LogoFDA 510(k) Search
K Number
K093728
Device Name
BE MICRO, TREA
Manufacturer
EB NEURO, S.P.A.
Date Cleared
2010-04-29

(147 days)

Product Code
OLVDQAGWLGWQMNR
Regulation Number
882.1400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

K010460, K052066, K061996

Not Found

No
The summary describes a device for collecting and recording physiological data (EEG/PSG) and does not mention any AI or ML capabilities for analysis or interpretation.

No
The device is used for collecting and recording physiological data for diagnostic purposes, not for treating conditions.

Yes
The device description states that it is "intended for use in collecting and recording physiological data to be used in diagnosis in EEG (electroencephalography) and PSG (sleep disorder studies) clinical investigation."

No

The device description explicitly states it 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". This indicates the presence of hardware components beyond just software.

Based on the provided information, the BE micro/Trea device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
  • BE micro/Trea Function: The BE micro/Trea collects and records physiological data directly from the patient's body (EEG and PSG signals). It does not analyze specimens taken from the body.
  • Intended Use: The intended use clearly states it's for collecting and recording physiological data for use in neurology and sleep disorder studies. This is a direct measurement of bodily functions, not an analysis of a sample.

Therefore, the BE micro/Trea falls under the category of a medical device that measures physiological signals, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

OLV, GWQ, GWL, MNR, DQA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Pediatric to adult population

Intended User / Care Setting

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

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K010460, K052066, K061996

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).

0

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

1

807.92 (a)(4)

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.

807.92(a)(5)

Intended Use(s)

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.

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).

2

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).

3

| 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 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 lifelines Track it
Recorder is a 36 channel
ambulatory
electroencephalograph
that is designed for use in
a variety of monitoring
application to record
physiological data for
EGG and Sleep studies | The Bio-logic Netlink Traveler is
indicated for use in the recording and
analysis of EEG tests. Typical routine
EEG tests are 20-30 minutes in
duration, but the Netlink Traveler can
also be used for longer tests, including
continuous long-term EEG monitoring
with patient video. Similarly,
the Netlink Traveler is indicated for use
in the recording and analysis of human
physiological data necessary for the
diagnosis of Sleep-related disorders. It
is intended to record and present this
data in a form that can improve the
speed of diagnosis and assist in
potential treatment decisions. In
general, EEG and Sleep testing is
indicated for use whenever it is
necessary to measure and record a
patient's electrophysiological activity,
including the electrical activity of the
brain, by attaching multiple electrodes
at various locations on the body. | Intended for use in
collecting and recording
physiological data to be
used in
polysomnography and
sleep disorder studies.
For use in either home
or hospital environments
with a pediatric through
adult patient population. |
| Target population | Pediatric through adult | Patients of all ages, from
children to adults. | Patients of all ages, from
children to adults, including
geriatric patients. | Pediatric through adult
(including all pediatric
subpopulations) |
| 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 order
of a physician. | Available only on the order
of a physician. | Available only on the order of a
physician. | Available only on the
order of a physician. |
| Power | Battery powered or USB
powered | Battery powered | Battery Powered | Battery powered or USB
powered |
| Communication
Interfaces | Physiological signals are
sent from the patient
sensors to the device
through the sensor cables.
In the recorder the data are
stored in flash memory in
both attended and
unattended studies. During
attended studies, the data is
also transmitted to a
computer in real-time via a
USB bridge. After
unattended studies, data
can be downloaded from
the recorder using the
USB bridge. | Physiological signals are
sent from the patient
sensors to the device
through the sensor cables.
In the recorder the data are
stored in flash memory in
both attended and
unattended studies. During
attended studies, the data
is also transmitted to a
computer wireless
(Bluetooth) interface.
After unattended studies,
data can be downloaded
from the recorder using
the Bluetooth connection | Physiological signals are sent
from the patient sensors to the
yoke through the sensor
cables.
The yoke sends the data to the
recorder where the data is
stored in flash memory in both
attended and unattended
studies. During attended
studies, the data is also
transmitted to a computer in
real-time via a Ethernet LAN
connection. After unattended
studies, data can be
downloaded from the recorder
using the LAN connection | Physiological signals are
sent from the patient
sensors to the yoke
through the sensor
cables.
The yoke sends the data
to the recorder where the
data is stored in flash
memory in both attended
and unattended studies.
During attended studies,
the data is also
transmitted to a
computer in real-time
via a USB cable. After
unattended studies, data
can be downloaded from
the recorder using a
USB 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 flash
chip | PCMCIA type II Compact
flash card | Compact flash memory | On internal NAND flash
chip |
| Data compression | No | No | Yes | No |
| Configuration | Wearable | Wearable | Wearable | Wearable |
| Sensors | Commercially available
sensors only | Commercially available
sensors only | Commercially available
sensors only | Commercially available
sensors only |
| Maximum number of
channels | 21 | 36 | 36 | 22 |
| Derived channel | Pulse Transit Time (PTT)

  • A calculation of the time
    between the occurrence of
    the R-wave on the EKG
    and 50% ascending slope
    on the plethysmogram.
    Heart rate - Derived from
    the ECG channel | Heart rate - Derived from
    the ECG channel | Heart rate - Derived from the
    ECG channel | Pulse Transit Time
    (PTT) - A calculation of
    the time between the
    occurrence of the R-
    wave on the EKG and
    50% ascending slope on
    the plethysmogram.
    Heart rate - Derived
    from 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 – 256Hz
    0.1 – 64 Hz
    DC – 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 the
    International Standard
    IEC 60601-1
    IEC 60601-1-4
    IEC 60601-1-26
    CSA C22.2 No 601.1-M90
    UL STD No 60601-1 | Unknown | Device complies with the
    International Standard
    IEC 601-1
    UL 2601
    UL 60601
    CSA C22.2 No 601-1 | Device complies with
    the International
    Standard
    IEC 60601-1
    IEC 60601-1-4
    IEC 60601-1-26
    CSA C22.2 No 601-1-
    M90
    UL 2601 |

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7

| Product Characteristic | BEmicro (Trea)
Submission device | Track-it
(Predicate Device) | Netlink Traveler
(Predicate Device) | Sandman Pocket
(Predicate device) |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electromagnetic
Compatibility (EMC) | Device complies with the
International Standard
IEC 60601-1-2, including
the following standards:
IEC 61000-3-2
IEC 61000-3-3
IEC 61000-4-2
IEC 61000-4-3,
IEC 61000-4-4,
IEC 61000-4-5,
IEC 61000-4-6,
IEC 61000-4-8
IEC 61000-4-11
EN55011 class B
EN55014-1 | Unknown | Unknown | Device complies with
the International
Standard
IEC 60601-1-2,
including the following
standards:
IEC 61000-3-2
IEC 61000-3-3
IEC 61000-4-2
IEC 61000-4-3,
IEC 61000-4-4,
IEC 61000-4-5,
IEC 61000-4-6,
IEC 61000-4-8
IEC 61000-4-11
EN55011 class B
EN55014-1 |

.

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8

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.

9

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

10

Indications for Use

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

Device Name:______________ (Trea -__OEM version )

Indications For Use:

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.

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