The Lifelines iEEG is an EEG system that allows acquisition, display, archive, storage and analysis of physiological signals. The intended user of this product is a qualified medical practitioner trained in electroencephalography who will exercise professional judgment in using the information. The Lifelines iEEG system also includes the display of a quantitative EEG plots, power spectrum, which is intended to help the user to monitor and analyze the EEG. This device does not provide any diagnostic conclusion about the patient's condition to the user.

Device Description

Lifelines iEEG is medical device used to acquire, display, archive, store and analyze EEG examinations. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of acquiring and presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The system software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.

The components of Lifelines iEEG are:

Lifelines iEEG software:
- . iEEG Centrum
- . iEEG Review
- iEEG Acquisition .
Lifelines Trackit, Lifelines Ltd, 510(k)#K010460
Lifelines Photic Stimulator, Lifelines Ltd, 510(k)# K101691 ●
Off the shelf PC and medical grade power supply ●
Off the shelf IP Video Camera ●

AI/ML Overview

This 510(k) submission for the Lifelines iEEG 2.0 device primarily focuses on demonstrating substantial equivalence to a predicate device (Natus Medical, Inc., DG Nervus/NicoletOne, K964280) rather than presenting a standalone study with acceptance criteria for clinical performance. The documentation emphasizes software verification and validation, along with conformance to various IEC standards for safety and essential performance.

Therefore, many of the requested sections related to clinical study design, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment are not explicitly addressed in this document. The device is an EEG system for acquisition, display, archive, storage, and analysis of physiological signals, and the submission argues that it is substantially equivalent to existing, legally marketed devices.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria or reported device performance metrics in terms of clinical accuracy (e.g., sensitivity, specificity for diagnostic tasks) are provided in this document. The submission focuses on demonstrating substantial equivalence based on intended use, technological characteristics, and conformance to safety and performance standards.

The document highlights the following characteristics of the Subject Device (Lifelines iEEG):

Feature/Characteristic	Subject Device Performance (Lifelines iEEG)	Predicate Device (DG Nervus/NicoletOne)
Intended Use	Acquisition, display, archive, storage, and analysis of physiological signals. Help user monitor and analyze EEG. Does not provide diagnostic conclusion.	Acquisition, display, store, and archive electroencephalographic signals.
Intended User	Qualified medical practitioner trained in Electroencephalography	Qualified medical practitioner trained in Electroencephalography
Population Age	All age groups	All age groups
Use Environment	Hospital, clinics, patients home	Hospital, clinic, patients home
Regulation Number	21 CFR 882.1400	21 CFR 882.1400
Product Code	GWQ, OLT	GWQ
Device allows acquisition of physiological signals	Yes	Yes
Device allows display, archive, review, and analysis of physiological signals	Yes	Yes
Identifies spikes	No	Yes
Identifies seizures	No	Yes
Displays calculated EEG measures	Yes	Yes
Calculated EEG measures displayed	Spectrum, Power Spectrum Density, band power, spectral edge, peak frequency	Spectrum, Spectrogram, band power, peak frequency, spectral edge
Users can add/delete events	Yes	Yes
Number of EEG channels	Software: up to 128; Hardware: up to 32	Up to 512
Type of EEG recording supported	EDF, NicoletOne, Lifelines iEEG	EDF, NicoletOne
Type of EEG analysis	Clinical, ambulatory, long term monitoring	Clinical, ambulatory, long term monitoring
Photic activation of the EEG	Yes	Yes
Differential input impedance	>20 Mohms	> 20MΩ
Common mode input impedance	>100 Mohms	> 100MΩ
Channel equivalent input noise	<3.5 µV pk-pk @ 0.16Hz to 70Hz	< 1.5µV pk-pk @ 0.16Hz to 70Hz
Frequency band	0.16Hz to 70Hz (–6dB)	0.16–500Hz (–6dB) (± 10%)
Low filter	0 Hz-5 Hz or off, in 11 predefined steps	0.16Hz-5Hz ( ± 10%), in 7 predefined steps or customizable up to 1000Hz or off
High filter	10 Hz–100 Hz or off, in 9 predefined steps	15Hz–100Hz (± 5%), in 7 predefined steps or customizable up to 1000Hz or off
Sampling rate	200, 256 Hz	1024, 512, 256 and 128 Hz
Wireless Communication between Amplifier and Computer	Yes	No
Video Camera Support	Yes	No

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission details non-clinical performance data, primarily software verification and validation, and conformance to electrical safety and EMC standards. There is no mention of a test set derived from patient data for evaluating clinical performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as there is no described clinical test set or ground truth establishment based on expert consensus for clinical performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as there is no described clinical test set or adjudication process for clinical performance.

