(280 days)
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).
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.
This document describes the Lifelines Trackit T4 EEG Amplifier, which is substantially equivalent to the predicate device, Lifelines R-40 EEG Amplifier (K151600). The information provided is primarily focused on pre-clinical performance testing and safety, not on a study proving a device meets specific acceptance criteria based on diagnostic accuracy or clinical outcomes.
Here's an analysis of the provided text in the context of your request:
1. Table of acceptance criteria and the reported device performance:
The document primarily shows that the new device (T4) performs similarly to its predicate (R-40) in various technical tests. The "acceptance criteria" are implied by the "Test specification" and the "Conclusion" indicating "Same test as predicate" or noting the specific values the predicate device achieved.
| Test | Test Method | T4 subject device (Reported Performance) | R-40 predicate device | Acceptance Criteria (Implied) |
|---|---|---|---|---|
| Insulation resistance | Measure resistance between TF1 'Aux. B' socket and USB plug metalwork. | > 200 MΩ (3.1) | > 200 MΩ (3.1) | > 200 MΩ |
| Dielectric strength | Increase voltage to 1500Vrms over 10s and hold for 1 min. | No flash-over/breakdown (3.2) | No flash-over/breakdown (3.2) | No signs of flash-over or breakdown |
| Mains on Applied Parts | Measure leakage current. | ≤ 5000uA AC (3.6) | ≤ 5000uA AC (3.6) | ≤ 5000uA AC |
| Patient leakage | Measure leakage current. | ≤ 100uA AC and ≤ 10uA DC (3.8) | ≤ 100uA AC and ≤ 10uA DC (3.8) | ≤ 100uA AC and ≤ 10uA DC |
| Calibration | Check for 8mVpp ±0.4 square wave signals on all channels at 1Hz frequency. | 8mVpp ±0.4 square wave (4.4) | 8mVpp ±0.4 square wave (4.4) | 8mVpp ±0.4 square wave signals on all channels at 1Hz frequency |
| Short circuit noise | Check short circuit noise for all channels. | < 1.5uVpp (4.8) | < 1.5uVpp (4.7) | < 1.5uVpp |
| HF response | Check HF response to 80 Hz. | (4.10) | (4.9) | Response to 80 Hz maintained (implied "Same test as predicate") |
| DC response | Check for a +300mV step and a -300mV step. | (4.11) | (4.10) | +300mV step and -300mV step detected (implied "Same test as predicate") |
| Impedance check | Check all channels indicate an impedance of 3000Ω ±500. | 3000Ω ±500 (4.16) | 3000Ω ±500 (4.15) | 3000Ω ±500 |
2. Sample size used for the test set and the data provenance:
The document describes "pre-clinical performance testing" using the device itself and comparing it to the predicate device. It does not refer to a "test set" of patient data or clinical samples. The tests were performed on the device hardware.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This was hardware performance testing, not a clinical study involving experts establishing ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. As above, this was not a clinical study requiring adjudication of expert opinions.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is an EEG amplifier, not an AI-powered diagnostic tool, and no MRMC study was conducted or mentioned. The document explicitly states: "Clinical testing was not performed with this device."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is an EEG amplifier; it does not operate as a standalone algorithm in the way a diagnostic AI would. The performance described is of the hardware itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance tests was defined by engineering specifications and direct measurements against those specifications, comparing the subject device's performance to that of the predicate device, or standard electrical and safety parameters.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not a machine learning or AI device that requires a training set with established ground truth.
Summary of the Study:
The study described is a series of pre-clinical bench tests (hardware performance tests) conducted to demonstrate that the Lifelines Trackit T4 EEG Amplifier achieved similar technical performance and safety characteristics to its predicate device, the Lifelines R-40 EEG Amplifier. The "acceptance criteria" were based on the predicate device's established performance and relevant international safety and performance standards (e.g., IEC 60601-1, IEC 60601-2-26, IEC 60601-1-2, etc.).
The document concludes that the T4 EEG Amplifier "meets the functional claims and intended use as described in the product labeling" and that its "safety and effectiveness are substantially equivalent to the predicate device." This determination of substantial equivalence relies on technical data rather than clinical performance data with patient populations.
