(280 days)
No
The description focuses on the hardware (amplifier, channels, inputs, communication) and basic data acquisition/storage. There is no mention of AI, ML, or any advanced analytical processing of the EEG signals within the device itself. The data review and analysis are performed by a clinician using separate software on a PC.
No
The device is described as an amplifier to 'acquire, store and transmit electrophysiological signals' and an 'adjunct device in patient assessment' used for diagnosis, not for treating conditions.
Yes
The device description explicitly states, "This equipment is intended only as an adjunct device in patient assessment; it must be used in conjunction with other methods of patient diagnosis." This indicates its role in assisting with diagnosis.
No
The device description explicitly details hardware components such as an amplifier, memory card, USB port, battery power, and optional wireless communication modules (Bluetooth and WLAN WiFi). It also mentions physical connections like touchproof inputs and interfaces for a pulse oximeter and patient event input.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "acquire, store and transmit electrophysiological signals (wireless or cabled)." This describes a device that measures electrical activity within the body (specifically the brain, as it's an EEG amplifier).
- Device Description: The description reinforces this by stating it's a "multi-channel electroencephalograph designed for use in routine EEG and lab monitoring applications." It measures electrical signals from electrodes placed on the patient.
- Lack of In Vitro Activity: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device directly interacts with the patient's body to acquire signals in vivo.
Therefore, based on the provided information, the Trackit T4 EEG Amplifier is a medical device used for physiological signal acquisition, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Trackit T4 EEG Amplifier is intended to be used as a front-end amplifier to acquire, store and transmit electrophysiological signals (wireless or cabled).
Product codes
GWO, GWL, GWQ
Device Description
The Trackit T4 EEG Amplifier is a multi-channel electroencephalograph designed for use in routine EEG and lab monitoring applications and due to its small size, can be used in ambulatory applications. In this situation, the EEG electrodes are fitted to the patient by a trained clinician prior to the patient being sent home. No subsequent intervention is required by the patient. Upon completion of the recording, the data which is stored on a memory card is reviewed by a clinician using review and analysis software on a PC.
It is a compact USB amplifier which provides 32 channels with internal expansion option) with built-in calibration and electrode impedance measurement. Also provided is a Nonin pulse oximeter interface, a Patient Event input and an Aux DC input. Optional wireless communication is available (Bluetooth and WLAN WiFi).
There are two variants of the Trackit T4 EEG Amplifier:
- Trackit T4-32 providing 24 referential + 8 poly channels. .
- . Trackit T4-68 providing 64 referential + 4 poly channels (using internal expansion board).
Plug-on Patient Connection Units (PCUs) provide 32 channel touchproof inputs (model T4-PCU 24+8) or 68 channels (model T4-PCU 64+4).
The Amplifier is intended to be connected to a USB port on a PC which is powered from a medically approved power supply. In addition it can be battery powered in ambulatory applications. This equipment is intended only as an adjunct device in patient assessment; it must be used in conjunction with other methods of patient diagnosis. The equipment does not sustain or support life.
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
Not Found
Intended User / Care Setting
A healthcare professional who has the training and knowledge to undertake EEG examinations and is familiar with EEG equipment and practice.
For use in research institutions, clinic, hospital, operating room and epilepsy evaluation environments. Home use.
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)
Pre-clinical Performance Testing: Bench testing was performed on the T4 EEG Amplifier. Comparison was made with the predicate device (R-40 Amp) to establish substantial equivalence based on various tests including Insulation resistance, Dielectric strength, Mains on Applied Parts leakage, Patient leakage, Calibration, Short circuit noise, HF response, DC response, and Impedance check. All tests concluded "Same test as predicate" or "Predicate has front-panel LEDs. Otherwise same".
Verification and validation testing confirmed that this device met the design requirements and user needs.
Clinical testing was not performed with this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. The FDA logo is on the right, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 4, 2018
Lifelines Ltd. % Yolanda Smith Consultant Smith Associates 1468 Harwell Ave Crofton, Maryland 21114
Re: K172271
Trade/Device Name: Trackit T4 EEG Amplifier Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWO. GWO. GWL Dated: April 5, 2018 Received: April 10, 2018
Dear Yolanda Smith:
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.