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

No MRMC comparative effectiveness study was done regarding the Lifelines iEEG device improving human reader performance. The device is an EEG system for acquisition and analysis, not an AI-assisted diagnostic tool that interprets EEG data for the user. Its quantitative EEG plots (power spectrum) are intended to help the user monitor and analyze the EEG, but it explicitly states: "This device does not provide any diagnostic conclusion about the patient's condition to the user."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No standalone performance study (in a diagnostic sense) was conducted or reported. The device's primary function is to acquire, display, and provide tools for analysis to a human expert, not to perform independent diagnostic interpretations. The document states it "does not provide any diagnostic conclusion." The non-clinical performance data focuses on the technical aspects of the software and hardware components.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for clinical performance evaluation as described in this document. The "ground truth" in the context of the reported non-clinical performance data would be the expected behavior of the software and hardware according to its design specifications and relevant international standards.

8. The sample size for the training set

This information is not provided. The device is an EEG acquisition and analysis system, not a machine learning model that would typically have a distinct "training set" of clinical data for learning diagnostic patterns.

9. How the ground truth for the training set was established

This information is not provided as there is no described training set for a machine learning model with established ground truth.

Summary of Device and Performance Context:

The Lifelines iEEG 2.0 is an electroencephalograph (EEG) system intended for qualified medical practitioners trained in electroencephalography. It allows for the acquisition, display, archive, storage, and analysis of physiological signals, including quantitative EEG plots (power spectrum).

The submission argues for substantial equivalence to the predicate device (DG Nervus/NicoletOne) by detailing similarities in intended use, users, population, use environment, regulation, and core principles of operation (signal processing, montage, filtering, data plotting).

The main differences noted are:

Lifelines iEEG does not offer automated spike and seizure detection, which the predicate device does. The applicant argues these are "nice-to-have features that are not essential to an EEG system."
Lifelines iEEG supports fewer EEG channels (up to 128 software, 32 hardware) compared to the predicate (up to 512).
Lifelines iEEG includes the OLT product code for quantitative EEG, and supports its own proprietary (.ieeg) recording type.
Lifelines iEEG includes wireless communication and video camera support as added features not present in the predicate.
Minor differences in channel equivalent input noise, frequency band, filter ranges, and sampling rates between the subject and predicate device.

The "study" described is primarily a non-clinical performance evaluation consisting of:

Software Verification and Validation
Immunity Verification
Third-party testing for conformance with IEC 60601-1:2005 (basic safety and essential performance)
Third-party testing for conformance with IEC 60601-1-2:2007 (electromagnetic compatibility)
Checklist testing for IEC 62304:2006 (Medical Device Software Life Cycle Processes)
Checklist testing for IEC 62366:2007 (Usability Engineering)
Third-party testing for conformance with IEC 60601-2-26:2002 (Particular requirements for the safety of electroencephalographs)

The absence of clinical performance data and acceptance criteria for diagnostic accuracy is consistent with the device's stated indications for use, which explicitly state it "does not provide any diagnostic conclusion about the patient's condition to the user." Its primary role is as a tool to aid qualified practitioners in their analysis.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three faces in profile, representing the department's focus on health and human well-being. The logo is simple, using only black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Auqust 21, 2015

Kvikna ehf c/o Yolanda Smith Smith Associates 1468 Harwell Ave Crofton, MD 21114

Re: K143487

Trade/Device Name: Lifelines iEEG 2.0 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLT, GWQ Dated: July 22, 2015 Received: July 23, 2014

Dear Ms. 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 (reporting of medical

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,

Carlos L. Pena -S

Carlos Peña, PhD, MS 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) K143487