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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
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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
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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 CourtOver Wallop, HampshireSO20 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
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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 andDifferences | |
|---|---|---|---|
| Product Code | GWL and GWQ | GWL and GWQ | Same |
| 510(k) no. | New device | K151600 | |
| Indications forUse | The T4 EEG Amplifier isintended to be used as afront-end amplifier toacquire, store and transmitelectrophysiological signals(wireless or cabled). | The R-40 EEG Amplifier isintended to be used as afront-end amplifier toacquire, store and transmitelectrophysiological signals(wireless or cabled). | Same |
| Description ofdevice | The T4 EEG Amplifier is astand-alone 32 channel (24EEG + 8 poly) EEG amplifierwith built-in calibration andelectrode impedancemeasurement. It isexpandable to 68 channelswith an internal expansionboard.The device can be poweredfrom an external batterypack for ambulatory usage.No intervention is requiredby the patient. | The R-40 EEG Amplifier is astand-alone 40 channel (32EEG + 8 poly) EEG amplifierwith built-in calibration andelectrode impedancemeasurement. | New device has 32channels instead of 40.Expandable to 68note 5.Added ambulatory usagewith external batterypacknote 3. |
| A Nonin XPOD interface isprovided for pulse oximetry.A USB connection is used tocommunicate with the hostcomputer with the option ofwireless (Bluetooth andWiFi). | A Nonin XPOD interface isprovided for pulse oximetry.A USB connection is used tocommunicate with the hostcomputer with the option ofwireless (Bluetooth andWiFi). | ) Same)))))) | |
| There are no physiologicalalarms. | There are no physiologicalalarms. | ) | |
| New device:Lifelines T4 EEG Amplifier | Predicate device:Lifelines R-40 EEG Amplifier | Similarities andDifferences | |
| ClinicalApplicationEnvironment | For use in researchinstitutions, clinic, hospital,operating room and epilepsyevaluation environments.Home use. | For use in researchinstitutions, clinic, hospital,operating room and epilepsyevaluation environments. | ) Same)))Addition of home usenote 8 |
| Intended User | A healthcare professionalwho has the training andknowledge to undertake EEGexaminations and is familiarwith EEG equipment andpractice. | A healthcare professionalwho has the training andknowledge to undertake EEGexaminations and is familiarwith EEG equipment andpractice. | Same |
| Channels | 24 EEG + 8 bipolar + SpO2 +patient event button.(64 EEG + 4 bipolar withinternal expansion board). | 32 EEG + 8 bipolar + SpO2 +patient event button. | Reduced number ofchannels in order toreduce the size of thedevice. Optional expansionavailablenote 5. |
| ADCresolution | 24 bits | 24 bits | Same |
| Full-scaleinput | ± 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(-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 |
| Impedancepass/faillevels | 2, 5, 10, 20, 50 kΩ limitsadjustable on host computerduring setup. | 2, 5, 10, 20, 50 kΩ limitsadjustable on front panel. | Facility removed from frontpanel to reduce the size ofthe devicenote 7. |
| SaO2 input | Yes | Yes | Same |
| E-Capconnector | No | Yes | E-Cap connector has beenremoved to reduce the sizeof the devicenote 6. |
| Front paneldisplay | Displays battery capacity,elapsed recording time,wireless connection status. | No | Added display showsdevice status duringambulatory usagenote 4. |
| Host PCcommunicat-ion | Wired (USB) or Wireless(802.11b/g) or Bluetooth | Wired (USB) or Wireless(802.11b/g) or Bluetooth | Same |
| Power | USB (isolated from patient)or external battery pack | USB (isolated from patient)or battery | New device can bepowered from externalbattery pack forambulatory usagenote 3. |
| Internalstorage | micro-SD flash card | micro-SD flash card | Same |
| New device:Lifelines T4 EEG Amplifier | Predicate device:Lifelines R-40 EEG Amplifier | Similarities andDifferences | |
| Internalbattery | Li-ion rechargeable | Li-ion rechargeable | Same |
| Patient eventbutton input | Yes | Yes | Same |
| Systemcomponents | Amplifier, laptop PC, medicalgrade power supply, Noninoximeter, patient eventbutton.Bag and straps. | Amplifier, laptop PC, medicalgrade power supply, Noninoximeter, patient eventbutton. | ) Same))Bag for ambulatoryusagenote 8. |
| Material | ABS | ABS | Same |
| Patientcontact | Device does not directlycontact the patient.EEG electrodes (notsupplied) are patient-applied. | Device does not directlycontact the patient.EEG electrodes (notsupplied) are patient-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/regulatory | IEC 60601-1 + ANSI + CANIEC 60601-2-26IEC 60601-1-2CE MarkIEC 60601-1-11 | IEC 60601-1 + ANSI + CANIEC 60601-2-26IEC 60601-1-2CE Mark | ) Same))Addition of IEC 60601-1-11Home Usenote 8 |
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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:
-
- 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.
-
- The Indications for Use for the new device are the same as the R-40.
-
- The new device can be powered from an external power pack for ambulatory use.
-
- The new device incorporates a small alpha-numeric display which shows battery capacity, elapsed recording time and wireless connection status during ambulatory use.
-
- 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.
-
- The Electro-cap connector has been removed in order to reduce the size of the device to optimize it for ambulatory use.
-
- The front-panel impedance limit feature has been removed. Impedance limits can be adjusted on the host computer during set-up.
-
- The new device is suitable for ambulatory and home use.
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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 | T4subjectdevice ¹ | R-40predicatedevice ² | Conclusion |
| Insulationresistance | Using an insulation tester measure the resistancebetween the TF1 'Aux. B' socket and the metalworkof the USB plug. Ensure that it is > $200 ΜΩ$ . | 3.1 | 3.1 | Same testaspredicate |
| Dielectricstrength | Connect a breakdown tester. Increase the voltageslowly over 10s to 1500Vrms and hold it for 1minute. Ensure that there are no signs of flash-overor breakdown. | 3.2 | 3.2 | Same testaspredicate |
| Mains onApplied Parts | Measure the Mains on Applied Parts leakagecurrent. Ensure that it is ≤ 5000uA AC. | 3.6 | 3.6 | Same testaspredicate |
| Patientleakage | Measure the Patient leakage current. Ensure that itis ≤100uA AC and ≤10uA DC. | 3.8 | 3.8 | Same testaspredicate |
| Calibration | Check for 8mVpp ±0.4 square wave signals on allchannels at 1Hz frequency. | 4.4 | 4.4 | Same testaspredicate |
| Short circuitnoise | Check that the short circuit noise for all channels is <1.5uVpp. | 4.8 | 4.7 | Same testaspredicate |
| HF response | Check HF response to 80 Hz. | 4.10 | 4.9 | Same testaspredicate |
| DC response | Check for a +300mV step and a -300mV step. | 4.11 | 4.10 | Same testaspredicate |
| Impedancecheck | Check all channels indicate an impedance of $3000Ω$±500. | 4.16 | 4.15 | Predicatehas front-panel LEDs.Otherwisesame |
4 Clause numbers in T4-32 Amp Final Test Specification
² Clause numbers in R-40 Amp Final Test Specification
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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.
§ 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).