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 of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172271
Device Name Trackit T4 EEG Amplifier
Indications for Use (Describe)
The Trackit T4 EEG Amplifier is intended to be used as a front-end amplifier to acquire, store and transmit electrophysiological signals (wireless or cabled).
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k)Summary
| SPONSOR | |
|---|---|
| Company Name: | |
| Lif | Lifelines, Ltd. |
| Company Address | 7 Clarendon Court |
| Over Wallop, Hampshire | |
| SO20 8HU United Kingdom | |
| Telephone: | +44 (0)1483 224 245 |
| Contact Person: | Michael Hulin |
Summary Preparation Date: July 17, 2017
DEVICE NAME
| Trade Name: | Trackit T4 EEG amplifier: |
|---|---|
| Common/Usual Name: | EEG Amplifier |
| Classification Name: | Electroencephalograph |
| Regulation Number: | 21 CFR 882.1400 |
| Product Code: | GWQ, GWL |
| Device Class: | Class II |
PREDICATE DEVICE
| Legally Marketed Equivalent Device | ||
|---|---|---|
| Company | Product | 510(k) # |
| Lifelines, Ltd. | R40 EEG Amplifier | K151600 |
DEVICE DESCRIPTION
The Trackit T4 EEG Amplifier is a multi-channel electroencephalograph designed for use in routine EEG and lab monitoring applications and due to its small size, can be used in ambulatory applications. In this situation, the EEG electrodes are fitted to the patient by a trained clinician prior to the patient being sent home. No subsequent intervention is required by the patient. Upon completion of the recording, the data which is stored on a memory card is reviewed by a clinician using review and analysis software on a PC.
lt is a compact USB amplifier which provides 32 channels with internal expansion option) with built-in calibration and electrode impedance measurement. Also provided is a Nonin pulse oximeter interface, a Patient Event input and an Aux DC input. Optional wireless communication is available (Bluetooth and WLAN WiFi).
There are two variants of the Trackit T4 EEG Amplifier:
- Trackit T4-32 providing 24 referential + 8 poly channels. .
- . Trackit T4-68 providing 64 referential + 4 poly channels (using internal expansion board).
Plug-on Patient Connection Units (PCUs) provide 32 channel touchproof inputs (model T4-PCU 24+8) or 68 channels (model T4-PCU 64+4).
The Amplifier is intended to be connected to a USB port on a PC which is powered from a medically
4
approved power supply. In addition it can be battery powered in ambulatory applications. This equipment is intended only as an adjunct device in patient assessment; it must be used in conjunction with other methods of patient diagnosis. The equipment does not sustain or support life.
DEVICE INDICATIONS FOR USE
The Trackit T4 EEG Amplifier is intended to be used as a front-end amplifier to acquire, store and transmit electrophysiological signals (wireless or cabled).
COMPARISON OF TECHNICAL CHARACTERISTICS
The following chart compares the new T4 EEG Amplifier with the company's R-40 EEG Amplifier as the predicate device. The new device has evolved from the R-40 with the goal of making it suitable for ambulatory and home use. Differences in characteristics are discussed in the notes in the following section.
| | New device:
Lifelines T4 EEG Amplifier | Predicate device:
Lifelines R-40 EEG Amplifier | Similarities and
Differences |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | GWL and GWQ | GWL and GWQ | Same |
| 510(k) no. | New device | K151600 | |
| Indications for
Use | The T4 EEG Amplifier is
intended to be used as a
front-end amplifier to
acquire, store and transmit
electrophysiological signals
(wireless or cabled). | The R-40 EEG Amplifier is
intended to be used as a
front-end amplifier to
acquire, store and transmit
electrophysiological signals
(wireless or cabled). | Same |
| Description of
device | The T4 EEG Amplifier is a
stand-alone 32 channel (24
EEG + 8 poly) EEG amplifier
with built-in calibration and
electrode impedance
measurement. It is
expandable to 68 channels
with an internal expansion
board.
The device can be powered
from an external battery
pack for ambulatory usage.
No intervention is required
by the patient. | The R-40 EEG Amplifier is a
stand-alone 40 channel (32
EEG + 8 poly) EEG amplifier
with built-in calibration and
electrode impedance
measurement. | New device has 32
channels instead of 40.
Expandable to 68note 5.
