BE micro/Trea intended use is collecting and recording physiological data to be used in neurology (EEG), polysomnography (PSG) and sleep disorder studies. The BE micro is intended for pediatric to adult population, and can be used either home or hospital environments. The BE micro/Trea is only to be used under the direction or supervision of a physician, or other trained health care professional.

Device Description

The BE micro is manufactured by EBNeuro and intended for use in collecting and recording physiological data to be used in diagnosis in EEG (electroencephalography) and PSG (sleep disorder studies) clinical investigation. The BE micro is a portable multi-channel recording system that capture and digitally amplifies neurological (EEG) and/or Polysomnography (PSG) physiological activity and records the acquired data onto an internal NAND flash memory chip and/or sends those data directly to a PC via the USB port. The BE micro system is a small, lightweight recording system that is comfortable for the patient and simple for the clinician to set up. The Amplifier can be worn by the patient allowing in such way the patient to freely move or sleep while recordings are being made, allowing a more comfortable and efficient test.

AI/ML Overview

The provided 510(k) summary for K093728 details the "BE micro/Trea" device, an electroencephalograph for collecting and recording physiological data in neurology and sleep studies. However, the document primarily focuses on establishing substantial equivalence to predicate devices through a comparison of technological characteristics and non-clinical performance data.

The document does NOT provide information regarding specific acceptance criteria for clinical performance, nor does it describe a study proving the device meets such acceptance criteria through clinical performance metrics (e.g., sensitivity, specificity, accuracy).

Instead, the "Summary of Non-Clinical Performance Data" section indicates:

"Data to verify and validate the measurement algorithm and software functionality. RESULT: PASS"
"Data to evaluate electrical safety and electromagnetic compatibility (per IEC 60601-1, IEC 60601-1-2, and other standards). RESULT: PASS"

This suggests that the performance requirements are related to the successful operation of the device's software and its compliance with electrical safety and EMC standards, rather than diagnostic accuracy or clinical effectiveness in identifying specific conditions.

Given the information provided, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

As no explicit clinical performance acceptance criteria and corresponding reported performance are provided in the document, this table is based on the non-clinical performance data statements.

Acceptance Criteria (Implied)	Reported Device Performance
Software functionality and measurement algorithm are verified and validated.	PASS
Compliance with electrical safety standards (e.g., IEC 60601-1, IEC 60601-1-4, etc.)	PASS
Compliance with electromagnetic compatibility (EMC) standards (e.g., IEC 60601-1-2)	PASS

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

Not applicable from the provided document. The non-clinical performance data described relates to software functionality and electrical/EMC compliance, not a test set for clinical performance.

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

Not applicable from the provided document, as no clinical test set requiring expert ground truth is described.

4. Adjudication Method for the Test Set

Not applicable from the provided document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned or summarized in the provided document.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone performance study for an algorithm related to clinical diagnosis is described. The "measurement algorithm and software functionality" likely refers to the core processing of physiological signals rather than a diagnostic algorithm.

7. Type of Ground Truth Used

Not applicable from the provided document for clinical performance. For the described non-clinical tests:

For software functionality, the "ground truth" would be the expected output or behavior according to design specifications.
For electrical safety and EMC, the "ground truth" is compliance with the specific parameters and limits defined in the referenced IEC and other standards.

8. Sample Size for the Training Set

Not applicable from the provided document, as no machine learning algorithm development (with training/test sets) for diagnostic purposes is described.

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

Not applicable from the provided document.

Conclusion from document analysis:

The 510(k) summary for K093728 establishes substantial equivalence primarily through a comparison of technological characteristics with predicate devices and demonstration of compliance with engineering standards for software functionality, electrical safety, and electromagnetic compatibility. It does not contain information about clinical performance acceptance criteria or a clinical study proving that the device meets such criteria for diagnostic accuracy or effectiveness. This is typical for Class II devices like electroencephalographs, where substantial equivalence can often be demonstrated through technological and performance comparisons to existing legally marketed devices without requiring extensive de novo clinical performance studies for diagnostic accuracy.