Device Name Lifelines iEEG 2.0

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ 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:	Kvikna Medical ehf
Company Address	Stórhöfði 21110 ReykjavikIceland
Telephone:	+354 578 8400
Contact Person:	Gardar Thorvardsson
Summary Preparation Date:	November 14, 2014
DEVICE NAME
Trade Name:	Lifelines iEEG 2.0
Common/Usual Name:	EEG System
Classification Name:	Electroencephalograph
Regulation Number:	21 CFR 882.1400 GWQ,
Product Code:	GWQ, OLT
Device Class:	Class II
PREDICATE DEVICE
Company	Product
Natus Medical, Inc	DG Nervus

DEVICE DESCRIPTION

●

510(k) # K964280

The components of Lifelines iEEG are:

Lifelines iEEG software:
- . iEEG Centrum
- . iEEG Review
- iEEG Acquisition .
Lifelines Trackit, Lifelines Ltd, 510(k)#K010460
Lifelines Photic Stimulator, Lifelines Ltd, 510(k)# K101691 ●
Off the shelf PC and medical grade power supply ●
Off the shelf IP Video Camera ●

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INDICATIONS FOR USE

Caution: Federal law restricts this device to sale by or on the order of a physician licensed by the law of the State in which he practices to use or order the use of the device.""

	Subject Device	Predicate Device	Similarities and Differences
Trade Name	Lifelines iEEG	DG Nervus(now NicoletOne)
Company	Kvikna Medical ehf	Natus Medical, Inc.
K Number		K964280
Intended Use	The Lifelines iEEG is an EEGsystem that allows acquisition,display, archive, storage andanalysis of physiological signals.The intended user of this productis a qualified medical practitionertrained inelectroencephalography who willexercise professional judgment inusing the information. TheLifelines iEEG system alsoincludes the display of aquantitative EEG plots, powerspectrum, which is intended tohelp the user to monitor andanalyze the EEG. This device doesnot provide any diagnosticconclusion about the patient'scondition to the user.	The Nervus DG is intended tobe used as anElectroencephalograph: toacquire, display, store andarchiveelectroencephalographicsignals from the brain using afull montage array (i.e. 16 ormore electrodes) and userspecified locations.	The Lifelines iEEG system(Subject Device) and the DGNervus have equivalentintended use.
Intended User	Qualified medical practitionertrained inElectroencephalography	Qualified medicalpractitioner trained inElectroencephalography	No difference.
Population age	All age groups	All age groups	No difference.
Use environment	Hospital, clinics, patients home	Hospital, clinic, patientshome	No difference.
Regulation Number	21 CFR 882.1400	21 CFR 882.1400	No difference.
Product Code	GWQ, OLT	GWQ	Lifelines iEEG includes OLTproduct code as it offersquantitative EEG in the formof power spectrum andrelated parameters.
Device allows acquisitionof physiological signals	Yes	Yes	No difference.
	Subject Device	Predicate Device	Similarities and Differences
Trade Name	Lifelines iEEG	DG Nervus(now NicoletOne)
Device allows display,archive, review andanalysis of physiologicalsignals	Yes	Yes	No difference.
Identifies spikes	No	Yes	Lifelines iEEG does not offerautomated spike detection
Identifies seizures	No	Yes	Lifelines iEEG does not offerautomated seizure detection
Displays calculated EEGmeasures	Yes	Yes	No difference.
Calculated EEG measuresdisplayed	Spectrum, Power SpectrumDensity, band power, spectraledge, peak frequency	Spectrum, Spectrogram,band power, peak frequency,spectral edge	No difference. The algorithmused to calculate Spectrogramin DG Nervus and Powerspectrum density in iEEG isthe same.
Users can add/deleteevents	Yes	Yes	No difference.
Number of EEG channels	Software: up to 128Hardware: up to 32	Up to 512	Lifelines system and LifelinesiEEG software system supportup to 128 channels, the DGNervus supports up to 512channels.
Type of EEG recordingsupported	EDF, NicoletOne, Lifelines iEEG	EDF, NicoletOne	The Lifelines iEEG system andthe Lifelines iEEG softwaresystem support the LifelinesiEEG (.ieeg) recording typewhich DG Nervus does not
Type of EEG analysis	Clinical, ambulatory, long termmonitoring	Clinical, ambulatory, longterm monitoring	No difference.
Photic activation of theEEG	Yes	Yes	No difference.
Differential inputimpedance	>20 Mohms	> 20MΩ	No difference.
Common mode inputimpedance	>100 Mohms	> 100MΩ	No difference.
Channel equivalent inputnoise	<3.5 µV pk-pk @ 0.16Hz to 70Hz	< 1.5µV pk-pk @ 0.16Hz to70Hz	Slight difference.
Frequency band	0.16Hz to 70Hz (–6dB)	0.16–500Hz (–6dB) (± 10%)	Slight difference.
Low filter	0 Hz-5 Hz or off, in 11 predefinedsteps	0.16Hz-5Hz ( ± 10%), in 7predefined steps orcustomizable up to 1000Hzor off	Slight difference.
High filter	10 Hz–100 Hz or off, in 9predefined steps	15Hz–100Hz (± 5%), in 7predefined steps orcustomizable up to 1000Hzor off	Slight difference.
Sampling rate	200, 256 Hz	1024, 512, 256 and 128 Hz,	Slight difference.
	Subject Device	Predicate Device	Similarities and Differences
Trade Name	Lifelines iEEG	DG Nervus(now NicoletOne)
Wireless Communicationbetween Amplifier andComputer	Yes	No	Wireless Communicationbetween Amplifier andComputer is an added featureof the Lifelines iEEG system.
Video Camera Support	Yes	No	Video Camera Support is anadded feature of the LifelinesiEEG system.

