manuals and/or on the side panel of the VitaLogik/CerebraLogik accordingly.

-

"Attention - see Accompanying Instructions for Use"

Image /page/6/Picture/15 description: The image shows a black and white drawing of a triangular warning sign. Inside the triangle is a large exclamation point. The exclamation point is centered within the triangle and is the most prominent feature of the image. The sign is simple and easily recognizable as a warning symbol.

Type BF Applied part (next to NIBP, SpO2, Temperature and EtCO2 connectors )

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Image /page/7/Picture/1 description: The image shows a black and white drawing of a person inside of a square. The person is standing with their arms outstretched to the sides and their legs apart. The person is a simple stick figure with a circle for a head and lines for the arms and legs. The square is a simple black line.

TYPE BF APPLIED PART

Image /page/7/Picture/3 description: The image shows a black and white drawing of a heart inside of a square. There are two symbols on either side of the square. The symbols are a vertical line with a horizontal line through the middle.

Type CF Applied Part - Defibrillation Proof (next to ECG, IBP and CO connector)

Symbols and labeling

### Voluntary Standards 6.

Appropriate voluntary standards for this device, to which conformance have been

demonstrated:

- * IEC 60601-1: (2005) Medical Electrical Equipment Part: 1 General Requirements for Safety
- * IEC 60601-1-1 (2000) Medical Electrical Equipment Part 1-1: General Requirements for Safety Collateral Standard: Safety Requirements for Medical Electrical Systems
- * IEC 60601-1-2 (2007): Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
- ゃ IEC 60601-2-27 (2005): Medical electrical equipment. Part 2. Requirements for safety of electrocardiograph monitoring equipment.
- * IEC 60601-2-30 (1999): Medical electrical equipment, Part 2 - requirements for safety of automatic cycling indirect blood pressure monitoring equipment
- * IEC 60601-2-34 (2005): Medical electrical equipment, Part 2 - Particular requirements for the safety of direct blood pressure monitoring equipment
- * IEC 60601-2-49 (2001): Particular Requirements for the safety of multifunction patient monitoring equipment
- ゃ IEC 60601-2-26 ed3.0 (2012): Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs

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### Indication for use 7.

## Monitor's Indications for Use (unchanged since latest approval: VitaLogik 6000 K093766, 7 May, 2010):

The VitaLogik is intended for use as a multiparameter physiological patient monitoring system. The VitaLogik can monitor ECG/heart rate, invasive blood pressure channels, temperature channels, pulse oximetry, respiration, non-invasive blood pressure and EtCO2.

This effectively allows the VitaLogik to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital.

Functions include display of multiparameter waveforms, vital signs, alarm & status messages. The Mennen Medical VitaLogik is intended for sale as a system for monitoring and recording patient information or any in-hospital application requiring patient monitoring.

The following are examples of intended clinical applications:

- * Critical Care Patients
- * Cardiac Step-down/Telemetry Units
- * Emergency Departments
- * Intra .- operative (Anesthesia) Monitoring
- * Post Anesthesia Care

## CerebraLogik - aEEG

The intended use of the CerebraLogik is to monitor the state of the brain by acquisition of EEG signals and display the stored EEG in a compressed form of Amplitude Integrated EEG - aEEG and in conjunction with other clinical data.

*The Intended Use of the CerebraLogik as indicated above is same as the Indications for Use.

Signature:

Heto Iner

Ifat Oren Shwarts

QA & Regulatory manager

Mennen Medical Ltd. [phone] ext. 213 Tel: Fax: [phone] E-mail: [e-mail]

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenus Document Control Center - WO66-G60 Silver Spring MD 20993-0002

December 27, 2013

Mennen Medical, Ltd. Ms. Ifat Shwarts QA and Regulatory Manager 4 Hayarden Street, Yavne P.O. Box 102 Rehovot, Israel, 76100

Re: K131789

Trade/Device Name: CerebraLogik aEEG Regulation Number: 21 CFR 882.1400 Regulation Name: Electroenchphalograph Regulatory Class: Class II Product Code: OMA, OMC Dated: November 21, 2013 Received: November 27, 2013

Dear Ms. Shwarts:

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. Iisting 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 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

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## Page 2 - Ms. Ifat Shwarts

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Image /page/10/Picture/7 description: The image shows the name "Carlos L. Pena -" in a bold, sans-serif font. The letters are black against a white background. The "L" in the middle name is stylized with a dotted pattern.

Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

K131789

Device Name:

. : 、ジェ

CerebraLogik aEEG

Indications For Use:

The intended use of the CerebraLogik is to monitor the state of the brain by acquisition of EEG signals and display the stored EEG in a compressed form of Amplitude Integrated EEG - aEEG and in conjunction with other clinical data.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Carlos Pena -S

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