Summary

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K093728 510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21 CFR 807.92.

807 92(a)(1)

Submitter Information

EBNeuro, S.p.A. Via Pietro Fanfani 97/A Florence, Italy 50127

Contact Person: Jamie Austin, RAC Regulatory Consultant, Anson Group Phone: (317) 569-9500 x 118 Facsimile: (317) 569-9520

Date: December 2, 2009

807.92(a)(2)

Trade Name: BE micro/Trea

Regulation Number: 21 CFR 882.1400

Regulation Name(s): Electroencephalograph

Regulatory Class: Class II

Product Code: OLV

Additional Product Codes: GWQ, GWL, MNR, and DQA

807.92(a)(3)

Predicate Device(s)

K# K010460 K052066 K061996

Name Track-it Netlink Traveler Sandman Pocket Manufacturer

Lifelines Ltd Bio-logic System Corp. EBNeuro S.p.A.

Additional substantial equivalence information is provided below.

APR 2 9 2010

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807.92 (a)(4)

Device Description

The BE micro is a portable multi-channel recording system that capture and digitally amplifies neurological (EEG) and/or Polysomnography (PSG) physiological activity and records the acquired data onto an internal NAND flash memory chip and/or sends those data directly to a PC via the USB port. The BE micro system is a small, lightweight recording system that is comfortable for the patient and simple for the clinician to set up.

The Amplifier can be worn by the patient allowing in such way the patient to freely move or sleep while recordings are being made, allowing a more comfortable and efficient test.

807.92(a)(5)

Intended Use(s)

The BE micro/Trea is only to be used under the direction or supervision of a physician, or other trained health care professional.

807.92(a)(6)

Technological Characteristics

The BE micro/Trea system utilizes the same technological characteristics as the predicate devices. A comparison of these characteristics can be summarized as follows:

. Design
- o BE micro/Trea and predicate(s) are designed for the same target populations and environments of use.
- o BE micro/Trea and predicate(s) utilize same type of operator interface.
- o BE mirco/Trea and predicate(s) have same type of configuration.
- BE micro/Trea and predicate(s) have same/similar sampling rates, data o storing, data compression, A/D resolution, and maximum number of channels.
. Material
- o BE mirco/Trea and predicate use same microprocessor.
Energy source .
- o BE micro/Trea and predicate(s) utilize same type of energy source(s).

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Summary of Substantial Equivalence

EBNeuro believes that the BE micro/Trea system is substantially equivalent to the Track-it (K010460), Netlink Traveler (K052066) and Sandman Pocket (K061996). Please see table below for detailed comparison of the specifications, characteristics, and performance/safety testing of the BE micro/Trea to the respective predicate devices.

807.92(b)(1)

Summary of Non-Clinical Performance Data

The following non-clinical performance data were gathered:

. Data to verify and validate the measurement algorithm and software functionality.
- o RESULT: PASS
. Data to evaluate electrical safety and electromagnetic compatibility (per IEC 60601-1, IEC 60601-1-2, and other standards).
- o RESULT: PASS

Non-Clinical Performance Data Conclusions

Software V&V testing demonstrated that the software functions as intended. Electrical safety and electromagnetic compatibility testing demonstrated that, like the referenced predicate device(s), the BE micro/Trea complies with IEC 60601-1, IEC 60601-1-2, and other safety/EMC standards (per table below).