COMPARISON OF PREDICATE PRODUCTS TECHNICAL CHARACTERISTICS

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Discussion of Similarities and Differences

The Lifelines iEEG system is an update to the previously released Lifelines iEEG software system (K123665). The main difference is the inclusion of acquisition capabilities, which includes both new software features and hardware components.

A list of new/improved features associated with the acquisition capabilities can be found in the following table:

Feature	Feature description / Enhancement
Acquire Portable Operator View	The view available to the operator of an acquisition system.
Acquisition	Acquisition of EEG and other signals.
Amplifier Setup	The amplifier setup provides the user interface to configure the EEGamplifier used.
Exam for Acquisition	Prepare for acquiring a patient.
Exam Spaces	It is now possible to set an exam space for an acquisition system.Two acquisition systems cannot share an exam space. When anacquisition system connects to a main central data storage, an examspace shall be generated for it if it doesn't already exist.
Exam Types	It is now possible to associate an xps document (help page) with anexam type.
Help Pages	Help pages, containing contact information for techs, etc. shall beeasy to customize by each customer.
Hyperventilation Timer	Patients are asked to hyperventilate as part of standard EEGprotocol. The timer shows the operator for how long the patient hasbeen hyperventilating and marks events for later reference.
Impedance Test	Impedance test is usually done in the beginning of an EEG test inorder to check the quality of the electrode connections. This is alsosometimes done while recording in order to check if any electrodeneeds to be fixed or re-applied.

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Feature	Feature description / Enhancement
Patient Room View	During home monitoring or long-term monitoring within a hospital,it is beneficial that the patient (or the patient's parents) are able tosee some information on the screen and even be able tocommunicate with the operator.
Photic Stimulation	The ability to control a photic stimulator from the system.
Synchronization	Synchronization of patient and exam data is now available whenacquiring without network connection. Transfer of recorded datafrom the acquisition system to the main database.
Trackit Acquisition	Acquisition from the Trackit EEG amplifier
Video Acquisition	Digital video is acquired synchronized to the EEG.
Video Acquisition Configuration	Configuration of video cameras for video acquisition.

The hardware components provided with the system can be found in the following table:

Part	Quantity
PC computer(Lenovo ThinkPad T440)	1
Lifelines Trackit Mk3 EEG Amplifier	1
Lifelines LED Photic Stimulator	0 or 1
Power over Ethernet Switch (PoE)(Planet Desktop PoE Switch)	0 or 1
Medical Grade Power Supply for PC(TRUMPower 20V Medical and ITE Power Adapter)	1
Medical Grade Power Supply for PoE Switch(TRUMPower 48V Medical and ITE Power Adapter)	0 or 1
IP Video Camera(HIKVISION IR Cube Network Camera)	0, 1 or 2
USB 3.0 Ethernet Adapter(Lenovo ThinkPad USB 3.0 Ethernet Adapter)	1
Network Cat6 RJ45 0,5 m	0 or 1
Network Cat6 RJ45 3,0 m	0, 1 or 2
Splitter Power Cord(C14 to C13 splitter cord)	0 or 1
Power Cord	1

