Trackit T4 EEG Amplifier

{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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k)Summary | SPONSOR | | |----------------------|------------------------------------------------------------------------| | Company Name:<br>Lif | Lifelines, Ltd. | | Company Address | 7 Clarendon Court<br>Over Wallop, Hampshire<br>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 | | | |------------------------------------|-------------------|-----------------| | <b>Company</b> | <b>Product</b> | <b>510(k) #</b> | | 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:<br>Lifelines T4 EEG Amplifier | Predicate device:<br>Lifelines R-40 EEG Amplifier | Similarities and<br>Differences | |----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | GWL and GWQ | GWL and GWQ | Same | | 510(k) no. | New device | K151600 | | | Indications for<br>Use | The T4 EEG Amplifier is<br>intended to be used as a<br>front-end amplifier to<br>acquire, store and transmit<br>electrophysiological signals<br>(wireless or cabled). | The R-40 EEG Amplifier is<br>intended to be used as a<br>front-end amplifier to<br>acquire, store and transmit<br>electrophysiological signals<br>(wireless or cabled). | Same | | Description of<br>device | The T4 EEG Amplifier is a<br>stand-alone 32 channel (24<br>EEG + 8 poly) EEG amplifier<br>with built-in calibration and<br>electrode impedance<br>measurement. It is<br>expandable to 68 channels<br>with an internal expansion<br>board.<br><br>The device can be powered<br>from an external battery<br>pack for ambulatory usage.<br>No intervention is required<br>by the patient. | The R-40 EEG Amplifier is a<br>stand-alone 40 channel (32<br>EEG + 8 poly) EEG amplifier<br>with built-in calibration and<br>electrode impedance<br>measurement. | New device has 32<br>channels instead of 40.<br>Expandable to 68note 5.<br>Added ambulatory usage<br>with external battery<br>packnote 3. | | | A Nonin XPOD interface is<br>provided for pulse oximetry.<br>A USB connection is used to<br>communicate with the host<br>computer with the option of<br>wireless (Bluetooth and<br>WiFi). | A Nonin XPOD interface is<br>provided for pulse oximetry.<br>A USB connection is used to<br>communicate with the host<br>computer with the option of<br>wireless (Bluetooth and<br>WiFi). | ) Same<br>)<br>)<br>)<br>)<br>)<br>) | | | There are no physiological<br>alarms. | There are no physiological<br>alarms. | ) | | | New device:<br>Lifelines T4 EEG Amplifier | Predicate device:<br>Lifelines R-40 EEG Amplifier | Similarities and<br>Differences | | Clinical<br>Application<br>Environment | For use in research<br>institutions, clinic, hospital,<br>operating room and epilepsy<br>evaluation environments.<br>Home use. | For use in research<br>institutions, clinic, hospital,<br>operating room and epilepsy<br>evaluation environments. | ) Same<br>)<br>)<br>)<br>Addition of home usenote 8 | | Intended User | A healthcare professional<br>who has the training and<br>knowledge to undertake EEG<br>examinations and is familiar<br>with EEG equipment and<br>practice. | A healthcare professional<br>who has the training and<br>knowledge to undertake EEG<br>examinations and is familiar<br>with EEG equipment and<br>practice. | Same | | Channels | 24 EEG + 8 bipolar + SpO2 +<br>patient event button.<br>(64 EEG + 4 bipolar with<br>internal expansion board). | 32 EEG + 8 bipolar + SpO2 +<br>patient event button. | Reduced number of<br>channels in order to<br>reduce the size of the<br>device. Optional expansion<br>availablenote 5. | | ADC<br>resolution | 24 bits | 24 bits | Same | | Full-scale<br>input | ± 375 mV | ± 375 mV | Same | | Sampling rate | 250 - 16000 Hz | 250 - 16000 Hz | Same | | Input noise | < 1.5 µV pk-pk | < 1.5 µV pk-pk | Same | | Bandwidth<br>(-3dB) | DC to 4193 Hz max. | DC to 4193 Hz max. | Same | | Calibration | 8000 µV at 1 sec period | 8000 µV at 1 sec period | Same | | Impedance<br>pass/fail<br>levels | 2, 5, 10, 20, 50 kΩ limits<br>adjustable on host computer<br>during setup. | 2, 5, 10, 20, 50 kΩ limits<br>adjustable on front panel. | Facility removed from front<br>panel to reduce the size of<br>the devicenote 7. | | SaO2 input | Yes | Yes | Same | | E-Cap<br>connector | No | Yes | E-Cap connector has been<br>removed to reduce the size<br>of the devicenote 6. | | Front panel<br>display | Displays battery capacity,<br>elapsed recording time,<br>wireless connection status. | No | Added display shows<br>device status during<br>ambulatory usagenote 4. | | Host PC<br>communicat-<br>ion | Wired (USB) or Wireless<br>(802.11b/g) or Bluetooth | Wired (USB) or Wireless<br>(802.11b/g) or Bluetooth | Same | | Power | USB (isolated from patient)<br>or external battery pack | USB (isolated from patient)<br>or battery | New device can be<br>powered from external<br>battery pack for<br>ambulatory usagenote 3. | | Internal<br>storage | micro-SD flash card | micro-SD flash card | Same | | | New device:<br>Lifelines T4 EEG Amplifier | Predicate device:<br>Lifelines R-40 EEG Amplifier | Similarities and<br>Differences | | Internal<br>battery | Li-ion rechargeable | Li-ion rechargeable | Same | | Patient event<br>button input | Yes | Yes | Same | | System<br>components | Amplifier, laptop PC, medical<br>grade power supply, Nonin<br>oximeter, patient event<br>button.