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Product Characteristic	BEmicro (Trea)Submission device	Track-it(Predicate Device)	Netlink Traveler(Predicate Device)	Sandman Pocket(Predicate device)
Manufacturer	EBNeuro S.p.A.	Lifelines Ltd	Bio-logic System Corp.	EBNeuro S.p.A.
510(k) number	TBA	K010460	K052066	K061996
Device class	Class II	Class II	Class II	Class II
Intended use	BE micro intended use iscollecting and recordingphysiological data to be usedin neurology (EEG),polysomnography (PSG) andsleep disorder studies. TheBE micro is intended forpediatric to adult population,and can be used either homeor hospital environments	The lifelines Track itRecorder is a 36 channelambulatoryelectroencephalographthat is designed for use ina variety of monitoringapplication to recordphysiological data forEGG and Sleep studies	The Bio-logic Netlink Traveler isindicated for use in the recording andanalysis of EEG tests. Typical routineEEG tests are 20-30 minutes induration, but the Netlink Traveler canalso be used for longer tests, includingcontinuous long-term EEG monitoringwith patient video. Similarly,the Netlink Traveler is indicated for usein the recording and analysis of humanphysiological data necessary for thediagnosis of Sleep-related disorders. Itis intended to record and present thisdata in a form that can improve thespeed of diagnosis and assist inpotential treatment decisions. Ingeneral, EEG and Sleep testing isindicated for use whenever it isnecessary to measure and record apatient's electrophysiological activity,including the electrical activity of thebrain, by attaching multiple electrodesat various locations on the body.	Intended for use incollecting and recordingphysiological data to beused inpolysomnography andsleep disorder studies.For use in either homeor hospital environmentswith a pediatric throughadult patient population.
Target population	Pediatric through adult	Patients of all ages, fromchildren to adults.	Patients of all ages, fromchildren to adults, includinggeriatric patients.	Pediatric through adult(including all pediatricsubpopulations)
Environment of use	Hospital and home	Hospital and home	Hospital and home	Hospital and home
Product Characteristic	BEmicro (Trea)Submission device	Track-it(Predicate Device)	Netlink Traveler(Predicate Device)	Sandman Pocket(Predicate device)
Recording modality	Attended and Unattended	Attended and Unattended	Attended and Unattended	Attended and Unattended
Prescription status	Available only on the orderof a physician.	Available only on the orderof a physician.	Available only on the order of aphysician.	Available only on theorder of a physician.
Power	Battery powered or USBpowered	Battery powered	Battery Powered	Battery powered or USBpowered
CommunicationInterfaces	Physiological signals aresent from the patientsensors to the devicethrough the sensor cables.In the recorder the data arestored in flash memory inboth attended andunattended studies. Duringattended studies, the data isalso transmitted to acomputer in real-time via aUSB bridge. Afterunattended studies, datacan be downloaded fromthe recorder using theUSB bridge.	Physiological signals aresent from the patientsensors to the devicethrough the sensor cables.In the recorder the data arestored in flash memory inboth attended andunattended studies. Duringattended studies, the datais also transmitted to acomputer wireless(Bluetooth) interface.After unattended studies,data can be downloadedfrom the recorder usingthe Bluetooth connection	Physiological signals are sentfrom the patient sensors to theyoke through the sensorcables.The yoke sends the data to therecorder where the data isstored in flash memory in bothattended and unattendedstudies. During attendedstudies, the data is alsotransmitted to a computer inreal-time via a Ethernet LANconnection. After unattendedstudies, data can bedownloaded from the recorderusing the LAN connection	Physiological signals aresent from the patientsensors to the yokethrough the sensorcables.The yoke sends the datato the recorder where thedata is stored in flashmemory in both attendedand unattended studies.During attended studies,the data is alsotransmitted to acomputer in real-timevia a USB cable. Afterunattended studies, datacan be downloaded fromthe recorder using aUSB cable.
Operator Interface	LCD Display	LCD Display	LCD Display	LCD Display
Microprocessor	TMS320UC5409	Unknown	Unknown	TMS320UC5402
Product Characteristic	BEmicro (Trea)Submission device	Track-it(Predicate Device)	Netlink Traveler(Predicate Device)	Sandman Pocket(Predicate device)
A/D Resolution	16 bit	16 bits	18 bit	16 bit
Data Storing	On internal NAND flashchip	PCMCIA type II Compactflash card	Compact flash memory	On internal NAND flashchip
Data compression	No	No	Yes	No
Configuration	Wearable	Wearable	Wearable	Wearable
Sensors	Commercially availablesensors only	Commercially availablesensors only	Commercially availablesensors only	Commercially availablesensors only
Maximum number ofchannels	21	36	36	22
Derived channel	Pulse Transit Time (PTT)- A calculation of the timebetween the occurrence ofthe R-wave on the EKGand 50% ascending slopeon the plethysmogram.Heart rate - Derived fromthe ECG channel	Heart rate - Derived fromthe ECG channel	Heart rate - Derived from theECG channel	Pulse Transit Time(PTT) - A calculation ofthe time between theoccurrence of the R-wave on the EKG and50% ascending slope onthe plethysmogram.Heart rate - Derivedfrom the ECG channel
Oximetry (option)	Yes	Yes	Yes	Yes
Sampling rate	Up to 2048 samples/s	1-256 sample/s selectable	256, 512 samples/s	up to 2048 samples/s
Product Characteristic	BEmicro (Trea)Submission device	Track-it(Predicate Device)	Netlink Traveler(Predicate Device)	Sandman Pocket(Predicate device)
Passbands	0.5 – 128 Hz	0.16 – 70 Hz	0.1 – 100 Hz	0.1 – 256Hz0.1 – 64 HzDC – 10 Hz(depending on channel type)
CMRR	>100 dB	>100 dB	>100 dB	>100 dB
Impedance check	Yes	Yes	Yes	Yes
Safety	Device complies with theInternational StandardIEC 60601-1IEC 60601-1-4IEC 60601-1-26CSA C22.2 No 601.1-M90UL STD No 60601-1	Unknown	Device complies with theInternational StandardIEC 601-1UL 2601UL 60601CSA C22.2 No 601-1	Device complies withthe InternationalStandardIEC 60601-1IEC 60601-1-4IEC 60601-1-26CSA C22.2 No 601-1-M90UL 2601