Other than the acquisition capabilities the Trend Analysis, Spectral Calculations and Save As... features are new to the system, other software functions are unchanged or changes are very minor. A list of new features and enhancements to existing features can be found in the following table:

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Feature	Enhancement
Auditing	Audit trail is now recorded when an exam is exported.
Events	Duration events now display the elapsed time in 20 second intervals and the entireduration at the end.
Exam Types	The following exam types are now predefined in the system: Video AmbulatoryGeneric *NicOne
Labels	The EEG labels M1 and M2 are now predefined in the system. They have the samecoordinates as A1 and A2 respectively.
Labels	The label type: *ECG Unipolar is now predefined in the system.
Labels	The non-EEG labels: ECGL and ECGR of type ECG Unipolar and ECG1 and ECG2 oftype ECG Unipolar are now predefined in the system.
Montages	It is now possible to apply an exam's "Input" montage. The Input montage containsall recorded channels and unipolar channels derived to common reference.
Online DataTransfer	If a wireless network is selected to be used, the internet gateway is now switched tothis connection automatically.
ReportGeneration	It is now possible to see all reports associated with exams belonging to the same visitin a single list.
Save As	It is now possible to save a copy of an exam as a new exam in the system.
SpectralCalculations	It is now possible to calculate the spectrum of a block of EEG.
Spike and Seizuredetection	When Persyst spike and seizure detection has been run on an exam, an event is nowadded at the beginning of the exam stating that the detection has been run and bywhich version of Persyst.
Task Processing	It is now possible to define tasks that run periodically with predefined intervalbetween runs.
Trend Analysis	Mathematically transformed EEG is now displayed on a compressed timescale.
Version Control	The client software now displays the name and (new) address of the manufacturer,namely: "Kvikna ehf, Storhofdi 21, 110 Reykjavik, Iceland"

The Lifelines iEEG system and the DG Nervus system have equivalent intended use, the same intended user, population, age and regulation number. Also, the principles of operations between the devices are more or less the same, including the signal processing. But the systems do have a few minor differences. The DG Nervus system identifies spikes and seizures but the Lifelines iEEG system does not. The DG Nervus system supports up to 512 EEG channels while the Lifelines iEEG supports up to 128 (software, the hardware supports up to 32 channels). The Lifelines iEEG system supports the Lifelines iEEG (.ieeg) recording type. The Lifelines iEEG states the OLT product code that DG Nervus does not. However the quantitative EEG functions are equivalent such that this does not reflect a true difference of the products.

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The principles of operation of the software are the same or very similar, including the signal processing i.e. the calculation of EEG montage, band-pass and notch filtering and the method used to plot the data to screen. The algorithm used to calculate Spectrogram in DG Nervus and Power spectrum density in iEEG is the same, in both cases the EEG is segmented into blocks and power spectrum calculated by Welch periodogram method. The results are also presented in the same way by color coding the power spectrum for each block of EEG and stacking the color coded blocks for the entire EEG recording. The major difference is that the Nervus DG system makes use of proprietary EEG amplifier and photic stimulator while the Lifelines iEEG system includes 30 party medical device components for the same purpose.

The spike and seizure detection, provided by the DG Nervus, are nice-to-have features that are not essential to an EEG system. Therefore, the fact that the Lifelines iEEG system does not include them does not impact safety nor efficacy of the system. The same can be said about number of EEG channels supported.

NON-CLINICAL PERFORMANCE DATA

Software Verification and Validation.

Immunity Verification.

Third party testing for conformance with IEC 60601-1:2005 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

Third party testing for conformance with IEC 60601-1-2:2007 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

Checklist testing for IEC 62304:2006 - Medical Device Software - Software - Software Life Cycle Processes

Checklist testing for IEC 62366:2007 - Medical Devices - Application Of Usability Engineering To Medical Devices

Third party testing for conformance with IEC 60601-2-26:2002 - Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs

CONCLUSION

Based upon the intended use, technological characteristics and safety and performance testing, it is the conclusion of Kvikna Medical ehf that the device consisting Lifelines iEEG system that allows acquisition, display, archive, storage and analysis of physiological signals, is as safe and effective as the predicate devices and raises no new issues of safety and effectiveness.

Regulation Number and Section

§ 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).