Added ambulatory usage
with external battery
packnote 3. |
| | A Nonin XPOD interface is
provided for pulse oximetry.
A USB connection is used to
communicate with the host
computer with the option of
wireless (Bluetooth and
WiFi). | A Nonin XPOD interface is
provided for pulse oximetry.
A USB connection is used to
communicate with the host
computer with the option of
wireless (Bluetooth and
WiFi). | ) Same
)
)
)
)
)
) |
| | There are no physiological
alarms. | There are no physiological
alarms. | ) |
| | New device:
Lifelines T4 EEG Amplifier | Predicate device:
Lifelines R-40 EEG Amplifier | Similarities and
Differences |
| Clinical
Application
Environment | For use in research
institutions, clinic, hospital,
operating room and epilepsy
evaluation environments.
Home use. | For use in research
institutions, clinic, hospital,
operating room and epilepsy
evaluation environments. | ) Same
)
)
)
Addition of home usenote 8 |
| Intended User | A healthcare professional
who has the training and
knowledge to undertake EEG
examinations and is familiar
with EEG equipment and
practice. | A healthcare professional
who has the training and
knowledge to undertake EEG
examinations and is familiar
with EEG equipment and
practice. | Same |
| Channels | 24 EEG + 8 bipolar + SpO2 +
patient event button.
(64 EEG + 4 bipolar with
internal expansion board). | 32 EEG + 8 bipolar + SpO2 +
patient event button. | Reduced number of
channels in order to
reduce the size of the
device. Optional expansion
availablenote 5. |
| ADC
resolution | 24 bits | 24 bits | Same |
| Full-scale
input | ± 375 mV | ± 375 mV | Same |
| Sampling rate | 250 - 16000 Hz | 250 - 16000 Hz | Same |
| Input noise | $200 ΜΩ$ . | 3.1 | 3.1 | Same test
as
predicate |
| Dielectric
strength | Connect a breakdown tester. Increase the voltage
slowly over 10s to 1500Vrms and hold it for 1
minute. Ensure that there are no signs of flash-over
or breakdown. | 3.2 | 3.2 | Same test
as
predicate |
| Mains on
Applied Parts | Measure the Mains on Applied Parts leakage
current. Ensure that it is ≤ 5000uA AC. | 3.6 | 3.6 | Same test
as
predicate |
| Patient
leakage | Measure the Patient leakage current. Ensure that it
is ≤100uA AC and ≤10uA DC. | 3.8 | 3.8 | Same test
as
predicate |
| Calibration | Check for 8mVpp ±0.4 square wave signals on all
channels at 1Hz frequency. | 4.4 | 4.4 | Same test
as
predicate |
| Short circuit
noise | Check that the short circuit noise for all channels is 4 Clause numbers in T4-32 Amp Final Test Specification
² Clause numbers in R-40 Amp Final Test Specification
8
PERFORMANCE DATA
Testing was undertaken by an independent certification body and provided confirmation that the device performance and physical attributes met the requirements of the standards listed below. These standards address safety, EMC compatibility, risk, usability and home use.
Verification and validation testing confirmed that this device met the design requirements and user needs.
Safety Testing
- 12.4.1 IEC 60601-1:2012. Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. Including ANSI/AAMI and CAN/CSA. 12.4.2 IEC 60601-2-26:2012. Medical electrical equipment. Particular requirements for the safety of electroencephalographs. 12.4.3 IEC 60601-1-2:2007. Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromaqnetic compatibility. 12.4.4 IEC 60601-1-6:2010 + A1:2013. Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability. 12.4.5 IEC 62366:2007 + A1:2014. Application of usability engineering to medical devices. 12.4.6 IEC 60601-1-11:2015. Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment & medical electrical systems used in the home healthcare environment. Including ANSI/AAMI and CAN/CSA. 12.4.7 ISO 14971:2007. Application of risk management to medical devices. 12.4.8 IEC 62133:2012. Secondary cells and batteries containing alkaline or other non-acid
- electrolytes Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications.
- 12.4.9 UN/DOT 38.3. Transportation testing for lithium batteries.
Clinical testing was not performed with this device.
CONCLUSION
The Lifelines Trackit T4 EEG Amplifier meets the functional claims and intended use as described in the product labeling. The safety and effectiveness are substantially equivalent to the predicate device.