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Product Characteristic	BEmicro (Trea)Submission device	Track-it(Predicate Device)	Netlink Traveler(Predicate Device)	Sandman Pocket(Predicate device)
ElectromagneticCompatibility (EMC)	Device complies with theInternational StandardIEC 60601-1-2, includingthe following standards:IEC 61000-3-2IEC 61000-3-3IEC 61000-4-2IEC 61000-4-3,IEC 61000-4-4,IEC 61000-4-5,IEC 61000-4-6,IEC 61000-4-8IEC 61000-4-11EN55011 class BEN55014-1	Unknown	Unknown	Device complies withthe InternationalStandardIEC 60601-1-2,including the followingstandards:IEC 61000-3-2IEC 61000-3-3IEC 61000-4-2IEC 61000-4-3,IEC 61000-4-4,IEC 61000-4-5,IEC 61000-4-6,IEC 61000-4-8IEC 61000-4-11EN55011 class BEN55014-1

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Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

EB Neuro S.P.A. c/o Ms. Jamie L. Austin, RAC The Anson Group. LLC 11460 North Meridian Street, Suite 150 Carmel, IN 46032

Re: K093728

APR 2 9 2010

Trade/Device Name: BE Micro Trea Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLV, GWQ, GWL, MNR, and DQA Dated: March 22, 2010 Received: March 24, 2010

Dear Ms. Austin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Jamie L. Austin, RAC

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including; but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

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

Sincerely yours,

Runk Thumpton

Malvina B. Eydelman Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K o93728

Device Name:______________ (Trea -__OEM version )

Indications For Use:

The BE micro/Trea is only to be used under the direction or supervision of a physician, or other trained health care professional.

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 CDRH, Office of Device Evaluation (ODE)

KRISTEN BOWSHER

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number_K093728

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).