Who is the manufacturer of BE MICRO, TREA?

Eb Neuro S.P.A. filed the 510(k) submission for BE MICRO, TREA (K093728).

What is the FDA product code for BE MICRO, TREA?

OLV. It is classified under 21 CFR 882.1400 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for BE MICRO, TREA?

510(k) clearance (submission type: Traditional).

What are the predicate devices for BE MICRO, TREA?

Track-it (K010460); Netlink Traveler (K052066); Sandman Pocket (K061996).

Who can help prepare an FDA 510(k) submission like BE MICRO, TREA?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BE MICRO, TREA

K093728 · Eb Neuro S.P.A. · OLV · Apr 29, 2010 · Neurology

Device Facts

Record ID	K093728
Device Name	BE MICRO, TREA
Applicant	Eb Neuro S.P.A.
Product Code	OLV · Neurology
Decision Date	Apr 29, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1400
Device Class	Class 2
Attributes	Pediatric

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 Story

BE micro/Trea is a portable, multi-channel recording system for EEG and PSG studies. It captures and digitally amplifies physiological signals from patient sensors; data is stored on internal NAND flash memory or transmitted to a PC via USB. Designed for wearable use, allowing patient mobility during attended or unattended recordings. Clinicians use the system to collect data for neurological and sleep disorder diagnosis. Output includes raw physiological waveforms and derived metrics like Heart Rate and Pulse Transit Time (PTT). The device is operated by clinicians or patients (under supervision) in hospital or home environments. Healthcare providers review the recorded data to assist in clinical decision-making and diagnosis.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was verified through software validation and verification (V&V) testing and electrical safety/electromagnetic compatibility testing per IEC 60601-1 and IEC 60601-1-2 standards. Results confirmed the device functions as intended.

Technological Characteristics

Portable, wearable multi-channel recorder. Battery or USB powered. 16-bit A/D resolution. Sampling rate up to 2048 samples/s. Internal NAND flash memory storage. Connectivity via USB bridge. Includes impedance check. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-26, CSA C22.2 No 601.1-M90, and UL 60601-1.

Indications for Use

Indicated for pediatric to adult patients requiring collection and recording of physiological data for neurology (EEG), polysomnography (PSG), and sleep disorder studies. Use restricted to physician or trained healthcare professional supervision in home or hospital settings.

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

Track-it (K010460)
Netlink Traveler (K052066)
Sandman Pocket (K061996)

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K162595 — Trex_HD · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Nov 4, 2016
K172271 — Trackit T4 EEG Amplifier · Lifelines , Ltd. · May 4, 2018

Submission Summary (Full Text)

{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 | . . ، {4}------------------------------------------------ : ﺗ · : . {5}------------------------------------------------ . : {6}------------------------------------------------ : 、・ : . . {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 | . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {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)…