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 Description

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.

AI/ML Overview

The provided documentation describes the CerebraLogik aEEG device, intended to monitor brain activity by acquiring EEG signals and displaying them as Amplitude Integrated EEG (aEEG). The submission is a Traditional 510(k) for the addition of this aEEG functionality to Mennen Medical's existing VitaLogik monitor family, asserting substantial equivalence to the Olympic CFM 6000 (K031149).

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for clinical performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Olympic CFM 6000) through bench testing and an animal study, comparing device characteristics and output patterns. The reported "performance" is that the CerebraLogik produced "same aEEG graphs" and "same aEEG pattern" as the predicate device under specific testing conditions.

Here's a table summarizing the comparative characteristics and the reported findings for direct comparison points:

Characteristic/Acceptance Criteria (Implied)	Predicate Device (Olympic CFM 6000) Performance	Subject Device (CerebraLogik aEEG) Performance	Outcome
EEG Noise floor	1.5 micro Volt peak to peak	1.5 micro Volt peak to peak	Same
aEEG Noise floor	1.0-1.5 micro Volt peak to peak	0.5-1 micro Volt peak to peak	Lower (Better)
Input Impedance active electrodes	25 K Ohm	600 K Ohm	Higher
Input Impedance active electrodes to reference	200 K Ohm	250 K Ohm	Higher
CMRR	120DB	110DB	Lower
Frequency response	2-15 Hz	Same, within +/- 2 dB	Same
Simulated EEG signal output (aEEG graphs)	Produced aEEG graphs	Produced "same aEEG graphs" as predicate during 3-hour sim. use	Same
Animal EEG/aEEG pattern	Recorded EEG/aEEG changes	Showed "same aEEG pattern" as predicate during 3 & 7-hour recordings	Same

Note: The acceptance criteria are implicitly drawn from the predicate device's specifications and the expectation that the new device should perform equivalently or better without raising new safety/effectiveness concerns.

2. Sample Size Used for the Test Set and Data Provenance

Bench Test (Simulated Use): EEG signal from one Grass EEG Simulator model EEG SIM. The signal was inserted in parallel to both devices for periods of 3 hours. Data provenance for the simulated signal is not explicitly stated but implies a synthetic source, not patient data.
Animal Study: EEG signals from anesthetized piglets. The number of piglets is not specified but it states "piglets" (plural). The recordings were made in parallel on both devices for periods of 3 and 7 hours. Data provenance is an animal model, not human patients. This data is retrospective for the purpose of the study as it was collected for comparison.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of human experts to establish ground truth for either the bench test or the animal study. The "ground truth" seems to be the output of the predicate device itself, with the new device's output being compared against it.

4. Adjudication Method for the Test Set

Since human experts were not used to establish ground truth or compare outcomes, there was no adjudication method described. The comparison was based on direct observation of "same aEEG graphs" and "same aEEG pattern" by the study's researchers/engineers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described focuses on technical equivalence and functional comparison of the device's output to a predicate device and simulated/animal signals, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The studies described are essentially standalone performance evaluations of the device's signal acquisition and processing capabilities. The device's output (aEEG graphs/patterns) was compared directly to the predicate device and the input signals, without a human in the loop affecting the device's generation of the aEEG display. The product itself, CerebraLogik aEEG, is a standalone module integrated into a monitor, providing processed EEG data for clinicians to interpret, but its output generation is algorithm-only.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the bench test, the ground truth was effectively the known electrical signal from the Grass EEG Simulator and the output of the predicate device (Olympic CFM 6000) when fed this signal.
For the animal study, the ground truth was the physiological EEG signal from anesthetized piglets, and the comparative output of the predicate device (Olympic CFM 6000) under the same conditions.

In both cases, it's a form of empirical comparison against a known input or a legally marketed predicate device's output, rather than an expert consensus, pathology, or outcomes data from human patients.

8. The Sample Size for the Training Set

The document does not mention any training set. The CerebraLogik aEEG module appears to be based on fixed algorithms for filtering, rectifying, and compressing EEG signals, rather than a machine learning model that would require a distinct training set. The descriptions focus on the implementation of these algorithms and their output comparison, not on their development or training.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned and the device's technology appears to be based on established signal processing rather than machine learning, this question is not applicable based on the provided text.

Summary

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Image /page/0/Picture/2 description: The image contains the logo for Mennen Medical. The logo consists of a circle with a stylized "m" inside, followed by the words "mennen medical" in a sans-serif font. The word "mennen" is on the top line, and the word "medical" is on the bottom line.

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 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
ndicationfor use	K031149	K131789
Intendedfor use	The Olympic CFM 6000 is intended tomonitor the state of the brain by acquisitionof EEG signals in the intensive care unit,operating room, and for clinical research.	CerebraLogik - aEEGThe intended use of theCerebraLogik is tomonitor the state of thebrain by acquisition ofEEG signals and displaythe stored EEG in acompressed form ofAmplitude IntegratedEEG - aEEG and inconjunction with otherclinical data
Indicationfor use	The Olympic CFM 6000is intended to be usedby a variety of clinicians to acquire and utilizeSSG signals, when used in conjunction withother clinical data, in intensive car areas,Operating Room, Emergency Room, andclinical research lab:- to monitor the state of the brain- for determination of, and long-term- monitoring of, the neurological status ofpatients that may have suffered anhypoxic-ischemic event.- For monitoring of neurological status to- assist in the clinical management andtreatment of the patient by observinghow the treatment affects theneurological status as shown by the	The Intended Use is sameas 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 ofneurological outcome- To monitor and record frequency andintensity of seizures in management ofanti-convulsive therapy.- To assist in the prediction of severity ofHypoxic-Ischemic Encephalopathy andlong-term outcome in infants who havesuffered 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 ofOperation	Recording of EEG andstorage and display ofAmplitude integratedEEG	Same:Recording of EEG and storage anddisplay of Amplitude integrated EEG
Number ofchannels	Single channel EEG &aEEG	Dual channel EEG & aEEG
Number ofelectrode inputs	3	5
Display size	10"	12" on VitaLogik 4000/450015" on VitaLogik 6000/650017" 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 StorageDevice	CD-RW drive	USB (Data Storage Device)
Recorder	Built-in	Built-in (option)
	RS-232 I/O port
Ethernet port	RJ-45 (10/100) Ethernetport	RJ-45 (10/100) Ethernet port
Serial port	PS2 standard keyboardserial port (service only)	PS2 standard keyboard serial port
Serial port	PS2 standard mouseserial port (service only)	PS2 standard mouse serial port
Marker	Yes	Yes
Section selection	No	Yes
Amplifier**
EEG Noise floor	1.5 micro Volt peak topeak	1.5 micro Volt peak to peak
aEEG Noise floor	1.0-1.5 micro Volt peak topeak	0.5-1 micro Volt peak to peak
Input Impedanceactive electrodes	25 K Ohm	600 K Ohm
Input Impedanceactive electrodes toreference	200 K Ohm	250 K Ohm
CMRR	120DB	110DB
Frequencyresponse	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 as indicated above is same as the Indications for Use.

Signature:

Heto Iner

Ifat Oren Shwarts

QA & Regulatory manager

Mennen Medical Ltd. +972-8-9323333 ext. 213 Tel: Fax: +972-8-9328510 E-mail: Ifat_oren@mmi.co.il

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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 (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" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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:

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

Page 1 of __ 1 __

Regulation Number and Section

§ 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).