<br>Bag and straps. | Amplifier, laptop PC, medical<br>grade power supply, Nonin<br>oximeter, patient event<br>button. | ) Same<br>)<br>)<br>Bag for ambulatory<br>usagenote 8. | | Material | ABS | ABS | Same | | Patient<br>contact | Device does not directly<br>contact the patient.<br>EEG electrodes (not<br>supplied) are patient-<br>applied. | Device does not directly<br>contact the patient.<br>EEG electrodes (not<br>supplied) are patient-<br>applied. | Same | | Size | 9 x 17 x 3 cm | 11 x 17 x 4 cm | New device is smallernote 1 | | Weight | 270 gm | 400 gm | New device is lighternote 1 | | Compliance/<br>regulatory | IEC 60601-1 + ANSI + CAN<br>IEC 60601-2-26<br>IEC 60601-1-2<br>CE Mark<br>IEC 60601-1-11 | IEC 60601-1 + ANSI + CAN<br>IEC 60601-2-26<br>IEC 60601-1-2<br>CE Mark | ) Same<br>)<br>)<br>Addition of IEC 60601-1-11<br>Home Usenote 8 | {5}------------------------------------------------ {6}------------------------------------------------ #### Similarities and Differences The technological characteristics are substantially similar; the new device has evolved from the R-40 with the intention of making it suitable for ambulatory and home use. It is based on existing, well established technologies and is intended for use in the established field of EEG. The differences between the new device and the predicate device are: - 1. The new device uses the same internal electronics as the R-40 but its case has been reduced in size to make it more suitable for ambulatory use. - 2. The Indications for Use for the new device are the same as the R-40. - 3. The new device can be powered from an external power pack for ambulatory use. - 4. The new device incorporates a small alpha-numeric display which shows battery capacity, elapsed recording time and wireless connection status during ambulatory use. - 5. The channel count has been reduced from 40 to 32 in order to reduce the size of the device to optimize it for ambulatory use. The channel count can optionally be increased to 68 with an internal expansion board, for more complex clinical examinations. - 6. The Electro-cap connector has been removed in order to reduce the size of the device to optimize it for ambulatory use. - 7. The front-panel impedance limit feature has been removed. Impedance limits can be adjusted on the host computer during set-up. - 8. The new device is suitable for ambulatory and home use. {7}------------------------------------------------ These differences raise no new questions concerning safety or effectiveness. The Lifelines T4 EEG Amplifier is substantially equivalent to the predicate device. #### Pre-clinical Performance Testing The table below provides details of the bench testing performed on the T4 EEG Amplifier. Comparison is provided with the predicate device (R-40 Amp) in order to establish substantial equivalence. | | | Test specification | | | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|-------------------------------|-------------------------------------------------------------| | Test | Test Method | T4<br>subject<br>device ¹ | R-40<br>predicate<br>device ² | Conclusion | | Insulation<br>resistance | Using an insulation tester measure the resistance<br>between the TF1 'Aux. B' socket and the metalwork<br>of the USB plug. Ensure that it is > $200 ΜΩ$ . | 3.1 | 3.1 | Same test<br>as<br>predicate | | Dielectric<br>strength | Connect a breakdown tester. Increase the voltage<br>slowly over 10s to 1500Vrms and hold it for 1<br>minute. Ensure that there are no signs of flash-over<br>or breakdown. | 3.2 | 3.2 | Same test<br>as<br>predicate | | Mains on<br>Applied Parts | Measure the Mains on Applied Parts leakage<br>current. Ensure that it is ≤ 5000uA AC. | 3.6 | 3.6 | Same test<br>as<br>predicate | | Patient<br>leakage | Measure the Patient leakage current. Ensure that it<br>is ≤100uA AC and ≤10uA DC. | 3.8 | 3.8 | Same test<br>as<br>predicate | | Calibration | Check for 8mVpp ±0.4 square wave signals on all<br>channels at 1Hz frequency. | 4.4 | 4.4 | Same test<br>as<br>predicate | | Short circuit<br>noise | Check that the short circuit noise for all channels is <<br>1.5uVpp. | 4.8 | 4.7 | Same test<br>as<br>predicate | | HF response | Check HF response to 80 Hz. | 4.10 | 4.9 | Same test<br>as<br>predicate | | DC response | Check for a +300mV step and a -300mV step. | 4.11 | 4.10 | Same test<br>as<br>predicate | | Impedance<br>check | Check all channels indicate an impedance of $3000Ω$<br>±500. | 4.16 | 4.15 | Predicate<br>has front-<br>panel LEDs.<br>Otherwise<br>same | 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.